PRE CRF at Enrollment Visit

1. 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

2. 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

3. 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”

4. 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