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October 2016


New Clinical Trial Rule Alters Reporting Requirements







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Ana I. Christian


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New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health and Human Services (HHS) issued a Final Rule creating new requirements for posting of clinical trials results information, which can be viewed at ClinicalTrials.gov1.

The Final Rule intends to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials.

Sponsors and sponsor-investigators of clinical trials should be aware of the following:

  • Interventional clinical trials with one or more arms and one or more pre-specified outcome measures must be registered on and their results information must be posted following completion of the trial.
  • The sponsor of a clinical trial can delegate its duty to register and post results to a qualified Principal Investigator, who then becomes the "Responsible Party."
  • Although an expanded access trial is not an "Applicable Trial" requiring registration, the Responsible Party must still submit information about whether an unapproved drug or biologic product is available for expanded access so that information can be linked in the database.
  • Results information must now be posted for drug, biologic, and device products that are not yet approved, as well as those that are approved by the Federal Food & Drug Administration (FDA), though there is the option to delay posting under certain circumstances.
  • Adverse event information that is collected as part of the clinical trial protocol must now be posted as part of the results information.
  • The Responsible Party is required to update the information posted at least annually.
  • The Final Rule sets forth the legal consequences for failing to comply, which include civil and criminal penalties and fines, and the NIH policy states that grant funding can be withheld and non-compliance may be considered in future funding decisions.

To view or download a pdf of the full alert, click here.

Types of Clinical Trials Subject to the Final Rule

All interventional clinical trials with one or more arms and with one or more pre-specified outcome measures are defined as controlled clinical trials which must be registered on and are considered "Applicable Clinical Trials." [More..]

The Responsible Party for Posting Clinical Trial Information

The "Responsible Party" is the sponsor of the study and is responsible for registering the trial on unless and until it designates a qualified Principal Investigator to fulfill the duty. [More..]

Required Elements for Registration at

Applicable clinical trials must be registered within 21 calendar days after the enrollment of the first human subject. [More..]

Expanded Access Records

A Responsible Party must submit information about whether expanded access to the investigational product being studied in an Applicable Drug Clinical Trial of an unapproved drug product (including an unlicensed biological product) is available. [More..]

Results Information Posting Requirements

The Final Rule represents an expansion of the requirement for results information submission for Applicable Clinical Trials of drug, biologic, and device products to those that are approved by the FDA and now also those that are not approved, licensed, or cleared by FDA. [More..]

Adverse Events Information Must be Submitted

The rule requires the Responsible Party to submit information summarizing the number and frequency of adverse events experienced by clinical trial participants by arm or comparison group, as well as a brief description of each arm or group as a component of clinical trial results information. [More..]

All Submitted Information Must be Updated at Least Annually

All submitted information must be updated at least annually if there are changes to report. Several of the data elements require more frequent updating to help ensure that users of have access to accurate information about important aspects of an Applicable Clinical Trial. [More..]

Legal Consequences of Non-Compliance with the Final Rule and NIH Policy

The Final Rule sets forth certain legal consequences for responsible parties who fail to comply. [More..]

Effective Date and Implementation

The Final Rule will be effective January 18, 2017 and Responsible Parties will have 90 calendar days after the effective date to come into compliance with its requirements. Applicable Clinical Trials of unapproved products that reach their primary completion date prior to the effective date of the rule are not subject to the rule. [More..]

To view or download a pdf of the full alert, click here.

For More Information

If you have questions regarding the Final Rule or how it may affect your long term care facility, please contact the Polsinelli attorneys listed in this communication.







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