Vaccination History aCRF

Illustrates Domains

Illustrates Variables

CMOCCUR
CMYN
CMCAT
CMTRT
CMSTDAT

Content

This CRF was used to collect vaccination data. In this study, the sponsor collected vaccinations in a separate CRF using the category "Vaccinations", rather than in a general Concomitant/Prior Medications (CM) CRF.

This CRF is designed to use electronic data collection (EDC) dynamic navigation. At the initial visit, the question about vaccination history is shown. At all subsequent visits, the question about vaccinations received during the study are shown. The CRF questions used to report the vaccinations were the same at all visits.

Vaccination History - Baseline Visit

Indicate if the subject had any vaccinations within 6 months prior to study entry. If Yes, include the appropriate details where indicated on the CRF.	Has the subject had any vaccinations within the 6 months prior to study entry? CMOCCUR CMOCCUR where CMTRT="VACCINE" and CMEVLINT="-P6M"	No Yes <From NY codelist>

Indicate if the subject had any vaccinations within 6 months prior to study entry. If Yes, include the appropriate details where indicated on the CRF.

Has the subject had any vaccinations within the 6 months prior to study entry?

CMOCCUR CMOCCUR where CMTRT="VACCINE" and CMEVLINT="-P6M"

<From NY codelist>

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 Note	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
1	PSOR V1.0	CMOCCUR	Has the subject had any vaccinations within the 6 months prior to study entry?	Any Vaccination in the past 6 Months	Indicate if the subject had any vaccinations within 6 months prior to study entry. If Yes, include the appropriate details where indicated on the CRF.	Text	CMOCCUR where CMTRT="VACCINE" and CMEVLINT="-P6M"		(NY)	The sponsor decided to represent this information in the submission datasets.	No;Yes

Vaccination History - Subsequent Visits

Indicate if the subject has had any vaccinations during the study. If Yes, include the appropriate details where indicated on the CRF.	Has the subject had any vaccinations during the study? CMYN Not submitted	No Yes <From NY codelist>

Indicate if the subject has had any vaccinations during the study. If Yes, include the appropriate details where indicated on the CRF.

Has the subject had any vaccinations during the study?

CMYN Not submitted

<From NY codelist>

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 Note	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
1	PSOR V1.0	CMYN	Has the subject had any vaccinations during the study?	Any Vaccination during the Study	Indicate if the subject has had any vaccinations during the study. If Yes, include the appropriate details where indicated on the CRF.	Text			(NY)	This sponsor used this item only to navigate the investigator to the appropriate CRF page.	No;Yes

Vaccination Details

	Concomitant Medication Category CMCAT Hidden/pre-populated	VACCINATION
Record only 1 vaccination per line. Include any booster shots as separate entries.	What vaccination did the subject receive? CMTRT	_________________
Record the date the vaccination was administered using this format (DD-MON-YYYY). If the subject had the vaccination administered prior to the start of the study, it is acceptable to have an incomplete date. Vaccinations administered during the study are expected to have a complete start date.	Start Date CMSTDAT CMSTDTC	_ _ / _ _ _ / _ _ _ _

View CRF Metadata

Order	TAUG Reference	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	Pre-Populated Value	Query Display	Hidden
1	PSOR V1.0	CMCAT	What is the category for the medication?	Concomitant Medication Category	Record the medication category, if not pre-printed on the CRF.	Text	CMCAT	VACCINATION		Yes
2	PSOR V1.0	CMTRT	What vaccination did the subject receive?	Vaccination	Record only 1 vaccination per line. Include any booster shots as separate entries.	Text	CMTRT
3	PSOR V1.0	CMSTDAT	What was the start date?	Start Date	Record the date the vaccination was administered using this format (DD-MON-YYYY). If the subject had the vaccination administered prior to the start of the study, it is acceptable to have an incomplete date. Vaccinations administered during the study are expected to have a complete start date.	Date	CMSTDTC		prompt