Reporting study results to reviewing comittees and trial registers
Within one year after the completion of the study (worldwide), the sponsor/principal investigator must submit a summary of the results of the study and/or publications to the reviewing committee (MERC or Competent Authority). If the CCMO has been the reviewing committee, the summary of the results can be uploaded through ToetsingOnline.
For trials involving medicinal products, the sponsor/principal investigator must send the final results within the year following completion to:
- The competent authority. A model for the summary of a final report for a drug trial is available on the CCMO website.
- Add to the European Eu Clinical Trial Register (input through CTIS)
The results will then be entered after valid reporting in EudraCT, with the exception of most Phase I studies involving adults.
* For registration studies involving children, a time limit of six months after completion of the study applies.
: for studies which obligate to the regulations of the ECTR a summary of the final results must be send to the involved member states, including a summary written in a manner that is understandable to laypersons. For more information see the ECTR regulation.
Note: It is important that the status of your study is updated into the trial register in which it is registered and that the results are entered.