Prior Psoriasis Treatments aCRF

Illustrates Domains

Illustrates Variables

CMCAT
CMTRT
CSPDEVID
CMONGO
CMRSDISC

Content

This CRF shows data collected on prior psoriasis treatments. The sponsor planned to investigate the use of prior biologic therapies on the results of the study treatment. The specific type and dose of phototherapy were not collected; an SDTM example can be found in Section 5.1, Phototherapy Administration.

	Concomitant Medication Category CMCAT Hidden/pre-populated	ANTIPSORIATIC
Indicate if the subject had any prior psoriasis treatments. If Yes, include the appropriate details where indicated on the CRF.	Has the subject had any psoriasis treatments before the study start? CMOCCUR CMOCCUR WHERE CMTRT="ANTIPSORIATIC" and CMPRESP="Y" and CMSTRF="BEFORE"	No Yes <From NY codelist>
Record the treatment subcategory.	What is the subcategory for the treatment? CMSCAT	BIOLOGIC NON-BIOLOGIC PHOTOTHERAPY
Record only 1 treatment per line. Provide the full trade or proprietary name of the; otherwise, the generic name may be recorded.	What was the name of the treatment? CMTRT	_________________
Provide the route of administration for the treatment.	Route CMROUTE	ORAL SUBCUTANEOUS TOPICAL TRANSDERMAL <From ROUTE codelist>
Record the dose of medication per administration (e.g., 200).	If the treatment was systemic, what was the individual dose? CMDSTXT CMDOSTXT or CMDOSE	_________________
If the medication was systemic, record the unit of the dose of medication taken (e.g., mg).	What was the unit? CMDOSU	<From UNIT codelist>
Record the device that was used for drug administration.	If the medication was a biologic, what device was used for drug administration? CSPDEVID SPDEVID	SINGLE-DOSE PEN MULTIPLE-DOSE PEN PRE-FILLED SYRINGE SYRINGE NOT APPLICABLE
Record the date the treatment was first started using this format (DD-MON-YYYY). If the subject has been taking the medication for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Prior treatments that are exclusionary should have both a start date and an end date.	Start Date CMSTDAT CMSTDTC	_ _ / _ _ _ / _ _ _ _
Record the treatment as ongoing if the subject has not stopped the treatment or medication at the time of data collection; the end date should be left blank.	Is the treatment ongoing? CMONGO CMENRF or CMENRTPT	Yes No <From NY codelist>
Record the date the treatment was stopped using this format (DD-MON-YYYY). If the subject has not stopped the treatment or taking the medication, leave this field blank.	End Date CMENDAT CMENDTC	_ _ / _ _ _ / _ _ _ _
Record the primary reason the treatment was discontinued.	What was the reason for treatment discontinuation? CMRSDISC	INADEQUATE EFFICACY ADVERSE EVENT OTHER-NOT RELATED TO EFFICACY/ADVERSE EVENTS

View CRF Metadata

Order	TAUG Reference	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTM Target Mapping	Controlled Terminology Code List Name	CRF Implementation Notes	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
1	PSOR V1.0	CMCAT	What is the category for the treatment?	Concomitant Medication Category	Record the treatment category, if not preprinted on the CRF.	Text	CMCAT					ANTIPSORIATIC			Yes
2	PSOR V1.0	CMOCCUR	Has the subject had any psoriasis treatments before the study start?	Prior Psoriasis Treatments	Indicate if the subject had any prior psoriasis treatments. If Yes, include the appropriate details where indicated on the CRF.	Text	CMOCCUR	CMOCCUR WHERE CMTRT="ANTIPSORIATIC" and CMPRESP="Y" and CMSTRF="BEFORE"	(NY)		No;Yes
3	PSOR V1.0	CMSCAT	What is the subcategory for the treatment?	Concomitant Medication Subcategory	Record the treatment subcategory.	Text	CMSCAT				BIOLOGIC;NON-BIOLOGIC;PHOTOTHERAPY
4	PSOR V1.0	CMTRT	What was the name of the treatment?	Concomitant Medication	Record only 1 treatment per line. Provide the full trade or proprietary name of the; otherwise, the generic name may be recorded.	Text	CMTRT
5	PSOR V1.0	CMROUTE	What was the route of administration of the treatment?	Route	Provide the route of administration for the treatment.	Text	CMROUTE		(ROUTE)		ORAL;SUBCUTANEOUS;TOPICAL;TRANSDERMAL		prompt
6	PSOR V1.0	CMDSTXT	If the treatment was systemic, what was the individual dose?	Dose	Record the dose of medication per administration (e.g., 200).	Text	CMDOSTXT; CMDOSE	CMDOSTXT or CMDOSE
7	PSOR V1.0	CMDOSU	What was the unit?	Unit	If the medication was systemic, record the unit of the dose of medication taken (e.g., mg).	Text	CMDOSU		(UNIT)		CAPSULE;g;IU;mg;mL;PUFF;TABLET;ug;mg/kg
8	PSOR V1.0	CSPDEVID	If the medication was a biologic, what device was used for drug administration?		Record the device that was used for drug administration.		SPDEVID			The "NOT APPLICABLE" response is not submitted. The sponsor would also need to submit the appropriate Device Domains (e.g., DI).	SINGLE-DOSE PEN;MULTIPLE-DOSE PEN;PRE-FILLED SYRINGE; SYRINGE;NOT APPLICABLE
9	PSOR V1.0	CMSTDAT	What was the start date?	Start Date	Record the date the treatment was first started using this format (DD-MON-YYYY). If the subject has been taking the medication for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Prior treatments that are exclusionary should have both a start date and an end date.	Date	CMSTDTC						prompt
10	PSOR V1.0	CMONGO	Is the treatment ongoing?	Ongoing	Record the treatment as ongoing if the subject has not stopped the treatment or medication at the time of data collection; the end date should be left blank.	Text	CMENRF; CMENRTPT	CMENRF or CMENRTPT	(NY)		Yes;No			checkbox
11	PSOR V1.0	CMENDAT	What was the end date?	End Date	Record the date the treatment was stopped using this format (DD-MON-YYYY). If the subject has not stopped the treatment or taking the medication, leave this field blank.	Date	CMENDTC						prompt
12	PSOR V1.0	CMRSDISC	What was the reason for treatment discontinuation?	Reason for Discontinuation of Treatment	Record the primary reason the treatment was discontinued.	Text	CMRSDISC				INADEQUATE EFFICACY;ADVERSE EVENT;OTHER-NOT RELATED TO EFFICACY/ADVERSE EVENTS