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1. Purpose of Policy 

Title VIII of the Food and Drug Administration Amendment Act of 2007 (FDAAA) established legal requirements for sponsors and designated principal investigators responsible for certain clinical trials to register and report results information to ClinicalTrials.gov. To comply with FDAAA, the National Institutes of Health (NIH) and the Center for Medicare and Medicaid Services (CMS) obliges grantees to follow registration and reporting requirements to qualify for funding. Further, the International Committee of Medical Journal Editors (ICMJE) established similar standards investigators must follow if they wish to publish in participating journals. This policy is intended to provide an organizational framework around and support to University investigators responsible for complying with regulation, grantor requirements and/or publication standards regarding registration and reporting.

2. Stakeholders Most Impacted by the Policy 

This policy applies to all faculty, staff and other employees, students, or other individuals conducting clinical trials requiring registration and results reporting on University premises, using University property or facilities, and Institutional Review Board authorization.

3. Key Definitions 

3.1 Aggregate Results: Data collected from individual-level records that have been combined for statistical or analytical purposes and that are maintained in a form that does not permit the identification of individuals.

3.2 Clinical Trial

• 3.2.1. Applicable Clinical Trial (ACT): includes interventional studies (with one or more arms) of FDA-regulated drugs, biological products or devices that meet one of the following conditions: (a) the trial has one or more sites in the U.S.; (b) the trial is conducted under an FDA investigational new drug application (IND) or investigational device exemption (IDE); or the trial involves a drug, biologic or device that is manufactured in the U.S. or its territories and is exported for research. Registration is required for applicable clinical trials (ACT) initiated after September 27, 2007 or ongoing as of December 26, 2007. There are two types of FDAAA-defined applicable clinical trials which must be registered and results reported.
• 3.2.1.1. Applicable Clinical Drug Trial: A controlled clinical investigation, other than a Phase I clinical investigation, of a drug or biological product subject to FDA regulation; and
• 3.2.1.2. Applicable Clinical Device Trial: A controlled trial with health outcomes of devices subject to FDA regulation, other than small feasibility studies or pediatric post-market surveillance required by FDA.
• 3.2.2 Clinical Trial (NIH): 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.
• 3.2.2.1. NIH requires registration and results reporting for all NIH-supported clinical trials, regardless of study phase, type of intervention, or whether or not they are subject to FDAAA
• 3.2.3. Qualifying Trial (CMS): The activity must be a clinical trial that qualifies for coverage (as specified in CMS Section 310.1 of the Medicare National Coverage Determination Manual) and the purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians’ services, durable medical equipment, diagnostic test, etc.). The trial must have therapeutic intent and must enroll patients with diagnosed disease, not only healthy volunteers.
• 3.2.4.  Clinical Trial (ICMJE): A clinical trial is a research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes—includes drugs, biologics, devices, surgical procedures, and behavioral treatments (see The Uniform Requirements for Manuscripts Submitted to Biomedical Journals). This definition includes Phase I studies.

3.3 ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).  A description of reported 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 the patient.  At most, the Web site will include a summary of the results.

3.4 Grantee: Recipient institution of a grant or cooperative agreement from a federal agency.

3.5 Primary (endpoint) Completion Date: The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. This applies whether the clinical trial concluded according to the pre-specified protocol or was terminated.

3.6 Principal Investigator (PI): The individual who is responsible and accountable for conducting the clinical trial.

• 3.6.1. Responsible Party: The responsible party is the person who is responsible for conducting a clinical trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial and must meet all of the requirements under this regulation. The University deems the terms Principal Investigator and Responsible Party to be synonymous for purposes of this policy.

3.7 Protocol Registration System: The PRS is a web-based data entry system used byClinicalTrials.gov for investigators to register a clinical study or submit results information for a registered study. Investigators must have a PRS account to register study information on ClinicalTrials.gov.

• 3.7.1. National Clinical Trial (NCT) Number: The NCT# is a unique identifier assigned by ClinicalTrials.gov to a study that has been successfully registered at its site. The NCT number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the Medicare National Coverage Determination Manual, Section 310.1.

4. Full Policy Details 

The University requires compliance with clinical trials registration and results reporting. It is the responsibility of the PI to ensure registration and results reporting are completed and updated, and in the timeframes required, by FDAAA, NIH, CMS and/or ICMJE. New or ongoing clinical trials shall be registered at if they meet the conditions below:  

4.1 Applicable clinical trials defined by  the FDAAA ;

4.2 Clinical trials funded, either in whole or in part, by the NIH;

4.3 Qualifying clinical trials which will render claims for items and services to the CMS;

4.4 Clinical trials that meet the clinical trial definition of the ICMJE and, the results of which, the investigator plans to publish in a member journal. [NOTE: ICMJE accepts registration at registries other than ClinicalTrials.gov to meet their publication requirements. WMU allows this flexibility in the selection of a registry only for trials that do not qualify at 4.1, 4.2 or 4.3 above.]

4.5 The Principal Investigator is responsible to respond to registry reviewer requests for information or changes, as applicable, in a timely fashion.

5. Accountability 

If a PI fails to comply with this policy, the Human Subjects Protection Office will notify the applicable department chair(s) and research dean(s). Failure to comply will result in notification to the IRB of record noting regulatory noncompliance in research registration and/or results reporting.

Sanctions: Western Â鶹´«Ã½Ó¦Óà University Principal Investigators that fail to comply with the requirements may be subject to enforcement actions.

5.1. Failure to comply with FDAAA requirements may result in financial penalties, including withholding of funds and sanctions imposed by the FDA.

5.2. Failure to comply with NIH may result in withholding of cash payments, disallowing cost for an activity, suspending or terminating either in part or whole the current award, withholding a future award and having a non-compliance notice publicly available.

5.3. Failure to comply with ICMJE requirements may result in an inability to publish in an ICMJE affiliated journal.

5.4. Failure to comply with CMS requirements can result in a lack of payment for a qualified research billing service and a need to refile the qualified research billing claim.

Western Â鶹´«Ã½Ó¦Óà University reserves the right to impose discipline or sanctions, up to and including termination, as provided for in applicable university policies.

6. Related Procedures and Guidelines 

ClinicalTrials.gov Registration Procedure

 7. Additional Information :NA