Last update: June 25th, 2025
- Annex I. Trial documentation and identification of documents when loaded into the ECM Portal or CTIS Portal
(Version 31st January 2022) - Annex II. Suppressed.
- Annex III. Suppressed.
- Annex IV. Suitability of the facilities
(Version 27th March 2023) - Annex VA. Insurance certificate Model
(Version 27th March 2023) - Annex VB. Additional Responsibility Commitment in relation to coverage of clinical trial insurance
(Version 10th December 2019) - Annex VI. Sponsor’s commitment for non-commercial clinical trials Model
(Version 9th May 2016) - Annex VII. Certificate of site / organization representative for low intervention clinical trials Model
(Version 9th May 2016) - Annex VIIIA. Guideline for correct preparation of a model patient information sheet and informed consent form (PIS/ICF)
(Version 25th June 2025) - Annex VIIIB. Paragraphs to be included in the Informed Consent Form for the collection and use of biological samples in clinical trials
(Version 20th December 2017, Date of Publication: 24 April 2018) - Annex IX. Minimum documentation necessary for requesting management of the contract to conduct clinical trials between the sponsor and the research sites. Date: 6th October 2016
(Version 10th November 2016) - Annex X. Contact persons for managing a contract with a research site
(Version 22nd February 2018) - Annex XI. Suppressed.
- Annex XII. Suppressed.
- Annex XIII. Compliance with Regulation for management of biological samples
(Version 18th November 2022)