ClinicalTrials.gov

Responsibilities

All investigators are responsible to know if their study meets the NIH definition of a clinical trial, and if so, to register the study on Clinical Trials.gov. Investigators are also responsible for completing the appropriate CITI Training.

PI's responsibilities for ClinicalTrials.gov include the following:

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.

For investigator-initiated trials, the lead principal investigator responsible for initiating, conducting, and coordinating the overall clinical trial is responsible for registration
For sponsor-initiated trials, the sponsor is responsible for registration
For trials sponsored or funded wholly or in part by the NIH, the Principal Investigator is responsible for registration
For trials associated with Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications with the FDA, the IND/IDE holder is responsible for registration
The sponsor, grantee, contractor, or awardee may designate the principal investigator of a clinical trial as the responsible party, provided that 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 for submitting information under the law

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.

clinicaltrials.gov - Help for researchers

clinicaltrials.gov - CHECKLIST

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.

For investigator-initiated trials, the lead principal investigator responsible for initiating, conducting, and coordinating the overall clinical trial is responsible for registration
For sponsor-initiated trials, the sponsor is responsible for registration
For trials sponsored or funded wholly or in part by the NIH, the Principal Investigator is responsible for registration
For trials associated with Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications with the FDA, the IND/IDE holder is responsible for registration
The sponsor, grantee, contractor, or awardee may designate the principal investigator of a clinical trial as the responsible party, provided that 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 for submitting information under the law

Investigators receiving NIH funds for a clinical trial whose Informed Consent is in the English-language may:

Submit to ClinicalTrials.gov Informed Consents for studies that have been registered on ClinicalTrials.gov. Within the Study record, the Informed Consent can be uploaded in the Document Section, just below the Protocol Section. Below are the steps to upload a single document.

To upload a single document for the first time:
1. Click on the "+ New Document" button on the Document Section page.
2. Select the appropriate document type.
3. Enter the Document Date from the document cover page.
4. Click on the "Browse..." button and locate the PDF/A file for upload.
5. Click on the green "Upload" button.
(Do not upload non-English language documents.)

Or:

If submitting to Regulations.gov website, upload the consent form to Docket ID: HHS-OPHS-2018-0021

Investigators receiving NIH funds for a clinical trial whose Informed Consent is NOT in the English-language may:

Upload the consent form to Docket ID: HHS-OPHS-2018-0021 on the Regulations.gov website.

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 ctgov_consents@augusta.edu with the name of the PI and the Study Name once you have uploaded your consent.

REMINDER If uploading consents to regulations.gov, keep a copy of receipt and tracking #.

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, (svpresearch@augusta.edu). 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. View a list of all the variables you will be asked to provide.

To begin the registration process, go to the gov registration website, and complete the login fields. In the "Organization" field, enter AugustaU.
The "Main Menu" page will appear. The "User Account" link provides information on changing your temporary password, and this should be done as soon as possible. This link also has a helpful "User’s Guide"

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.

NIH Changes

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 assigned to one or more interventions (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? NIH FAQ on the Definition of a Clinical Trial

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:

A statement that "This application includes a trial which requires registration in ClinicalTrials.gov,"
National Clinical Trial (NCT) number (i.e. the ClinicalTrials.gov number)
Brief Title as listed in ClinicalTrials.gov, and
Name of the individual or entity responsible for registering the study for each study being conducted under the application. (As grantee, Augusta University designates the lead investigator of the trial as the responsible party.)

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."

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:

A statement that "This application includes a trial which requires registration in ClinicalTrials.gov"
National Clinical Trial (NCT) number (i.e. the ClinicalTrials.gov number)
Brief Title as listed in ClinicalTrials.gov and
Name of the responsible party for each study being conducted under the application. (As grantee, Augusta University designates the lead investigator of the trial as the responsible party.)

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.

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