CDASH Concomitant Medications (CM)

Description/Overview

The CDASHIG CM domain contains data 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). If additional fields are needed to collect other data about a medication of interest, those should be added as non-standard fields.

Note:

Sponsors may use terms like concomitant medications, treatments, or therapies, as appropriate for the study. The following text may use one of these terms, but sponsors can always use the term most appropriate for their study.
The term prior refers to medications/treatments that were started before study participation, because limited information may be available on prior medications taken by a subject; the core requirements were constrained to reflect this limitation.
Sponsors should define the appropriate collection period for prior and concomitant medications/treatments in the study protocol.

Specification

TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

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

Mapping Instructions

Controlled Terminology Codelist Name

Subset Controlled Terminology/CDASH Codelist Name

Implementation Notes

Interventions

CM

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

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.

Interventions

CM

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

Paper: For single-site studies, this is typically pre-printed in the header of each CRF page. 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 on CRFs that are shipped to each site.

EDC: This should be pre-populated.

Interventions

CM

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

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 in all collection domains. However, this collection variable is populated only in the tabulation DM domain.

Interventions

CM

N/A

4

CMCAT

Category for Medication

A grouping of topic-variable values based on user-defined characteristics.

What is the category for the (concomitant) [medication/treatment/therapy/produuct]?

(Concomitant) [Medication/Treatment/Therapy/Product Category]; NULL

Char

O

Record the (concomitant) [medication/treatment/therapy/product] category, if not pre-printed on the CRF.

CMCAT

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Applicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, 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 in the column heading.

Interventions

CM

N/A

5

CMSCAT

Subcategory for Medication

A sub-division of the CMCAT values based on user-defined characteristics.

What is the subcategory for the (concomitant) [medication/treatment/therapy/product]?

(Concomitant) [Medication/Treatment/Therapy/Product subcategory]; NULL

Char

O

Record (concomitant) [medication/treatment/therapy/product] subcategory, if not pre-printed on the CRF.

CMSCAT

Maps directly to the tabulation variable listed in the Tabulation Target column.

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.

Interventions

CM

N/A

6

CMYN

Any Concomitant Medications Taken

An indication of whether any (concomitant) medications/treatments/therapies/products were taken/given.

Were/Was any (concomitant) [medication/treatment/therapy/product] taken?

Any (Concomitant) [Medication(s)/Treatment(s)/Therapy(ies)/Product(s)]

Char

O

Indicate if the subject took any (concomitant) [medication(s)/treatment(s)/therapy(ies)/product(s). If Yes, include the appropriate details where indicated on the CRF.

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 all other fields on the CRF were deliberately left blank.

Interventions

CM

N/A

7

CMSPID

CM 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.

CMSPID

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

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 medication/treatment/productrecords with AEs and/or MH. 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.

Interventions

CM

N/A

8

CMTRT

Reported Name of Drug, Med, or Therapy

Verbatim medication name of intervention

What was the (concomitant) [medication/treatment/therapy/product] name/term)?

(Concomitant) [Medication/Treatment/Therapy/Product]

Char

HR

Record only 1 [medication/treatment/therapy/product] per line. Provide the full trade or proprietary name of the [medication/treatment/therapy/product]; otherwise the generic name may be recorded.

CMTRT

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

In most cases, the verbatim intervention name will be coded to a standard dictionary (e.g., WHODrug) after data have been collected on the CRF. For the collection of verbatim intervention name, the recommendation is for sites to provide the full trade or proprietary name, which is more exact than the generic. The full trade name provides the base generic and the appropriate salt for that particular drug. In addition, for coding purposes, it helps with ATC selection (e.g., Tylenol with codeine #1 has a different ATC code than Tylenol with codeine #3). This field can be used for either prior or concomitant medication/treatments/products.

Interventions

CM

N/A

9

CMPRESP

CM Pre-Specified

An indication that a specific intervention or a group of interventions is pre-specified on a CRF.

N/A

Char

O

N/A

CMPRESP

Maps directly to the tabulation variable listed in the Tabulation Target column.

(NY)

N/A

For pre-specified interventions, this is a hidden field on a CRF defaulted to "Y", or added during the tabulation dataset creation. If a study collects both pre-specified and free-text interventions, the value of CMPRESP should be "Y" for all pre-specified interventions and null for interventions reported as free text.

Interventions

CM

N/A

10

CMOCCUR

CM Occurrence

An indication whether the prespecified medication/treatment/therapy/product (CMTRT) or the group of medications/treatments/therapies/products was administered when information about the occurrence of a specific intervention was solicited.

Did the subject take [prespecified (concomitant) medication/treatment/therapy/product/dose]?; Has the subject taken [prespecified (concomitant) medication/treatment/therapy/product/dose/]?

[Specific (Concomitant) [Medication/Treatment/Therapy/Product]

Char

O

Indicate if [specific medication/treatment/product] was taken by checking Yes or No.

CMOCCUR

Maps directly to the tabulation variable listed in the Tabulation Target column. If the question was not asked or answered, populate the tabulation variable CMSTAT with "NOT DONE".

(NY)

N/A

CMOCCUR is used to report the occurrence of a pre-specified medication/treatment/product. CMOCCUR is not used for spontaneously free-text reported concomitant medication/treatments/products. The site should be able to indicate that the question was not asked or answered.

Interventions

CM

N/A

11

CMINGRD

Concomitant Meds Active Ingredients

Medication ingredients.

What were the active ingredients?

Active Ingredients

Char

O

Prior to a subject's clinical visit, remind all subjects to bring all medications bottles, packs etc. they are taking with them to their clinical visit. Record all active ingredient(s) off the intervention label and separate each ingredient with a comma for the name of drug, medication, treatment or product taken. For example, the medication Dolmen, if manufactured in Spain, the active ingredients should be collected as noted below: Active Ingredient: Acetylsalicylic Acid, Ascorbic acid, codeine phosphate.

N/A

Does not map to a tabulation variable.

N/A

This may be collected in addition to the medication/treatment/product name. Collecting this provides more detailed information when coding to a medication dictionary like WHODrug Dictionary Enhanced Format C, which codes to the ingredient level for many trade-name medications. For example, depending on the country where it is manufactured, the active ingredients in the medication dolmen may be different: In Spain, acetylsalicylic acid, ascorbic acid, codeine phosphate; in Italy and Czech Republic, tenoxicam; in Estonia and Latvia, dexketoprofen trometamol.

Interventions

CM

N/A

12

CMINDC

CM Indication

The condition, disease, symptom, or disorder that the concomitant (non-study) medication/treatment/therapy/product was used to address or investigate (e.g., why the medication/treatment/therapy/product was taken or administered).

For what indication was the (concomitant) [medication/treatment/therapy/product] taken?

Indication

Char

R/C

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

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

This is not the pharmacological/therapeutic classification of an agent (e.g., antibiotic, analgesic), but rather the reason for its administration to the subject. This additional information is collected on the CRF when applicants want to capture the reason(s) a subject took a medication/treatment/product. This information could be used as deemed appropriate for coding; analysis (e.g., in the classification of medications); reconciling medications/treatments/products taken by a subject with provided medical history; and/or AEs/SAEs, as part of the data clean-up and monitoring process.

Interventions

CM

N/A

13

CMAENO

Related Adverse Event ID

Identifier for the adverse event that is the indication for this medication/treatment/therapy/product.

What was the identifier for the adverse event(s) for which the (concomitant) [medication/treatment/therapy/product] was taken?

Adverse Event Identifier

Char

O

Record the identifier of the Adverse Event for which this (concomitant) [medication/treatment/therapy/product] was taken.

N/A

This does not map directly to a tabulation variable. For tabulation datasets, may be used to create RELREC to link this record with a record in the AE domain.

N/A

The intent is to establish a link between the medication/treatment and the AE that was reported. CMAENO can be used to identify a relationship between records in CM dataset and records in the AE dataset.

Interventions

CM

N/A

14

CMMHNO

Related Medical History Event ID

Identifier for the medical history condition that is the indication for this medication/treatment/therapy/product.

What was the identifier for the medical history event(s) for which the (concomitant) [medication/treatment/therapy/product] was taken?

Medical History Event Identifier

Char

O

Record the identifier of the medical history event for which this (concomitant) [medication/treatment/therapy/product] was taken.

N/A

This does not map directly to a tabulation variable. For tabulation datasets, may be used to create RELREC to link this record with a record in the MH domain.

N/A

The intent is to establish a link between the medical history condition and the intervention taken for the condition. CMMHNO can be used to identify a relationship between records in the CM dataset and records in the MH dataset.

Interventions

CM

N/A

15

CMDOSE

CM Dose per Administration

The dose of medication/treatment/product (e.g., --TRT ) given at one time, represented as a numeric value.

What was the individual dose (of the concomitant [medication/treatment/therapy/product] per administration)?

[Dose/Amount] (per administration)

Num

O

Record the dose of (concomitant) [medication/treatment/product] taken per administration (e.g., 200).

CMDOSE

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Used when the dose/amount taken/administered/consumed has only numeric entries. If non-numeric entries are possible, use the collection field CMDSTXT.

Interventions

CM

N/A

16

CMDSTXT

Concomitant Meds Dose Description

The dose of medication/treatment/product taken per administration.

What was the individual dose of the (concomitant) [medication/treatment/therapy/product]?

Dose

Char

O

Record the dose of (concomitant) [medication/treatment/product] taken per administration (e.g., 200).

CMDOSTXT; CMDOSE

This does not map directly to a tabulation variable. Numeric values map to CMDOSE in the tabulation dataset. Non-numeric values (e.g., "200-400") map to CMDOSTXT in the tabulation dataset.

N/A

Defining this data collection field as a dose text field allows for flexibility in capturing dose entries as numbers, text, or ranges. The data collected in this text-format field should be separated or mapped to either tabulation CMDOSE if numeric or CMDOSTXT if text.

Interventions

CM

N/A

17

CMDOSTOT

CM Total Daily Dose

The total amount of CMTRT taken over a day, using the units in CMDOSU.

What was the total daily dose of the (concomitant) [medication/treatment/therapy/product]?

Total Daily Dose

Num

O

Record the total dose of (concomitant) [medication/treatment/therapy/product] taken daily.

CMDOSTOT

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

For use when only total daily dose is collected on the CRF. For general medications/treatments/produts, it is not recommended to use Total Daily Dose. Instead, this can be calculated from other fields (e.g., Units, Dose, Frequency).

Interventions

CM

N/A

18

CMDOSU

CM Dose Units

The unit associated with the concomitant medication/treatment/therapy/product taken (e.g., mg in "2 mg 3 times per day").

What is the unit (for the dose of concomitant [medication/treatment/therapy/product])?

(Dose) Unit

Char

R/C

Record the dose unit of the dose of concomitant [medication/treatment/therapy/product] taken (e.g., mg.).

CMDOSU

Maps directly to the tabulation variable listed in the Tabulation Target column.

(UNIT)

(CMDOSU)

When applicants collect data for amount of dose taken (i.e., Dose, Total Daily Dose), Unit must be collected as well (if applicable).

Interventions

CM

N/A

19

CMDOSFRM

CM Dose Form

The pharmaceutical dosage form in which the CMTRT is physically presented.

What was the dose form of the (concomitant) [medication/treatment/therapy/product]?

Dose Form

Char

O

Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy/product] taken.

CMDOSFRM

Maps directly to the tabulation variable listed in the Tabulation Target column.

(FRM)

(CMDOSFRM)

Some drugs have multiple forms; this field may be needed to code the drug to an ATC level. However, in general, this level of detail should not be necessary except for medications/treatments/products of interest.

Interventions

CM

N/A

20

CMDOSFRQ

CM Dosing Frequency per Interval

The number of doses given/administered/taken during a specific interval.

What was the frequency of the (concomitant) [medication/treatment/therapy/product]?

Frequency

Char

O

Record how often the (concomitant) [medication/treatment/therapy/product] was taken (e.g., BID, PRN).

CMDOSFRQ

Maps directly to the tabulation variable listed in the Tabulation Target column.

(FREQ)

(CMDOSFRQ)

The frequency of the concomitant medication/treatment/product. When collected, the recommendation is to collect dosing information in separate fields (e.g., CMDOSE, CMDOSEU, CMDOSFRQ) for specific and consistent data collection and to enable programmatically using these data.

Interventions

CM

N/A

21

CMROUTE

CM Route of Administration

The route of administration of the concomitant medication/treatment/therapy/product.

What was the route of administration of the (concomitant) [medication/treatment/therapy/product]?

Route

Char

R/C

Provide the route of administration for the (concomitant) [medication/treatment/therapy/product].

CMROUTE

Maps directly to the tabulation variable listed in the Tabulation Target column.

(ROUTE)

(CMROUTE)

This additional information may be important to collect on the CRF when the applicant wants to capture a medication's/treatment's /product's route of administration, for purposes such as coding; also, the medication/treatment/product may have more than 1 route. Some companies may use route in coding medications/treatments/products, to be able to choose a precise preferred name and ATC code.

Interventions

CM

N/A

22

CMSTDAT

Concomitant Meds Start Date

The start date is when the concomitant medication/treatment/therapy/product was first taken, represented in an unambiguous date format (e.g., DD-MON-YYYY).

What was the (concomitant) [medication/treatment/therapy/product/dose] start date?

Start Date

Char

R/C

Record the date the concomitant [medication/treatment/product] was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant [medication/treatment/product] for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Concomitant [medication/treatment/product] taken during the study are expected to have a complete start date. Prior concomitant [medication/treatment/product] that are exclusionary should have both a start and end date.

CMSTDTC

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 CMSTDTC in ISO 8601 format.

N/A

The assumption is that applicants should either have a Start Date or will indicate that the medication,therapy or product was started before, during, or after the study period. The preferred method is to collect a complete Start Date. Partial dates (e.g., providing year only) for medications/treatment/product started a considerable amount of time prior to the start of study are acceptable.

Interventions

CM

N/A

23

CMSTTIM

Concomitant Meds Start Time

The time the concomitant medication/treatment/therapy/product was started, represented in an unambiguous time format (e.g., hh:mm:ss).

What was the (concomitant) [medication/treatment/therapy/product/dose] start time?

Start Time

Char

R/C

Record the time (as complete as possible) that the concomitant [medication/treatment/product] was started.

CMSTDTC

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 CMSTDTC in ISO 8601 format.

N/A

Recommend collecting the time a concomitant medication/treatment/product was started only when a protocol or data collection scenarios supports it. Typically, a start time is not collected unless the subject is under the direct care of the site at the time a concomitant medication/treatment/product administered or the subject records the start time in a diary.

Interventions

CM

N/A

24

CMPRIOR

Prior Concomitant Meds

Indication the concomitant medication/treatment/therapy/product was given or taken prior to [CMSTTPT] or prior to the date in DM.RFSTDTC.

Was the (concomitant) [medication/treatment/therapy/product] given/taken prior to [CMSTTPT]?; Was the (concomitant) [medication/treatment/therapy/product] given/taken prior to study start?

Prior to [CMSTTPT]; Prior to Study

Char

O

Check if the concomitant [medication/treatment/therapy/product] was started before the study.

CMSTRF; CMSTRTPT

This does not map directly to a tabulation variable. May be used to populate a value into a tabulation relative timing variable such as CMSTRF or CMSTRTPT. When populating CMSTRF, or CMSTRTPT, if the value of the collection field CMPRIOR is "Y" a value from the CDISC CT (STENRF) may be used. When CMPRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC), the tabulation variable CMSTRF should be populated. When CMPRIOR is compared to another time point, the tabulation variables CMSTRTPT and CMSTTPT should be used. Note: CMSTRTPT must refer to the time-point anchor described in CMSTTPT.

(NY)

N/A

Applicants may collect this information rather than start dates.

Interventions

CM

N/A

25

CMONGO

Ongoing Concomitant Meds

Indication the concomitant medication/treatment/therapy/product is ongoing when no end date is provided.

Was the (concomitant) [medication/treatment/therapy/product] ongoing (as of [the study-specific time point or period])?

Ongoing (as of [the study-specific time point or period])

Char

R/C

Record the concomitant [medication/treatment/therapy/product] as ongoing if the subject has not stopped taking the concomitant [medication/treatment/therapy/product] at [the timepoint defined by the study]. If the concomitant medication/treatment/therapy/product is ongoing, the end date should be left blank

CMENRF; CMENRTPT

This does not map directly to a tabulation variable. May be used to populate a value into a tabulation relative timing variable (e.g., CMENRF, CMENRTPT). When populating CMENRF, if the value of CMONGO is "Y", the values of "DURING", "AFTER", or "DURING/AFTER" may be used. When populating CMENRTPT, if the value of CMONGO is "Y", the value of "ONGOING" may be used. When CMONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable CMENRF should be populated. When CMONGO is used in conjunction with another time point, the tabulation variables CMENRTPT and CMENTPT should be used. Note: CMENRTPT must refer to a time-point anchor described in CMENTPT.

(NY)

N/A

This box should be checked to indicate that the concomitant medication/treatment/product has not stopped at the time of data collection. It is expected that every recorded medication/treatment/product should have either an end date or be checked as ongoing, but not both. However, in cases where ongoing concomitant medications/treatments/products are not permitted, it may not be necessary to include an Ongoing field in the CRF.

Interventions

CM

N/A

26

CMENDAT

Concomitant Meds End Date

The date that the subject ended/stopped taking the concomitant medication/treatment/therapy/product, represented in an unambiguous date format (e.g., DD-MON-YYYY).

What was the (concomitant) [medication/treatment/therapy/product/dose] end date?

End Date

Char

R/C

Record the date the concomitant [medication/treatment/product] was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant [medication/treatment/product] leave this field blank.

CMENDTC

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 CMENDTC in ISO 8601 format.

N/A

The assumption is that applicants should either have an End Date or will indicate that the medication, therapy or product was ongoing at the time of collection or at the end of the study. However, in cases where the end date can be determined from dates collected elsewhere in the CRF it is not necessary to include an End Date field on the CRF. For example, if all concomitant medications/treatments/products are administered only once during a trial, the end date will be the same as the start date.

Interventions

CM

N/A

27

CMENTIM

Concomitant Meds End Time

The time when the subject ended/stopped taking the concomitant medication/treatment/therapy/product, represented in an unambiguous time format (e.g., hh:mm:ss).

What was the [medication/treatment/therapy/product/dose] end time?

End Time

Char

R/C

Record the time (as complete as possible) that the concomitant medication/treatment/product was stopped.

CMENDTC

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 CMENDTC in ISO 8601 format.

N/A

Recommend collecting the time a concomitant medication,treatment, product was ended only when a protocol or data collection scenario requires it or the subject records the end time in a diary. Typically, an end time is not collected unless the subject is under the direct care of the site at the time a concomitant medication/treatment/product is stopped.

Interventions

CM

N/A

28

CMRSDISC TOBA-353 - Getting issue details... STATUS

Reason for Intervention Discontinuation

The reason the Intervention was discontinued.

What was the reason the (concomitant) [medication/treatment/therapy/product/--TRT] was [discontinued/stopped/ended]?

Reason for discontinuation of concomitant medication/treatment/therapy/product.

Char

O

Record the reason the concomitant medication/treatment/product was stopped.

CMRSDISC

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

Although frequently used for prior meds, this can be used for any intervention at any timepoint.

When the dosing is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the intervention.

Interventions

CM

N/A

29

CMDECOD

Standardized Medication Name

The dictionary or applicant-defined standardized text description of the topic variable, CMTRT, or the modified topic variable (CMMODIFY), if applicable.

N/A

Char

O

N/A

CMDECOD

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

This field does not typically appear on the CRF. Applicants will populate this through the coding process. Equivalent to the generic drug name in published (e.g., WHODrug, SNOMED, ICD9) or applicant-defined dictionaries.

Interventions

CM

N/A

30

CMCLAS

CM Medication Class

The class for the intervention (often obtained from a coding dictionary).

N/A

Char

O

N/A

CMCLAS

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

This field does not typically appear on the CRF. Applicants will populate this through the coding process. This would generally be the class code used for analysis.

Interventions

CM

N/A

31

CMCLASCD

CM Medication Class Code

The assigned dictionary code for the class for the intervention.

N/A

Char

O

N/A

CMCLASCD

Maps directly to the tabulation variable listed in the Tabulation Target column.

N/A

This field does not typically appear on the CRF. Applicants will populate this through the coding process. This would generally be the class code used for analysis.

Interventions

CM

N/A

32

CMATC1

ATC Level 1 Description

Dictionary text description of the first level of hierarchy within the Anatomical Therapeutic Chemical (ATC) classification system; indicates the anatomical main group.

N/A

Char

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC1" and SUPPCM.QLABEL="ATC Level 1 Description".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

33

CMATC1CD

ATC Level 1 Code

Dictionary code denoting the first level of hierarchy within the ATC classification system; indicates the anatomical main group.

N/A

Num

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM ="MATC1CD" and SUPPCM.QLABEL="ATC Level 1 Code".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

34

CMATC2

ATC Level 2 Description

Dictionary text description for the second level of hierarchy within the ATC classification system; indicates the therapeutic main group.

N/A

Char

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC2" and SUPPCM.QLABEL="ATC Level 2 Description".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

35

CMATC2CD

ATC Level 2 Code

Dictionary code denoting the second level of hierarchy within the ATC classification system; indicates the therapeutic main group.

N/A

Num

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC2CD" and SUPPCM.QLABEL="ATC Level 2 Code".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

36

CMATC3

ATC Level 3 Description

Dictionary text description of the third level of hierarchy within the ATC classification system; indicates the therapeutic/pharmacological subgroup.

N/A

Char

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC3" and SUPPCM.QLABEL="ATC Level 3 Description".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

37

CMATC3CD

ATC Level 3 Code

Dictionary code denoting the third level of hierarchy within the ATC classification system; indicates the therapeutic/pharmacological subgroup.

N/A

Num

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC3CD" and SUPPCM.QLABEL="ATC Level 3 Code".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

38

CMATC4

ATC Level 4 Description

Dictionary text description of the fourth level of hierarchy within the ATC classification system; indicates the chemical/therapeutic/pharmacological subgroup.

N/A

Char

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC4" and SUPPCM.QLABEL="ATC Level 4 Description".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

39

CMATC4CD

ATC Level 4 Code

Dictionary code denoting the fourth level of hierarchy within the ATC classification system; indicates the chemical/therapeutic/pharmacological subgroup.

N/A

Num

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC4CD" and SUPPCM.QLABEL="ATC Level 4 Code".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

40

CMATC5

ATC Level 5 Description

Dictionary text description of the fifth level of hierarchy within the ATC classification system; indicates the chemical substance.

N/A

Char

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC5" and SUPPCM.QLABEL="ATC Level 5 Description".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Interventions

CM

N/A

41

CMATC5CD

ATC Level 5 Code

Dictionary code denoting the fifth level of hierarchy within the ATC classification system; indicates the chemical substance.

N/A

Num

O

N/A

SUPPCM.QVAL

This does not map directly to a tabulation variable. This information could be represented in a SUPPCM dataset as the value of SUPPCM.QVAL where SUPPCM.QNAM="CMATC5CD" and SUPPCM.QLABEL="ATC Level 5 Code".

N/A

This field does not typically appear on the CRF. This is populated through the applicant's coding process.

Metadata Checks Findings

Metadata Check User Macros FAQ

Content: For variable N/A / N/A / CMRSDISC, it is either invalid in the Interventions class domain or not a recognized domain-specific variable

Assumptions

General medications/treatments/products are defined as any medications/treatments/products reported by a subject when asked if they have taken any medications in an open-ended way that does not ask about any specific intervention. Additional information might be sourced by referring to a subject’s medical record.
Medications of interest are defined as any medications or classes of interventions specifically mentioned in the protocol and were not the primary focus for determining the Collection Core designations for the domain.
As with all the data collection variables recommended in the TIG standard, it is assumed that applicants will add other data variables as needed to meet protocol-specific and other data collection requirements.
The CMOCCUR field provides a structure for capturing the occurrence of specific interventions of interest.

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CDASH Concomitant Medications (CM)