E-Register of Studies
The electronic ENCePP register of studies is currently under development and its release is expected for 4th Quarter 2010
The electronic ENCePP register of studies aims to provide a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies. Its purpose is to:
- Increase transparency
- Reduce publication bias
- Promote information exchange
- Facilitate collaborations within the scientific community
- Facilitate optimal use of pharmacoepidemiology and pharmacovigilance expertise in Europe by preventing unnecessary duplication of research.
Registration of studies in the electronic register is mandatory only for “ENCePP studies”; it is voluntary for all other studies.
For clinical trials conducted in the EU, registration in the EUDRACT database is a legal obligation. Additional registration of clinical trials in the ENCePP e-register is only obligatory for “ENCePP studies”.
How to register an ‘ENCePP Study’:
Given that registration of studies in the electronic register is one of the three CoRe requirements to be met for a study to qualify as an ENCePP study, an interim solution has been developed pending finalisation of the database, enabling researchers to receive the ENCePP study seal.
The following steps have been put in place whilst the development of the database is being finalised:
- The “Data Entry Form” is available here for download.
- Investigators who wish to register their studies should fill in the form and send it by email to the ENCePP Secretariat. This needs to be done before the study starts.
- The original signed declaration, the checklist of the Code of Conduct and checklist of methodological standards should be sent to the ENCePP Secretariat (c/o EMA, 7 Westferry Circus, London E14 4HB, United Kingdom) before the study commences.
- A copy of the study protocol should also be submitted at this stage, either electronically (preferably as PDF file) or by post.
- Upon receipt of the documents, the ENCePP Secretariat checks for completeness of the “Data Entry Form”, the signed declaration and checklists, and assigns a provisional registration number to the study.
- The ENCePP Secretariat dispatches a letter signed by the Chair of the ENCePP Steering Group, confirming the a priori eligibility of the study to be considered as an “ENCePP study” and places the ENCePP study seal in the log of ENCePP study applications.
- The ENCePP Secretariat maintains a log of ENCePP study applications received during the interim phase. This log is published on the ENCePP website, and updated whenever new studies are added, or if the status of a study is changed.
- By clicking on individual entries included in the log it is possible to access pdf-versions of the related documentation (signed checklists, signed declaration, data entry form and any other information relevant to the study). This complies with the transparency requirements laid down in the Code of Conduct.
Any information and documents placed on the register during the interim phase will be migrated to the finalised database by the ENCePP Secretariat. Investigators will then be requested to check for accuracy of the migrated information.
How to register Non-ENCePP studies:
Please note that it is currently not possible to register non-ENCePP studies until finalisation of the dedicated database.
The electronic register of studies, once available, will be open to register all pharmacoepidemiological and pharmacovigilance studies regardless of whether there is an application for the ENCePP study seal or the research centre participating in the ENCePP network.
Investigators who only wish to register their studies, i.e. no request is made for an ENCePP study seal, need to submit a completed data entry form and any other relevant document they wish to make publicly available. There is no obligation to adhere to the ENCePP Code of Conduct or comply with the Checklist of Methodological Standards for ENCePP Study Protocols. However, investigators are required to regularly update the entry of their studies in the register.