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:

  1. 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;
  2. Informed consent documents for the clinical trial(s) will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov;
  3. 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 University of Pittsburgh Office for ClinicalTrials.gov (http://rcco.pitt.edu/clinicaltrialsgov) provides resources and procedures to assist Responsible Parties with fulfilling the requirements for submission of clinical trial information to ClinicalTrials.gov.

How do I update the OSIRIS application to include the NCT number?

When there is not an open modification, the PI, primary research coordinator or secondary research coordinator must:

  1. Login to OSIRIS
  2. Click the Studies tab located in the mid-section of the page, then click on this study.
  3. Click Update ClinicalTrials.gov Information under My Activities on the left-hand side of the study workspace.
  4. Provide the NCT number and update any other fields, as needed.
  5. Verify that you have entered the correct NCT number by clicking Check ClinicalTrials.gov Info and comparing the information displayed. (The information will not display until the record is made public on the ClinicalTrials.gov website.)
  6. Click OK at the bottom right of the page to save the changes.

I entered the NCT number into OSIRIS, so why do I not see this information in the OSIRIS application?

The NCT number and associated ClinicalTrials.gov information may not appear in OSIRIS until the record is made public on the ClinicalTrials.gov website and OSIRIS has downloaded the information. This may take two to three days.

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.

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:

  1. Login to the ClinicalTrials.gov Protocol Registration and Results System (PRS)
  2. Go to the “Contact ClinicalTrials.gov PRS” link in top right corner of your home page.
  3. Include the ClinicalTrials.gov ID (NCT number) in the message and request a one-on-one call to discuss your need for help.
  4. 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.