Question 1. Study identification
|Field / Label Name||Guidance Note|
|Official title||Please enter the official full title of the study as stated in the protocol.|
|EU PAS Register number||This field will be populated automatically and will contain the unique study reference number (format: EUPASNNNNNN).|
|Study title acronym||Please enter the acronym, if existing, or initials used to identify this study.|
|Study type||Please select the type of study among the possible options or provide a brief description if none of the possible choices apply to your study.|
|EUDRACT Number||Only if study type is clinical trial. Format YYYY-NNNNNN-CC. This is an optional field.|
|Brief description of the study||Please provide a short description of the study intended for the public. The description should include the rationale and the objective(s) of the study.|
|Was this study originally requested by a regulator?||Please answer yes to this question if conduct of this study was specifically requested by a regulatory body. Also please specify country of Regulator(s).|
|RMP study category||A post-authorisation study may constitute a pharmacovigilance activity required in the Risk Management Plan (RMP) of an authorised medicinal product. Studies are categorized as follows, according to regulatory procedure. Please select one option to indicate the RMP category of your study as applicable (the RMP category may be clarified with the marketing authorization holder):
EU RMP category 1 (imposed as condition of marketing authorisation) A post-authorisation safety study (PASS) may be imposed as condition of the marketing authorisation because it is key to the benefit-risk profile of the product. In the EU Risk Management Plan (EU RMP) these studies are referred to as category 1 studies in the pharmacovigilance plan of an authorised medicinal product. If the condition is a non-interventional PASS, it will be subject to the supervision set out in Art 107 (m)-(q) of Directive 2001/83/EC and the format and content of such non-interventional PASS as described in Implementing Regulation 526/2012 Annex III (see GVP Module VIII).
EU RMP category 2 (specific obligation of marketing authorisation) A PASS may be a specific obligation in the context of a conditional marketing authorisation (MA) or a MA under exceptional circumstances. In the EU RMP these studies are referred to as category 2 studies in the pharmacovigilance plan of an authorised medicinal product. If the specific obligation is a non-interventional PASS, it will be subject to the supervision set out in Article 107 (m)-(q) of Directive 2001/83/EC and the format and content of such non-interventional PASS as described in Implementing Regulation 526/2012 Annex III (see GVP Module VIII).
EU RMP category 3 (required) PASS which do not fall in category 1 or 2 but are required to investigate a safety concern as part of the pharmacovigilance plan of an authorised medicinal product are legally enforceable. In the EU RMP these studies are referred to as category 3 studies (see GVP Module VIII).
Non-EU RMP only PASS which are included in risk management systems outside the jurisdiction of EU medicines regulation (e.g. Risk Evaluation and Mitigation Strategies (REMS) under US regulation).
Not applicable Any post-authorisation study (PAS) which is not subject to regulatory supervision and not a RMP pharmacovigilance activity.
|Other study registration identification number(s)||Please provide information on whether this study has been registered elsewhere (free text max. 2000 characters). This field may also contain a universal resource locator (URL).|