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The Concomitant Medication (CM) domain is based on the Interventions General Observation class. The CM domain is used to represent information relating to concomitant and prior medications used by the subject, such as those given on an as-needed basis or condition-appropriate medications. The same basic data collection variables should be collected for all medications, treatments, and therapies (prior, general concomitant medications, and medications of interest). Reacreational substances are not represented in this domain (see Section 3.3.2.7,  Prior Usage of Recreational Products (Including Tobacco Products). However, medical products recognized to reduce nicotine dependence would be represented in this domain (e.g., Nicotine replacement patches).   

Example

This is an example CRF used to collect general concomitant medications/products in a study. This CRF was designed to allow the applicant to use either CMENRF or CMENRTPT to represent an intervention was ongoing. In order to save space, some of the example permissible values are only shown in the metadata specifications.


This is the metadata specifications for Section 1 and 2 of the CRF.  

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Were any concomitant medications/products taken?Any Concomitant Medications/ProductsIndicate if the subject took any concomitant medications/products. If Yes, include the appropriate details where indicated on the CRF.Text

Not Submitted(NY)

Section 2 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the category for the concomitant medication/product?Concomitant Medication/Product CategoryRecord the medication/product category, if not pre-printed on the CRF.TextCMCATCMCAT

GENERAL
3What is the medication/product line number?CM Line NumberIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.TextCMSPIDCMSPID



4What was the medication/product?Medication/ProductRecord only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.TextCMTRTCMTRT



5For what indication was the medication/product taken?IndicationRecord the reason the medication/product 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).TextCMINDCCMINDC



6What was the individual dose of the medication/product?DoseRecord the dose of medication/treatment per administration (e.g., 200).TextCMDOSTXT OR CMDOSECMDOSTXT/  CMDOSE



7What is the unit?UnitRecord the dose unit of the dose of medication/product taken (e.g., mg).TextCMDOSUCMDOSU(UNIT)CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug

8What was the dose form of the medication/product?Dose FormRecord the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the medication/product  taken.TextCMDOSFRMCMDOSFRM(FRM)AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET

9What was the frequency of the medication/product?FrequencyRecord how often the medication/product was taken (e.g., BID, PRN).TextCMDOSFRQCMDOSFRQ(FREQ)BID; PRN; QD; QID; QM; QOD; TID

10What was the route of administration of the medication/product?RouteProvide the route of administration for the medication/product.TextCMROUTECMROUTE(ROUTE)INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL

11What was the start date?Start DateRecord the date the  medication/treatment was first taken using this format. If the subject has been taking the medication/product for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date.  Medications/Products taken during the study are expected to have a complete start date. Prior  medications/products that are exclusionary should have both a start date and an end date.DateCMSTDTCCMSTDAT



12Is the medication ongoing?OngoingRecord the  medication/product as ongoing if the subject has not stopped taking the  medication/product at the time of data collection and the end date should be left blank.TextCMENRF OR  CMENRTPTCMENRF or CMENRTPT(NY)No; Yes

13What was the end date?End DateRecord the date the  medication/product was stopped using this format. If the subject has not stopped taking the  medication/product leave this field blank.DateCMENDTCCMENDAT





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 Section 2.8.7.6, Representing References and Relative Timing. 

The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document. 

Rows 1-4:The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 6-8: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 9:The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating the product in this study.

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RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMDECODCMINDCCMCLASCMDOSECMDOSTXTCMDOSUCMDOSFRMCMDOSFRQCMROUTECMSTDTCCMENDTCCMENRF
1ABC123CMABC123-00011ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-142006-10-14
2ABC123CMABC123-00012ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-152006-10-15
3ABC123CMABC123-00013ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-162006-10-16
4ABC123CMABC123-00014ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-172006-10-17
5ABC123CMABC123-00015ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-01-182006-01-18
6ABC123CMABC123-00021DIOVANvalsartanHYPERTENSIONANTIHYPERTENSIVES20
mgTABLETBIDORAL2004
AFTER
7ABC123CMABC123-00022ZOLOFTsertralinePANIC ATTACKSPSYCHOANALEPTICS50
mgTABLETODORAL2004-01
AFTER
8ABC123CMABC123-00023ASTELINazelastineINFLUENZANASAL PREPARATIONS
2 sprays in each nostril-137 mcgmcgSPRAYBIDNASAL2006-02-26
AFTER
9ABC123CMABC123-00024ASPIRINacetylsalicylic acidPAINANALGESICS100
mgTABLETPRNORAL2004-01-01
AFTER
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Example

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sponsor only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What was the medically recognized product name? Medication
TextCMTRTCCMTRT


DRUG USED IN  NICOTINE DEPENDENCE
2
Pre-Specified Intervention
TextCMPRESPCMPRESP


Y
3Did the subject previously use medically recognized products to reduce nicotine dependency?Any Medically Rrecognized Products Taken For Nicotine DependencyIndicate if the subject had used any medically recognized products to attempt to reduce nicotine dependencyTextCMOCCURCMOCCUR
(NY)No;Yes;Not Done
4How many times did the subject attempt to use use medically recognized products to reduce nicotine dependencyTimes the Subject Attempted to Reduce Nicotine DependencyRecord the number of times a subject attempted to use medically recognized products to reduce nicotine dependencyTextFAORRESFAORRESFAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "


5
Category
TextFACAT FACAT


ATTEMPTS TO REDUCE NICOTINE DEPENDENCE
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
6What is the category of the medication/product the subject used to attempt to reduce nicotine dependency? Medication
TextCMTRTCMCAT



NICOTINE REPLACEMENT THERAPY: NOT A NRT
7What is the medication/product subcategory, if not pre-printed on the CRF.SubcategoryApplicant DefinedTextCMSCATCMSCAT


LAST ATTEMPTED USE WITH THIS MEDICATION
8What was the name of the medication/product the subject used to reduce nicotine dependency

 MedicationRecord only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.TextCMTRTCMTRT



9What was the duration of the medication/product used to reduce nicotine dependency for the last attempt?Collected DurationProvide the duration of the medication/product used. TextCMCDURCMDUR



10What was the duration unit of the medication/product used to reduce nicotine dependency for the last attempt?Collected Duration UnitSelect the appropriate duration unit of the medication/product used.TextCMCDURUCMDUR
(UNIT)DAYS; MONTHS; YEARS

These example SDTM datasets represent the data collected on the above CRF.
Rows 1, 3, 7, 9:Show whether the subject has used any medications to help with nicotine dependence. This was prespecified on the CRF, hence CMPRESP="Y". The applicant assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary.
Rows 2, 4, 5, 6, 8:Show the various medications that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation. CMPRESP is null since the specific medication used is not prespecified.

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RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMSCATCMPRESPCMOCCURCMDTCCMDUR
11234CM12340051DRUG USED IN NICOTINE DEPENDENCE

YY2008-08-08
21234CM12340052NICOTINE PATCH XYZNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P2M
31234CM12340061DRUG USED IN NICOTINE DEPENDENCE

YY2008-11-12
41234CM12340062NICOTINE GUM ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P3M
51234CM12340063NICOTINE LOZENGES ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P2W
61234CM12340061BUPROPIONDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPTED USE WITH THIS MEDICATION


P1M
71234CM12340072DRUG USED IN NICOTINE DEPENDENCE

YY2008-06-12
81234CM12340073VARENICLINEDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPTED USE WITH THIS MEDICATION


P40D
91234CM12340121DRUG USED IN NICOTINE DEPENDENCE

YN2008-03-05
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FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.  

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RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFASTRESCFADTC
11234FA12340051TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE442008-08-08
21234FA12340061TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE552008-11-12
31234FA12340071TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE332008-06-12
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Example

This example is an additional example of data collected on the previous use of smoking cessation products at the baseline visit.  This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.  

 

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been used, and the questions in the second section collect each individual product used. In order to save space, some of the permissible values are only shown in the metadata specifications. 

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the category for the medication?Concomitant Medication Category
TextCMCAT



SMOKING CESSATION PRODUCT
2Were any smoking cessation products taken?Any Smoking Cessation Products Taken Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF.TextCMOCCURCMOCCUR; 
(NY)No;Yes
Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.  
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
3What was the smoking cessation product used?Smoking Cessation ProductSelect the smoking cessation product.TextCMTRTCMTRTCMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.    


NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4

Did the subject previously use the selected medication/product for smoking cessation?

Smoking Cessation Product UsedIndicate if the subject had used the selected smoking cessation productTextCMOCCURCMOCCUR
(NY)No; Yes
5

What was the name of the other smoking cessation product used? 

Smoking Cessation Product OtherIndicate the Other type of product previously used. TextCMTRTOCMTRT



6Was the smoking cessation product discontinued due to an adverse experience?   Reason Smoking Cessation Product DiscontinuedIndicate if the product was discontinued due to an Adverse ExperienceTextCMRSDISCCMRSDISCIf Yes then CMRSDISC = "ADVERSE EXPERIENCE"(NY)No:Yes:
7What was the last date the product was used? Last Date Smoking Cessation Product Used Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded. DateCMENDAT CMENDTC



This is the SDTM date for the data collected above. In this example, the applicant only represented whether the product was used in the last 14 days. CMPRESP was populated by the applicant for all pre-specified products. Medication specified as "OTHER" were not considered prespecified.   
Row 1:Shows the subject reported they had not previously used any smoking cessation product ( CMOCCUR ="N") . CMPRESP was included to indicate that the use of smoking cessation product was specifically asked on the CRF.
Rows 2, 5, 8, 11, 14, 17:Show the subject reported they had used a smoking cessation product (CMOCCUR ="Y") . CMPRESP was included to indicate that the use of a smoking cessation product was specifically asked on the CRF.
Rows 3, 6, 9, 12, 15, 18:Show the subject reported they had not used nicotine patches (CMOCCUR is "N"). Note: that all other rows for the products not used are not show for simplicity CMPRESP is used to represent that this product was pre-specified.
Rows 4, 7, 10, 13, 16:Shows the subject reported using the product specified in CMTRT. CMENDTC indicates the last day the product was used. CMPRESP is used to represent that this product was pre-specified. CMOCCUR is Y. Subject ABC-0006 discontinued BUPROPION for an adverse event.
Row 19:Shows the subject used natural supplement ABC for smoking cessation. Since this product was not specified on the CRF, CMPRESP is null.

Row Captions Debug Message

Remember to keep number agreement between labels and captions.

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RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMPRESPCMOCCURCMRSDISCCMDTCCMENDTC
1ABCCMABC-00011SMOKING CESSATION PRODUCT
YN
2020-01-05
2ABCCMABC-00021SMOKING CESSATION PRODUCT
YY
2020-02-15
3ABCCMABC-00022NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-02-15
4ABCCMABC-00023NICOTINE GUMSMOKING CESSATION PRODUCTYY
2020-02-152020-02-02
5ABCCMABC-00031SMOKING CESSATION PRODUCT
YY
2020-04-15
6ABCCMABC-00032NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-04-15
7ABCCMABC-00033NICOTINE LOZENGESMOKING CESSATION PRODUCTYY
2020-04-152012
8ABCCMABC-00041SMOKING CESSATION PRODUCT
YY
2021-04-16
9ABCCMABC-00042NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-04-16
10ABCCMABC-00043NICOTINE INHALERSMOKING CESSATION PRODUCTYY
2021-04-162021-01
11ABCCMABC-00051SMOKING CESSATION PRODUCT
YY
2020-09-24
12ABCCMABC-00052NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-09-24
13ABCCMABC-00053VARENICLINESMOKING CESSATION PRODUCTYY
2020-09-242020-08-07
14ABCCMABC-00061SMOKING CESSATION PRODUCT
YY
2021-04-16
15ABCCMABC-00022NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2021-04-16
16ABCCMABC-00063BUPROPIONSMOKING CESSATION PRODUCTYYADVERSE EVENT2021-04-162020-01-09
17ABCCMABC-00071SMOKING CESSATION PRODUCT
YY
2020-07-10
18ABCCMABC-00022NICOTINE PAtCHSMOKING CESSATION PRODUCTYN
2020-07-10
19ABCCMABC-00072NATURAL SUPPLEMENT ABCSMOKING CESSATION PRODUCT
Y
2020-07-102020-04-10
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