ClinicalTrials.gov Registration

 

Frequently Asked Questions (FAQs)

 

What is the requirement?

The International Committee of Medical Journal Editors (ICMJE) announced that in order for clinical trial results to be considered for publication in journals that adhere to ICMJE standards, all clinical trials that start recruiting on or after July 1, 2005 must be registered with a public registry before the enrollment of the first patient. Ongoing trials not registered at inception will be considered by the ICMJE for publication if they are registered before September 13, 2005. Details of this requirement are described at the International Committee of Medical Journal Editors web site.

Note: This is not a regulatory requirement related to human subjects research.

 

What is the purpose of this requirement?

As described on the ICMJE web site, the Committee’s purpose is “to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making,” and to foster conditions in which decisions about care “rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish.”

 

How is “clinical trial” defined?

The ICMJE Web site defines a clinical trial as “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.”

 

The phrase “medical intervention” suggests that this requirement applies only to biomedical clinical trials. Is that correct?

No. “Medical intervention” is defined as any intervention used to modify a health outcome. According to the ICMJE, this term includes “drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.”

 

Does it apply only to industry-sponsored clinical trials?

No. It does not matter who the sponsor is or whether there is an external sponsor.

 

Are there any exceptions?

Yes. ICMJE’s goal is to register “clinically directive” trials – “trials whose primary purpose is to affect clinical practice.” Excluded are trials whose “primary goal is to assess major unknown toxicity or determine pharmacokinetics.”

Note this important advice from the ICMJE: If in doubt about whether a trial is “clinically directive,” register it.

 

Where/what are the registries?

The ICMJE describes the characteristics of an acceptable trial registry and the required minimal data for each trial. One of the registries that meets the ICMJE descriptive criteria is ClinicalTrials.gov, a service of the NIH, developed by the National Library of Medicine. To find out more about the Protocol Registration System (PRS) at ClinicalTrials.gov, visit the PRS Information web site.

 

Who does the registration?

The PI is responsible for ensuring that registration requirements are met. Even though some sponsors will do the actual registration work for the PIs, it is still the PI’s responsibility to ensure that the registration has been accomplished. Before enrolling subjects, every PI should ask the trial’s sponsor, “Is this clinical trial fully registered?” Assuming an affirmative response, investigators should personally check the registry indicated by the sponsor to ensure that all ICMJE Minimal Registration Data Set elements are included.

• NIH-sponsored trials should be registered by the Institute that is funding the research.
• Industry-sponsored trials (industry-written protocol) should be registered by the sponsor.
• Investigator-initiated trials (for which industry has supplied drug or grant funds) should be registered by the PI.
• Trials for which PIs hold their own INDs or IDEs should registered by the PI.
• Multi-site trials should be should be coordinated among the sites and registered by the “lead sponsor” so that ClinicalTrials.gov does not receive multiple registrations for the same trial.
• For registration instructions, see below “How do PIs register their trials?”

 

How is the University involved?

 The OSU is already registered as an institution at ClinicalTrials.gov. ClinicalTrials.gov asks each institution to identify a PRS administrator. At the OSU, the administrator is the Human Protections Administrator in the Office of Sponsored Program and Research Compliance.

 

How do PIs register their trials?

If after reading this information, you determine that you need to register your clinical trial at ClinicalTrials.gov, follow these steps:

1. Send an email message to: irb@oregonstate.edu
2. Include in the message your name, telephone number, and email address.
3. Receive by return email from ClinicalTrials.gov a login name and a temporary password.
4. Go to the Clinicaltrials.gov Registration web site.
5. Complete the login fields.
6. Browse the Main Menu page. Under “User Account,” follow the instructions for changing your temporary password as soon as possible. Refer to the “User’s Guide” for additional information. As the PI, you are a “user,” and you are responsible for entering the information about your trial, ensuring that the information is correct, and updating the information in a timely manner.
7. On the Main Menu page, under Protocol Record hit “Create” and complete the study description template. Note that the ICMJE/WHO required fields are marked in green. Complete the following (potentially confusing) fields as follows:
   • Organization’s Unique Protocol ID: Use the OSU IRB Application Number.
   • Board Chair: Wayne Kradjan, Pharm.D.; (541) 737-5785; Wayne.Kradjan@oregonstate.edu; Pharmacy, Oregon State University, Corvallis, Oregon, 97331.
   • Oversight Authorities: If this is not an FDA-regulated protocol, state “ United States:IRB”
   • Sponsor: The database will default to “ Oregon State University” (although OSU is not actually the trial’s sponsor).
   • Collaborators: Sponsorship can be clarified by entering the actual sponsor’s name as an “agency.” For example, if this is an investigator-initiated clinical trial and you (the PI) hold the IND/IDE, list yourself.
   • Record Verification Date: Enter the date on which you complete and submit the template. Note: The PI is responsible for periodic updates to the study record, e.g., when enrollment has been completed or if the protocol changes, the PI is responsible for changing the record.
   • Last Follow-Up Date: Skip this field.
   • Data Entry Closure Date: Skip this field.
   • Conditions: Use the MeSH controlled vocabulary (provided). If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.
   • Keywords: Use the MeSH controlled vocabulary (provided). If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.
   • If the PI did not personally complete the template, send the draft template to him/her for review and approval. Note: This is an important step.

8. Submit the completed, PI-approved, template. The completed template will go to the OSU PRS administrator. The administrator will check to be sure that the trial has been approved by the IRB and will release the template to ClinicalTrials.gov.

 

 

Does the registration posting need review by the Institutional Review Board (IRB)?

No. While it is true that ClinicalTrials.gov was initially established as a place where potential subjects and others could obtain information about clinical trials, the primary intent of registration is to ensure that research results can be published in scientific journals. Registration is performed by completing a template, and there is little, if any, room for creativity. The OSU IRB will not review the postings.