Vaccination History aCRF

Illustrates Domains

CM

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"

<From NY codelist>

View CRF Metadata


OrderTAUG ReferenceCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NameCRF Implementation NotePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1PSOR V1.0CMOCCUR

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


Any Vaccination in the past 6 MonthsIndicate if the subject had any vaccinations within 6 months prior to study entry. If Yes, include the appropriate details where indicated on the CRF.TextCMOCCUR 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

<From NY codelist>

View CRF Metadata


OrderTAUG ReferenceCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NameCRF Implementation NotePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1PSOR V1.0CMYNHas the subject had any vaccinations during the study?Any Vaccination during the StudyIndicate 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

CMCAT Hidden/pre-populated
VACCINATION
Record only 1 vaccination per line. Include any booster shots as separate entries.
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.
CMSTDAT CMSTDTC
_ _ / _ _ _ / _ _ _ _
View CRF Metadata


OrderTAUG ReferenceCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NameCRF Implementation NotePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1PSOR V1.0CMCATWhat is the category for the medication?Concomitant Medication CategoryRecord the medication category, if not pre-printed on the CRF.TextCMCAT



VACCINATION

Yes
2PSOR V1.0CMTRTWhat vaccination did the subject receive?VaccinationRecord only 1 vaccination per line. Include any booster shots as separate entries.TextCMTRT







3PSOR V1.0CMSTDATWhat was the start date?Start DateRecord 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.DateCMSTDTC




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