Registering with Clinicaltrials.gov
Which trials must be registered?
Trials that must be registered under the Act are called “applicable clinical trials.” Under the statute, these trials generally include:
- Trials of Drugs and Biologics: Controlled, *clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and
- Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
*The FDA defines a clinical investigation as any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Purely observational studies are exempt from registration requirements.
- Professional Publication - ICMJE guidelines currently define a clinical trial as, “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. NIH encourages registration of ALL trials whether required under the law or not, and ICMJE advises that those who are uncertain whether their trial meets the ICMJE definition of eligible trials should err on the side of registering if they wish to seek publication in an ICMJE journal. See ICMJE FAQs
Who is responsible for registering trials on ClinicalTrials.gov?
The entity responsible for registering is the “responsible party.” The statute defines the responsible party as:
(1) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3)
(2) the principal investigator of such clinical trial if so 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 data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.” See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)).
Steps for registering and "releasing" your clinical trial through UTHealth
- Contact Protocol Registration System (PRS) Administrator:
Elizabeth.M.Gendel@uth.tmc.edu at 713-500-3587.
- Request account setup for PRS users, provide user ID, full user name and email address
- Receive by return email from ClinicalTrials.gov a login name and a temporary password
- Access the PRS website here: http://register.clinicaltrials.gov.
"Organization"= UTexas_Houston. Your User ID is generally your first initial immediately followed by your last name.
- Browse the Main Menu page. Follow the instructions for changing the temporary password. Refer to the “User’s Guide” for additional information.
- Go to Main Menu > Protocol Records > Create, then follow the prompts for creating your registration. As the PI or designee, you are responsible for entering your trial information, ensuring that it is correct, and updating the registry in a timely manner and as required by federal law.
- The Responsible Party should always be the Principal Investigator.
- Restrict your objectives to your Primary Objective and only one or two Secondary Objectives.
- Once you have completed all sections, go to the top, left corner of this screen and click the word "Complete."
- Your PI, as Responsible Party, can then "Approve" and "Release" the record to the clinicaltrials.gov listing.
- Records are made available to the public through the ClinicalTrials.gov website within 2 to 5 days of release, following system validation and quality assurance review. New records may take up to 10 business days to be assigned an NCT number and appear in the databank.
Per the Act, the party responsible for the listing (PI or Sponsor) must also include study results in the registry. The results submissions should include lay language summaries of subject demographics and characteristics, primary and secondary outcomes, and disclosures of any privacy agreements. Timelines for this information are set forth (see related links below). Results must be submitted within 1 year of the end of the study (when the final patient attends the final visit).
How else does the FDA Amendments Act of 2007 affect UTHealth Investigators?
The FDA has the authority to enforce compliance to these clinical trial registry requirements put forth by the Act. If a sponsor fails to register any trial which meets the eligibility criteria, fails to submit trial results, or submits false data or information, the NIH will post a notice describing the infractions on the registry data bank. The FDA is also authorized to impose monetary penalties for failure to comply with the requirements of the Act. Any person who violates the provisions of the Act will be subject to penalties up to $10,000. After 30 days of notification, uncorrected violations could incur additional $10,000 daily penalties until the violation is corrected.
Please refer to FDA Amendments Act of 2007 for more information.