Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Public consultation document on "draft implementing technical guidance - List of fields for result-related information to be submitted to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41 of Regulation (EC) No 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01".
Apart from this initiative, please note that the information contained in EudraCT (ie protocol-related information) is going to be made publicly accessible, in accordance with the applicable guidelines, in September 2010.
Period of consultation
From 1 June 2010 to 30 September 2010.
Contributions to and results of the consultation
One submitting party (SEC Associates) requested not to publish its submission.
Below are the public responses to the above-mentioned public consultation:
- ACRO - Association of Clinical Research Organizations
- AESGP - Association of the European Self-Medication Industry
- Astellas
- AstraZeneca
- Celgene
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- Elan Pharma international Ltd
- EORTC - European Organization for Research and Treatment of Cancer
- EUCROF European CRO Federation
- EuropaBio, the European Association of Bioindustries
- European Union geriatrics Medicine Society
- FP7 PREDICT consortium
- German Clinical Trials Register
- Hoffmann-La-Roche, Basel
- Professor Dr David Hutchinson - Brookwood International Academy/Canary Ltd
- H. Lundbeck A/S
- Novo Nordisk A/S
- Les Laboratoires Servier : [1] - [2]
Objective of the consultation
At present, no result-related data is uploaded in EudraCT. This draft document sets out the details as to how result-related information should be uploaded in EudraCT in the future. This draft document is herewith submitted for public consultation.
The consultation document
The consultation document can be downloaded here:
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.