ClinicalTrials.gov Applicable Definitions

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Overview

The UCSF Clinical Trials Registration & Reporting Policy external site (opens in a new window) establishes UCSF standards for clinical trial registration and results reporting requirements.

UCSF Clinical Trial Definition

The UCSF Clinical Trials Registration & Reporting policy external site (opens in a new window) complies with the definitions of a clinical trial for:

The UCSF Clinical Trials Registration & Reporting policy external site (opens in a new window) uses the International Committee of Medical Journal Editors (ICMJE) external site (opens in a new window) definition of a Clinical Trial, which defines a clinical trial as:

“[A]ny research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”

FDA Applicable Clinical Trials (ACTs)

Applicable Clinical Trial (ACT) Definition

The term used in the Food and Drug Administration Amendments Act (FDAAA) to designate interventional studies of drugs, biologics and devices for which information must be submitted to the Clinical Trial Registry Data Bank. An applicable drug clinical trial is a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of FDAAA.  An applicable device clinical trial is either: (1) a prospective clinical study of health outcomes comparing an intervention with a device subject to sections 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); or (2) a pediatric post market surveillance of a device as required under section 522 of the Food, Drug, and Cosmetic Act.

Study Record Registration

All ACTs must register within 21 days of enrollment of the first participant to satisfy FDAAA Law. Note, UCSF policy requires registration of all clinical trials before the enrollment of the first participant to comply with ICMJE policy.

Results Reporting Requirement

Summary results information is due within one year of the Primary Completion date external site (opens in a new window) , for all ACTs.

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NIH-Funded Clinical Trials

National Institutes of Health (NIH) external site (opens in a new window) Clinical Trial Definition

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Registering a Study Record

NIH Funded Clinical Trials must register within 21 days of enrollment of the first participant to satisfy NIH policy. Note, UCSF policy requires registration of all clinical trials before the enrollment of the first participant to comply with ICMJE policy.

Maintaining a Study Record

Upon Actual Study Completion Date external site (opens in a new window) (last participant's last study visit) – a blank informed consent form (ICF) that was used to enroll participants may be uploaded to your CT.gov record no later than 60 days after the last study visit by any participant to satisfy the Revised Common Rule external site (opens in a new window) requirement.

Results Reporting Requirement

Summary results information is due within one year of the Primary Completion date, for all National Institutes of Health (NIH) external site (opens in a new window) funded Clinical Trials.

NOTE: Though the submission of results on ClinicalTrials.gov is necessary for NIH-funded clinical trials, submission of results on ClinicalTrials.gov is not sufficient to satisfy the NIH Data Management and Sharing Policy requirements external site (opens in a new window) .

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