VIII.B.2. Study registration

For non-interventional PASS conducted pursuant to an obligation imposed by an EU competent authority, the date of study registration in the electronic study register shall be included as a milestone in the final study report [IR Annex III]. For this purpose, the EU PAS Register maintained by the Agency and accessible through the European medicines web-portal serves as the electronic study register (8) .

In order to support transparency on all non-interventional PASS and to facilitate exchange of pharmacovigilance information between the Agency, national competent authorities and marketing authorisation holders, the marketing authorisation holders should also enter in the EU PAS Register all non-interventional PASS required in the risk management plan agreed in the EU or conducted voluntarily in the EU.

Non-interventional PASS should be registered in the EU PAS Register before the study commences or at the earliest possible date, for example if data collection had already started for a study included in the risk management plan. The study protocol should be uploaded as soon as possible after its finalisation and prior to the start of data collection. Updated study protocols in case of substantial amendments, progress reports and the final study report should also be entered in the register (as soon as possible and preferably within two weeks after their finalisation). Study information should normally be submitted in English. If the study protocol or the study report is written in another language, the marketing authorisation should facilitate access to study information by including an English translation of the title, the abstract of the study protocol and the abstract of the final study report.

Where prior publication of the protocol could threaten the validity of the study (for example, in studies with primary data collection where prior knowledge of the study objective could lead to information bias) or the protection of intellectual rights, a study protocol with redactions made by the marketing authorisation holder may be entered into the register prior to the start of data collection. These redactions should be justified and kept to the minimum necessary for the objective aimed by the redaction process. Whenever a redacted study protocol is published prior to the start of data collection, the title page of the protocol should include the mention “Redacted protocol” and the complete study protocol should be made available to the Agency and national competent authorities upon request. The complete study protocol should be entered in the register as soon as possible and preferably within two weeks after the end of data collection.