Clinical Trials Registration
The National Library of Medicine (NLM) in collaboration with the Food and Drug Administration (FDA) developed Clinical Trials, a service of the National Institutes of Health. Its purpose is to “link patients to medical research” to provide information to the public about federally and privately supported clinical research for a range of diseases and conditions.
Investigators or sponsors must register clinical trials in the Protocol Registration System (PRS) of ClinicalTrials.gov to comply with the International Committee of Medical Journal Editors (ICMJE) Initiative, which requires prior entry of clinical trials in a public registry as a condition for publication. PRS also accepts registration for any IRB-approved trial that conforms to applicable regulations of the appropriate national health authorities, including interventional and observational trials.
Requirements
The FDA Amendments Act of 2007 (FDAAA or U.S. Public Law 110-85 [PDF]) requires registration of “ applicable clinical trials ” involving drugs, biologics, or devices that are subject to FDA regulations. Note: For more information on “applicable clinical trials,” see PRS and U.S. Public Law 110-85. In most cases, the sponsor of the trial will be the “responsible party” for registering the trial. However, in some cases, as outlined below, FDAAA allows the sponsor to delegate all registration and reporting responsibilities to the principal investigator (PI).
The Sponsor can designate a PI as the “responsible party” for registering a clinical trial at ClinicalTrials.gov when:
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The trial is investigator-initiated,
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The investigator has access to and control over the data from the clinical trial, and
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The investigator has the right to publish the results of the clinical trial.
If a PI is responsible for registration, he/she may designate an individual (PRS User) to register the trial(s) and complete registration information. However, the PI is ultimately responsible for ensuring that the information entered is accurate and for releasing the protocol record for PRS posting. The PRS User must also review the trial information on a periodic basis (typically every six months) and make any needed changes to the registry.
Additionally, for clinical trials, responsible parties are required to post lay summaries of the study protocol and study results, as well as a description of the quality assurance procedures used throughout the trial.
Effective March 7, 2012, FDA regulations [PDF] also require informed consent processes and documents for applicable clinical trials involving drugs, biologics, and devices to include a specific statement that clinical trial information will be entered into a publicly available databank at ClinicalTrials.gov. This requirement applies to new studies and does not affect protocols approved prior to the effective date.
Institutional Protocol Registration System Administrators
Protocol Registration System Administrators are responsible for releasing clinical trial information to ClinicalTrials.gov on behalf of the University. This includes creating accounts for Ohio University investigators or their designated PRS Users, editing and approving clinical trial records prior to initial release, and ensuring timely protocol updates. PRS Administrators also serve as points of contact for the ClinicalTrials.gov support staff to resolve questions associated with the provided information. Please contact the Office of Research and Sponsored Programs (ORSP) Service Center at ORSP@ohio.edu to request an individual login, if you have forgotten your login/password, or for any questions.