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"
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<From NY codelist> |
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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
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<From NY codelist> |
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Vaccination Details
| Record only 1 vaccination per line. Include any booster shots as separate entries. |
CMTRT
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_________________ | |
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| 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
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