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FAQs on Clinical Trials Registration

What is Clinical Trials Registration?
Clinical Trials registration is public disclosure of key information of a clinical trial. The US Food and Drug Administration (FDA), the International Committee of Medical Journal Editors (ICMJE), and the World Health Organization (WHO) are just a few of the groups calling for clinical trials registration. The registry developed and maintained by the National Library of Medicine at NIH is the most commonly used such registry and can be accessed at ClinicalTrials.gov.


Why have clinical trial registries developed?
Allegations of selective publication and biased reporting of clinical trials have led to the demand for full disclosure and transparency. Clinical trial registries are one way to provide this transparency.


Do I have to register my clinical trials?

(1) Section 801 of the Food and Drug Administration Amendments Act of 2007 requires the following studies to register:

  • Phase 2 – 4 Interventional studies;
  • Studies involving drugs, biologics, or medical devices regulated by FDA;
  • Studies that have at least one site in the US or is conducted under an IND or IDE; and
  • Studies initiated or ongoing as of September 27, 2007 or later

For more information regarding ‘applicable clinical trials’, see Elaboration of Definitions of Responsible Party and Applicable Clinical Trials.

(2) The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial. ICJME requires registration of any human research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.


Who makes up ICMJE?
ICMJE signatories:
New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, The Lancet, The Medical Journal of Australia, The New Zealand Medical Journal, Norwegian Medical Journal, Canadian Medical Association Journal, Croation Medical Journal, Dutch Journal of Medicine, Journal of the Danish Medical Association.


Who is responsible for completing the registration?
FDA regulated research:

  • The sponsor of the clinical trial, as defined/identified under the FDA regulations This is generally the IND/IDE holder and could be either the company or the investigator.
  • The Principal Investigator of the clinical trial if designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the date from the clinical trial, and has the right to publish the results of the trial.

For additional details, please see Elaboration of Definitions of Responsible Party and Applicable Clinical Trials.


For ICMJE Registration:
While anyone involved in the clinical trial could register the trial, in practice this responsibility usually falls with the individual submitting the publication to the ICMJE journal, which is usually the Principal Investigator.


I just received an email from ClinicalTrials.gov informing me that my record is “In Progress”. What does “In Progress” mean to me? NIH identifies the progress of clinical trials registration in stages. “In Progress” means that you are creating (or modifying) the record.


I just received an email from ClinicalTrials.gov informing me that my record is “Completed”. What does “completed” mean to me?
NIH identifies the progress of clinical trials registration in stages. “Completed” means you have finished entering the data for this study and the record is now ready for our review.


I just received an email from ClinicalTrials.gov informing me that my record is “Approved”. What does “approved” mean to me?
NIH identifies the progress of clinical trials registration in stages. “Approved” means the Institutional Administrator has reviewed the record and has made any necessary changes.


I just received an email from ClinicalTrials.gov informing me that my record is “Released”. What does “released” mean to me?
NIH identifies the progress of clinical trials registration in stages. “Released” means the Institutional Administrator has released the record for posting to ClinicalTrials.gov.


Why can I not find my trial in ClinicalTrials.gov?
After a protocol record has been entered (or modified) and marked as ‘Complete’, it must be approved and released by a PRS administrator. From the time the record is released, it normally takes between 2 and 5 working days for internal quality assurance review and processing for publication on the ClinicalTrials.gov website. Records that contain Results may take up to 30 days.


When will the "NCT number" for my trial be assigned?
The NCT number is assigned following quality assurance review, just prior to publication on ClinicalTrials.gov (see above). The NCT number then becomes visible in the protocol Registration System (PRS).


Who should I list as the sponsor in the ClinicalTrials.gov database?
a. If your study was initiated and funded by a pharmaceutical or device company, the company is the sponsor. Check with them about registration.
b. If your study is funded by the federal government and you are the grantee, the granting agency is the sponsor. Send us the grant number and title and we will work with ClinicalTrials.gov to get you registered through the granting agency.
c. If the study is funded (or not) in any other way, your “home hospital/institution” is considered the “sponsor”.


Who is the “Oversight Authority” the ClinicalTrials.gov database?
a. If your study involves a drug, biologic or device, the oversight authority should be listed as: United States: Food and Drug Administration.
b. If your study does not fall under the FDA’s purview, the oversight authority should be listed as: United States: Institutional Review Board.


What about collaborators?
List all collaborators applicable to a specific trial. If ClinicalTrials.gov does not have a match for a collaborator in their system, a link to ‘recognize it’ will appear.


I'm a DFHCC investigator, do I register with my home institution, MGH, BWH or Faulkner Hospital?
Yes, register with your home institution and list DFHCC as a collaborator. DFCI Administrator will assist investigators affiliated with MGH, BWH or Faulkner with entering their study data into ClinicalTrials.gov registry. Once trial registration is complete, administrator will notify Partners registration administrator to transfer the record to investigator’s ClinicalTrials.gov account.


What is the NIH Public Policy Access?
NIH Public Policy Access ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.


Is this policy the same as the requirement for registering clinical trials?
NO.
These are two separate and unrelated requirements.