Tutorials on posting results on EudraCT

In order to post results in EudraCT, please follow the steps below:

1. Set up an EMA account on the EMA website and use the new credentials to register as results user on the EudraCT website (log in using EMA credentials, click on “become a results user”, log out and log in again).
       → in case of login problems (inactive accounts/forgotten password): refer to EMA account management



2. Request assignment to become the primary user for your trial: download the form, and fill it in, inserting your results user email as Requestor's email, then log in, click on “your page” and “request assignment”, insert your trial's details and upload the filled in form.



3. Ask another person to set up an EMA account and register as results user (see step 1) and nominate him/her as back-up user



4. Go to “your page”, click on “edit” nearby your trial and upload results as:
   
   

   a summary attachment (e.g. pdf file), if the end of trial date of your trial is before 21st of July 2013 and your trial is not part of a PIP/Art 46 or in case your trial was prematurely ended, no subjects recruited, or only partial results are available. You can also notify that your trial was transitioned to CTIS and its results will be posted there (this is not mandatory)

   a full data set, in all other cases. You can refer to the Data Dictionary (column I) to know how to fill in each field. Tutorials may also be of help: -  Trial Information -  Subject Disposition -  Baseline Characteristics -  End Points -  Adverse Events -  More Information

    
5. If you have uploaded the full data set, validate results. To correct errors/warnings, refer to the validation rules (look for your error/warning and see the relevant “rule description”).



6. Make sure to post your results, after you have uploaded them, by clicking on “post results” at the top right corner of the webpage.

Once posted, results can be modified through either amending the posted version (within two weeks from posting) or posting an additional version (once results are 'finalised', two weeks after posting): see EudraCT results: updating of posted/finalised results.



To practice posting results, you can use the EudraCT training environment.

For questions, please refer to our Frequently Asked Questions. If the answer to your question is not there, Contact us.