Support for ClinicalTrials.gov Study Registration
The CTSI Research Navigator Program hosts monthly clinics to provide support for ClinicalTrials.gov users. The clinic is the first Wednesday of each month from 9-11am. Please see the CTSI Weekly Update for the date and time. To subscribe to the CTSI Listserv, click here.
The Office of Regulatory Support (ORS) offers services to support research teams with registration and reporting of clinical research trials at ClinicalTrials.gov, a database of clinical research trials conducted in the United States and around the world.
- Determination of Registration Requirements
- Assistance with ClinicalTrials.gov Account Management
- Technical Assistance with Entry of Study Information
ORS provides guidance in determining whether a clinical research trial must be registered, who is responsible for the registration, whether study results must be reported and the deadlines for both registration and results reporting.
Study registration and reporting of results and adverse events are required by federal law for most clinical trials. Registration is also a requirement for publication in many medical journals. The International Committee of Medical Journal Editors (ICMJE) also requires trial registration, as a condition for publication. Click here for more details about ICMJE requirements.
Study Registration and Reporting Required by Federal Law:
U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA) requires registration of "Applicable Clinical Trials":
Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation;
Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric post-market surveillance studies.
Basic results and adverse events must be reported for applicable clinical trials.
The consent form for Registered Clinical Trials must include the following statement:
“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 website at any time."
The party responsible for registration and reporting is:
The sponsor of the clinical trial OR the principal investigator (PI), if the PI:
- Is designated by the sponsor; and
- Is responsible for conducting the trial; and
- Has access to and control over the data
Investigators should confer with the study sponsor to determine who the responsible party is, and to ensure that the study is registered at ClinicalTrials.gov once, and only once. If a non-University of Rochester (UR) Sponsor delegates responsibility to UR faculty, registration must be managed within the non-UR Sponsor's ClinicalTrials.gov account.
Penalties for responsible parties who fail to register or who submit false or misleading information are significant, and may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds.
By law, registration of Applicable Clinical Trials is required to occur within 21 days of first subject enrollment. However, ORS recommends trial registration in the ClinicalTrials.gov database prior to first subject enrollment, to satisfy both the law and ICMJE requirements.
FDAAA became law on 9/27/2007 and went into effect on 12/26/2007. The following guidance describes registration timing for Applicable Clinical Trials that were initiated before 9/28/2007:
- Trials that were initiated on or before 9/27/2007 and “ongoing” as of 12/26/2007 and that involve a “serious or life threatening disease or condition” must have been registered in full by 12/26/2007.
- Trials that were initiated on or before 9/27/2007 and “ongoing” as of 12/26/2007 that do not involve a “serious or life threatening disease or condition” must have been registered in full by 9/27/2008.
FDAAA requires reporting of study results for Applicable Clinical Trials no later than 12 months afterthe date of final data collection for the primary outcome measure, referred to as the “Primary Completion Date.”
Reporting of results can be delayed beyond the 12-month required timeline if:
- The trial is of a drug or device that has not been approved for marketing by the FDA for any indication; result reporting will be required within 30 days of initial approval;
- The trial is of a drug or device for which the manufacturer has filed or is preparing to file an application seeking approval of the new use studied in the trial; or
- A request for delay that “demonstrates good cause” has been granted by the Director of the NIH.
At this time, the ICMJE does not require the recording of study results in the ClinicalTrials.gov database. ORS recommends that PIs stay informed about these requirements, as they evolve.
ORS holds the University of Rochester (UR) Institutional Administrator account for the ClinicalTrials.gov Protocol Registration System (PRS), and provides guidance and management to all account holders within the PRS. Within the UR process, there are two additional account types:
Each department or center within UR, with faculty who are required to register studies at ClinicalTrials.gov, designates one or more Group Administrators.
ORS establishes user IDs for these administrators and grants them administrative privileges within the PRS. The ORS provides necessary assistance to familiarize Group Administrators with the PRS and with their responsibilities, which include:
- Managing Group User accounts
- Reviewing and ensuring release of data entered into study-registration records created by Group Users
- Ensuring Group User attention to PRS system messages
An individual investigator (the Responsible Party), or their designee, contacts the assigned Group Administrator to receive a PRS User ID. The Group User enters data regarding the study into the PRS.
A group user who creates a PRS record and maintains registration data should not also be the Group Administrator who reviews and releases the record to the PRS.
ORS can provide technical assistance to support the entry and release of required study information, including study registration, results reporting and adverse events reporting.
ClinicalTrials.gov staff provided a comprehensive overview of the PRS on October 21, 2009.
- Ethical and scientific rationale for trial registration and results reporting
- Clinical trial registration, results and adverse event reporting requirements
- Key principles for entering results information and ClinicalTrials.gov review criteria
- Penalties for non-compliance
- Next Steps – Items under consideration for expansion of ClinicalTrials.gov
Detailed information and instructions about registration, required data elements, results reporting and adverse events reporting can be found through the following links:
Background and FAQs:
- ClinicalTrials.gov Registration Fact Sheet
- FAQ – Obtaining a PRS account & Entering Protocol Data
- What NIH Grantees Need to Know about FDAAA
Guidance for Results and Adverse Events Reporting:
- "Basic Results" Data Element Definitions (DRAFT)
- Results Reporting – Helpful Hints
- Results Reporting – Pre-Submission Checklist
- Guide to Results Data Entry (CHEST, 2009 Jul;136(1):295-303)
- Adverse Events Reporting