Requirements of clinical trial registration

Are you compliant with the requirements of clinical trial registration for all your clinical trials?

Registration of clinical trial is mandatory for transparent research and ethical conduct of any clinical trial. Per International Committee of Medical Journal Editors Policy, all clinical trials should be registered in a public registry before enrolment of the first participant for the trials to be considered for publication. The clinical trials should be registered on the applicable Primary Registries in the World Health Organization registry network.

Per the final rule, all Phase 2 to 4 interventional clinical trials need to be registered on ClinicalTrials.gov within 21 days of enrolment of the first participant.
Per the revised Clinical Trials Information System (CTIS) rules, all clinical trials should be registered in the EU database prior to being started.
The clinical trial registration is not mandatory for Phase 1 or small feasibility studies on Clinical Trials.gov based on the applicable regulations (although, most of the Sponsors voluntarily register their Phase 1 clinical trials).
Failure to register a clinical trial may attract civil monetary penalties (up to $10000 per day) and withholding of federal funds for funded clinical trials. Though EMA does not state any monetary penalty, Member States shall lay down rules on penalties applicable to noncompliance on the information intended to be made publicly available to the EU database.

The registration of clinical trials on publicly accessible database serves following purposes:
1. Provides information to potential participants and referring clinicians
2. Fulfil ethical obligations to participants and the research community
3. Reduce publication bias and selective reporting
4. Promote more efficient allocation of research funds
5. Help institutional review boards (IRBs) determine the appropriateness of a trial

Are you compliant with the requirements of clinical trial registration?