Prior Psoriasis Treatments aCRF

Illustrates Domains

CM

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.

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"

<From NY codelist>

Record the treatment subcategory. What is the subcategory for the treatment?
CMSCAT
Record only 1 treatment per line. Provide the full trade or proprietary name of the; otherwise, the generic name may be recorded.
CMTRT
_________________
Provide the route of administration for the treatment. Route
CMROUTE

<From ROUTE codelist>

Record the dose of medication per administration (e.g., 200).
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
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.
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

<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.
CMENDAT CMENDTC
_ _ / _ _ _ / _ _ _ _
Record the primary reason the treatment was discontinued. What was the reason for treatment discontinuation?
CMRSDISC
View CRF Metadata
OrderTAUG ReferenceCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NameCRF Implementation NotesPermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1PSOR V1.0CMCATWhat is the category for the treatment?Concomitant Medication CategoryRecord the treatment category, if not preprinted on the CRF.TextCMCAT



ANTIPSORIATIC

Yes
2PSOR V1.0CMOCCURHas the subject had any psoriasis treatments before the study start? Prior Psoriasis TreatmentsIndicate if the subject had any prior psoriasis treatments. If Yes, include the appropriate details where indicated on the CRF.TextCMOCCUR

CMOCCUR WHERE CMTRT="ANTIPSORIATIC" and CMPRESP="Y" and CMSTRF="BEFORE"

(NY)
No;Yes



3PSOR V1.0CMSCATWhat is the subcategory for the treatment?Concomitant Medication Subcategory

Record the treatment subcategory.

TextCMSCAT


BIOLOGIC;NON-BIOLOGIC;PHOTOTHERAPY





4PSOR V1.0CMTRTWhat was the name of the treatment?Concomitant MedicationRecord only 1 treatment per line. Provide the full trade or proprietary name of the; otherwise, the generic name may be recorded.TextCMTRT







5PSOR V1.0CMROUTEWhat was the route of administration of the treatment?RouteProvide the route of administration for the treatment.TextCMROUTE
(ROUTE)
ORAL;SUBCUTANEOUS;TOPICAL;TRANSDERMAL
prompt

6PSOR V1.0CMDSTXT

If the treatment was systemic, what was the individual dose?

DoseRecord the dose of medication per administration (e.g., 200).TextCMDOSTXT;  CMDOSECMDOSTXT or CMDOSE






7PSOR V1.0CMDOSU

What was the unit?

UnitIf the medication was systemic, record the unit of the dose of medication taken (e.g., mg).TextCMDOSU
(UNIT)
CAPSULE;g;IU;mg;mL;PUFF;TABLET;ug;mg/kg



8PSOR V1.0CSPDEVID

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





9PSOR V1.0CMSTDATWhat was the start date?Start DateRecord 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.DateCMSTDTC




prompt

10PSOR V1.0CMONGOIs the treatment ongoing?OngoingRecord 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.TextCMENRF;  CMENRTPTCMENRF or CMENRTPT(NY)
Yes;No

checkbox
11PSOR V1.0CMENDATWhat was the end date?End DateRecord 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.DateCMENDTC




prompt

12PSOR V1.0CMRSDISCWhat was the reason for treatment discontinuation?Reason for Discontinuation of TreatmentRecord the primary reason the treatment was discontinued.TextCMRSDISC


INADEQUATE EFFICACY;ADVERSE EVENT;OTHER-NOT RELATED TO EFFICACY/ADVERSE EVENTS