| Observation Class | Domain | Data Collection Scenario | Implementation Options | Order Number | Collection Variable | Collection Variable Label | DRAFT Collection Definition | Question Text | Prompt | Data Type | Collection Core | Case Report Form Completion Instructions | Tabulation Target | | Controlled Terminology Codelist Name | Subset Controlled Terminology/CDASH Codelist Name | Implementation Notes |
| Events | AE | N/A | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or the EDC system. This field can be included into the database or populated during tabulation dataset creation. |
| Events | AE | N/A | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed for the CRFs that are shipped to each site. EDC: This should be pre-populated. |
| Events | AE | N/A | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system generated. This collection variable is typically collected for all domains. However, this collection variable is populated only in the tabulation DM dataset. |
| Events | AE | N/A | N/A | 4 | AEYN | Any Adverse Experience | An indication of whether any AEs were experienced during the study. | Were any adverse events experienced? | Any Adverse Experiences | Char | O | Indicate if the subject had any adverse experiences. If Yes, include the appropriate details where indicated on the CRF. | N/A | Does not map to an tabulation variable. | (NY) | N/A | 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. |
| Events | AE | N/A | N/A | 5 | AECAT | Category for Adverse Experience | A grouping of topic-variable values based on user-defined characteristics. | What is the category of the adverse experience? | [Adverse Experience Category]; NULL | Char | O | Record the adverse experience category, if not pre-printed on the CRF. | AECAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column heading. |
| Events | AE | N/A | N/A | 6 | AESCAT | Subcategory for Adverse Experience | A sub-division of the AECAT values based on user-defined characteristics. | What is the subcategory of the adverse experience? | [Adverse Experience Subcategory]; NULL | Char | O | Record the adverse experience subcategory, if not pre-printed on the CRF. | AESCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. AESCAT can only be used if there is an AECAT and it must be a subcategorization of AECAT. |
| Events | AE | N/A | N/A | 7 | AESPID | AE Applicant-Defined Identifier | A applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field. | [Applicant-defined question] | [Applicant defined] | Char | O | If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier. | AESPID | Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain. | N/A | N/A | Because SPID is an applicant-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 pre-printed number (e.g., line number, record number) on the CRF. This field may be populated by the applicant's data collection system. |
| Events | AE | N/A | N/A | 8 | AETERM | Reported Term for the Adverse Experience | The reported or pre-specified name of the adverse experience. | What is the adverse experience term? | Adverse Experience | Char | HR | 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). Using accepted medical terminology, enter the diagnosis (if known); otherwise enter a sign or symptom. | AETERM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Can be represented either as an open-entry field to capture verbatim terms reported by subjects or pre-printed, in the situation where solicited AEs of interest are captured. In most cases, the verbatim term (i.e., investigator-reported term) will be coded to a standard medical dictionary (e.g., MedDRA, WHO ART) after the data have been collected on the CRF. |
| Events | AE | N/A | N/A | 9 | AEOCCUR | Adverse Experience Occurrence | An indication of whether a pre-specified adverse experience or a group of adverse experiences occurred when information about the occurrence of a specific experience is solicited. | Did the subject have [pre-specified adverse experience/group of adverse experiences]? | [Specific Adverse Experience ] | Char | O | Indicate if [specific adverse experience] has occurred/is occurring, by checking Yes or No. | FA.FAORRES | This does not map directly to an tabulation variable. Because the tabaulation AE domain is intended to hold only adverse experiences that actually happen, all values collected in AEOCCUR for pre-specified AEs should be represented in a Findings About Adverse Experiences data set (FAAE) where FAORRES=the value of AEOCCUR where FATESTCD="OCCUR". In addition, where AEOCCUR="Y", there should be a corresponding record in the AE domain. | (NY) | N/A | The collection variable AEOCCUR is used to indicate the occurrence of pre-specified adverse experiences (e.g., "Did the subject have high blood pressure?"). AEOCCUR should not be used for spontaneously reported adverse experiences. The site should be able to indicate that the response was not asked or answered. |
| Events | AE | N/A | N/A | 10 | AEPRESP | Pre-specified Adverse Experience | An indication that a specific experience or group of experiences are pre-specified on a CRF. | N/A | N/A | Char | O | N/A | AEPRESP | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | A hidden field on a CRF defaulted to "Y", or added during tabulation dataset creation, when the AE is pre-specified. Null for spontaneously reported experiences. If a study collects both pre-specified and free-text adverse experiences, the value of AEPRESP should be "Y" for all pre-specified experiences and null for experiences reported as free-text. AEPRESP is a permissible field and may be omitted from the tabulation dataset if all experiences were collected as free text. |
| Events | AE | N/A | N/A | 11 | AESTDAT | Adverse Experience Start Date | The start date of the adverse experience, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What is the adverse experience start date? | Start Date | Char | HR | Record the start date of the adverse experience using this format (DD-MON-YYYY). | AESTDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable AESTDTC in ISO 8601 format. | N/A | N/A | N/A |
| Events | AE | N/A | N/A | 12 | AESTTIM | Start Time of Adverse Experience | The start time of the adverse experience, represented in an unambiguous time format (e.g., hh:mm:ss). | What is the adverse experience start time? | Start Time | Char | R/C | Record the start time (as complete as possible) of the adverse experience. | AESTDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable AESTDTC in ISO 8601 format. | N/A | N/A | 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. |
| Events | AE | N/A | N/A | 13 | AELOC | AE Location of Experience | A description of the anatomical location relevant for the adverse experience. | What is the anatomical location of the adverse experience? | Anatomical Location | Char | O | Indicate the anatomical location of the adverse experience. | AELOC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LOC) | N/A | Collected or pre-printed when the applicant needs to identify the specific anatomical location. applicants may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, PORTOT are used to further describe the anatomical location. |
| Events | AE | N/A | N/A | 14 | AELAT | Adverse Experience Laterality | Qualifier for anatomical location, further detailing the side of the body relevant for the experience. | What is the side of the anatomical location of the adverse experience? | Side | Char | O | Record the side of the anatomical location of the adverse experience. | AELAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LAT) | N/A | May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Events | AE | N/A | N/A | 15 | AEDIR | Adverse Experience Directionality | Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen. | What is the directionality of the anatomical location of the adverse experience? | Directionality | Char | O | Record the directionality of the anatomical location of the adverse experience. | AEDIR | Maps directly to the tabulation variable listed in the Tabulation Target column. | (DIR) | N/A | May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Events | AE | N/A | N/A | 16 | AEPORTOT | AE Location Portion or Totality | Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of). | What is the portion or totality of the anatomical location of the adverse experience? | Portion or Totality | Char | O | Indicate the portion or totality anatomical location of the adverse experience. | AEPORTOT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (PORTOT) | N/A | Collected when the applicant needs to identify the specific portionality for the anatomical locations. applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Events | AE | N/A | N/A | 17 | AEONGO | Ongoing Adverse Experience | Indication that an adverse experience is ongoing when no end date is provided. | Is the adverse experience ongoing (as of [the study-specific time point or period])? | Ongoing (as of [the study-specific time point or period]) | Char | O | Indicate if the adverse experience has not resolved at the time of data collection; leave the End Date blank. | AEENRTPT; AEENRF | This does not map directly to an tabulation variable. May be used to populate a value into a tabulation relative timing variable such as AEENRF or AEENRTPT. When populating AEENRF, if the value of AEONGO is "Y", the value of "DURING", "AFTER" or "DURING/AFTER" may be used. When populating AEENRTPT, if the value of AEONGO is "Y", the value of "ONGOING" may be used. When AEONGO refers to the Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable AEENRF should be populated. When AEONGO is compared to another time point, the tabulation variables AEENRTPT and AEENTPT should be used. Note: AEENRTPT must refer to a time-point anchor described in AEENTPT. | (NY) | N/A | 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 End Date was deliberately left blank. Often used as a tick/checkbox. |
| Events | AE | N/A | N/A | 18 | AEENDAT | Adverse Experience End Date | The date when the adverse experience resolved/ended, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the adverse experience end date? | End Date | Char | R/C | Record the date that the adverse experience. resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank. | AEENDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable AEENDTC in ISO 8601 format. | N/A | N/A | The definition of resolved is applicant-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. |
| Events | AE | N/A | N/A | 19 | AEENTIM | End Time of Adverse Experience | The time when the adverse experience ended/resolved, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the adverse experience end time? | End Time | Char | R/C | Record the time (as complete as possible) that the adverse experience resolved. | AEENDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable AEENDTC in ISO 8601 format. | N/A | N/A | 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. |
| Events | AE | N/A | N/A | 20 | AESEV | AE Severity/Intensity | The severity or intensity of the experience. | What is the severity of the adverse experience? | Severity | Char | R/C | The reporting physician/healthcare professional will assess the severity of the experience using the applicant-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported adverse experience to similar type experiences observed in clinical practice. Severity is not equivalent to seriousness. | AESEV | Maps directly to the tabulation variable listed in the Tabulation Target column. | (AESEV) | N/A | Either AESEV or AETOXGR must appear on the CRF. Some studies may mandate the collection of both. |
| Events | AE | N/A | N/A | 21 | AETOXGR | AE Standard Toxicity Grade | The grade of the severity of the experience using a standard "toxicity" scale (e.g., NCI CTCAE). | What is the [NCI CTCAE/Name of scale (toxicity) grade] of the adverse experience? | [NCI CTCAE/ Name of the scale] (Toxicity) Grade | Char | R/C | The reporting physician/healthcare professional will assess the severity of the adverse experience using the specified grades scale. | AETOXGR | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the toxicity scale name and version used to map the terms utilizing the Define-XML external codelist attributes. | N/A | N/A | Either AESEV or AETOXGR must appear on the CRF. Some studies may mandate the collection of both. Published toxicity-like scales can be used. |
| Events | AE | N/A | N/A | 22 | AESER | AE Serious Experience | An indication of whether the adverse experience is determined to be "serious," based on what is defined in the protocol. | Was the adverse experience serious? | Serious | Char | R/C | Assess if the adverse experience should be classified as "serious," based on the criteria defined in the protocol. | AESER | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | 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 SAE-type fields must be present on the CRF. Applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 23 | AESDTH | Results in Death | An indication the serious adverse experience resulted in death. | Did the adverse experience result in death? | Death | Char | R/C | Record whether the serious adverse experience resulted in death. | AESDTH | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 24 | DTHDAT | Death Date | Date of death for any subject who died. | What [is/was] the subject's date of death? | Death Date | Char | O | Record the date of death. | DM.DTHDTC | This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DTHDTC in ISO 8601 format. | N/A | N/A | In the CDASH model, Death Date is a timing variable; it is not included as a timing variable in the SDTM. It may be collected on any CRF deemed appropriate by the applicant, but should only be collected once. The tabulation variable DTHDTC is mapped to the DM domain during the tabulation dataset creation process. The tabulation variable DM.DTHFLG is not a collection variable, but it is typically populated during the tabulation dataset creation process. Death Date may be mapped to other tabulation domains, as deemed appropriate by the applicant (e.g., DS). |
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| AE | N/A | N/A | 25 | AESLIFE | Is Life Threatening | An indication the serious adverse experience was life threatening. | Was the adverse experience life threatening? | Life Threatening | Char | R/C | Record whether the serious adverse experience is life threatening. | AESLIFE | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 26 | AESHOSP | Requires or Prolongs Hospitalization | An indication the serious adverse experience resulted in an initial or prolonged hospitalization. | Did the adverse experience result in initial or prolonged hospitalization for the subject? | Hospitalization (initial or prolonged) | Char | R/C | Record whether the serious adverse experience resulted in an initial or prolonged hospitalization. | AESHOSP | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 27 | AESDISAB | Persist or Signif Disability/Incapacity | An indication the serious adverse experience was associated with a persistent or significant disability or incapacity. | Did the adverse experience result in disability or permanent damage? | Disability or Permanent Damage | Char | R/C | Record whether the serious adverse experience resulted in a persistent or significant disability or incapacity. | AESDISAB | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 28 | AESCONG | Congenital Anomaly or Birth Defect | An indication the serious adverse experience was associated with a congenital anomaly or birth defect. | Was the adverse experience associated with a congenital anomaly or birth defect? | Congenital Anomaly or Birth Defect | Char | R/C | Record whether the serious adverse experience was associated with congenital anomaly or birth defect. | AESCONG | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 29 | AESINTV | Needs Intervention to Prevent Impairment | An indication an adverse experience 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. | Did the adverse experience require intervention to prexperience permanent impairment or damage resulting from the use of a medical product? | Needs Intervention to Prevent Impairment | Char | O | Record whether the serious adverse experience required intervention to prevent permanent impairment or damage due to the use of a medical product. | SUPPAE.QVAL | This does not map directly to an tabulation variable. applicants should see requirements for the reporting of adverse experiences involving medical devices. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 30 | AESMIE | Other Medically Important Serious Experience | An indication additional categories for seriousness apply. | Was the adverse experience a medically important event not covered by other serious criteria? | Other Serious (Important Medical experiences) | Char | R/C | Record whether the serious adverse experience is an "important medical exvent," which may be defined in the protocol or in the investigator brochure. | AESMIE | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 31 | AESCAN | Involves Cancer | An indication the serious experience was associated with the development of cancer. | Was the adverse experience associated with the development of cancer? | Cancer | Char | O | Record whether the serious adverse experience was associated with development of cancer. | AESCAN | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate database. Applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 32 | AESOD | Occurred with Overdose | An indication the serious experience occurred with an overdose. | Did the adverse experience occur with an overdose? | Overdose | Char | O | Record whether the serious adverse experience occurred with an overdose. | AESOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If details regarding SAEs are collected in the clinical database, then it is recommended that a separate Yes/No variable be defined for each SAE type. Applicants may only collect the AESER field when collecting individual SAE types in a separate pharmacovigilance database. Applicants should consult with regulatory agencies regarding the collection of this data. |
| Events | AE | N/A | N/A | 33 | AEREL | AE Causality | An indication the study product had a causal effect on the adverse experience, as determined by the clinician/investigator. | Was this adverse experience related to study product? | Relationship to Study Product | Char | HR | Indicate if the cause of the adverse experience is related to the study product and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions). | AEREL | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology is used to indicate the relationship between the AE and the study product. It is recommended that applicants check with the regulatory authority for population of this variable to ensure it meets expectations for submission. There is no industry-wide controlled terminology for relationship to product exposure. It is recommended that applicants establish terminology and apply it consistently. |
| Events | AE | N/A | N/A | 34 | AEACN | Action Taken with Study Product | A description of the action taken with study product as a result of the experience. | What action was taken with study product? | Action Taken with Study Product | Char | R/C | Record changes made to the study product resulting from the adverse experience. | AEACN | Maps directly to the tabulation variable listed in the Tabulation Target column. | (TPACN) | N/A | CDISC Controlled Terminology is used to indicate the action taken with the product in response to the AE. How to handle multiple actions taken is up to the applicant. If this information is collected elsewhere (e.g., on the Exposure CRF), then it is not required to be collected on the AE CRF. This variable is not to be used for actions taken with devices. |
| Events | AE | N/A | N/A | 35 | AEACNDEV | Actions Taken with Device | A description of the action taken, with respect to a device used in a study (which may or may not be the device under study), as a result of the experience. | What action was taken with a device used in the study? | Action Taken with Device | Char | O | Record actions taken resulting from the adverse experience that are related to a study or non-study device. | SUPPAE.QVAL | This does not map directly an tabulation variable. The applicant may represent this data in a SUPPAE dataset where SUPPAE.QNAM = "AEACNDEV" and SUPPAE.QLABEL = "Actions Taken with Device". | N/A | N/A | Applicant-defined controlled terminology for actions that are related to the device. |
| Events | AE | N/A | N/A | 36 | AEACNOTH | Other Action Taken | A description of other action taken as a result of the experience that is unrelated to dose adjustments of the study product. | What other action was taken? | Other Action Taken | Char | O | Record all other action(s) taken resulting from the adverse experience that are unrelated to study products given because of this AE. | AEACNOTH | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This is usually collected as a free-text field. If possible/desired, the applicant can create controlled terminology. |
| Events | AE | N/A | N/A | 37 | AEOUT | Outcome of Adverse Experience | A description of the outcome of an experience. | What is the outcome of this adverse experience? | Outcome | Char | | Record the appropriate outcome of the experience in relation to the subject's status. | AEOUT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (OUT) | N/A | CDISC Controlled Terminology is used to indicate the outcome of the experience as it relates to the subject's status. 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. |
| Events | AE | N/A | N/A | 38 | AEDIS | AE Caused Study Discontinuation | An indication of whether the experience caused the subject to discontinue from the study. | Did the adverse experience cause the subject to be discontinued from the study? | Caused Study Discontinuation | Char | O | Record if the adverse experience caused the subject to discontinue from the study. | SUPPAE.QVAL | This does not map directly an tabulation variable. May be used to create a RELREC tabulation dataset to link the AE to the DS dataset record. The applicant may also represent this data in a SUPPAE dataset where SUPPAE.QNAM = "AEDIS" and SUPPAE.QLABEL = "Caused Study Discontinuation", if appropriate. | (NY) | N/A | Because the Action Taken field was defined to only collect changes made in relation to the study product due to the AE, an additional field was created to identify the AE(s) that caused the subject to discontinue from the study. Some applicants opt to capture this information only on the Subject Disposition CRF, whereas others choose to collect this data on both the Subject Disposition and AE CRFs, so the specific AE term(s) and related data can be identified. If the CRF is designed to link the DS and AE tabulation records, then RELREC can be used to identify that relationship. |
| Events | AE | N/A | N/A | 39 | AERLNSYN | AE Relationship to Non-Study Trtmnt or Prod | An indication whether, in the investigator's opinion, the experience may have been due to a product other than study product. | Was this adverse experience due to product other than study product? | Related to Non-Study Product | Char | O | Indicate if this adverse experience was due to product other than study product. If Yes, briefly describe this non-study product relationship. | N/A | Does not map to a tabulation variable. | (NY) | N/A | The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the AERELNST collection field on the CRF was deliberately left blank. |
| Events | AE | N/A | N/A | 40 | AERELNST | AE Relationship to Non-Study Trtmnt or Prod | Description of the investigator's opinion as to whether the adverse experience may have been due to a product other than study product. | What is the relationship to non-study product? | Relationship to Non-Study Product | Char | O | Record the investigator's opinion as to whether the experience may have been due to a product other than study product. | AERELNST | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | May be reported as free text (e.g., "MORE LIKELY RELATED TO ASPIRIN USE"). If possible/desired, applicants can create controlled terminology. |
| Events | AE | N/A | N/A | 41 | AESI | Adverse Experience of Special Interest | An adverse experience of special interest (serious or non-serious) is one of scientific and medical concern specific to the applicant's product or program, for which ongoing monitoring and rapid communication by the investigator to the applicant can be appropriate. Such an experience might warrant further investigation in order to characterize and understand it. Depending on the nature of the experience, rapid communication by the study applicant to other parties (e.g., regulators) might also be warranted. | Is this experience of special interest? | Adverse Experience of Special Interest | Char | O | Record the investigator's opinion as to whether the experience is an adverse experience of special interest by the applicant. | N/A | Does not map to a tabulation variable. | (NY) | N/A | This collection field may be used just to trigger other CRF pages, or populate a value in AECAT or AESCAT. This information could be represented in a SUPPAE dataset where SUPPAE.QNAM = "AESI" and SUPPAE.QLABEL = "Adverse experience of Special Interest. |
Events | AE | N/A | N/A | 42 | AEPATT | Pattern of Adverse Experience | Used to indicate the pattern of the experience over time. | What is the adverse experience pattern? | Pattern | Char | O | For each adverse experience, check the pattern of the AE. If a single experience, choose Single. | AEPATT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Used to report the pattern of the AE (e.g., "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT"). For crossover studies, it is NOT recommended to capture this field for intermittent AEs. Instead, the AE should have corresponding start and stop dates to capture when the AE started and stopped. |
| Events | AE | N/A | N/A | 43 | AECONTRT | Concomitant or Additional Product Given | An indication whether a concomitant or additional product given because of the occurrence of the experience. | Was a concomitant or additional product given due to this adverse experience? | Concomitant or Additional Product Given Due to This AE | Char | O | Indicate if any non-study treatments or products were received because of this adverse experience. If Yes, medications should be recorded on the ConMed CRF and procedures recorded on the Procedures CRF. | AECONTRT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | If medication data are reported, the CMAENO variable (on the CM CRF) may be used to collect the associated AE Identifier in order to populate RELREC. If procedures are reported, the PRAENO variable (on the PR CRF) may be used to collect the associated AE Identifier in order to populate RELREC. |
| Events | AE | N/A | N/A | 44 | AEMODIFY | AE Modified Reported Term | If the value for AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text. | N/A | N/A | Char | R/C | N/A | AEMODIFY | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This is not a data collection field that would appear on the CRF. applicants will populate this through the coding process. |
| Events | AE | N/A | N/A | 45 | AEDECOD | AE Dictionary-Derived Term | The dictionary or standardized text description of AETERM or the modified topic variable (AEMODIFY), if applicable. | N/A | N/A | Char | O | N/A | AEDECOD | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. | N/A | N/A | This is typically not a data collection field that would appear on the CRF. applicants will populate this through the coding process. Equivalent to the Preferred Term (PT) in MedDRA. |
| Events | AE | N/A | N/A | 46 | AELLT | | The dictionary-derived text description of the lowest level term. | N/A | N/A | Char | R/C | N/A | AELLT | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | AE | N/A | N/A | 47 | AELLTCD | AE Lowest Level Term Code | The dictionary-derived code for the lowest level term. | N/A | N/A | Num | R/C | N/A | AELLTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | AE | N/A | N/A | 48 | AEPTCD | AE Preferred Term Code | The dictionary-derived code for the preferred term. | N/A | N/A | Num | R/C | N/A | AEPTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | AE | N/A | N/A | 49 | AEHLT | AE High Level Term | The dictionary-derived text description of the high level term for the primary system organ class (SOC). | N/A | N/A | Char | R/C | N/A | AEHLT | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | AE | N/A | N/A | 50 | AEHLTCD | AE High Level Term Code | The dictionary-derived code for the high level term for the primary system organ class (SOC). | N/A | N/A | Num | R/C | N/A | AEHLTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | AE | N/A | N/A | 51 | AEHLGT | AE High Level Group Term | The dictionary-derived text description of the high level group term for the primary system organ class (SOC). | N/A | N/A | Char | R/C | N/A | AEHLGT | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | AE | N/A | N/A | 52 | AEHLGTCD | AE High Level Group Term Code | The dictionary-derived code for the high level group term for the primary system organ class (SOC). | N/A | N/A | Num | R/C | N/A | AEHLGTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | AE | N/A | N/A | 53 | AESOC | AE Primary System Organ Class | The dictionary-derived text description of the primary system organ class (SOC). | N/A | N/A | Char | R/C | N/A | AESOC | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as the AEBODSYS if the primary SOC was used for analysis. |
| Events | AE | N/A | N/A | 54 | AESOCCD | AE Primary System Organ Class Code | The dictionary-derived code for the primary system organ class (SOC). | N/A | N/A | Num | R/C | N/A | AESOCCD | Maps directly to the tabulation variable listed in the Tabulation Target column. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the Define-XML external codelist attributes. Applicants should include an Origin in the define metadata document to indicate that the data was "ASSIGNED". | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as AEBDSYCD if the primary SOC was used for analysis. |
| Events | AE | N/A | N/A | 55 | AEACNOYN | Any Other Actions Taken | An indication whether any other actions were taken in response to the adverse experience that were unrelated to study product changes or other treatments/products given because of this adverse experience. | Were any other actions taken in response to this adverse experience? | Any Other Action(s) Taken | Char | O | Indicate whether any other action(s) were taken in response to the adverse experience that are unrelated to study product changes or other treatments/products given because of this experience. If Yes, briefly describe these actions. | N/A | Does not map to a tabulation variable. | (NY) | N/A | The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that the AEACNOTH field on the CRF was deliberately left blank. |