- What are the potential consequences of noncompliance?
Potential consequences of noncompliance include:
- Civil or criminal judicial actions
- Civil monetary penalty
- Grant funding actions
- Disqualification from certain publications
- Do I need to update my study record due to COVID-19?
If the Overall Recruitment Status and/or Individual Site Status of a University of Pittsburgh investigator-initiated clinical study registered on ClinicalTrials.gov is changing due to the COVID-19 situation, you should update the study record as you normally would, within 30 days of the change. If enrollment and/ or other study activities are “on pause” rather than under an official IRB suspension, consider still selecting Suspended, which will populate the Why Study Stopped data element, where you may then more clearly explain the status. Additional information regarding study record maintenance requirements is available on the Record Maintenance page. Contact CTgov@pitt.edu with questions.
Instructions for updating a study record:
- Login to the ClinicalTrials.gov PRS (Organization: UPittsburgh)
- Open and update the record, then click “Entry Complete” on the Record Summary page.
- The Responsible Party must follow all prompts in the “Next Step” box on the Record Summary page, until the “Release Confirmation” page appears, to approve and submit the updated record for review and posting to the public study record.
- How do I complete the Dissemination Plan section of the PHS Human Subjects and Clinical Trials Information Form in NIH funding applications?
You are required to explain briefly your plan for the dissemination of NIH-funded clinical trial information and address how the expectations of the policy will be met. The plan must contain sufficient information to assure the following:
- The applicant will ensure that clinical trial(s) under the award are registered and results information is submitted to ClinicalTrials.gov as outlined in the policy and according to the specific timelines stated in the policy;
- Informed consent documents for the clinical trial(s) will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov;
- The recipient institution has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements.
You should begin by familiarizing yourself with the requirements as summarized here on our website (see links in sidebar to the right). An example response is provided below.
EXAMPLE Dissemination Plan
The application Project Director/Principal Investigator will ensure that processes are in place to achieve and maintain compliance with the following Policy requirements for all clinical trials proposed in this application:
- Clinical trial registration information will be submitted to ClinicalTrials.gov no later than 21 calendar days following the study start date.
- Clinical trial summary results information will be submitted to ClinicalTrials.gov no later than 1 year following the primary completion date.
- Clinical trial information submitted to ClinicalTrials.gov will be verified, updated and corrected in accordance with all applicable deadlines established in the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR 11.64).
- Informed consent documents for FDAAA 801 Applicable Clinical Trials (ACTs) will include the statement specified at 21 CFR 50.25(c) relating to posting of clinical trial information at ClinicalTrials.gov. Informed consent documents for all other clinical trials will include a similar statement.
The University of Pittsburgh is committed to supporting compliance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. As such, the Office of Research Protections (www.ecshsr.pitt.edu/ct) provides services to assist Responsible Parties with fulfilling the requirements for submission of clinical trial information to ClinicalTrials.gov.
- What is the specific wording that must be included in the informed consent document?
The following statement, verbatim, must be included in informed consent documents for Applicable Clinical Trials (ACTs) required to be registered per the Food and Drug Administration Amendments Act, Section 801 (FDAAA 801):
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Informed consent documents for clinical trials that are not FDAAA 801 ACTs, but are required to be registered per the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, also must include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov. The above language (less the phrase “as required by U.S. Law”) may be used in these cases.
- May I use ClinicalTrials.gov to comply with the requirement under the Revised Common Rule at 45 CFR 46.116(h) to post my clinical trial informed consent form?
The regulation defines a clinical trial as 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 the interventions on biomedical or behavioral health-related outcomes.
The regulation states that one IRB-approved informed consent form used to enroll subjects must be posted on a publicly available Federal website 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. To date, DHHS has identified two websites that may be used to satisfy this requirement: ClinicalTrials.gov and Regulations.gov.
If your trial is registered on ClinicalTrials.gov, we recommend that you submit the consent form in your study record during the required timeframe stated above. If your trial is not registered on ClinicalTrials.gov, follow the instructions provided by DHHS to submit the consent form to Regulations.gov during the required timeframe stated above. Refer to the Study Documents page for additional information, and contact CTgov@pitt.edu with questions.
- How do I contact the PRS ClinicalTrials.gov staff for guidance on inputting study results or responding to comments issued by a PRS reviewer?
The staff at ClincialTrials.gov provides free one-on-one help via conference call to anyone who has a registered trial. You can send them a publication or data set, and they will take you step-by-step through how to set up your database. They will also go through a submission that is incomplete and guide you through the necessary steps to resolve outstanding issues.
To send a message to the Clinicaltrials.gov staff:
- Login to the ClinicalTrials.gov Protocol Registration and Results System (PRS)
- Go to the “Contact ClinicalTrials.gov PRS” link in top right corner of your home page.
- Include the ClinicalTrials.gov ID (NCT number) in the message and request a one-on-one call to discuss your need for help.
- They will reply to the e-mail listed on your home page.
- Are the costs (including staff time) of registration and results reporting (including summary adverse event information) in ClinicalTrials.gov allowable charges on an NIH grant?
Given the nature of this requirement and that the project staff will generally be in the best position to submit and maintain these data, the costs of FDAAA compliance will generally be allowable as direct charges to NIH supported grants. While it is expected that these costs will be covered by the funds provided with the grant, administrative supplements could also be considered. Please refer to the NIH for more information.
- How much time does it take to enter data?
Entering data into ClinicalTrials.gov may take considerable time depending on the number of outcomes, study size and adverse events. It is important to ensure that the study outcomes, descriptions and time frames are entered correctly when the record is created. It is recommended that preparation and analysis of the results data be completed by 10 months after the primary completion date, thus allowing adequate time for entry into the ClinicalTrials.gov record and resolution of any comments from the PRS QA staff.
- How can I learn more about ClinicalTrials.gov?
Both the ClinicalTrials.gov public website and the PRS website have a wealth of resources for education and guidance, which we encourage you to explore and consult.
- Is registration required by UPMC for billing purposes?
UPMC billing requires an NCT number when any study procedure is billed to insurance. This is based on the Center for Medicare and Medicaid Services (CMS) Change Request 8401.