PRE CRF at Enrollment Visit Severity Grade Resolved conditions - do not update severity Just mark “no” for ongoing at Enrollment Acute conditions – update as needed; that is, if severity has changed since SV (higher or lower severity) Ex. Grade 2 earache originally reported at SV that improves to Grade 1 at EV

PRE CRF at Enrollment Visit – con’t Chronic conditions – assign severity at SV based on current status. Update at EV only if there is clear indication/evidence the condition has changed in severity. In “Comments”, add details about typical frequency of episodes and severity of episodes Ex. #1 Hypertension At SV, bp is grade 2 At EV, bp is grade 1; update PRE entry to grade 1, ongoing at Enrollment The PRE-CRF can be found in the Screening Visit tab in the training binder (look at this together)

PRE CRF at Enrollment Visit – con’t Ex.2 Menstrual cramping At SV, described by ppt at Grade 2 for past year At EV, she says she has milder cramps at her last menses, which was between SV and EV Keep PRE grade as 2, ongoing at Enrollment, and note milder recent cramps in “Comments”

Documenting PRE Resolution Will need to have a way to know if pre-existing conditions have resolved during follow-up, as this will impact AE reporting If a PRE resolves during follow-up, then re-occurs, it will need to be documented as an AE One tool – Pre-existing Conditions Resolution Tracking document Transcribe all PREs ongoing at EV; record resolution dates as they become available