Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1

Document Information

Document information
Reference	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
Validity area	EU
Scope(s)	NIS
Document name	GVP: Module VIII EMA/813938/2011
Version / Revision	Rev. 3 (2017)
Status	Current
Document type	Official guideline
Language(s)	EN
Description	Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3)
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	NIS
Document part	VIII.B.4.3.1
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Progress report and interim report requirements (PASS)

Text

VIII.B.4.3. Study reports VIII.B.4.3.1. Progress report and interim report of study results The progress report is meant to include relevant information to document the progress of the study, for example, the number of patients who have entered the study, the number of exposed patients or the number of patients presenting the outcome, problems encountered and deviations from the expected plan. The progress report may include an interim report of study results. The interim report of study results is meant to include results of any planned interim analysis of study data before or after the end of data collection. Upon request from a national competent authority, progress reports for PASS imposed as an obligation or conducted voluntarily shall be submitted to the competent authorities of the Member States in which the study is conducted [DIR Art 107m(5)]. They may also be requested by the Agency for PASS concerning centrally-authorised products. Requests for progress reports may be made before the study commences or any time during the study conduct. They may be guided by the communication of riskbenefit information arising from the study or the need for information about the study progress in the context of regulatory procedures or important safety communication about the product. Requirements and recommendations for submission of progress reports are specified in GVP Module VIII Addendum I. The timing of the submission of progress reports should be agreed with the relevant competent authorities and specified in the study protocol when they have been agreed before the study commences.