REGISTER TRIALS ON CLINICALTRIALS.GOV
The FDA regulations require the responsible party to register applicable clinical trials. The responsible party is the sponsor of the clinical trial, meaning the person who initiates a clinical investigation.
If unclear as to who is responsible registering an applicable clinical trial, investigators should consult with the sponsor, funding agency, and/or other study investigators to define who the responsible party will be.
GUIDANCE ON POSTING INFORMED CONSENT FORMS FOR NIH-FUNDED CLINICAL TRIALS
The Revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision. The for must be posted after recruitment closes, and no later than 60 days after the last study visit.
FDA regulations require the responsible party to register applicable clinical trials. The responsible party is the sponsor of the clinical trial, meaning the person who initiates a clinical investigation.
If unclear as to who is responsible registering an applicable clinical trial, investigators
should consult with the sponsor, funding agency, and/or other study investigators
to define who the responsible party will be.
Institutions submitting documents to either ClinicalTrials.gov or Regulations.gov must protect participant privacy in accordance with applicable federal, state, and local laws and regulations (e.g., the HIPAA Privacy Rule, Certificates of Confidentiality) and any applicable terms of their NIH award.
In order for the Office of SVP Research to monitor compliance with this requirement, please send an email to email@example.com with the name of the PI and the Study Name once you have uploaded your consent.
MANAGE TRIALS ON CLINICALTRIALS.GOV
The individual or entity responsible for registering the study (responsible party) is responsible for ensuring that the information is complete, accurate, and updated. This includes reviewing the listing and making necessary changes every six months or more frequently if significant changes occur. You are also responsible for noting when enrollment ceases. All correspondence from ClinicalTrials.gov will come to the e-mail address of the owner of the account the trial was registered under.
AU SUPPORT FOR CLINICALTRIALS.GOV
Step 1: Search ClinicalTrials.gov to ensure that the trial is not already listed. NIH-sponsored clinical trials and many industry-sponsored trials have already been registered on this site. If the trial is not listed, continue.
Step 2: Establish an account with the ClinicalTrials.gov Protocol Registration System (PRS) by sending an e-mail message to AU’s PRS administrator, (firstname.lastname@example.org). The subject line should state “ClinicalTrials.gov Protocol Registration,” and the body of the message should contain your name, telephone number, and email address. Within two business days, you will receive an e-mail message from ClinicalTrials.gov containing your login name and temporary password
Step 3: Upon receipt of your login information, proceed with registering the trial. This process will take approximately one hour, and it will be helpful to have the protocol, informed consent document, and IRB approval (if available) on hand. IRB approval is not required to register a trial. Note that this system offers the option to save data if you do not have time to complete the entire process. A list of all the variables you will be asked to provide can be found at http://prsinfo.clinicaltrials.gov/definitions.html.
To complete the protocol template, begin from the “Main Menu” page, go to “Protocol Record” and select “Create.” You can copy and paste information from the protocol into the data fields.
Recent changes in the NIH definition of a clinical trial may now require that your study be registered at ClinicalTrials.gov.
NEW NIH CLINICAL TRIALS DEFINITION
"A research study in which one or more human subjects are prospectively assignedprospectively assignedPROSPECI to one or more interventionsinterventionsi (which may include placebo or other control) to evaluate the effects of those interventions
on health related biomedical or behavioral outcomes."
DOES YOUR STUDY MEET THE NIH DEFINITION OF A CLINICAL TRIAL?
health-related biomedical or behavioral outcomes.
NIH FAQ ON THE DEFINITION OF A CLINICAL TRIAL
FOR COMPETING RENEWAL APPLICATIONS
Competing renewal applications that include studies that are required to be registered must include as part of the Human Subjects Section of the Research Plan the following items:
FOR NEW APPLICATIONS
New applications that include studies required to be registered must include as part of the Human Subjects Section of the Research Plan a statement that “This application includes a trial which requires registration in ClinicalTrials.gov.” The study would then be registered, and the National Clinical Trial (NCT) number, Brief Title as listed in ClinicalTrials.gov, and the individual or entity responsible for registering the study for each study being conducted under the application will be part of the required Just-In-Time (JIT) information. If a New application does not include studies that are required to be registered, the Human Subjects Section of the Research Plan should include a statement that “This application does not include a trial which requires registration in ClinicalTrials.gov.”
FOR NON-COMPETING PROGRESS REPORTS
Non-competing progress reports that include studies that are required to be registered must include as part of the Human Subjects Section of the Progress Report the following items:
If the application does not include studies that are required to be registered, the Human Subjects Section of the Research Plan should include a statement that “This application does not include a trial which requires registration in ClinicalTrials.gov.” These requirements apply to all non-competing progress reports with budget start dates of April 1, 2008 or later (applications due on or after 2/1/08).
FDA REGULATIONS SPECIAL REQUIREMENTS FOR IND, IDE, OR BLA STUDIES
Studies conducted under an IND or IDE must include in the informed consent documents and the informed consent process a statement that clinical trial information for the study has been or will be submitted for inclusion in ClinicalTrials.gov as required by FDA regulations.
A certification must accompany human drug, biological, and device product submissions made to FDA. At the time of submission of an IND, IDE, or BLA application or submission of a report, amendment, supplement or resubmission, such application or submission must be accompanied by a certification that all applicable requirements related to clinical trial registration have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers.
The official certification form, FDA 3674 entitled "Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank is available on the FDA's website.
For sponsor held INDs, IDEs, and BLAs, the sponsor must provide the certification. For investigator held INDs, IDEs, and BLAs, the individual holding the IND, IDE, or BLA must provide the certification.
Where can I find more information from the NIH about the requirement to register clinical trials? https://grants.nih.gov/policy/clinical-trials.htm