ClinicalTrials.gov – Who, How, Consent Form Posting, Legal Requirements
Who is responsible for registration and results reporting on ClinicalTrials.gov?
Compliance with regulations that pertain to ClinicalTrials.gov is the responsibility of either the Principal Investigator (for some PI initiated studies) or the sponsor. This begins with complying with all BMC/BU Medical Campus HRPP Policies that pertain to clinical trials (section 6.6.9). The BMC/BU Medical Campus Administrator of ClinicalTrials.gov provides information, guidance and support in all aspects of ClnicalTrials.gov with additional oversight by the BMC Research Compliance Officer and the Director of the Office of Human Research Affairs (OHRA).
All studies meeting the definition of a clinical trial according to the International Committee of Medical Journal Editors/ICMJE (see Section 13), must be registered with ClinicalTrials.gov before final IRB approval will be issued. The National Clinical Trial/NCT number (assigned at registration) should be provided to the IRB as documentation that the trial has been registered. Once registered, the responsible party (RP) must comply with all applicable updating and posting requirements.
For clinical trials with an IND or IDE held by the Principal Investigator at Boston Medical Center or Boston University Medical Campus, the Principal Investigator is the responsible party/RP, regardless of how the clinical trial is funded.
For clinical trials with external funding that are initiated by an external sponsor and do not have an IND or IDE held by the Principal Investigator at Boston Medical Center or Boston University Medical Campus, the responsible party/RP is the sponsor of the clinical study, as defined in 42 CFR 11.10(a). The external sponsor will be responsible for registering the trial on ClinicalTrials.gov, updating the record, and if required, posting results and documents.
For all other clinical trials, regardless of funding, that are initiated by the Principal Investigator at Boston Medical Center or Boston University Medical Campus, the responsible party/RP is the home institution of the Principal Investigator (Boston Medical Center or Boston University).
Boston Medical Center and Boston University Medical Campus will only agree to register a study on ClinicalTrials.gov if: the Principal Investigator is the sponsor of the study, or if Boston Medical Center or Boston University Medical Campus is the prime awardee of the external funding, or if Boston Medical Center or Boston University Medical Campus is considered the main site in a multi-site study, regardless of funding.
How do you register a study on ClinicalTrials.gov?
Record registration on clinicalTrials.gov is a process that starts when the RP creates a new record. The PI and any member/s of the research team who the PI designates can be given access to the record by the PRS Administrator who will make them ‘new users’ on the appropriate PRS CTgov database. Each user will be assigned a username by the PRS Administrator and they will receive an email from ClinicalTrials.gov with instructions on how to reset their password assigned by ClinicalTrials.gov. To access the record, the user goes to register.clinicaltrials.gov and enters the Organization name/home institution [BostonMC or BostonU] and selects the record so they can create the registration record and as required or when needed make edits/updates to information in the record. There are many tools and tips in ClinicalTrials.gov to help the RP or delegated research team member create the registration record. In addition, at the top of each section within the protocol section there are links to ‘Definitions’ and ‘Help’ which provide guidance as to which options to select and how to complete each section. The PRS Administrator will also provide guidance and answer questions.
Once complete, reviewed, and approved by the PRS Administrator, the registration record is released for ClinicalTrials.gov PRS review. A ClinicalTrials.gov staff member will then review the study record and focus on apparent validity, meaningful entries, logic and internal consistency, and formatting. The RP may be asked to clarify items or make corrections to the record before publication on ClinicalTrials.gov. Ensuring that the record is consistent with the ClinicalTrials.gov Protocol Review Criteria before releasing it will expedite publication on ClinicalTrials.gov. Once review staff accept it for publication, the record, including its NCT Number, will be available on ClinicalTrials.gov within 2–5 business days.
How do you report results on ClinicalTrials.gov?
Reporting results on ClinicalTrials.gov is an important and time-consuming process that should start months before the 10-month window after the actual primary completion date when results are expected. There are many tools to assist this process on ClinicalTrials.gov including templates and videos for each section, and the PRS Administrator can be very helpful during this process. In addition, at the time of results posting, a detailed IRB-approved protocol and a detailed statistical plan [which can be part of the protocol] must be posted in the Documents section of the record. A blank IRB-approved copy of the consent form can also be posted in the Document section and it must be posted if required by 45 SFR 46.116(h) as described below.
How to post a consent form on ClinicalTrials.gov and comply with 45 CFR 46.116(h)?
One of the revisions of the 2018 Common Rule that became effective on January 21, 2019 [45 CFR 46.116(h)] specifies that a consent form must be posted on a federal website for all clinical trials who receive specific federal funding* and are either (a) approved by an IRB on or after January 21, 2019 or (b) approved earlier but transitioned to Revised Common Rule requirements earlier than 61 days after the last study visit. The requirement states that:
- an unsigned copy of one IRB-approved consent form that has been used in enrolling participants in a clinical trial conducted or supported by a Common Rule department/agency*
- must be posted on a publicly available federal website
- after recruitment closes and no later than 60 days after the last study visit
Compliance is required for all studies that meet the Common Rule definition of a clinical trial,
“a research study in which one or more human subjects are prospectively assigned to one or more interventions … to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes”. This includes social, behavioral and educational clinical trials.
The purpose of the consent form-posting requirement is to be more transparent about consent forms being used in clinical trials and to ultimately improve the quality of consent forms. It is important to know that even if a consent form changes during the clinical trial, only one IRB-approved version of the consent form needs to be posted.
Although in the future other federal websites might be identified, currently there are two federal websites that have been identified for posting the consent forms –
- ClinicalTrials.gov or
- Regulations.gov (in a docket folder, Docket ID: HHS-OPHS-2018-0021).
For BMC/BU Medical Campus researchers, the policy is to post the consent form on ClinicalTrials.gov.
*for a list of the 20 Common Rule Departments and Agencies visit https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
For questions or assistance please contact Karla Damus, Administrator, ClinicalTrials.gov and MCSR Research Licensure, firstname.lastname@example.org, 617 358 5337.
ClinicalTrials.gov legal requirements
“Responsible parties” (as defined in 42 CFR 11.10(a)) must comply with the applicable provisions of section 402(j) of the Public Health Service Act (PHS Act) and the applicable regulations in 42 CFR part 11. The statute and regulations set forth the requirements for responsible parties to submit registration and summary results information to the ClinicalTrials.gov data bank for specified “applicable clinical trials” (ACTs) of drug products (including biological products) and device products.
ACTs are described in section 402(j)(1)(A) of the PHS Act and in 42 CFR 11.10(a). Any applicable clinical trial that (1) is initiated after September 27, 2007, or (2) was initiated on or before September 27, 2007, and was ongoing on December 26, 2007, must be registered with the ClinicalTrials.gov data bank (see section 402(j)(2)(C) of the PHS Act and 42 CFR 11.22(a)). For ACTs that are required to be registered, 42 CFR 11.42 describes for which trials results information must be submitted (see 81 FR 65121 for summary table) and whether they must submit the results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the PHS Act or the results information specified in 42 CFR 11.48.
42 CFR 11.66 describes the potential legal consequences for responsible parties if they do not comply with the requirements to submit registration and results information on applicable clinical trials. Such potential legal consequences include civil or criminal judicial actions, civil monetary penalty actions, and grant funding actions.
As of 2022, potential fines for late FDAAA are $13,237/study/day.