Registering with Clinicaltrials.gov
Changes to ClinicalTrials.gov Registration and Results Entry Requirements Effective 1/18/2017
On 9/16/2016, the Department of Health and Human Services (DHHS) released a Final Rule and NIH released a new policy that describe changes to their requirements for clinical trial registration and results submission.
The Final Rule describes the legal requirements for clinical trial registration and results submission and replaces the legal requirements described by Section 801 of the Food and Drug Amendments Act of 2007 (FDAAA). View a table comparing the Final Rule to FDAAA.
The new NIH policy is in most ways similar to the Final Rule, except that NIH now requires that all NIH-funded clinical trials register and submit results, whether or not the trial is required to register the Final Rule. Thus, the NIH policy now covers more types of trials than the law, including phase 1 studies, device feasibility studies, and trials that do not involve any FDA-regulated product, such as trials involving only behavioral interventions. View a table comparing the new NIH policy to the Final Rule.
Final Rule Compliance Dates: The Final Rule will become effective on 1/18/2017, and trials that are required by law to be registered (i.e., “applicable clinical trials”) must be in compliance with the Final Rule by 4/18/2017. The new registration requirements described in the Final Rule will apply to trials initiated on or after 1/18/2017, and the new results submission requirements of the final rule will apply to trials that reach their primary completion date on or after 1/18/2017. Trials initiated before 1/18/17 will follow the registration requirements in place before the Final Rule went into effect (that is, the requirements set forth by FDAAA), and trials that reach their primary completion date before 1/18/2017 will follow the results submission requirements of FDAAA.
NIH Policy Compliance Dates: The new NIH policy applies to applications submitted on or after 1/18/2017 for clinical trials initiated on or after 1/18/17, as well as to competing renewal applications that include a new clinical trial (i.e., a clinical trial initiated on or after the effective date of the policy). Compliance will be a term and condition of NIH awards. This policy does not apply to: 1) NIH-funded clinical trials initiated before the effective date of 1/18/17, 2) clinical trials that use NIH-supported infrastructure but do not receive NIH funds to support their conduct, or 3) clinical trials of ongoing, non-competing awards.
LINKS TO RESOURCES FOR CHANGES TO CLINICALTRIALS.GOV REQUIREMENTS:
Informed Consent Upload per the Revised Common Rule
Section 45 CFR 46.116(h) of the revised Common Rule states that for clinical trials conducted or supported by a Federal department or agency, one IRB-approved informed consent form (ICF) that was used to enroll subjects must be posted by the awardee on a publicly available Federal Web site. This requirement applies to all federally-funded clinical trials that were initially approved by an IRB on or after January 21, 2019. For the purposes of determining whether a study approved with conditions is subject to the revised Common Rule, the date that the IRB voted to conditionally approve the study is the date that should be used (rather than the date that all conditions were met). The ICF must be posted after the clinical trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol. The UTHealth PI is responsible for ensuring that the ICF is uploaded on time. For UTHealth PI-initiated clinical trials, investigators will post ICFs to ClinicalTrials.gov. Redactions of, for instance, confidential commercial information are permitted—before posting any ICF to ClinicalTrials.gov, contact the UTHealth PRS Administrator at email@example.com, who will coordinate a review of the ICF to identify any information that should be redacted, as well as provide guidance on the legally required methods for redaction and preparation of the file for upload.
Which Trials Must be Registered and Submit Results by Law?
Studies that must be registered and submit results by law are called “Applicable Clinical Trials," which are defined at this link. The Final Rule and FDAAA have the same definition of Applicable Clinical Trial. These trials most generally include:
- Interventional Trials of Drugs and Biologics, other than phase 1 drug studies
- Interventional Trials of Devices, other than device feasibility studies
- Pediatric Post-Market Surveillance Studies
Which Trials Must be Registered and Submit Results per NIH Policy?
NIH policy requires registration and results entry for all NIH-funded clinical trials, whether or not the trial is required to register by law. Thus, the NIH policy covers more types of trials than the law, including phase 1 drug studies, device feasibility studies, and trials that do not involve any FDA-regulated product, such as trials involving only behavioral interventions. NIH provides guidance on their definition of clinical trial at this link.
Who is Responsible for Registration and Results Submission by Law and per NIH policy?
The entity responsible for registering and submitting results is the "Responsible Party,” defined at this link and this link. For UTHealth PI-initiated studies, the UTHealth PI is designated the Responsible Party and is responsible for registration and results submission. For industry-sponsored trials or multi-site trials, the industry sponsor or lead site is typically responsible for registration and results submission. Note that only one record should be created for a trial.
Steps for Registering Your Clinical Trial at ClinicalTrials.gov
- Contact Protocol Registration System (PRS) Administrator to request a PRS account:
Elizabeth Massey Gendel, PhD
- Receive a login name and a temporary password from ClinicalTrials.gov by email
- Access the PRS website at: http://register.clinicaltrials.gov
Your User ID is generally your first initial immediately followed by your last name.
- Change your temporary password.
- Click "New Record" on the top left corner of the main page and then follow the prompts for creating your record.
- The Responsible Party (i.e., the PI of the study) is responsible for entering trial information, ensuring that it is correct, and updating the registry in a timely manner and as required by federal law.
- Once you have completed all sections, click "Complete."
- The PI, as Responsible Party, will then "Approve" and "Release" the record (i.e., submit the record to ClinicalTrials.gov for review).
- 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.
When are Results due by Law and per NIH Policy?
The Responsible Party must post results to the record no later than one year after the study's Primary Completion Date, which is the "date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated."
Registration and Publication in Medical Journals
Medical journals following the International Committee of Medical Journal Editors (ICMJE) guidelines require registration as a condition of publication. Note that the ICMJE guidelines require registration of trials of all intervention types, including trials that do not involve any FDA-regulated product, such as trials involving only behavioral interventions. Additionally, phase 1 drug studies and device feasibility studies must be registered per the ICMJE guidelines. The ICMJE guidelines do not require results submission.
- ICMJE gives a definition of a clinical trial at this link:
- "ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events."
- U.S. Public Law 110-85
- FDA Amendments Act of 2007 (FDAAA)
- NIH Guidance on Law
- ICMJE FAQs
- PRS and U.S. Public Law 110-85
- NIH FAQs on clinical trial registration
- How to Register Your Study
- How to Submit Your Results
- Data Element definitions for clinicaltrials.gov
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