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:

- Registration within 21 days of the enrollment of the first participant.

- Results reporting within 12 months of the Primary Completion Date.

- Certification (Form FDA 3674) to accompany FDA application.

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:

- Registration within 21 days of the enrollment of the first participant.

- Non-ACT Voluntary Submission results reporting within 12 months of the Primary Completion Date.

- Certification in NIH grant applications, contract proposals, and progress reports.

- Dissemination Plan provides assurance of internal policy and compliance of requirements.

- PHS Human Subjects and Clinical Trials (HSCT) form data may be exported in XML format from ASSIST to ClinicalTrials.gov PRS.

- Registration prior to enrollment of the first participant, prior to award and in coordination with VA Office of Research Development (ORD).

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:

- Registration prior to enrollment of the first participant, prior to award and in coordination with VA Office of Research Development (ORD).

- Updates every 6 months and/or within 30 days of change in recruitment status or last follow-up.

- Results reporting within 12 months of the Primary Completion Date.

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

- Registration prior to enrollment of the first participant, as applicable. Patient registries must be registered in the Agency for Healthcare Research and Quality (AHRQ) Registry of Patient Registries (RoPR) in correspondence with the Clinicaltrials.gov NCT study record or methodological and other projects that are not clinical studies or patient registries, not appropriate for Clinicaltrials.gov or RoPR must be registered in the Health Services Research Projects in Progress (HSRProj) database.

- Reporting of compliance as milestones of the contract and interim progress reports;

- Results reporting within 30 days of the draft final research report due date to PCORI, with completion of the final milestone as the submission of results to Clinicaltrials.gov

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

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

Requirements:

- Registration prior to enrollment of the first participant, which may be made on alternative World Health Organization (WHO) registries.

- Data Sharing Statement prior to enrollment.

- Non-ACT Voluntary Submission of study will require results within 12 months of Primary Completion Date.

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

Requirements:

- A Clinicaltrials.gov unique identifier number (NCT) provided upon registration to be reported on Medicare or Medicaid claims as long as the patient is a study participant.

- Non-ACT Voluntary Submission of study will require results within 12 months of Primary Completion Date.

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

- Requires posting of an informed consent form after recruitment closes and no later than 60 days after the last study visit on a federal website, in which Regulations.gov may alternatively be used (if not already registered in Clinicaltrials.gov or for trials whose consent is not in English).

- Non-ACT Voluntary Submission requires registration and results reporting, in order to upload the Informed consent in the Results-Documents Upload Information.

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:

- Cancer Studies will list USC as Sponsor and Responsible Party. Contact Victoria Soto, Clinical Research Regulatory Administrator (323) 865-0432 to download study information and update study record.

- Non-Cancer Studies will list the eligible Principal Investigator to serve as the Responsible Party, delegated by USC. Contact Jean Chan, HSC Associate Director (213) 821-7134 for any other questions.

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

- Cancer Studies do not require PI to setup PRS user accounts. Contact Victoria Soto, Clinical Research Regulatory Administrator (323) 865-0432 to create and update study record.

- Non-cancer Studies require PRS user accounts for PIs and other authorized users who will enter and manage study data. Contact Jean Chan, HSC Associate Director (213) 821-7134 to request any new accounts or assistance with resetting your password.

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:

FDA Clinical Trials (ACTs) required within 21 days after first enrollment
NIH Clinical Trials required within 21 days after first enrollment
VA Clinical Trials required prior to enrollment
PCORI Clinical Trials required prior to enrollment
ICMJE Studies must be registered and include a data sharing statement prior to enrollment
CMS Reimbursement requires NCT number to be reported on Medicare/Medicaid claims

UPDATE STUDY RECORD

Data Elements require updates within 15-30 days.
Clinicaltrials.gov recommends that other changes or updates occur every 6 months.
Record Verification Date must be updated annually or every 12 months.

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:

- The Study Protocol and Statistical Analysis Plan are required to be uploaded as part of results information.

- Informed Consent documents are optional and may be uploaded in the Results Section to meet DHHS Common Rule Requirements to post an approved copy after recruitment closes or no later than 60 days after the last study visit.

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