Last update: 24th September 2021
- Annex I. Trial documentation and identification of documents when loaded into the ECM Portal
(Version 10th December 2019, Correction dated on 22nd September 2021) - Annex II. Safety related documentation that the sponsor should submit to the health authorities of the Autonomous Communities (AC)
(Version 22nd February 2018) - Annex III. Suitability of the investigator
(Version 13th January 2016) - Annex IV. Suitability of the facilities
(Version 23rd June 2017) - Annex VA. Insurance certificate Model
(Annex number updated on 10th December 2019) - 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 22th April 2021) - 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. Annual follow-up report of the clinical trial
(Version 10th December 2019) - Annex XII. Report on exceptional measures adopted to manage the problems derived from the COVID-19 emergency
(version 29th June 2020)