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This is an example CRF used to collect general concomitant medications in a study. 


CMCAT
Hidden/pre-populated
GENERAL
Indicate if the subject took any concomitant medications/treatments. If Yes, include the appropriate details where indicated on the CRF.Were any concomitant medications taken?
CMYN 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
2CMYNWere any concomitant medications taken?Any Concomitant MedicationsIndicate if the subject took any concomitant medications/treatments. 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.  

Rows 1-6:The subject reported each instance of aspirin use. The frequency in each record is (CMDOSFRQ) 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 be 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

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMDOSECMDOSTXTCMDOSUCMDOSFRMCMDOSFRQCMROUTECMSTDTCCMENDTCCMENRF
1ABCCMABC-00011ASPIRIN100
mgTABLETONCEORAL2004-01-012004-01-01
2ABCCMABC-00012ASPIRIN100
mgTABLETONCEORAL2004-01-022004-01-02
3ABCCMABC-00013ASPIRIN100
mgTABLETONCEORAL2004-01-032004-01-03
4ABCCMABC-00014ASPIRIN100
mgTABLETONCEORAL2004-01-072004-01-07
5ABCCMABC-00015ASPIRIN100
mgTABLETONCEORAL2004-01-072004-01-07
6ABCCMABC-00016ASPIRIN100
mgTABLETONCEORAL2004-01-092004-01-09
7ABCCMABC-00021DIOVAN20
mgTABLETBIDORAL2004
AFTER
8ABCCMABC-00022ZOLOFT50
mgTABLETODORAL2004-01
AFTER 
9ABCCMABC-00023ASTELIN
2 sprays in each nostril -137 mcg mcgSPRAYBIDNASAL2004-01-092004-06-10
10ABCCMABC-00031ASPIRIN100
mgTABLETPRNORAL2004-01-01
AFTER

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