On-Study Crohn's Disease Background Medication, Non-study Drugs

Illustrates Domains

CM
ADEFF

Illustrates Variables

CMTRT
CMROUTE
CMADJ
CMDOSFRQ
CMINDC
CMENRF

Content

CRF Instructions

At baseline visit indicate whether the subject is currently taking any of the medications for the Crohn's disease class of medication specified. At subsequent visits, indicate if the subject has had any medication changes since the last study visit for the Crohn's disease class of medication specified.

Section 1 - Background Crohn's Disease Medication: Subsequent Visits

SUBSEQUENT VISITS: Indicate if the there were any changes in the Crohn's background therapy since the last visit. If "Yes", record the appropriate information on the Background Crohn's Disease Medication CRF.	Were there any changes in the Crohn's disease background therapy since the last visit? CHG_CMYN Not submitted	Yes No <From NY codelist>

SUBSEQUENT VISITS: Indicate if the there were any changes in the Crohn's background therapy since the last visit. If "Yes", record the appropriate information on the Background Crohn's Disease Medication CRF.

Were there any changes in the Crohn's disease background therapy since the last visit?

CHG_CMYN Not submitted

<From NY codelist>

View CRF Metadata

Row Number	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTM Target Variable Mapping	Controlled Terminology Code List Name	CRF Implementation notes	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden
1	CHG_CMYN	Were there any changes in the Crohn's disease background therapy since the last visit?	Any Change	SUBSEQUENT VISITS: Indicate if the there were any changes in the Crohn's background therapy since the last visit. If "Yes", record the appropriate information on the <b>Background Crohn's Disease Medication CRF</b>.	text			(NY)	This is asked at all visits subsequent to baseline. It is used for EDC navigation to the appropriate form.	Yes;No

Section 2 - Background Crohn's Disease Medications

	Medication Category CMCAT Hidden/pre-populated	ON-STUDY BACKGROUND CROHN'S DISEASE MEDICATIONS
	CMINDC Hidden/pre-populated	CROHN'S DISEASE
Record medication subcategory.	Medication Subcategory CMSCAT	Biologics Immunomodulators Aminosalicylates (5-ASAs) Corticosteroids
Record only 1 treatment per line. Provide the full trade or proprietary name of the medication/treatment; otherwise, record the generic name.	What was the name of the medication taken? CMTRT	_________________
SUBSEQUENT VISIT ONLY: If the treatment dose was adjusted, Record the reason for the change	What was the reason for the dose adjustment? CMADJ	Treatment complete Worsening symptoms Improving symptoms Treatment no longer indicated
Record the date the concomitant medication/treatment was first taken using this format (DD-MON-YYYY).	Start 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 leave the end date blank.	Is the medication ongoing? CMONGO CMENRF	Yes No <From 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.	End date CMENDAT CMENDTC	_ _ / _ _ _ / _ _ _ _
Record the dose of medication/treatment per administration (e.g., 200).	What was the individual dose of the medication? CMDSTXT CMDOSTXT or CMDOSE	_________________
Record the dose unit of the dose of the biologic concomitant medication taken (e.g., mg).	What was the unit? CMDOSU	_____
Record how often the medication was taken (e.g., BID, PRN).	What was the frequency of the medication? CMDOSFRQ	_________________
Provide the route of administration for the medication.	What was the route of administration? CMROUTE	_________________

View CRF Metadata

Row	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTM Target Variable Mapping	Controlled Terminology Code List Name	CRF Implementation notes	Permissible Values	Pre-specified Value	Query Display	Hidden
1	CMCAT	What is the category for the concomitant medication?	Medication Category	Record the (concomitant) [medication/treatment/therapy] category, if not printed on the CRF.	text	CMCAT					ON-STUDY BACKGROUND CROHN'S DISEASE MEDICATIONS	Prompt	Y
2	CMINDC	N/A	N/A	N/A	text	CMINDC					CROHN'S DISEASE		Y
3	CMSCAT	What is the subcategory for the medication?	Medication Subcategory	Record medication subcategory.	text	CMSCAT				Biologics; Immunomodulators; Aminosalicylates (5-ASAs); Corticosteroids		Prompt	Y
4	CMTRT	What was the name of the medication taken?	Treatment Name	Record only 1 treatment per line. Provide the full trade or proprietary name of the medication/treatment; otherwise, record the generic name.	text	CMTRT
5	CMADJ	What was the reason for the dose adjustment?	Reason Adjusted	SUBSEQUENT VISIT ONLY: If the treatment dose was adjusted, Record the reason for the change	text	CMADJ			Sponsors may require that changes to a 0 dose are recorded as a change, along with the reason for this change.	Treatment complete; Worsening symptoms; Improving symptoms; Treatment no longer indicated
6	CMSTDAT	What was the start date for medication?	Start Date	Record the date the concomitant medication/treatment was first taken using this format (DD-MON-YYYY).	date	CMSTDTC
7	CMONGO	Is the medication ongoing?	Ongoing	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 leave the end date blank.	text	CMENRF		(NY)	This does not map directly to an SDTM variable. When populating CMENRF, if the value of CMONGO is "Y", the value of "DURING", "AFTER" or "DURING/AFTER" may be used. If the value remains as "Y" at the end of the study reference period, CMENRF will be "AFTER".	Yes; No
8	CMENDAT	What was the end date of for the medication?	End date	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.	date	CMENDTC
9	CMDSTXT	What was the individual dose of the medication?	Dose	Record the dose of medication/treatment per administration (e.g., 200).	text	CMDOSTXT; CMDOSE	CMDOSTXT or CMDOSE
10	CMDOSU	What was the unit?	Unit	Record the dose unit of the dose of the biologic concomitant medication taken (e.g., mg).	integer	CMDOSU
11	CMDOSFRQ	What was the frequency of the medication?	Frequency	Record how often the medication was taken (e.g., BID, PRN).	text	CMDOSFRQ
12	CMROUTE	What was the route of administration?	Route	Provide the route of administration for the medication.	text	CMROUTE