PIP Annual Report

We are currently preparing a PIP Annual Report submission in IRIS and I wonder if you can help me with the following information?
1. Will the application form generated within the IRIS system replace the need to provide the populated PIP annual deferral report PDF template?
2. What is the definition of the "Actual or planned start of study" to be included in the scientific information section? If study is not yet started does should this date equal the "date of initiation" date in the most recent PIP decision?

In answer to the questions:

1. There is no need to provide additional documents in an annual report on PIP deferred measures. The information in the portal forms is sufficient. If the applicant desires, it is possible to provide additional documents with the submission, but this is optional. 
2. There can be two possible situations:
   • The study has already started: please put the actual start date of the study (for clinical trials, this is usually first patient first visit)
   • The study has not started yet: please put the currently planned date of start, regardless of what was agreed in the PIP (if anything).