Study Documents

Important Note: Submitted documents will be posted for public access.

What are the general requirements for submitting study documents to ClinicalTrials.gov?

  • Documents must be in English and PDF Archive (PDF/A) format. 
  • Every document must include a cover page with the following information: 
    • Official Title: The Official Title entered in the ClinicalTrials.gov study record.
    • ClinicalTrials.gov ID (NCT number): If the study record is already public, the NCT number assigned to the record.
    • Document Date: The date on which the document was most recently updated and, if needed, approved by a human subjects protection review board. This date must match that entered in the Document Date field when uploading the document
  • Refer to the “Definitions” and “Help” links at the top of the Documents Section page in the study record for further guidance.

What are the requirements for disclosing the Protocol and Statistical Analysis Plan?

Results submissions to ClinicalTrials.gov for studies that have a Primary Completion Date on or after January 18, 2017 must include a copy of the protocol and the statistical analysis plan (if not included in the protocol), incorporating all amendments that have been approved by a human subjects protection review board (if applicable) and that apply to all clinical study Facility Locations. An updated version, if applicable, is required with each partial results submission. These documents may be uploaded optionally at any time.

The responsible party may redact names, addresses, and other personally identifiable information, as well as any trade secret and/or confidential commercial information (as those terms are defined in the Freedom of Information Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905)) contained in the protocol or statistical analysis plan prior to submission, unless such information is otherwise required to be submitted as part of clinical trial registration or results information.

Definitions from ClinicalTrials.gov:

Study Protocol: The written description of the clinical study, including objective(s), design, and methods. It may also include relevant scientific background and statistical considerations.

Statistical Analysis Plan (SAP): The written description of the statistical considerations for analyzing the data collected in the study. Includes how data are analyzed, what specific statistical methods are used for each analysis, and how adjustments are made for testing multiple variables. If some analysis methods require critical assumptions, the written description should allow data users to understand how those assumptions were verified.

Guideline:

If a protocol document has been approved as part of your IRB application, use that document. Otherwise, you may utilize your approved IRB application and/or grant to create a document based on the Protocol Template. The identifying information on the cover page is required under 42 CFR 11.48(a)(5). You may choose to modify the suggested section headings, so long as you address all of the elements included in the definitions provided above. 

What are the requirements for disclosing the Informed Consent Form?

Refer to OHRP for the latest information and answers to common questions on this requirement.

What is the scope?

For this requirement to be applicable, the study must: (1) be subject to the Revised Common Rule (“2018 Rule”), (2) be a clinical trial, and (3) have enrolled participants. Studies approved prior to January 21, 2019 will continue to comply with the Pre-2018 Rule at University of Pittsburgh. However, exceptions exist for some multi-center trials (see below).

 

What is required? 

Only one consent form per trial needs to be posted. This requirement applies regardless of the number of participating institutions or the number of consent form documents, (e.g., Adult, Child, Pre-Screen, etc.) and/or the number of approved versions. The posted consent form must be: (1) IRB approved (have an approval stamp, where applicable), (2) a version used to enroll subjects, and (3) posted after the trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Please note that a document posted outside of this specific time window will not satisfy the requirement.

 

Who is responsible? 

The main funding awardee(s) of the trial is responsible for ensuring that the consent form is posted in accordance with the Rule. The University of Pittsburgh is delegating the task of posting the consent form to the Principal Investigator.  

 

What if there are concerns about releasing certain information to the public domain?
Concerns regarding redaction of information in a consent form that will be posted must be addressed to the Common Rule department or agency funding the clinical trial. 

 

Where must the consent form be posted? 

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. If your trial is not registered on ClinicalTrials.gov, follow the instructions provided by DHHS to submit the consent form to Regulations.gov.  

 

What are the requirements for posting of consent forms for multi-center clinical trials initially approved under the Pre-2018 Rule?

If one or more other participating institutions transition the trial from the Pre-2018 Rule to the 2018 Rule, the consent form posting requirement will apply, unless the specified posting time frame has passed (i.e., the window between closure to recruitment and 60 days after the last study visit by any subject is in the past).