ENCePP Study Seal

1. The ENCePP Study Seal concept

Key to ENCePP is to uphold high standards throughout the research process based on the principles of robust methodologies, transparency and scientific independence.

To recognise studies following the ENCePP principles of standards, transparency and independence, the 'ENCePP Study Seal' has been introduced. The Seal publicly identifies such studies and acts a a form of quality mark that can be reproduced in publications etc.

Studies conducted in accordance with the following principles may qualify for the ‘ENCePP Study Seal’:

• The study's primary purpose is to generate data of potential scientific or public health importance and not to promote the sale of a medicinal product;
• The design of the research is not aimed towards producing a pre-specified result;
• The highest possible level of transparency regarding the use of methodological standards in the study protocol;
• The contractual arrangements between investigators and the study funder clearly define the research assignment and address critical areas of interaction, remuneration, protocol agreement, analysis of results and publication of results;
• Remuneration is only granted as specified in the research contract and independent of a particular study result;
• The study is registered in the EU PAS Register prior to its start, thereby making publicly available information on the research process;
• The study results (synopsis or manuscript) are published in the EU PAS Register in line with agreed timelines.

2. Conditions for the ENCePP Study Seal

Any pharmacoepidemiological and pharamcovigilance study may qualify for the 'ENCePP Study Seal' if ALL of the following conditions are met:

I. The (primary) lead investigator belongs to an entity that is included in the ENCePP Inventory of Centres and Networks.

II. The (primary) lead investigator provides the following documentation of commitment to comply with the provisions of the ENCePP Code of Conduct prior to study start:

  • Signed Checklist of the ENCePP Code of Conduct (Code of Conduct Annex 2)
  • Signed Declaration on compliance with the ENCePP Code of Conduct (Code of Conduct Annex 3)
  • Signed ENCePP Checklist for Study Protocols
  • Declaration of Interests (Code of Conduct Annex 5)

III. The study is registered in the EU PAS Register together with the full protocol prior to study start.

The documents listed under point II. should be submitted in electronic format (scanned signed originals) to the ENCePP Secretariat (email: ENCePP_Secretariat@ema.europa.eu) within the timelines described below. No signature is required on the Declaration of Interests form which may be emailed directly to the ENCePP Secretariat following completion on screen.

3. The application process: step-by-step

The flow chart below shows the steps of applying for the ENCePP Study Seal including timelines for the submission of documents to the ENCePP Secretariat. The application process should be started at least one month prior to the actual study start date to ensure steps 1 and 2 are completed satisfactorily before the study commences. The original and final versions of the protocol are made publicly available after the final study report.

4. Display of the seal

Provided all the conditions described in section 2. are met, a study will a priori be granted the ENCePP Study Seal. A confirmation will be sent to the (primary) lead investigator and the 'ENCePP Study Seal' symbol will be displayed in the EU PAS Register next to the study title. The ENCePP Study Seal will make instantly recognisable to the general public that the study is conducted in adherence to the ENCePP research principles and methodological standards.

Investigators are reminded of the ongoing obligations the ENCePP Study Seal places on the conduct of a study, namely to adhere to the entirety of the provisions of the ENCePP Code of Conduct throughout the research process. With respect to the EU PAS Register, researchers are obliged to:

• Keep the study record updated in line with the agreed milestones;
• Upload the original and final versions of the protocol;
• Make publicly available a synopsis of the main study results.

The ENCePP Secretariat should be informed without delay if a study deviates from and/or no longer follows the provisions of the Code.

See also: Q&A on the ENCePP Seal