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NEED TO GET THE CORRECT REFERNCES  More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables. 

This is an example CRF used to collect general concomitant medications in a study. This CRF was designed to allow the sponsor to use either CMENRF or CMENRTPT to represent an intervention was ongoing.  

CMCAT
Hidden/pre-populated
GENERAL
Indicate if the subject used any Nicotine patches . If Yes, include the appropriate details where indicated on the CRF.Were any Nicotine patches used?
CMOCCUR Not Submitted
<NY codelist>
If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.
CMSPID
_________________
Record only one treatment per line. Provide the full trade or proprietary name of the medication/treatment; otherwise, record the generic name .
CMTRT
_________________
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 " and include a description of the condition(s).
CMINDC
_________________
Record the dose of medication/treatment per administration (e.g., 200).
CMDSTXT CMDOSTXT/ CMDOSE
_________________
Record the dose unit of the dose of concomitant medication/treatment taken (e.g., mg).Unit
CMDOSU
<UNIT codelist>
Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy] taken.Dose Form
CMDOSFRM
<FRM codelist>
Record how often the medication was taken (e.g., BID, PRN).Frequency
CMDOSFRQ
<FREQ codelist>
Provide the route of administration for the medication.Route
CMROUTE
<ROUTE codelist>
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 medications taken during the study are expected to have a complete start date. Prior concomitant medications that are exclusionary should have both a start date and an end date.
CMSTDAT CMSTDTC
_ _ / _ _ _ / _ _ _ _
Record the concomitant medication/treatment as ongoing if the subject has not stopped taking the concomitant medication/treatment at the time of data collection and the end date should be left blank.Is the medication ongoing?
CMONGO CMENRF or CMENRTPT
<NY codelist>
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.
CMENDAT CMENDTC
_ _ / _ _ _ / _ _ _ _
OrderCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG TargetSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1CMCATWhat is the category for the medication?Concomitant Medication CategoryRecord the medication category, if not pre-printed on the CRF.TextCMCAT


GENERAL

Yes
2CMOCCURWere any Nicotine patches used? Any Nicotine patches  Used? Indicate if the subject used  any Nicotine patches . If Yes, include the appropriate details where indicated on the CRF.TextN/A
(NY)Yes; No



3CMSPIDWhat is the medication identifier?CM NumberIf collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.TextCMSPID



prompt

4CMTRTWhat was the medication?Concomitant MedicationRecord only one treatment per line. Provide the full trade or proprietary name of the medication/treatment; otherwise, record the generic name .TextCMTRT






6CMINDCFor what indication was the medication taken?IndicationRecord 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 " and include a description of the condition(s).TextCMINDC






7CMDSTXTWhat was the individual dose of the medication?DoseRecord the dose of medication/treatment per administration (e.g., 200).TextCMDOSTXT;  CMDOSECMDOSTXT/  CMDOSE


prompt

8CMDOSUWhat is the unit?UnitRecord the dose unit of the dose of concomitant medication/treatment taken (e.g., mg).TextCMDOSU
(UNIT)CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug
prompt

9CMDOSFRMWhat was the dose form of the medication?Dose FormRecord the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy] taken.TextCMDOSFRM
(FRM)AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET
prompt

10CMDOSFRQWhat was the frequency of the medication?FrequencyRecord how often the medication was taken (e.g., BID, PRN).TextCMDOSFRQ
(FREQ)BID; PRN; QD; QID; QM; QOD; TID
prompt

11CMROUTEWhat was the route of administration of the medication?RouteProvide the route of administration for the medication.TextCMROUTE
(ROUTE)INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL
prompt

12CMSTDATWhat was the start date?Start DateRecord 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 medications taken during the study are expected to have a complete start date. Prior concomitant medications that are exclusionary should have both a start date and an end date.DateCMSTDTC



prompt

13CMONGOIs the medication ongoing?OngoingRecord the concomitant  medication/treatment as ongoing if the subject has not stopped taking the concomitant medication/treatment at the time of data collection and the end date should be left blank.TextCMENRF;  CMENRTPTCMENRF or CMENRTPT(NY)Yes

checkbox
14CMENDATWhat was the end date?End DateRecord 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.DateCMENDTC



prompt


This is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in SDTMIG Section 4.4.7, Use of Relative Timing Variables. The sponsor include CMDECOD. The sponsor is required to provide the dictionary name and version in the Define-XML document. 

Rows 1-6:The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 7-9:The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft.
Row 10:The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating safety and efficacy in this study.

cm.xpt

cm.xpt

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMDECODCMCLASCMDOSECMDOSTXTCMDOSUCMDOSFRMCMDOSFRQCMROUTECMSTDTCCMENDTCCMENRF
1ABCCMABC-00011ASPIRINacetylsalicylic acidANALGESICS100
mgTABLETONCEORAL2004-01-012004-01-01
2ABCCMABC-00012ASPIRINacetylsalicylic acidANALGESICS100
mgTABLETONCEORAL2004-01-022004-01-02
3ABCCMABC-00013ASPIRINacetylsalicylic acidANALGESICS100
mgTABLETONCEORAL2004-01-032004-01-03
4ABCCMABC-00014ASPIRINacetylsalicylic acidANALGESICS100
mgTABLETONCEORAL2004-01-072004-01-07
5ABCCMABC-00015ASPIRINacetylsalicylic acidANALGESICS100
mgTABLETONCEORAL2004-01-072004-01-07
6ABCCMABC-00016ASPIRINacetylsalicylic acidANALGESICS100
mgTABLETONCEORAL2004-01-092004-01-09
7ABCCMABC-00021DIOVANvalsartanANTIHYPERTENSIVES20
mgTABLETBIDORAL2004
AFTER
8ABCCMABC-00022ZOLOFTsertralinePSYCHOANALEPTICS50
mgTABLETODORAL2004-01
AFTER
9ABCCMABC-00023ASTELINazelastineNASAL PREPARATIONS
2 sprays in each nostril-137 mcgmcgSPRAYBIDNASAL2004-01-092004-06-10
10ABCCMABC-00031ASPIRINacetylsalicylic acidANALGESICS100
mgTABLETPRNORAL2004-01-01
AFTER
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