Module232025

07/05/2025

Overview PIP procedure

2 nd discussion PDCO + OE Day 60

1 st discussion PDCO Day 30

Day 61 Update Sum Report

Adoption of Opinion

Stop Clock

Start Clock

Clock stop

60 days

60 days

Day 1 After

OE

3 rd discussion PDCO Day 90

Validation, Sum Report

Adoption of Opinion, OR List of Issues

OE= oral explanation

The Organisation for Professionals in Regulatory Affairs

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Importance of clock stop • The clock-stop is your chance of amending the PIP during the procedure. • Due to time constraints, no major changes to the PIP can be made after restart of procedure. • If major change of study is made at day 90, you will need to withdraw PIP.. • …and submit new PIP.. All new/amended study synopses must be submitted for the restart procedure !!

The Organisation for Professionals in Regulatory Affairs

20