Clinical Trials Registration & Results Reporting
Federal regulations and policy require public registration of clinical trials and results reporting.
Registration Requirements by Agency
FDA Defined Applicable Clinical Trials (ACT)
Applicable clinical trials, regardless of funding source, must be registered (42 CFR Part 11). ACTs generally include:
- Controlled clinical trials of FDA-regulated drugs or biologics (Phases II – IV)
- Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies)
- Research studies testing a clinical hypothesis about health outcomes, including:
- research whose primary purpose is to affect clinical practice
- nutritional studies
National Institutes of Health (NIH) Funded Research
NIH funded clinical trials require registration per NIH policy. If the answer is “yes” to all four of the following questions, then the research study meets the NIH definition of a clinical trial and must be registered.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention (placebo or control)?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
Use the NIH Decision Tool to help determine if your study meets the NIH definition of clinical trial.
International Committee of Medical Journal Editor (ICMJE) Requirements
Registration is required prior to enrollment of the first research participant in order to be eligible to publish in a journal that follows the ICJME guidelines. Studies requiring registration include:
- All studies meeting the NIH definition of clinical trial
- Phase 1 drug studies
- Device feasibility studies
Center for Medicare and Medicaid Services (CMS) Requirements
It is important to note that the CMS requires a National Clinical Trial (NCT) number for coverage of routine costs of qualifying clinical trials. An NCT number is provided by successful registration at ClinicalTrials.gov.
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 1st subject is enrolled (if the 1st 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 |
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.
What Must be Reported
Results are submitted as four separate modules:
- Participant Flow: A tabular summary of the progress of participants through each stage of the study, by study arm or comparison group.
- Baseline Characteristics: A tabular summary of the data collected at the beginning of a study for all participants, by study arm or comparison group, such as demographics and baseline data.
- Outcome Measures and Statistical Analysis: A tabular summary of outcome measure values, by study arm or comparison group, including tables for each prespecified Primary and Secondary Outcomes.
- Adverse Events: A tabular summary of all anticipated and unanticipated Serious Adverse Events and a tabular summary of anticipated and unanticipated other adverse events exceeding a specific frequency threshold.
How to Report Results
- Login to the ClinicalTrials.gov PRS and open the applicable study record
- Click “Enter Results”
- Complete all required and optional data elements
- Upload supplemental documentation
- Full study protocol
- Statistical analysis plan, if separate from the protocol. Documents need to be the most recent version reviewed by the IRB and include a cover page with the official title of the study, the NCT number, and the date of the document. The Responsible Party may redact the following from the protocol prior to results submission:
- Names, addresses, and other personally identifiable information
- Trade secret and/or confidential commercial information
- Release the record and verify that the status changes to “Released”
- Monitor the record for any comments from PRS staff that need to be addressed
ClinicalTrials.gov Reporting FAQ's
Who can help me register my study?
Office of Research Support & Compliance Quality Program
orsc@uts.cc.utexas.edu
512-471-8871
What do I have to include in my informed consent form if my study is registered?
Applicable Clinical Trials (FDA)
The following language must be inserted into informed consent forms verbatim:
“A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
NIH and Other Sponsors
NIH funded clinical trials that began on or after 1/18/2017 must refer to ClinicalTrials.gov in their informed consent document (unless they are conducted under a grant submitted prior to that date, with no competing renewals on or after 1/18/2017). Use the following language:
“This trial will be registered and may report results on https://www.ClinicalTrials.gov, a publicly available registry of clinical trials.”
The ClinicalTrials.gov information posted to the ORSC website is adapted from the University of Michigan, ClinicalTrials.gov resources at Spectrum, the Stanford Center for Clinical and Translational Research and Education, supplemented by resources from the University of Texas at Houston Science Center and the ClinicalTrials.gov website.
When is a University of Texas at Austin researcher a Responsible Party under HHS and ICJME guidelines?
Generally, a University of Texas at Austin researcher is the Responsible Party when:
- The PI is the PI of record for an ACT.
- The PI is the PI of record for an NIH funded clinical trial.
- The PI wishes to publish in an ICJME journal.
- The PI holds the IND or IDE.
- The PI drafted the protocol and is the PI of record for an FDA-regulated IND-exempt clinical investigation of a drug or biologic.
- The PI drafted the protocol for an FDA-regulated clinical investigation of 1) a nonsignificant risk device or an 2) IDE-exempt device.
- A foundation, cooperative group, or group of investigators wrote the protocol and a University of Texas at Austin investigator has been delegated this responsibility in an agreement.
When is a University of Texas at Austin researcher not responsible for registration and resulting reporting?
Generally a University of Texas at Austin researcher is not the Responsible Party when:
- The manufacturer of a clinical investigation of a drug, biologic, or medical device wrote the protocol and is the sponsor.
- A University of Texas at Austin researcher is a sub-recipient of a contract or grant from another organization or institution, unless a University of Texas At Austin researcher has been assigned this responsibility in the award agreement.
What if the University of Texas at Austin is not the IRB of record for a study?
A University of Texas at Austin researcher may still be the Responsible Party even if the University of Texas at Austin does not serve as the IRB of record, e.g.—the study is at a Central IRB or UT is relying on another institution’s IRB.
What if my protocol is an expanded access protocol for a drug or biologic?
Expanded access protocols should be registered on ClinicalTrials.gov by the manufacturer of the drug or biologic. Single patient INDs (i.e., single use compassionate or treatment use) do not require registration. Single patient IDE projects are not applicable device clinical trials and do not require registration. This scenario will typically be limited to Dell Medical School researcher physicians.
Is there a charge for listing a study on ClinicalTrials.gov?
No. There is no fee for listing.
My study is not yet approved by the IRB. Can I still enter it on ClinicalTrials.gov?
Most studies require approval from a human subjects review board. If your study requires approval, you may register your study on ClinicalTrials.gov prior to getting approval if the Overall Recruitment Status of the study is “Not yet recruiting” within PRS. If a study requires human subjects review board approval, approval must be obtained before the study's Overall Recruitment Status is changed to “Recruiting.” When board approval is obtained, please update the Protocol Section of the study record in PRS and “Release” (submit) the study for processing.
Are clinical studies with no external sources of funding required to be registered on ClinicalTrials.gov?
Unfunded studies that otherwise meet the requirements of this policy (e.g., falling under the definition of an ACT or for publication purposes) must register with ClinicalTrials.gov and otherwise meet the requirements stated above.
How do I upload studies with a large dataset to ClinicalTrials.gov?
A new feature in the eRA Human Subjects System in the PRS allows study records to be exported as an XML file, with upload fields that will be captured directly into ClinicalTrials.gov PRS. For details, see the NIH Office of Extramural Research page on Submitting Inclusion Data. Video Guides are available on the NIH eRA Training Page.
What if I leave the University of Texas at Austin?
If a researcher who serves as a Responsible Party leaves the University of Texas at Austin, the study must be assigned a new University of Texas at Austin responsible party or the study record transferred to the ClinicalTrials.gov system at the researcher’s new institution.
More information is available at the ClinicalTrials.gov Protocol Registration and Results System.