Concomitant Medications


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.


Concomitant and prior medications should be coded outside of the CRF collection page.

Variable

Decision

Rationale

CMYN

Modified Question text to Were/Was any (concomitant) [medication(s)/treatment(s) taken?

Chose the most common text. Individual users should select the text that is most appropriate for their study

DOSFRQO

Created a variable for dose frequency other

Give the ability for the user to select “other dose”, a dose not part of the drop-down list

ROUTEO

Created a variable for route other

Give the ability for the user to select “other route”, a route not part of the drop-down list

CMDOSTXT, CMDOSFRQ, CMROUTE

Created a subset of the most popular choices

The codelists are lengthy – users should subset the list to what is most appropriate for their study

 


"Form CM - Concomitant Medications [CDASH_2-1_FO_3]" Form Preview
Form CM - Concomitant Medications
CM - Concomitant Medications Header
Were any medications/therapies taken? No  Yes  
CM - Concomitant Medications       [No information given about how to repeat this Field Group] 
What was the (concomitant) [medication/treatment/therapy] (name/term)? For what indication was the (concomitant) [medication/treatment/therapy] taken? What was the individual dose of the (concomitant) [medication/treatment/therapy]? What is the unit (for the dose of concomitant [medication/treatment/therapy])? Other, Specify What was the dose form of the (concomitant) [medication/treatment/therapy]? Other, Specify What was the frequency of the (concomitant) [medication/treatment/therapy]? Dose Frequency Other, Specify What was the route of administration of the (concomitant) [medication/treatment/therapy]? Other, Specify What was the (concomitant) [medication/treatment/therapy/dose] start date? Was the (concomitant) [medication/treatment/therapy] ongoing (as of [the study-specific time point or period])? What was the (concomitant) [medication/treatment/therapy/dose] end date?
 01 Jan 2000
No  Yes  
 01 Jan 2000
* Mandatory field

Package(s)
CM eCRF Package