ClinicalTrials.gov Registration

In general, the following clinical trials must be registered on ClinicalTrials.gov:

• Applicable Clinical Trials (ACTs) - clinical trials of FDA-regulated products (drugs, devices, or biologics), or pediatric post market surveillances of a device, as long as the trial is neither a feasibility study of a device prototype nor a phase 1 study of a drug. (Phase 1 studies usually evaluate safety, maximally tolerated dose, pharmacokinetics, etc.). To determine if your study is an ACT, click here.
• NIH-funded clinical trials – all clinical trials funded in whole or in part by NIH require registration and results reporting if the grant application was received by NIH on or after Jan. 18, 2017. Click here to determine if your study meets NIH's definition of a clinical trial.
• Clinical trials being considered for publication in ICMJE-affiliated journals must be registered on ClinicalTrials.gov before the first participant is enrolled. For more information on the International Committee of Medical Journal Editors’ (ICMJE) publication requirements, click here.
• PCORI-funded patient registries and clinical studies must be registered on ClinicalTrials.gov. For more information on Patient-Centered Outcomes Research Institute (PCORI) requirements for registration, click here.

• Basic experimental studies involving humans (BESH) are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial. BESH therefore are subject to NIH clinical trials policies such as registration and results reporting. Click here for additional information.

• Your funding agency may have its own requirements; be sure to check the terms of your award letter.

The Responsible Party is a term referring to the individual who is ultimately responsible for ensuring the trial is registered and updated appropriately at required intervals as required by all applicable regulations and policies. The University of Louisville designates any researcher in the role of Principal Investigator (PI) as the Responsible Party for the following clinical trials:

1. Trials in which the PI holds the IND/IDE (the PI is also considered the sponsor-investigator). 2. Trials initiated by the Principal Investigator.

3. NIH-sponsored trials for which University of Louisville is the grantee institution.

4. Trials initiated by private industry or other outside entities, for which the Principal Investigator accepts the role of the Responsible Party in an explicit agreement.

The Responsible Party must comply with all regulations for submitting registration and summary results information, including adverse events information, and is responsible for ensuring knowledge of the regulations and requirements for updates and other required information according to HHS regulations, the NIH, and this policy.

The Responsible Party may delegate individuals to assist in completing the ClinicalTrials.gov record, however, the final responsibility of review, approval, and release lies with the Responsible Party.

In the event the PI intends to leave UofL, they must contact the UofL PRS administrator in the Human Subject Protection Program to assist in the designation of a new PI or transfer the record the new institution.

Use the flow diagram. to determine who the Responsible Party is and what option should be selected.

The University of Louisville, following the Regulations of 42 CFR Part 11, requires registration on ClinicalTrials.gov of ACTs and NIH-funded trials, no later than 21 days after the first subject is enrolled. Studies registered per ICMJE require registration prior to first subject enrollment.

Elements of successful registrations include the following:

• The study record should not contain personal pronouns.
• Acronyms and abbreviations are spelled out the first time they are used in the record.
• The IRB# is listed as the Unique Protocol ID.
• Outcome Measures are measurable quantities (i.e. nouns). The description contains the name and description of the metric/scale used to measure the outcome measure. The timeframe for the assessment of the measurement must be discrete and specific.

When are Updates Required?

Updates to the record are required throughout the life of the record. Specifically, updates must be made within 30 days of changes in the study status (e.g., changes in recruitment status, protocol amendments, PI changes, study closures, etc.). If no changes are made to the record, the Record Verification field must be updated at least once every 6 months. Information about events and timeline requirements can be found here

Results Summary Data

The Responsible Party is required to submit summary results data to ClinicalTrials.gov within 12 months of the primary completion date for ACTs, NIH, and PCORI-funded studies. The results submission must include the following:

• Participant Flow
• Baseline Characteristics
• Outcome Measures and Statistical analyses
• Adverse Events

All results information must be aggregated, summary level data. Do not include data for the individual participants. No written results or conclusions are allowed in the free-text fields. For detailed information on how to submit summary results data, click here

Uploading Documents

For ACTs with primary completion dates on or after January 18, 2017, the protocol and statistical analysis plan (SAP) must be uploaded to ClinicalTrials.gov. The protocol should be clear, concise, written in English and should clearly delineate the primary and secondary outcome measures. It must have a cover page with the official title, the NCT number and the protocol version date.

Clinical trials which receive IRB approval after January 21, 2019 and are supported by federal funding must upload an unsigned copy of one of the Informed Consent Forms (ICF) used in the study. The ICF must be uploaded after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol.

Personal identifiable information, trade secrets, and confidential information should be redacted from all documents prior to uploading, unless such information is required by the regulation. The documents should all be converted to PDF/A (A=archivable) format.

In the event the PI (Responsible Party) becomes aware he/she is leaving the university and has an active record, the UofL PRS administrator (trialgov@louisville.edu) must be informed in writing. The UofL PRS administrator will review the clinicaltrials.gov record status and notify the department chair. The record can either be reassigned to another PI within UofL or transferred to the PI’s new institution.

What role does the UofL PRS administrator have?

The UofL PRS administrator in the Human Subject Protection Program creates PRS user accounts. You will receive an external email from register@ClinicalTrials.gov once the account is created. You will need to modify your password. If you need a password reset, email the request to trialgov@louisville.edu

The UofL PRS administrator helps facilitate record transfers at the request of the PI (Responsible Party).

If a protocol record becomes delinquent the PRS administrator will contact the Responsible Party. A second notification will be sent if the record remains delinquent. If a third notice becomes necessary, the department chair will be copied on the notification.

If the protocol record remains delinquent one month after the last notification without acceptable activity/progress, the Associate Vice President of Research and the relevant dean will be notified.

If the record remains without acceptable activity/progress the IRB and the Executive Vice President of Research and Innovation (EVPRI) will be notified of the noncompliance. Potential sanctions may be applied as stated in UofL Policy and Procedures Database Numbers RES-1.02-Responding to Violations of University of Louisville Research Policies and RES-5.01 Responsible Conduct of Research.

A PI, Responsible Party, or staff receiving an FDA notice of noncompliance, must notify the UofL PRS administrators immediately. (trialgov@louisville.edu)

	FDA	NIH	ICJME
DEFINITION OF CLINICAL TRIAL	FDA Clinical Trial Definition	NIH Definition of Clinical Trial	ICJME Definition of Clinical Trial
WHY TRIALS MUST BE REGISTERED?	FDA Applicable Clinical Trial (ACT) Checklist	NIH checklist	See NIH checklist
TYPE OF INTERVENTION	FDA approved drug, device, or biologic	Any intervention	Any intervention
STUDY PHASE	Any phase except phase 1 studies or device prototype feasibility studies	Any and all phases (including pilot, phase 1, and feasibility studies)	Any and all phases (including pilot, phase 1, and feasibility studies)
DEADLINE FOR REGISTERING	Prior to first patient enrollment (institutional)	Prior to first patient enrollment (institutional)	Before first participant is enrolled (ICJME’s policy)
RESULTS DATA REQUIRED?	Yes	Yes	Not required, but encouraged
DOES SYSTEM PROMPT FOR RESULTS DATA?	Yes	No	N/A
FUNDING SOURCE	Any or no funding source	NIH funding only	Any or no funding source
PENALTY FOR NON-COMPLIANCE	Monetary penalty up to $10,000/day for the duration of violation	Monetary penalty including withholding grant funds	Rejection of publication submission
REQUIRED FIELDS	Fields marked with * or *§ are required	Secondary ID (in Study Identification module) - enter grant# Collaborators (in Sponsor/Collaborators module) – enter funding center name	IPD Sharing Statement - Starting Jan. 2019, the "Plan to Share IPD" field must be answered in the original registration. The answer must be YES or NO (Select NO if undecided). Click here for more information.