Clinical Trials Registration and Results Reporting

Federal regulations and policy require public registration of clinical trials and results reporting.

Registration Requirements by Agency

Summary Table of Registration Requirements

Entity	Clinical Trial Definition	Registration & Reporting Requirements	Penalties
International Committee of Medical Journal Editor Requirements	Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.	Registration: Prior to first enrollment Results Reporting: None Data Sharing: Publication must include data sharing statement	Inability to publish in ICMJE journals
National Institutes of Health	A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.	Registration: Within 21 days of first enrollment. Registration with ICMJE is required prior to 1st enrollment Results Reporting: No later than 12 months after primary completion date	Loss of grant funding Future funding may be affected
Food and Drug Administration	Applicable Clinical Trial Drugs & Biologics: controlled clinical investigations, other than Phase 1 of products subject to FDA regulation Devices: 1) controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies 2) pediatric postmarket surveillance as required by FDA	Registration: Within 21 days of first enrollment. Registration with ICMJE is required prior to 1st enrollment Results Reporting: No later than 12 months after primary completion date	Civil monetary penalties up to $11,383 per day until noncompliance is resolved

Flow Chart for Registration Determination

To help decide whether research must be registered. 

Registration Determination Flow Chart (PDF)

Note: Regardless of the funding status or source for a clinical trial involving human subjects, the UT IRB recommends following the compliance practices required by NIH as a best practice. Publication in certain journals could be jeopardized if researchers do not comply with these best practices. 

Registration Steps

Who Should Register

The individual responsible for registering a clinical trial is considered the “Responsible Party.” At The University of Texas at Austin, any researcher in the role of Principal Investigator of investigator-initiated research is designated the Responsible Party with some exceptions: 

If there is an IND or IDE held by someone other than the PI, the IND or IDE holder is the Responsible Party 
Multi-site studies typically designate the lead institution as the Responsible Party

The Responsible Party is required to ensure that study registration, required record updates, and results reporting are completed in a timely manner, according to HHS regulations and federal policy. 

When to Register

ICJME recommends registration prior to enrollment of the first research participant. 

Federal regulations and NIH policy require new qualifying trials/studies to register no later than 21 days after the first participant is consented. 

Where to Register

ClinicalTrials.gov is the primary database for registering and reporting clinical trial results. Other public databases exist as an option. Before selecting a database other than ClinicalTrials.gov, review the list of acceptable databases for ICJME journals. 

How to Register

Request an individual account to ClinicalTrials.gov

Request an individual account to the ClinicalTrials.gov Protocol Registration and Results Submission System (PRS). A PI, as well as any administrator who will assist the PI, should each obtain an individual account.

Contact the Office of Research Support & Compliance Quality Program at orsc@uts.cc.utexas.edu. Include name, school/college, department, email address, and phone number along with the request.

After the request is processed, a log-in name and temporary password will be sent by email from ClinicalTrials.gov.

Register the clinical trial

The “Record Owner” of the registration is the individual who begins the record. At UT, the Responsible Party should also be the Record Owner. Typically, the Responsible Party will be the PI. Once the Responsible Party (PI) has created the new record, s/he can give access to the record to any administrators who will help with registration.

Log into the PRS System and select “New Record” from the Quick Links menu.
Select “UTexasAustin” as the organization.
Click “New Record” and enter the required data elements. Use the protocol, informed consent documents, and the IRB application to complete the registration form.
Use the UT IRB # as the “Unique Protocol ID.”
Preview, inspect, and once all sections are complete, click “complete.”
The PI, as Responsible Party, will then “Approve” and “Release” the record to ClinicalTrials.gov for review.
Verify in PRS that the “Record Status” is “Released.” ClinicalTrials.gov will not process the record unless it is released.

More information is available at How to Register.

Address PRS Review Comments

Anytime the Responsible Party releases a record, PRS staff will review it for any apparent errors, deficiencies, and/or inconsistencies based on the PRS Review Criteria. If PRS Staff identify potential issues with a record, they will add comments to the record. Major comments must be corrected or addressed. Comments identified as Advisory, should be addressed to improve clarity of the record.

Once a record is released, the Responsible Party should:

Monitor the record for any PRS review comments.
Respond, in a timely fashion, to any communications from oversight units (i.e. Regulatory Affairs, ORCR, etc.) regarding PRS review comments related to a study record.
Make corrections in response to PRS review comments within 15 days.
Release the record for PRS review, once all corrections have been made.

Once the record is accepted by ClinicalTrials.gov staff for publication, the record, including its NCT Number, will be available on ClinicalTrials.gov within 2–5 business days.

Required Updates

In general, the Responsible Party must review and update, as necessary, an active study record at least once every 12 months. Failure to do so will result in the record being identified as having a problem that needs to be addressed.

Federal policy further requires that some elements be updated more often, as summarized in the table below. In addition, federal policy requires that if a protocol is amended in such a manner that changes are communicated to human subjects, updates to any relevant clinical trial information must be submitted no later than 30 calendar days after the amendment is approved by the IRB. More information is available on the Clinical Trials website.

Data Element	Deadline for Updating (all days are calendar days)
Study start date	30 days after the 1^st subject is enrolled (if the 1^st subject was not enrolled at the time of registration)
Intervention name(s)	30 days after a nonproprietary name is established
Availability of Expanded Access	30 days after expanded access becomes available (if available after registration); and 30 days after an NCT number is assigned to a newly created expanded access record
Expanded Access status	30 days after a change in the availability of expanded access
Expanded Access type	30 days after a change in the type(s) of available expanded access
Overall recruitment status	30 days after a change in overall recruitment status
Individual site status	30 days after a change in status of any individual site
IRB review status	30 days after a change in status
Primary completion date	30 days after the trial reaches its actual primary completion date
Enrollment	At the time of the primary completion date is changed to “actual” the actual number of participants enrolled must be submitted
Study completion date	30 days after the clinical trial reaches its actual study completion date
Responsible Party, by official title	30 days after a change in the responsible party or the official title of the responsible party
Responsible Party contact information	30 days after a change in the responsible party or the contact information for the responsible party
Device product not approved or cleared by the US FDA	15 days after a change in approval or clearance status has occurred
Record verification date	Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time

Source: US Department of Health and Human Services

Reporting Results

Federal regulations and the NIH policy require reporting of results for Applicable Clinical Trials (ACT), Probably Applicable Clinical Trial (pACT) and NIH funded clinical trials. The Responsible Party is required to report results information for a registered clinical trial no later than one year after the Primary Completion Date identified in the registration record.

The Primary Completion Date is the “date the last subject was examined or received an intervention to collect final data for the primary outcome measure” of the study. The PI and/or study statistician should be involved in preparing results for reporting to ensure the information is accurately summarized and in the format required by law.

Clinical Trials Registration & Results Reporting