Determine if the competing application or funded grant supports an applicable clinical trial (ACT) that is required under FDAAA to be registered in ClinicalTrials.gov. In addition to the information below, see the interactive flowchart Identifying an “Applicable Clinical Trial” (PDF - 393 KB)

Under the statute, “applicable clinical trials” generally include: 

(1) Trials of Drugs and Biologics:  Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation;

(2) Trials of Devices:  Controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance.

If the trial is an applicable clinical trial, then determine whether the trial is required to be registered under FDAAA:  

• Trials initiated after 9/27/2007 must be registered in full not later than 21 days after the first patient is enrolled, or by 12/26/2007, whichever is later.
• Trials that were initiated on or before 9/27/2007 and “ongoing” (see Definitions) as of 12/26/2007 and that do involve a “serious or life threatening disease or condition” (see Definitions) must be registered in full by 12/26/2007.
• Trials that were initiated on or before 9/27/2007 and ongoing as of 12/26/2007 and that do not involve a serious or life threatening disease or condition must be registered in full by 9/27/2008.
• Trials that were ongoing as of 9/27/2007, did involve a serious or life threatening disease or condition and were completed (meaning, not ongoing) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registration requirements under the Food and Drug Administration Modernization Act (FDAMA) of 1997. 
• Trials that were ongoing as of 9/27/2007, did not involve a serious or life threatening disease or condition, and were completed (meaning, not ongoing) by 12/26/2007 are not subject to these requirements, nor were they subject to pre-existing registration requirements under FDAMA.

Please access the following FAQs for NIH Grantees:

• Who determines if a clinical trial supported by an NIH grant (or proposed in an application) is considered an applicable clinical trial, and subject to the registration requirement under FDAAA?
• When must an applicable clinical trial be registered?
• If a clinical trial is not an "applicable clinical trial", can it be registered in ClinicalTrials.gov?

Complete statutory definitions and more detailed information on the NIH’s current thinking about the meaning of “applicable clinical trial” may be found in the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF - 115 KB).

All competing applications (new and renewal) and progress reports for NIH grants (including cooperative agreements) supporting applicable clinical trials must include a certification of compliance with FDAAA.  This includes applications where the trial has not yet begun (e.g. is proposed) or is not yet required to be registered (e.g. less than 21 days since first subject was enrolled), as well as applications and progress reports that include an on-going trial that is already registered in ClinicalTrials.gov.

To learn more, please review Certifying compliance in NIH Grants and Progress Reports.

In addition to the information below, see the interactive flowchart Identifying the “Responsible Party” (PDF - 177 KB)

FDAAA defines the responsible party as:

(1) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3), or

(2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee (provided that “the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements” for submitting information under the law.)  See PL 110-85, Section 801(a) (PDF - 549 KB), (adding new 42 U.S.C. 282(j)(1)(A)(ix)). 

Complete statutory definitions and more detailed information on the NIH’s current thinking about the meaning of responsible party may be found in the current “Elaboration of Definitions of Responsible Party and Applicable Clinical Trial”.

Please access the following FAQs for NIH Grantees:

• What entity or individual is the responsible party for an applicable clinical trial supported by an NIH grant (including cooperative agreements)?
• There is more than one award supporting a non-IND/IDE applicable clinical trial. Who determines which grantee is the responsible party, and how do the other grantees learn that this determination has been made?

Please access the following FAQs for NIH Grantees:

• Is a certification of compliance with FDAAA required for grants supporting an applicable clinical trial when the grantee institution is not the sponsor and therefore not the responsible party (e.g. an IND/IDE is held by another entity or individual)?
• I am the PD/PI on an NIH grant, but I am not the responsible party for the applicable clinical trial that the grant supports. The trial is not in compliance with FDAAA; may I register or submit results of the trial in ClinicalTrials.gov?

Applicable clinical trials must be registered with ClinicalTrials.gov via a web based data entry system called the Protocol Registration System (PRS).

• Go to ClinicalTrials.gov PRS Information and follow directions for registration of applicable clinical trials.
• PRS requires that multiple groups within a single entity (e.g., company, university, government agency) share a single PRS organization account.  Thus, the first step in the registration process is to identify the PRS organization account for the institution and submit a request for the PRS account administrator information.
  • Access the Administrator Contact Request page to view the list of organization accounts and submit a request for administrator contact information.
• In rare cases, NIH grantees may need to create individual PRS accounts.
• When registering the trial, fill in all applicable data elements and make sure that the information is accurate.  The ClinicalTrials.gov Protocol Data Element Definition (DRAFT) provides a list of data elements and their definitions.
• It is particularly important that information about the responsible party and the "primary completion date" (see Definitions) is accurate. This information will enable ClinicalTrials.gov to send automated email reminders about the need to update the trial record.
• Be sure to add the NIH grant number(s) in the “Secondary IDs” field
  • Please access: “How should NIH support be indicated in the ClinicalTrials.gov record?”

FDAAA requires that the responsible party:

• update the applicable clinical trial record no less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period;
• Note that the terms and conditions accepted by all ClinicalTrials.gov account holders require that clinical trial records be reviewed and verified at least once every 12 months.  To review this and other terms and conditions, access the PRS Account Application Web site.

• update the recruitment status not later than 30 days after the recruitment status of the trial has changed; and
• update the primary completion date of the applicable clinical trial not later than 30 days after the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.

At this time, FDAAA requires the responsible party to submit summary results information (including adverse events) no later than 1 year after the primary completion date (see Definition) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.  However, NIH encourages results reporting for all NIH supported clinical trials registered in ClinicalTrials.gov, regardless of whether or not they are required to do so under FDAAA.

Please access the following FAQs for NIH Grantees:

• Is the information submitted to ClinicalTrials.gov for an applicable clinical trial subject to review?
• Under what circumstances can the responsible party delay or request an extension for submission of results for an applicable clinical trial?
• Are there resources on how to report results in ClinicalTrials.gov?

Additional Basic Results Database resources are available at http://prsinfo.clinicaltrials.gov/fdaaa.html, including information on adverse event reporting, and extensions or delayed submission of results.