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Results FAQs

1. Am I required to post clinical trial results at this stage?
The European Commission has published guidance which describes the inclusion of clinical trial results and can be found here:Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006). This process is now operational in EudraCT version 9.

 

2. What are the required modalities and timings of posting result-related information for different trial types?
Please refer to Commission Guideline (2012/C 302/03) here.

 

3. What are the different record statuses of trial result records in EudraCT
The trial results in EudraCT have the following three statuses: draft (when results are being prepared), posted (when the results have passed the validation stage) and finalised (when the results are final and are published if the trial record meets the publication rules). When results are in draft, the data can be updated at any time.

 

4. Will results for PIP and/or paediatric trials have to be provided within 6 months of the end of the trial? Does this accelerated timeline only refer to trials after marketing authorisation?
Result-related information for paediatric trials should be posted to EudraCT within 6 months of the end of the trial. Result-related information for non-paediatric trials included in an agreed PIP should be posted within 12 months of the end of the trial. This is irrespective of whether the product is authorised or not.

 
5. Are results required in EudraCT for phase 1 studies in adults. Will they be publicly posted in the EU CTR?
All the results for phase I-IV clinical trials are required to be posted to EudraCT. However, Phase 1 trials, which are conducted solely in adults and which are not part of an agreed PIP are not made public.
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