CDASH SAE v2.0 scraping for specifications

CDASH Question Text,CDASH Prompt,E2B Variable Name,E2B (R2) Data Element,E2B (R3) Data Element,E2B (R3) Data Element Name,CDASH Variable Name,DRAFT CDASH Definition,CDISC Controlled Terminology,CDASH SAE Form Completion Instructions,CDASH SAE Implementation Notes,CDASH SAE Core,SDTM Mapping Indicator (Y/N),Seq. for Order
Were any adverse events experienced?,Any Adverse Events,N/A,N/A, N/A , N/A ,AEYN,An indication whether any AEs were experienced during the study, (NY),"Indicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF. \n At time of awareness, event may be AE or SAE (an AE that meets SAE criteria).","This question relates to the occurrence of an adverse event, not just serious events. The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.",O,N,1
[Sponsor-defined question] ,[Sponsor defined], N/A , N/A , N/A , N/A ,AESPID,"A sponsor-defined identifier. In CDASH, this is typically used for preprinted or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined CDASH identifier field.",N/A,"If collected on the CRF, sponsors may insert instructions to ensure each record has a unique identifier.","Because SPID is a sponsor-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications, procedures, and/or medical history records with AEs. If CMAENO or PRAENO is used, this is the identifier to which CMAENO or PRAENO refers. May be used to record preprinted number (e.g., line number, record number) on the CRF. This field may be populated by the sponsor's data collection system.",O,Y,2
What is the adverse event term?,Adverse Event,primarysourcereaction,B.2.i.0,E.i.1.1a,Reaction / Event as Reported by the Primary Source in Native Language,AETERM,The reported or prespecified name of the adverse event.,N/A,"Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). \n Using accepted medical terminology, enter the diagnosis (if known); otherwise enter a sign or symptom. If a diagnosis subsequently becomes available, then this diagnosis should be entered on the AE form, replacing the original entries, where appropriate. \n Death should not be recorded as an event but should be recorded as the outcome of the event. The condition that resulted in the death should be recorded as the event unless cause of death (event leading to death) is unknown at the time of report. The report should not be delayed if unable to identify the event, in this case the report should be submitted with the adverse event recorded as ""Death"" or ""Unknown cause of death"". Once available, the event term should be replaced with the appropriate event term. \n Do not use abbreviations.","Can be represented either as a free text field to capture verbatim terms reported by subjects or could be preprinted in the situation where solicited AEs of interest are captured. \n In most cases, the verbatim term (i.e., investigator-reported term) will be coded to a standard medical dictionary such as MedDRA or WHO ART, after the data have been collected on the CRF. The coded data will be stored in field(s) not defined by CDASH. \n If unable to identify the event (the cause of death or event leading to death is unknown at the time of report), the report should be submitted with ""death"" as AE term, to be replaced with the appropriate event term once available. \n If the event starts out as an AE and later meets SAE criteria, AE term may need to be updated accordingly.",HR,Y,3
Was the adverse event serious?,Serious,serious,B.2.i.3,E.i.3.1,Term Highlighted by the Reporter,AESER,An indication whether the adverse event is determined to be serious based on regulations/protocol definition,(NY),Assess if an adverse event should be classified as serious based on the serious criteria defined in the regulations/protocol.,"This field is related to the individual SAE type fields, which may or may not be collected on the CRF. Either AESER or all the Adverse Serious type fields must be present on the CRF. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data.",R/C,Y,4
Did the adverse event result in death?,Death,seriousnessdeath, A.1.5.2,E.i.3.2a,Results in Death,AESDTH,An indication the serious adverse event resulted in death,(NY),Record whether the serious adverse event resulted in death.,"If details regarding SAEs are collected in the clinical database, it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field because the individual SAE types might be collected in a separate pharmacovigilance database and therefore not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data.",R/C,Y,5
Was the adverse event life-threatening?,Life threatening,seriousnesslifethreatening,A.1.5.2,E.i.3.2b,Life Threatening,AESLIFE,Indicates if a serious adverse event was life-threatening,(NY),Record whether the serious adverse event is life-threatening.,"If details regarding SAEs are collected in the clinical database, it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field because the individual SAE types might be collected in a separate pharmacovigilance database and therefore not collected in the clinical database. \n Additional detail for the SAE report could be collected and reported as separate sponsor-defined fields or captured in the narrative.",R/C,Y,6
Did the adverse event result in initial or prolonged hospitalization for the subject?,Hospitalization (initial or prolonged),seriousnesshospitalization,A.1.5.2,E.i.3.2c,Caused / Prolonged Hospitalisation,AESHOSP,An indication the serious adverse event resulted in an initial or prolonged hospitalization,(NY),Record whether the serious adverse event resulted in an initial or prolonged hospitalization.,"If details regarding SAEs are collected in the clinical database, it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field because the individual SAE types might be collected in a separate pharmacovigilance database and therefore not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data. \n Additional detail for the SAE report could be collected and reported as separate sponsor-defined fields or captured in the narrative.",R/C,Y,7
Did the adverse event result in disability or permanent damage?,Disability or Permanent Damage,seriousnessdisabling,A.1.5.2,E.i.3.2d,Disabling / Incapacitating,AESDISAB,An indication the serious adverse event resulted in an initial or prolonged hospitalization,(NY),Record whether the serious adverse event resulted in a persistent or significant disability or incapacity.,"If details regarding SAEs are collected in the clinical database, it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field because the individual SAE types might be collected in a separate pharmacovigilance database and therefore not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data. \n Additional detail for the SAE report could be collected and reported as separate sponsor-defined fields or captured in the narrative.",R/C,Y,8
Was the adverse event associated with a congenital anomaly or birth defect?,Congenital Anomaly or Birth Defect,seriousnesscongenitalanomali,A.1.5.2,E.i.3.2e,Congenital Anomaly / Birth Defect,AESCONG,An indication the serious adverse event was associated with a congenital anomaly or birth defect,(NY),Record whether the serious adverse event was associated with congenital anomaly or birth defect.,"If details regarding SAEs are collected in the clinical database, it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field because the individual SAE types might be collected in a separate pharmacovigilance database and therefore not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data. \n Additional detail for the SAE report could be collected and reported as separate sponsor-defined fields or captured in the narrative.",R/C,Y,9
Did the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product?,Needs Intervention to Prevent Impairment,seriousnessother, A.1.5.2,E.i.3.2f,Other Medically Important Condition,AESMIE,"An indication an adverse event required medical or surgical intervention to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, due to the use of a medical product",(NY),Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.,"If details regarding SAEs are collected in the clinical database, it is recommended that a separate Yes/No variable be defined for each SAE type. Sponsors may only collect the AESER field because the individual SAE types might be collected in a separate pharmacovigilance database and therefore not collected in the clinical database. The sponsor should check if the regulatory agencies to which the data will be submitted require the collection of this data. \n Additional detail for the SAE report could be collected and reported as separate sponsor-defined fields or captured in the narrative.",R/C,Y,10
What was the date the adverse event started?,Start Date,reactionstartdate,B.2.i.4b,E.i.4,Date of Start of Reaction / Event,AESTDAT,"The start date of the adverse event, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,"Record the start date of the AE using this format (DD-MON-YYYY). This is the date that the event started, even if it was not serious on this date.",The E2B variable can be used for date and time; this is specified in E2B as the date format variable B.2.i.a (YY / YYMM / YYMMDD / YYMMDDHHMM),HR,Y,11
What was the adverse event start time?,Start Time,reactionstartdate,B.2.i.4b,E.i.4,Date of Start of Reaction / Event,AESTTIM,"The start time of the adverse event, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,"Record the start time (as complete as possible) of the AE. This is the time that the event started, even if it was not serious at this time.",Collecting the time an AE started is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. An example is where the subject is under the direct care of the site at the time the event started and the study design is such that it is important to know the AE start time with respect to dosing.,R/C,Y,12
What was the date the adverse event/reaction became serious?,Serious adverse event/ reaction start date,N/A,N/A,N/A,N/A,SASTDAT,The date when the adverse event was determined to be serious. Can be on or after the date the adverse event occurred.,N/A,Record the date when the AE became serious. Record only if different from the AE start date.,"Use the standard CDASH date format. See CDASH Model v1.1 for details. This field does not map directly to a standard SDTM variable. \n The start date of the SAE is the date when the adverse event/reaction became serious, whether or not it has the same value as the start date of the AE. Here, SASTDAT is a separate variable from AESTDAT. \n Use of this field is recommended if the clinical collection tool is the primary source for collection of the data for the safety database. \n This may not be needed if the sponsor collects a new AE record in the clinical database when the event becomes serious.",R/C,N,13
What is the start time of the serious adverse event/reaction?,Serious adverse event/reaction start time,N/A,N/A,N/A,N/A,SASTTIM,Time the adverse event/reaction became serious,N/A,Enter the time the adverse event/reaction became serious.,"Use the standard CDASH time format. See CDASH Model v1.1 for details. This field does not map directly (1:1) to a standard SDTM variable. \n The start time of the SAE is the time when the adverse event/reaction became serious, whether or not it has the same value as the start time of the AE. Here, SASTTIM is a separate variable from AESTTIM. \n Use of this field is recommended if the clinical collection tool is the primary source for collection of the data for the safety database. \n This may not be needed if the sponsor collects a new AE record in the clinical database when the event becomes serious.",O,N,14
What was the adverse event end date?,End Date,reactionenddate,B.2.i.5b,E.i.5,Date of End of Reaction / Event,AEENDAT,"The date when the adverse event resolved/ended, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,"Record the date that the AE resolved using this format (DD-MON- YYYY). This is the date on which the event ended, regardless of whether it was still serious on this date.","The definition of resolved is sponsor-specific. The preferred method is to collect a complete end date (if applicable). Partial dates (e.g., providing year only, month and year only) may be acceptable. \n For AEs that meet SAE criteria, the end date of the SAE is the date when the serious adverse event/reaction reached a final outcome. Here, SAENDAT is treated as a separate variable from AEENDAT; however, depending on the data policy of the implementer, AEENDAT and SAENDAT can be identical. \n The E2B variable can be used for date and time; this is specified in E2B as the date format variable B.2.i.a (YY / YYMM / YYMMDD / YYMMDDHHMM).",HR,Y,15
What was the adverse event end time?,End Time,reactionenddate,B.2.i.5b,E.i.5,Date of End of Reaction / Event,AEENTIM,"The time when the adverse event ended/resolved, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,"Record the time (as complete as possible) that the AE resolved. This is the time at which the event ended, regardless of whether it was still serious at this time.",Collecting the time an AE resolved is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. An example is where the subject is under the direct care of the site at the time the event resolved and the study design is such that it is important to know the AE end time with respect to dosing.,R/C,Y,16
Is the adverse event ongoing (as of [the study-specific time point or period])?,Ongoing (as of [the study-specific time point or period]),reactionenddate,B.2.i.5b,E.i.5,Date of End of Reaction / Event,AEONGO,Indication that an adverse event is ongoing ,(NY),Indicate if the adverse event has not resolved at the time of data collection; leave the End Date blank.,"Completed to indicate that the AE has not resolved at the time of data collection, when no end date is collected. In some cases the ongoing status may be determined from AE Outcome. The purpose of collecting this field is to help with data cleaning and monitoring; this field provides further confirmation that the end date was deliberately left blank. Often used as a tick/checkbox.",O,Y,17
What was the end date of the serious adverse event/reaction?,Serious adverse event/reaction end date,reactionenddate,B.2.i.5b,E.i.5,Date of End of Reaction / Event, SAENDAT,Date the serious adverse event/reaction ended,N/A,Enter the date the serious adverse event/reaction ended.,"The definition of resolved may be sponsor-specific. \n This field does not map directly to a standard SDTM variable. \n The end date of the SAE is the date when the serious adverse event/reaction reached a final outcome. Here, SAENDAT is treated as a separate variable from AEENDAT; however, depending on the data policy of the implementer, AEENDAT and SAENDAT can be identical.",R/C,N,18
What was the end time of the serious adverse event/reaction?,Serious adverse event/reaction end date,reactionenddate,B.2.i.5b,E.i.5,Date of End of Reaction / Event, SAENTIM,Time the serious adverse event/reaction ended,N/A,Enter the time the serious adverse event/reaction ended.,"The definition of resolved may be sponsor-specific. \n This field does not map directly to a standard SDTM variable. \n The end time of the SAE is the time when the serious adverse event/reaction reached a final outcome. Here, SAENTIM is treated as a separate variable from SAENTIM; however, depending on the data policy of the implementer, AEENTIM and SAENTIM can be identical.",O,N,19
What was the outcome of this adverse event?,Outcome,reactionoutcome,B.2.i.8,E.i.7,Outcome of Reaction / Event at the Time of Last Observation,AEOUT,A description of the outcome of an event,(OUT),Record the appropriate outcome of the event in relation to the subject's status.,"CDISC Controlled Terminology is used to indicate the outcome of the event as it relates to the subject's status. The Outcome controlled terminology includes ICH E2B values. The use of this field is the recommended way to describe whether and how the AE resolved. Because the outcome of an AE may be ""Death"", if this field is NOT used, be sure to provide another form, such as Disposition, with clear instructions to record deaths there.",R/C,Y,20
Was this adverse event related to study treatment?,Relationship to Study Treatment,drugreactionrelatedness,B.4.k.18.4,G.k.9.i.2.r.3,Result of Assessment,AEREL,"An indication the study treatment had a causal effect on the adverse event, as determined by the clinician/investigator",N/A,"Indicate if the cause of the adverse event is related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).","Sponsored-defined controlled terminology is used to indicate the relationship between the AE and the study treatment (e.g., ICH E2B examples include ""Not Related"", ""Unlikely Related"", ""Possibly Related"", ""Related""). Another possibility is the use of ""Y"" and ""N"". CDISC Controlled Terminology may be defined in the future. It is recommended that sponsors check with the appropriate regulatory authority for population of this variable to ensure it meets expectations for submission.",HR,Y,21
What action was taken with study treatment?,Action Taken with Study Treatment,actiondrug,B.4.k.16,G.k.8,Action(s) Taken with Drug,AEACN \n,Changes made to the study treatment in response to the adverse event,(ACN),Record changes made to the study treatment resulting from the adverse event.,CDISC Controlled Terminology should be used to indicate the action taken with the study treatment in response to the AE.,HR,Y,22
Which event is being assessed for relatedness with the drug?,Adverse event assessed,drugreactionasses,B.4.k.18.1b,G.k.9.i.1,Reaction(s) / Event(s) Assessed,SACSLTAE,AE to which the relatedness assessment belongs,N/A,Not completed by site.,"This variable links data in the SA domain to the AE domain. It is recommended that this field be auto-populated with a value from an identifier variable in AE (e.g., AELNKID, AESPID, AEREFID).",O,N,23
Who made this assessment?,Causality assessment source,drugassessmentsource,B.4.k.18.2,G.k.9.i.2.r.1,Source of Assessment,SACSTSCR,Source of assessment,N/A,Not completed by site.,"Source of assessment (e.g., initial reporter, investigator, regulatory agency, company)",O,N,24
How was this assessment done?,Causality assessment method,drugassessmentmethod,B.4.k.18.3,G.k.9.i.2.r.2,Method of Assessment,SACSTMTH,Method of assessment,N/A,Not completed by site.,"Method of assessment (e.g., global introspection, algorithm, Bayesian calculation)",O,N,25
Could the event have been related to/caused by the drug or study participation?,Causality assessment,drugresult,B.4.k.18.4,G.k.9.i.2.r.3,Result of Assessment, SACSLTRES,Sponsor's assessment of the relationship between the event and participating in the trial,N/A,Not completed by site.,"Indicate whether the event could have been related to the drug or treatment, intervention, or study participation (e.g., procedure).",HR,N,26
What was the result of dechallenge?,Dechallenge Result, N/A , N/A ,G.k.9.i.4,Did Reaction Recur on Re-administration?,SADCHLLT,"Outcome of withdrawing interrupting, or otherwise altering administration of study treatment",(SADCRR),Record the result of study treatment dechallenge.,"Deploy in the CRF as appropriate within the sponsor's processes for collecting serious AE data. \n Acceptable responses are ""POSITIVE"", ""NEGATIVE"", and ""NOT APPLICABLE"". \n Dechallenge is applicable only if Action Taken with Study Drug indicates a change in dose or drug. (i.e., AEACN response cannot be ""Dose Not Changed"", ""Not Applicable"" or ""Unknown"").",R/C,N,27
What was the result of rechallenge?,Rechallenge Result, N/A , N/A ,G.k.9.i.4,Did Reaction Recur on Re-administration?,SARCHLLT,Outcome of restarting or otherwise returning administration of study treatment to previous level,(SARCRR),Record the result of study treatment rechallenge.,"Deploy in the CRF as appropriate within the sponsor's processes for collecting serious AE data. \n Acceptable responses are ""POSITIVE"", ""NEGATIVE"", and ""NOT APPLICABLE"". \n Rechallenge is applicable only if dechallenge occurred.",R/C,N,28
What are the additional details of the SAE?,Narrative,narrativeincludeclinical,B.5.1,H.1,"Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information",SANARR,Additional facts related to a serious adverse event,N/A,Record any additional facts not already reported that further clarify the serious event or facts surrounding it.,Deploy in the CRF as appropriate within the sponsor's processes for collecting serious AE data.,O,N,29
Was [study treatment/dose] administered?; Has the subject taken [study treatment/dose]?,[Study Medication/Treatment],N/A,N/A,N/A,N/A,ECOCCUR,An indication whether the study treatment was administered when information about the occurrence of a specific intervention is solicited,(NY),"Indicate if the subject took study treatment. If Yes, include the appropriate details where indicated.",N/A,O,Y,1
What was the [study treatment/investigational product] name?,[Study Treatment/Investigational Product Name], medicinalproduct, B.4.k.2.1,G.k.2.2,Medicinal Product Name as Reported by the Primary Source, ECTRT,Name of the intervention or treatment known to the subject and/or administrator,N/A,Record the name of study treatment.,N/A,R/C,Y,2
What was the dose (per administration) (of [study treatment/dose])?,Dose,drugstructuredosagenumb,B.4.k.5.1,G.k.4.r.1a,Dose (number),ECDSTXT,The dose of study medication taken (per administration),N/A,Record the dose or amount of study treatment that was administered to/taken by the subject in the period recorded; from the start date/time to the end date/time inclusive.,N/A,R/C,Y,3
What were the units for the dose?,Units,drugstructuredosageunit,B.4.k.5.2,G.k.4.r.1b \n,Dose (unit),ECDOSU,"The unit for intended dose (per administration) for ECDOSE, ECDOSTOT, or ECDOSTXT",(UNIT),"Record the unit of dose or amount taken per period recorded (e.g., ng, mg, mg/kg).",N/A,R/C,Y,4
What was the frequency of [study treatment/dose] dosing?,Frequency,drugseparatedosagenumb; \n drugintervldosageunitnumb; \n drugintervaldosagedefinition,B.4.k.5.3; \n B.4.k.5.4; \n B.4.k.5.5,N/A; \n G.k.4.r.2; \n G.k.4.r.3 \n,Number of Units in the Interval; \n Definition of the Time Interval Unit,ECDOSFRQ,The number of doses given/administered/taken during a specific interval,(FREQ),Record the number of doses given/administered/taken during a specific interval.,The single CDASH variable maps to more than one E2B variable. This mapping is out of scope for data collection and must be managed operationally.,R/C,Y,5
What was the lot number of the [study treatment/dose] used?,Lot Number,drugbatchnumb,B.4.k.3,G.k.4.r.7,Batch / Lot Number,ECLOT,Lot Number of the ECTRT product,N/A,Record the lot number that appears on the container holding the study treatment.,N/A,R/C,Y,6
What was the anatomical location of the ([study treatment/dose]) administration?,Anatomical Location,N/A,N/A, N/A,N/A,ECLOC,A description of the anatomical location of administration,(LOC),"Record the body location where the study treatment was administered (e.g., SHOULDER, HIP, ARM).",N/A,O,Y,7
What was the ([intended/planned/actual]) ([study treatment/dose]) (start) date?,(Start) Date,drugstartdate,B.4.k.12b, G.k.4.r.4 ,Date and Time of Start of Drug,ECSTDAT,"The start date of study treatment, intended or actual, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,Record the start date of the study treatment administration using this format (DD-MON-YYYY).,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,HR,Y,8
What was the ([intended/planned/actual]) ([study treatment/dose]) (start) time?,(Start) Time,drugstartdate,B.4.k.12b, G.k.4.r.4 ,Date and Time of Start of Drug,ECSTTIM,"The start time of study treatment, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,Record the start time (as complete as possible) when administration of study treatment started.,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,9
What was the ([intended/planned/actual]) ([study treatment/dose]) (end) date?,(End) Date,drugenddate,B.4.k.14b, G.k.4.r.5 ,Date and Time of Last Administration,ECENDAT,"The end date of study treatment, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,Record the end date of the study treatment administration using this format (DD-MON-YYYY).,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,10
What was the ([intended/planned/actual]) ([study treatment/dose]) (end) time?,(End) Time,drugenddate,B.4.k.14b, G.k.4.r.5 ,Date and Time of Last Administration,ECENTIM,"The end time of study treatment, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,"Record the time (as complete as possible) when study treatment administration stopped (e.g., for infusions this is the time when the infusion ended).",Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,11
What was the (concomitant) [medication/treatment/therapy] (name/term)?,(Concomitant) [Medication/Treatment/Therapy],medicinalproduct,B.4.k.2.1, G.k.2.2,Medicinal Product Name as Reported by the Primary Source,CMTRT,Verbatim medication name or treatments (include only treatments with data collection characteristics similar to medications),N/A,"Record only 1 [medication/treatment/therapy] per line. Provide the full trade or proprietary name of the [medication/treatment/therapy]; otherwise, the generic name may be recorded.",N/A,HR,Y,12
What was the individual dose of the (concomitant) [medication/treatment/therapy]?,Dose,drugstructuredosagenumb,B.4.k.5.1,G.k.4.r.1a,Dose (number),CMDSTXT,The dose of medication/treatment taken per administration,N/A,"Record the dose of (concomitant) [medication/treatment] taken per administration (e.g., 200).","Implementers might choose to use CMDOS, instead of using the text field of CMDSTXT, if the collected dose will always be numeric.",O,Y,13
What is the unit (for the dose of concomitant [medication/treatment/therapy])?,(Dose) Unit,drugstructuredosageunit,B.4.k.5.2,G.k.4.r.1b \n,Dose (unit), CMDOSU,"The unit associated with the concomitant medication/treatment/therapy taken (e.g., mg in ""2mg three times per day"")",(UNIT),"Record the dose unit of the dose of medication taken (e.g., mg.).",N/A,R/C,Y,14
What was the frequency of the (concomitant) [medication/treatment/therapy]?,Frequency,drugseparatedosagenumb; \n drugintervldosageunitnumb; \n drugintervaldosagedefinition,B.4.k.5.3; \n B.4.k.5.4; \n B.4.k.5.5,N/A; \n G.k.4.r.2; \n G.k.4.r.3 \n,Number of Units in the Interval; \n Definition of the Time Interval Unit,CMDOSFRQ,The number of doses given/administered/taken during a specific interval,(FREQ),"Record how often the (concomitant) [medication/treatment/therapy] was taken (e.g., BID, PRN).",N/A,O,Y,15
What was the route of administration of the (concomitant) [medication/treatment/therapy]?,Route,drugadministrationroute,B.4.k.8, G.k.4.r.10.1 ,Route of Administration (free text),CMROUTE,The route of administration of the (concomitant) [medication/treatment/therapy],(ROUTE),Provide the route of administration for the (concomitant) [medication/treatment/therapy].,N/A,R/C,Y,16
"For what indication, was the (concomitant) [medication/treatment/therapy] taken?",Indication,N/A,N/A, G.k.7.r.1,Indication as Reported by the Primary Source,CMINDC,"The condition, disease, symptom, or disorder that the concomitant (non-study) medication/treatment/therapy was used to address or investigate (e.g., why the medication/treatment/therapy was taken or administered)",N/A,"Record the reason the medication was taken based on clinical investigator's evaluation. If taken to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If taken to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as ""Prophylaxis for [description of the condition(s)]"".",N/A,R/C,Y,17
What was the (concomitant) [medication/treatment/therapy/dose] start date?,Start Date,drugstartdate,B.4.k.12b, G.k.4.r.4 ,Date and Time of Start of Drug,CMSTDAT,"The start date when the concomitant medication/treatment/therapy was first taken, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,"Record the date the concomitant [medication/treatment] was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant [medication/treatment] for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Concomitant [medication/treatment] taken during the study are expected to have a complete start date. Prior concomitant [medication/treatment] that are exclusionary should have both a start and end date.",Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,18
What was the (concomitant) [medication/treatment/therapy/dose] start time?,Start Time,drugstartdate,B.4.k.12b, G.k.4.r.4 ,Date and Time of Start of Drug,CMSTTIM,"The time the concomitant medication/treatment/therapy was started, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,Record the time (as complete as possible) that the concomitant [medication/treatment] was started.,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,19
What was the (concomitant) [medication/treatment/therapy/dose] end date?,End Date,drugenddate,B.4.k.14b, G.k.4.r.5 ,Date and Time of Last Administration,CMENDAT,"The date that the subject ended/stopped taking the concomitant medication/treatment/therapy, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,"Record the date the concomitant [medication/treatment] was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant [medication/treatment], leave this field blank.",Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,20
What was the [medication/treatment/therapy/dose] end time?,End Time,drugenddate,B.4.k.14b, G.k.4.r.5 ,Date and Time of Last Administration,CMENTIM,"The time when the subject ended/stopped taking the concomitant medication/treatment/therapy, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,Record the time (as complete as possible) that the concomitant medication/treatment was stopped.,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,21
Is there any other relevant information on the drug?,Additional drug information,drugadditional,B.4.k.19,G.k.11,Additional Information on Drug (free text),SADRGADD \n,Free-text field for additional information on drug,N/A \n,"Enter any other relevant information on the drug (e.g., beyond expiration date, batch and lot tested and found to be within specifications).",This should be used to specify any additional information pertinent to the case that is not covered by preceding sections. This item can also be used to provide additional information concerning the indication for the drug.,O,N,22
What was the (concomitant) [medication/treatment/therapy] (name/term)?,(Concomitant) [Medication/Treatment/Therapy],patientdrugname,B.1.8a,D.8.r.1,Name of Drug as Reported,CMTRT,Verbatim medication name or treatments (include only treatments with data collection characteristics similar to medications),N/A,"Record only 1 [medication/treatment/therapy] per line. Provide the full trade or proprietary name of the [medication/treatment/therapy]; otherwise, the generic name may be recorded.",N/A,HR,Y,1
What was the individual dose of the (concomitant) [medication/treatment/therapy]?,Dose,N/A,N/A,N/A,N/A,CMDSTXT,The dose of medication/treatment taken per administration,N/A,"Record the dose of (concomitant) [medication/treatment] taken per administration (e.g., 200).",N/A,O,Y,2
What is the unit (for the dose of concomitant [medication/treatment/therapy])?,(Dose) Unit,N/A,N/A,N/A,N/A,CMDOSU,"The unit associated with the concomitant medication/treatment/therapy taken (e.g., mg in ""2mg three times per day"")",(UNIT),"Record the dose unit of the dose of concomitant [medication/treatment/therapy] taken (e.g., mg.).",N/A,R/C,Y,3
What was the frequency of the (concomitant) [medication/treatment/therapy]?,Frequency,N/A,N/A,N/A,N/A,CMDOSFRQ,The number of doses given/administered/taken during a specific interval,(FREQ),"Record how often the (concomitant) [medication/treatment/therapy] was taken (e.g., BID, PRN).",N/A,O,Y,4
What was the route of administration of the (concomitant) [medication/treatment/therapy]?,Route,N/A,N/A,N/A,N/A,CMROUTE,The route of administration of the (concomitant) [medication/treatment/therapy],(ROUTE),Provide the route of administration for the (concomitant) [medication/treatment/therapy].,N/A,R/C,Y,5
For what indication was the (concomitant) [medication/treatment/therapy] taken?,Indication,patientdrugindication,B.1.8f.2,D.8.r.6b,Indication (MedDRA code),CMINDC,"The condition, disease, symptom, or disorder that the concomitant (non-study) medication/treatment/therapy was used to address or investigate (e.g., why the medication/treatment/therapy was taken or administered).",N/A,"Record the reason the medication was taken based on clinical investigator's evaluation. If taken to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If taken to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as ""Prophylaxis for [description of condition]"".","Note that in mapping from CMINDC (a free-text field), coding will need to be performed, as E2B (R3) uses MedDRA code values.",R/C,Y,6
What was the (concomitant) [medication/treatment/therapy/dose] start date?,Start Date,patientdrugstartdate,B.1.8c,D.8.r.4,Start Date,CMSTDAT,"The start date when the concomitant medication/treatment/therapy was first taken, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,"Record the date the concomitant [medication/treatment] was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant [medication/treatment] for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Any concomitant [medication/treatment] taken during the study is expected to have a complete start date. Prior concomitant [medication/treatment] that is exclusionary should have both a start and end date.",Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD.,R/C,Y,7
What was the (concomitant) [medication/treatment/therapy/dose] start time?,Start Time,patientdrugstartdate,B.1.8c,D.8.r.4,Start Date,CMSTTIM,"The time the concomitant medication/treatment/therapy was started, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,Record the time (as complete as possible) that the concomitant [medication/treatment] was started.,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD.,R/C,Y,8
What was the (concomitant) [medication/treatment/therapy/dose] end date?,End Date,patientdrugenddate,B.1.8e,D.8.r.5,End Date,CMENDAT,"The date that the subject ended/stopped taking the concomitant medication/treatment/therapy, represented in an unambiguous date format (e.g., DD-MON-YYYY).",N/A,"Record the date the concomitant [medication/treatment] was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant [medication/treatment], leave this field blank.",Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD.,R/C,Y,9
What was the [medication/treatment/therapy/dose] end time?,End Time,patientdrugenddate,B.1.8e,D.8.r.5,End Date,CMENTIM,"The time when the subject ended/stopped taking the concomitant medication/treatment/therapy, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,Record the time (as complete as possible) that the concomitant [medication/treatment] was stopped.,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD.,R/C,Y,10
What was the ([subject's/associated person's]) date of death? \n,Death date ,patientdeathdate,B.1.9.1b,D.9.1,Date of Death,DTHDAT,Date of death for any subject who died ,N/A,Record the date of death. ," When collecting data for SAEs on clinical CRFs, it is highly recommended that death date be included. There are 2 possible variable names in the CDASH Model/IG that could be used to collect the date on which a subject died, and from which sponsors should choose: DSSTDAT or DTHDAT. \n Only collect the date of death once. For example, if the date of death is collected on the Death Details form, then this field would not be collected on the AE or SAE CRF module. ", R/C ,Y,1
What was the ([subject's/associated person's]) date of death? ,Death Date,patientdeathdate,B.1.9.1b,D.9.1,Date of Death,DSSTDAT ,Date of death for any subject who died,N/A,Record the date of death.,"When collecting data for SAEs on clinical CRFs, it is highly recommended that death date be included. There are 2 possible variable names in the CDASH Model/IG that could be used to collect the date on which a subject died, and from which sponsors should choose: DSSTDAT or DTHDAT. \n Only collect the date of death once. For example, if the date of death is collected on the Death Details form, then this field would not be collected on the AE or SAE CRF module.", R/C ,Y,2
What was the time of death? ,Time of Death,N/A,N/A,D.9.1,Date of Death,DSSTIM,"The time of the specified protocol milestone (e.g., informed consent, randomization) or disposition event (e.g., study completion or discontinuation), represented in an unambiguous time format (e.g., hh:mm:ss)", N/A,Record the time (as complete as possible) that the subject died.,Collection of time of death is at the discretion of the sponsor.,O ,Y,3
What was the reported primary cause of death?,Primary cause of death,patientdeathreport,B.1.9.2b,D.9.2.r.2,Reported Cause(s) of Death (free text),PRCDTH_DDORRES,In case of death: reported cause(s) of death,N/A,Record the reported primary cause of the subject's death.,"This should be populated even when the death date is unknown. \n The initially reported cause of death might be different than the autopsy-determined cause. For this reason, these variables may contain the same or different values. \n This domain is not restricted to SAE reporting. Depending upon implementation decisions made by the sponsor, death details may be reported for non-adverse events (e.g., in the case of disease progression, deaths reported outside the AE collection period).",HR,Y,4
What was the reported secondary cause of death?,Secondary cause of death,patientdeathreport,B.1.9.2b,D.9.2.r.2,Reported Cause(s) of Death (free text),SECDTH_DDORRES,In case of death: reported cause(s) of death,N/A,Record the reported secondary cause of the subject's death.,"If more than 1 secondary cause of death is collected, the sponsor might need to repeat this field using different variable names for each repeat; however, this will be system-dependent.",O,Y,5
Was an autopsy performed?,Autopsy performed,patientautopsyyesno,B.1.9.3,D.9.3,Was Autopsy Done?,AUTOPIND_DDORRES,In case of death: was autopsy done?,(NY) ,"Indicate if an autopsy was performed on the subject. If Yes, include the appropriate details where indicated on the CRF.","Autopsy is a procedure from which there will usually be findings. Autopsy information should be handled as per recommendations in the Procedures domain. Recommended values are ""Y"", ""N"", and ""U"".",HR,Y,6
What was the source of notification?,Source of Notification,N/A , N/A,N/A,N/A,NOTESRC_DDORRES,The source of information about death details,N/A,Record the source of information about the subject's death.,The source of notification or information may apply to 1 or to multiple additional death details. The CRF should be designed to allow the record generated by this collection to be grouped with all records also associated with this source. \n The sponsor may choose to create sponsor-defined controlled terminology for this variable. \n Recommended if the CRF is used to collect other death-related data such as cause of death or an indication that an autopsy was performed.,R/C,Y,7
What is the subject's date of birth?,Birth Date,patientbirthdate,B.1.2.1b ,D.2.1 ,Date of birth,BRTHDAT,"A subject's date of birth (with or without the time of birth). The complete Date of Birth is made from the temporal components of Birth Year, Birth Month, Birth Day, and Birth Time.",,"Record the date of birth to the level of precision known (e.g., day/month/year, year, month/year) in this format (DD-MON- YYYY).","This may be subset into the CDASH variables of BRTHDD, BRTHMO, BRTHYY, BRTHTIM as needed per specifications of the EDC system.",R/C,Y,1
What is the sex of the subject?,Sex,patientsex, B.1.5,D.5,Sex,SEX,Sex of the subject as determined by the investigator,(SEX),Record the appropriate sex,"Collect the subject's sex or gender, as reported by the investigator. This is a phenotypic assessment and not a genotypic assessment. \n",HR,Y,2
Which of the following 5 racial designations best describes you? (More than 1 choice is acceptable.),Race,N/A,N/A,N/A,N/A,RACE,An arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control and Prevention).,(RACE),"Study participants should self-report race, with race being asked about after ethnicity.",Use RACE when the 5 designations for race used by the FDA are collected (American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; White). Sponsors should refer to the FDA guidance.[4] ,R/C,Y,3
Do you consider yourself Hispanic/Latino or not Hispanic/Latino?,Ethnicity,N/A,N/A,N/A,N/A,ETHNIC,"A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group ",(ETHNIC),"Study participants should self-report ethnicity, with ethnicity being asked about before race.",For use when values are being collected using the exact non-extensible ETHNIC codelist (C66790) values. Sponsors should refer to the FDA's guidance[4] regarding the collection of ethnicity.,R/C,Y,4
What was the hospital admission date?,Hospital Admission Date,N/A,N/A,N/A,N/A,HOSTDAT,"The start date the healthcare encounter, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,"Record the start date of the healthcare encounter (e.g., date of admission) using this format (DD-MON-YYYY).","The preferred method is to collect a complete start date. Partial dates (e.g., providing year only, month and year only) may be acceptable. \n Collecting this SAE-related data in the clinical database is the decision of the sponsor.",R/C,Y,1
What was the hospital discharge date?,Hospital Discharge Date,N/A,N/A,N/A,N/A,HOENDAT,"The end date of the healthcare encounter, (date of discharge) represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,Record the end date of the healthcare encounter using this format (DD-MON-YYYY).,"The preferred method is to collect a complete end date. Partial dates (e.g., providing year only, month and year only) may be acceptable. \n Collecting this SAE-related data in the clinical database is the decision of the sponsor.",R/C,Y,2
What was the discharge diagnosis?,Hospital Discharge Diagnosis \n,N/A,N/A,N/A,N/A,HODDIAG,The clinician-determined condition of the subject at the time of release from the care facility,N/A,Record the discharge diagnosis.,Collecting this SAE-related data in the clinical database is the decision of the sponsor.,R/C,Y,3
What was the lab test name?,[Laboratory Test Name],testname,B.3.1c,F.r.2.1,Test Name (free text),LBTEST,Descriptive name of the lab test or examination used to obtain the measurement or finding. Any test normally performed by a clinical laboratory is considered a lab test.,(LBTEST),"Record the name of the lab measurement or finding, if not preprinted on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended.",N/A,HR,Y,1
What was the result of the lab test?,(Result),testresult,B.3.1d,F.r.3.2,Test Result (value / qualifier),LBORRES,Result of the measurement or finding as originally received or collected,N/A,Record the laboratory test result.,N/A,HR,Y,2
What was the unit of the lab result?,Unit,testunit,B.3.1e,F.r.3.3,Test Result (unit),LBORRESU,The unit of the result as originally received or collected,(UNIT),"Record or select the original unit in which these data were collected, if not preprinted on CRF.","When mapping, note that E2B R3 terminology applies the UCUM (Unified Code for Units of Measure)",R/C,Y,3
What was the date of the lab specimen collection,Collection Date,testdate,B.3.1b,F.r.1,Test Date,LBDAT,"The date of specimen collection, represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,"Record the date when the specimen collection was done, using this format (DD-MON-YYYY).",Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,4
What was the (start) time of the lab specimen collection?,[Start] Collection Time,testdate, B.3.1b,F.r.1,Test Date,LBTIM,"The time of specimen collection, represented in an unambiguous time format (e.g., hh:mm:ss)",N/A,Record the time of collection (as complete as possible).,Mapping of CDASH date and time variables needs to be done to achieve the E2B (R3) format of CCYYMMDD,R/C,Y,5
What [is/was] the specimen (material) type?,Specimen (Material) Type,N/A,N/A,N/A,N/A,LBSPEC,The type of specimen used for a measurement,(SPECTYPE),N/A,N/A,O,Y,6
What was the high limit of the reference range for this lab test?,Normal Range Upper Limit,hightestrange,B.3.1.2,F.r.5,Normal High Value,LBORNRHI,The upper end of normal range or reference range for continuous results stored in LBORRES,N/A,Record the upper limit of the reference range of the lab test.,N/A,R/C,Y,7
What was the lower limit of the reference range for this lab test?,Normal Range Lower Limit,lowtestrange,B.3.1.1,F.r.4,Normal Low Value,LBORNRLO,The lower end of normal range or reference range for continuous results stored in LBORRES,N/A,Record the lower limit of the reference range of the lab test.,N/A,R/C,Y,8
What was the medical history event or concurrent condition?,Medical History Term,medicalhistoryepisode,B.1.7.2 ,D.7.2,Text for Relevant Medical History and Concurrent Conditions (not including reaction / event),MHTERM,The reported or pre-specified name of the medical condition or event. \n,N/A,"Record all relevant medical conditions or events, as defined in the protocol. Record only 1 medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.","Subject's relevant medical history and concurrent conditions (e.g., disease)",HR,Y,1
N/A,N/A,patientepisodename,B.1.7.1a.2,D.7.1.r.1b,Medical history (disease / surgical procedure / etc.) (MedDRA code),MHLLTCD,MedDRA Dictionary- Lowest Level Term code,N/A,N/A,Sponsors may choose to have the coding explicitly done in EDC and transfered to Safety. This field does not typically appear on the CRF. Sponsors will populate this through the coding process. This is applicable to items using MedDRA coding and must provide the MedDRA version number as well.,O,Y,2
What was the medical history event or concurrent condition start date?,Start Date,patientmedicalstartdate,B.1.7.1c,D.7.1.r.2,Start Date,MHSTDAT,"The start date of medical history event or condition represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,Record the start date of the medical event or condition using this format (DD-MON-YYYY).,"The sponsor may choose to capture a complete date or any variation thereof (e.g., month and year).",O,Y,3
Is the medical history event or concurrent condition ongoing?,Ongoing,patientmedicalcontinue,B.1.7.1d,D.7.1.r.3,Continuing,MHONGO,Indication the medical condition or event is ongoing when no end date is provided,(NY),"Record the medical condition or event as ongoing (""Y"") if it has not ended at the time of data collection. If the medical condition or event is ongoing, the end date should be left blank.","Completed to indicate that the condition has not resolved at the time of data collection. It is expected that every reported condition has either an End Date or the Ongoing field is populated, but not both.",O,Y,4
What was the medical history event or concurrent condition end date?,End Date,patientmedicalenddate,B.1.7.1f,D.7.1.r.4,End date,MHENDAT,"The end date of medical history event or condition represented in an unambiguous date format (e.g., DD-MON-YYYY).",N/A,Record the end date of the medical event or condition using this format (DD-MON-YYYY).,"The sponsor may choose to capture a complete date or any variation thereof (e.g., month and year, year).",O,Y,5
What was the procedure name?,Procedure Name,patientmedicalhistorytext,B.1.7.2,D.7.2,Text for Relevant Medical History and Concurrent Conditions (not including reaction / event),PRTRT,"The verbatim surgical, therapeutic, or diagnostic procedure's name",N/A,Record only one procedure per line.,"In most cases, the verbatim procedure names or therapy will be coded to a standard dictionary (e.g., MedDRA, SNOMED) after the data have been collected on the CRF.",HR,Y,1
N/A,N/A,patientepisodename,B.1.7.1a.2,D.7.1.r.1b,Medical history (disease / surgical procedure / etc.) (MedDRA code),PRLLTCD,MedDRA Lowest Level Term code,N/A,N/A,This field does not typically appear on the CRF. Sponsors will populate this through the coding process.,O,Y,2
What was the procedure (start) date ?,(Start) Date,patientmedicalstartdate,B.1.7.1c,D.7.1.r.2,Start date,PRSTDAT,"The start date of procedure represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,Record the start date of the medical procedure using this format (DD-MON-YYYY).,"The preferred method is to collect a complete start date. Partial dates (e.g., providing year only) are acceptable for procedures started a considerable amount of time prior to the start of study.",O,Y,3
What was the procedure (end) date?,(End) Date,patientmedicalenddate,B.1.7.1f,D.7.1.r.4,End Date,PRENDAT,"The end date of procedure represented in an unambiguous date format (e.g., DD-MON-YYYY)",N/A,Record the end date of the procedure using this format (DD-MON-YYYY).,"The preferred method is to collect a complete end date. Partial dates (e.g., providing year only) are acceptable for procedures started a considerable amount of time prior to the start of study.",O,Y,4
What is the estimated date of conception?,Estimated Date of Conception,N/A,N/A,N/A,N/A,EDCDTC_RPRES,An approximate calculated date at which the conception event took place,N/A,Record the estimated date of conception of the current pregnancy using this format (DD-MON-YYYY).,N/A,R/C,Y,1
What is the estimated date of delivery?,Estimated Date of Delivery,N/A,N/A,N/A,N/A,EDLVRDTC_RPRES,An approximate calculation of the delivery date,N/A,Record the estimated date of delivery using this format (DD-MON-YYYY).,N/A,R/C,Y,2
What was the start date of the last menstrual period?,Last Menstrual Period Start Date,parentlastmenstrualdate, B.1.10.3b ,D.10.3,Last Menstrual Period Date of Parent,LMPSTDTC_RPRES,The first day of the most recent menstrual period of the parent,N/A,Record the start date of the parent's most recent menses prior to the fetus or newborn's serious adverse event using this format (DD-MON-YYYY).,"The date of the first day of the parent's last menstrual period prior to the adverse event, when the SAE is for the fetus/newborn. The ""parent"" may be the study subject or, if the fetus or newborn is the study subject, the parent may be an associated person.",R/C,Y,3
What was the date the pregnancy was confirmed?,Pregnancy Confirmation Date,N/A,N/A,N/A,N/A,PCONFIND_RPDAT,"The date on which the reproductive system result or finding was collected, represented in an unambiguous date format (e.g., DD-MON-YYYY).",N/A,"Record the date on which the pregnancy was confirmed, using this format (DD-MON-YYYY).",N/A,R/C,Y,4
Was the pregnancy confirmed?,Pregnancy Confirmed,N/A,N/A,N/A,N/A,PCONFIND_RPORRES,An indication as to whether the subject's pregnancy has been confirmed,(NY),"For the current pregnancy, indicate if the pregnancy has been confirmed.",N/A,R/C,Y,5
What is the Apgar score at 1 minute?,Apgar Score (1 Min),N/A,N/A,N/A,N/A,APGR01_RSORRES,APGR01-Total Apgar Score,N/A,N/A,"This is a standardized, scored assessment of infant development, recorded as the Total Apgar Score at 1 minute after birth. As these are scored assessments they belong in the RS domain as ""Clinical Classifications""",R/C,Y,1
What is the Apgar score at 10 minutes?,Apgar SCore (10 Min),N/A,N/A,N/A,N/A,APGR01_RSORRES,APGR01-Total Apgar Score,N/A,N/A,"This is a standardized, scored assessment of infant development, recorded as the Total Apgar Score at 1 minute after birth. As these are scored assessments they belong in the RS domain as ""Clinical Classifications""",R/C,Y,2
What is the Apgar score at 5 minutes?,Apgar Score (5 Min),N/A,N/A,N/A,N/A,APGR01_RSORRES,APGR01-Total Apgar Score,N/A,N/A,"This is a standardized, scored assessment of infant development, recorded as the Total Apgar Score at 1 minute after birth. As these are scored assessments they belong in the RS domain as ""Clinical Classifications""",R/C,Y,3
What is the birth weight?,Birth Weight,N/A,N/A,N/A,N/A,BRTHWT_VSORRES,A measurement of the weight of a neonate at birth.,N/A,Record the birth weight of the newborn.,This is a vital sign of the newborn child,R/C,Y,4
What is the delivery date?,Delivery Date,N/A,N/A,N/A,N/A,ADLVRDTC_RPRES,The date on which the delivery procedure actually occurs.,N/A,Record the date of delivery using this format (DD-MON-YYYY).,This date is also the birth date of the child,R/C,Y,5
What is the pregnancy termination date?,Pregnancy Termination Date,N/A,N/A,N/A,N/A,PRGENDTC_RPRES,The date on which the pregnancy ended.,N/A,Record the date of the end of the pregnancy using this format (DD-MON-YYYY).,N/A,R/C,Y,6
What is the mode of delivery?,Mode of delivery,N/A,N/A,N/A,N/A,DLVRMODE_RPORRES,Description of the method by which a fetus is delivered,(MODDLV),Record the method by which the fetus was delivered.,N/A,R/C,Y,7
What is the estimated gestational age?,Gestational Age,N/A,N/A,N/A,N/A,EGESTAGE_SCORRES,An approximate calculation of the gestational age,N/A,"Record the calculated, estimated gestational age of the newborn.","The estimated gestational age at birth is the length of time for in utero development of the newborn, as well as the length of time of the current pregnancy",R/C,Y,8
What is the newborn's head circumference?,Head Circumference,N/A,N/A,N/A,N/A,FTHDCIRC_VSORRES,A circumferential measurement of the head at the widest point,N/A,Record the circumference of the head in centimeters.,"Note that this result is recorded in centimeters. This value will be stored in the corresponding VSORRESU. If collecting in multiple or other units, the unit of measure should be collected separately.",R/C,Y,9
What was the pregnancy outcome?,Pregnancy Outcome,N/A,N/A,N/A,N/A,PRGOUT_RPORRES,Findings observed at the end of a pregnancy.,N/A,Record the narrative outcome of the pregnancy.,This is a free-text field for a narrative describing the outcome of the birth.,R/C,Y,10
What was the delivery date of the partner's pregnancy?,Partner's Delivery Date,N/A,N/A,N/A,N/A,ADLVRDTC_RPRES,(use definition from new RPTEST/CD term,N/A,"Record the delivery date of the partner to the level of precision known (e.g., day/month/year, year, month/year) in this format (DD-MON-YYYY).","This is the date of delivery of the partner's pregnancy, and is also the birth date of the child. ",R/C,Y,1
What is the number of pregnancies of the partner?,Partner Number of Pregnancies,N/A,N/A,N/A,N/A,PREGNN_RPORRES,"The number of times a woman has been pregnant, including any current pregnancy, irrespective of the pregnancy outcomes",N/A,"Record the number of times the woman (partner) has been pregnant, including a current pregnancy.",N/A,R/C,Y,2
What is the partner's number of ectopic pregnancies?,Partner Number of Ectopic Pregnancies,N/A,N/A,N/A,N/A,ECTPREGN_RPORRES,A measurement of the total number of ectopic pregnancies experienced by a female subject,N/A,N/A,N/A,R/C,Y,3
What is the partner's number of induced abortions?,Partner Number of Induced Abortions,N/A,N/A,N/A,N/A,INABORTN_RPORRES,(definition from new RPTEST/CD),N/A,Record the total number of induced abortions the partner has had. ,N/A,R/C,Y,4
What is the partner's number of full-term live births?,Partner Number Full Term Live Births,N/A,N/A,N/A,N/A,BRTHFTN_RPORRES,A measurement of the total number of live birth events at which the gestational age of the neonate is 39 weeks and 0 days through 40 weeks and 6 days,N/A,N/A,N/A,R/C,Y,5
What is the partner's number of late fetal deaths?,Partner Number Late Fetal Deaths,N/A,N/A,N/A,N/A,FETLDTHN_RPORRES,"A measurement of the total number of fetal deaths (death of a fetus at 16 weeks, 0 days to 19 weeks, 6 days of gestation) experienced by a female subject",N/A,N/A,N/A,R/C,Y,6
What is the partner's number of premature births?,Partner Number of Premature Births,N/A,N/A,N/A,N/A,PREMBTHN_RPORRES,A measurement of the total number of birth events (both live and dead) at which the gestational age of the neonate is less than 37 weeks and 0 days,N/A,N/A,N/A,R/C,Y,7
What is the partner's number of previous pregnancies?,Partner Number of Previous Pregnancies,N/A,N/A,N/A,N/A,PRVPREGN_RPORRES,A measurement of the total number of pregnancy events experienced by the female subject prior to the current pregnancy,N/A,"Record the number of previous pregnancies. If currently pregnant, do not include this current pregnancy in the count.",N/A,R/C,Y,8
What is the partner's number of spontaneous abortions?,Partner Number of Spontaneous Abortions,N/A,N/A,N/A,N/A,SPABORTN_RPORRES,A measurement of the total number of spontaneous abortions (in which the fetus is less than 20 weeks gestational age) experienced by a female subject,N/A,Record the number of spontaneous abortions (in which the fetus is less than 20 weeks gestational age). ,N/A,R/C,Y,9
How many of the partners's previous pregnancies have reached parity?,Number of Partner pregnancies reaching parity,N/A,N/A,N/A,N/A,PARITY_RPORRES,The number of pregnancies reaching viable gestational age (including live births and stillbirths),N/A,"Record the number of pregnancies reaching 20 weeks and 0 days of gestation or beyond, regardless of the number of fetuses or outcomes.",N/A,R/C,Y,10
"What is the total number of pregnancies (including the current, if applicable)?",Total Number of pregnancies,N/A,N/A,N/A,N/A,PREGNN_RPORRES,"The number of times a woman has been pregnant, including any current pregnancy, irrespective of the pregnancy outcomes",N/A,"Record the number of times the woman has been pregnant, including a current pregnancy.",N/A,R/C,Y,1
What is the number of ectopic pregnancies?,Number of ectopic pregnancies,N/A,N/A,N/A,N/A,ECTPREGN_RPORRES,A measurement of the total number of ectopic pregnancies experienced by a female subject,N/A,N/A,N/A,R/C,Y,2
What is the number of induced abortions?,Number of induced abortions,N/A,N/A,N/A,N/A,INABORTN_RPORRES,The number of surgical or medical procedure that terminates a pregnancy by removing the products of conception,N/A,Record the total number of induced abortions the woman has had. ,N/A,R/C,Y,3
What is the number of full-term live births?,Number Full Term Live Births,N/A,N/A,N/A,N/A,BRTHFTN_RPORRES,A measurement of the total number of live birth events at which the gestational age of the neonate is 39 weeks and 0 days through 40 weeks and 6 days,N/A,N/A,N/A,R/C,Y,4
What is the number of late fetal deaths?,Number of Late Fetal Deaths,N/A,N/A,N/A,N/A,FETLDTHN_RPORRES,"A measurement of the total number of fetal deaths (death of a fetus at 16 weeks, 0 days to 19 weeks, 6 days of gestation) experienced by a female subject",N/A,N/A,N/A,R/C,Y,5
What is the number of premature births?,Number of Premature Births,N/A,N/A,N/A,N/A,PREMBTHN_RPORRES,A measurement of the total number of birth events (both live and dead) at which the gestational age of the neonate is less than 37 weeks and 0 days,N/A,N/A,N/A,R/C,Y,6
What is the number of previous pregnancies?,Number of Previous Pregnancies,N/A,N/A,N/A,N/A,PRVPREGN_RPORRES,A measurement of the total number of pregnancy events experienced by the female subject prior to the current pregnancy,N/A,"Record the number of previous pregnancies. If currently pregnant, do not include this current pregnancy in the count.",N/A,R/C,Y,7
What is the number of spontaneous abortions?,Number of Spontaneous Abortions,N/A,N/A,N/A,N/A,SPABORTN_RPORRES,A measurement of the total number of spontaneous abortions (in which the fetus is less than 20 weeks gestational age) experienced by a female subject,N/A,Record the number of spontaneous abortions (in which the fetus was less than 20 weeks gestational age). ,N/A,R/C,Y,8
How many pregnancies have been carried to a viable gestational age (parity)?,Parity,N/A,N/A,N/A,N/A,PARITY_RPORRES,"The number of pregnancies reaching 20 weeks and 0 days of gestation or beyond, regardless of the number of fetuses or outcomes",N/A,"Record the number of pregnancies reaching 20 weeks and 0 days of gestation or beyond, regardless of the number of fetuses or outcomes",N/A,R/C,Y,9
What is the date of the ([subject's/partner's]) last menstrual period?,Last Menstrual Period,patientlastmenstrualdate,B.1.6.b,D.6 \n,Last Menstrual Period Date,LMPSTDTC_RPRES,The first day of the most recent menstrual cycle.,N/A,"Enter the date of first day of the ([subject's/partner's]) last menstrual period prior to the adverse event, in this format (DD-MON-YYYY).",The date of the first day of the subject's or partner's last menstrual period prior to the adverse event. Data would go to appropriate domain (RP for Reproductive Systems findings or APPR for Associated Persons Reproductive System findings). For some studies a modification of the CDASH Variable Name might be needed to differentiate PR from APPR when both are collected).,R/C,Y,1
What is the site country?,Site Country,reportercountry,A.2.1.3 ,C.2.r.3,Reporter's Country Code,SITECO,The country for a site within a study,N/A,Record the country of the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the site's country should be auto-populated from a trial management system as part of the reporter's location information.",HR,N,1
What is the site postcode?,Site Postcode,reporterpostcode,A.2.1.2f ,C.2.r.2.6,Reporter's Postcode,SITEPC,The postcode for a site within a study,N/A,Record the postcode of the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the site postcode should be auto-populated from a trial management system as part of the reporter's location information.",HR,N,2
What is the site state or province?,Site State or Province,reporterstate,A.2.1.2e,C.2.r.2.5,Reporter's State or Province,SITEST,The state or province for a site within a study,N/A,Record the state or province of the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the site's state or province should be auto-populated from a trial management system as part of the reporter's location information.",HR,N,3
What is the site city?,Site City,reportercity,A.2.1.2d,C.2.r.2.4,Reporter's City,SITEC,The city for a site within a study,N/A,Record the city of the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the site's city should be auto-populated from a trial management system as part of the reporter's location information.",HR,N,4
What is the site street address?,Site Street Address,reporterstreet,A.2.1.2c,C.2.r.2.3,Reporter's Street,SITES,The street address for a site within a study,N/A,Record the street address of the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the site's street address should be auto-populated from a trial management system as part of the reporter's location information.",HR,N,5
What is the site telephone number?,Site Telephone Number,sendertel,A.3.1.4f,C.3.4.6,Sender's Telephone,SITETEL,The telephone number for a site within a study,N/A,Record the telephone number of the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the site's telephone number should be auto-populated from a trial management system as part of the reporter's location information.",HR,N,6
What is the site fax number?,Site Fax Number,senderfax,A.3.1.4i,C.3.4.7,Sender's Fax,SITEFAX,The fax number for a site within a study,N/A,Record the fax number of the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the site's fax number should be auto-populated from a trial management system as part of the reporter's location information.",R/C,N,7
What is the reason for SAE report nullification or amendment?,Reason for Nullification or Amendment,nullificationreason,A.1.13.1,C.1.11.2,Reason for nullification / amendment,SANULARS,The reason for serious adverse event report nullification or amendment,N/A,"If case is nullified or amended, provide a reason for the change.",Only to be used if the report is nullified or amended,R/C,N,8
What is the date the report was submitted to the sponsor?,Sponsor Awareness Date,receivedate,A.1.6b,C.1.4,Date Report Was First Received from Source,SAAWRDAT,The date the SAE report was initially reported to the sponsor,N/A,N/A,"Although this field is not typically entered on an eCRF, it should be displayed clearly on the CRF and/or the EDC system.",HR,N,9
What is the given name of the investigator?,Investigator Given Name,reportergivename,A.2.1.1b,C.2.r.1.2,Reporter's Given Name,INVGNAM,The first name of the primary investigator for a site,N/A,Record the first name of the principal investigator at the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, if possible, the investigator's first name should be auto-populated from a trial management system as part of the reporter's full name.",HR,N,10
What is the middle name of the investigator?,Investigator Middle Name,reportermiddlename,A.2.1.1c,C.2.r.1.3,Reporter's Middle Name,INVMNAM,The middle name of the primary investigator for a site,N/A,Record the middle name of the principal investigator at the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, if possible, the investigator's middle name should be auto-populated from a trial management system as part of the reporter's full name.",O,N,11
What is the family name of the investigator?,Investigator Family Name,reporterfamilyname,A.2.1.1d,C.2.r.1.4,Reporter's Family Name,INVFNAM,The family name of the primary investigator for a site,N/A,Record the family name of the principal investigator at the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, if possible, the investigator's family (last) name should be auto-populated from a trial management system as part of the reporter's full name.",HR,N,12
What is the title of the investigator?,Investigator Title,reportertitle,A.2.1.1a,C.2.r.1.1,Reporter's Title,INVTL,The title of the primary investigator for a site,N/A,Record the title of the principal investigator at the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information; as such, the investigator's title should be auto-populated from a trial management system.",HR,N,13
What is the email address of the investigator?,Investigator email Address,senderemailaddress,A.3.1.4l,C.3.4.8,Sender's E-mail Address,INVEMAIL,The email address of the primary investigator for a site,N/A,Record the email address of the principal investigator at the site.,"The principal investigator for a site is responsible for the collection and reporting of SAE information. If E2B is generated from the EDC, the site PI's email address should be auto-populated as the sender.",O,N,14
What is the study identifier?,[Protocol/Study],sponsorstudynumb,A.2.3.1,C.5.3,Sponsor Study Number,STUDYID,A unique identifier for a study,N/A,N/A,"Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system.",HR,N,15
What is the SAE report category?,Report Category,casenullification,A.1.13,C.1.11.1,Report nullification / amendment,SAERCAT,Category of the SAE report,(SAERCAT),Select the category of the SAE report.,"This field merges the concepts previously held in NULYN so that sponsors may differentiate between Initial, amended (Follow-Up), and nullified reports. \n Depending on the reporting system, it may be derived (initial vs amendment). If a site nullifies a case, then the SANULARS variable must be populated.",R/C,N,16
What is the subject's age at onset of the SAE?,Subject Onset Age,patientonsetage,B.1.2.2a,D.2.2a,Age at time of onset of reaction / event (number),SAESTAGE,"The age of the subject at the time of onset of the SAE, expressed in AGEU",N/A,Record the age of the subject at the time of onset of the SAE.,"If possible, this field should be calculated from BRTHDAT or AGE at informed consent relative to AESTDAT. \n Intended for Drug Safety and not part of Demographics data for submission purposes",R/C,N,17
What is the subject's age unit at onset of the SAE?,Subject Onset Age Unit,patientonsetageunit,B.1.2.2b,D.2.2b,Age at time of onset of reaction / event (unit),SAESTAGU,The unit of time that is routinely used to express the age of a person,(AGEU),"Record the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, DAYS, HRS, DECADE).",Intended for Drug Safety and not part of Demographics data for submission purposes.,R/C,N,18
What is the subject's age group?,Subject Age Group,patientagegroup,B.1.2.3,D.2.3,Patient age group (as per reporter),SAAGEGRP \n,The Age Group of the subject when more precision is not available,,Record the Age Group if the person who experienced the SAE is not the subject or if the birth date of the \n subject was not recorded in the demographics form for the subject.,Deploy for use if subject birth dates are not collected on demographics form or if SAE data is collected \n in the EDC for non-subjects and date of birth is not available for those subjects. \n The sponsor should use and define age groups. The sponsor may use age groupings based upon the ICH submission guidelines.,O,N,19
What is the gestational period of the fetus at the time of observation of the SAE?,Gestational Onset Period,gestationperiod, B.1.2.2.1a,D.2.2.1a,Gestation period when reaction / event was observed in the foetus (number),SAGESTAG,Gestational period of the fetus at time reaction/event was observed (numeric),N/A,Enter the fetus's gestational period at the time the SAE was observed.,"If the fetus is the subject of the investigation, the GESTAGE may be calculated from the value in SCORRES where SCTESTCD = EGESTAGE and need not be re-collected.",R/C,N,20
What is the fetal gestational period unit at the time of observation of the SAE?,Gestational Period Unit,gestationperiodunit, B.1.2.2.1b,D.2.2.1b,Gestation period when reaction / event was observed in the foetus (unit),SAGESTGU \n \n \n,Unit for gestational period of the fetus at the time the reaction/event was observed,(AGEU),Enter the fetus's gestational period unit at the time the SAE was observed.,This field is needed to complete the SAE form submitted to drug safety. This field is not intended to be part of the regulatory file submission.,R/C,N,21
What are the details of the SAE/reaction?,SAE Narrative,narrativeincludeclinical,B.5.1,H.1,"Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information",SANARR,Additional facts related to a serious adverse event,N/A,Include these sections: \n * Description of the SAE \n * Description of the work-up and evaluation therapeutic measures taken to treat the SAE \n * Outcome of the SAE \n * Additional relevant information,"Summarize the details relevant to the case with enough information to allow for a full understanding of the case, and to perform a causality assessment. \n The reporter (investigator) presents their findings and assessment in the SAE report to the sponsor. \n The sender (sponsor) has corresponding sections for their comments and assessment, captured in H.3.r.",R/C,N,1
What is the rationale for the final assessment for causality?,Rationale for Final Investigator Causality,reportercomment,B.5.2,H.2,Reporter's Comments,SAIRATNL,Rationale for final investigator causality,N/A,Provide the conclusion of the medical review and the determination of causality. Include the rationale for the conclusion.,"This should be a clear, concise statement as to whether or not the product caused the SAE, and the reason(s) why or why not.",R/C,N,2
What is the subject's identifier?,Subject,patientinvestigationnu mb,B.1.1.1d,D.1.1.4,Patient medical record number(s) and source(s) of the record number (investigation number),SUBJID,A unique subject identifier within a site and study,N/A,Record the identifier for the subject.,"Paper: This is typically recorded in the header of each CRF page. \n EDC: The subject identifiers may be provided to the site using an auto-populated list in the system. SUBJID = Subject Identifier, which must be unique within the study (often the ID of the subject as recorded on a CRF).",HR,Y,1
What is the estimated gestational age?,Gestational Age,N/A,N/A,N/A,N/A,EGESTAGE_SCORRES,An approximate calculation of the gestational age,N/A,N/A,"If the fetus is the subject of investigation, then EGESTAGE is documented in SCORRES. If the fetus is an associated person to the subject of the investigation (parent), then EGESTAGE belong in RPORRES.",O,Y,2
What was the result of the weight measurement?,Weight,patientweight, B.1.3 ,D.3,Body weight (kg),WEIGHT_VSORRES,Subject Weight,N/A,Record the subject's weight.,Transfer to the safety database the result value closest in time to the onset of the reaction/event. ,HR,Y,1
What was the unit of the weight measurement?,Weight Unit,patientweight,B.1.3,D.3,Body weight (kg),WEIGHT_VSORRESU,Subject Weight Unit,(UNIT),Record the original unit of the subject's weight,"If the collected result unit is not in kilograms (kg), a conversion step will be required prior to submission to regulatory agencies.",HR,Y,2
What was the result of the height measurement?,Height,patientheight, B.1.4 ,D.4,Height (cm),HEIGHT_VSORRES,Subject Height,N/A,Record the subject's height. ,Transfer to the safety database the result value closest in time to the onset of the reaction/event. ,HR,Y,3
What was the unit of the height measurement,Height Unit,patientheight,B.1.4,D.4,Height (cm),HEIGHT_VSORRESU,Subject Height Unit,(UNIT),Record the original unit of the subject's height.,"If the collected result unit is not in centimeters (cm), a conversion step will be required prior to submission to regulatory agencies.",HR,Y,4