University of Southern California

Research

ClinicalTrials.gov

DETERMINE APPLICABLE REGULATIONS THAT MAY APPLY TO YOUR STUDY

The U.S. Department of Health and Human Services (DHHS) National Institutes of Health (NIH) and the Food and Drug Administration (FDA) established a registry of clinical studies that are both federal and privately funded to provide public information on a wide range of diseases and conditions.  Registration and reporting requirements follow various policies and laws.


FDA Clinical Trials
FDA Clinical Trials are defined as an applicable clinical trial (ACT) which include intervention studies that include drug, biological products, and medical devices.

Requirements:


NIH-Funded Clinical Trials
NIH-Funded Clinical trials may include biomedical studies and ACTs, as well as behavioral and basic experimental studies of humans (BESH).

Requirements:

National Cancer Institute (NCI) supported interventional clinical trials or studies conducted at Norris Cancer Hospital must be reported in the Cancer Center Data Table 4 Report to NCI and registered in the Clinical Trials Reporting Program (CTRP). Exceptions to CTRP registration include NCI Cancer Therapy Evaluation Program (CTEP), and Division of Cancer Prevention Protocol Information Offices (DCP PIOS), which includes National Clinical Trials Network (NCTN) trials. Protocol amendments to CTRP within 20 days of IRB approval , bi-annual updates, and annual reports.


Department of Veteran’s Affairs (VA) Sponsored Clinical Trials,
These include biomedical or health-related intervention studies on humans.

Requirements:


Patient-Centered Outcomes Research (PCORI) Funded Clinical Trials
Requirements:


Medical Journal Publications
(Recommended by the International Committee of Medical Journal Editors (ICMJE)

These include biomedical or health-related intervention studies on humans.

Requirements:


Patient Care Reimbursements on Clinical Trials
(Specifically to Centers for Medicare and Medicaid Services (CMS)

Requirements:


Federally Funded Clinical Trials
(Governed by DHHS Office for Human Research Protections)


DETERMINE RESPONSIBLE PARTY

Duplicate registrations are discouraged. For sponsored-initiated, multi-site, or studies that include any drugs or devices, consult with the lead organization, which may be the IND/IDE holder, an industry sponsor, or contract research organization (CRO) to determine use of their Clinicaltrials.gov registration ID.

If they choose to delegate to you as the Responsible Party:

Investigator-Initiated Studies:


ARE PROTOCOL REGISTRATION AND RESULTS SYSTEM (PRS) ACCOUNTS NEEDED?

Requests for new accounts should include Name, Department, Email, and Phone number.


CLINICALTRIALS.GOV PRS REQUIREMENTS

STUDY REGISTRATION
Clinicaltrials.gov Protocol Review Criteria;

PRS typically take 2-5 business days to post publicly and provide NCT number after release by the Responsible Party (if no comments are provided). PRS Review Comments should be addressed within 15 calendar days

Agency requirements detailed above and summarized as follows:

UPDATE STUDY RECORD

RESULTS REPORTING
Clinicaltrials.gov Results Review Criteria;

The review may take up to 30 days if ACT or NIH funded. Other types of study records may take longer. A recommendation is to submit results at least 3 months in advance of the deadline. PRS Review Comments should be addressed within 25 calendar days. Primary and secondary results are required to be reported within 1 year of the entered Primary Completion Date. All results are expected within 1 year of the Study Completion Date.

Additionally:

Certifications for delayed submissions may be requested for certain conditions, if seeking FDA approval, licensure, or clearance of a new product.


PENALTIES FOR NON-COMPLIANCE WITH REGISTRATION & REPORTING

CIVIL MONETARY PENALTIES
May be up to $12,103 a day per study if violations are not corrected. See FDA Draft Guidance.

LOSS OF FUNDS
Can Include:

FAILURE TO MEET ETHICAL OBLIGATIONS TO THE PUBLIC AND RESEARCH COMMUNITY
Can Include:


CLINICALTRIALS.GOV PRS RESOURCES