Clinicaltrials.gov Registration and Reporting

Clinicaltrials.gov is a publicly available registry and results database administered by the National Library of Medicine. The site is meant to provide increased stewardship, transparency, and access to research and research results. This page includes guidance as well as Office for Research Protections (ORP) policy.

The Quality Management program supports and monitors Penn State investigator compliance with FDA-regulations, NIH policy, and ORP policy regarding clinicaltrials.gov, except for College of Medicine investigators. If you primary affiliation is with the College of Medicine, please contact clinicaltrials.gov@pennstatehealth.psu.edu.

Registration Required by Federal Agencies

Some studies are required to be registered by FDA regulations and/or NIH policy. The Office for Research Protections Quality Management program can help you determine whether your FDA-regulated or NIH-funded study requires registration and results reporting. Information on this can be found on our clinical trials webpage: https://www.research.psu.edu/qm/clinicaltrials. Please also feel free to contact us at ORP-QM@psu.edu or 814-865-1775.

Voluntary Registration and Registration for Publication

An investigator can voluntarily register any study, and many journals have editorial policies regarding clinicaltrials.gov registration. For example, over 1,000 journals follow the recommendations of the International Committee of Medical Journal Editors. For an interventional study, the ICMJE recommends registration of the study be a requirement for publication and that the study be registered before the first subject is enrolled. Journals that do not adopt ICMJE recommendations may still have an editorial policy for clinicaltrials.gov registration.

The Quality Management program does not monitor compliance with editorial policies for clinicaltrials.gov registration. However, voluntary registrations and registrations for publication must comply with the following ORP policy, which reflects clinicaltrials.gov terms of service:

When the recruitment status of a study changes, the clinicaltrials.gov record must updated within 30 days. All other information in the record must be reviewed, verified, and updated as necessary and no less than every 12 months. Records must be kept free of problems. The Responsibility Party is responsible for compliance with deadlines and maintaining an accurate and complete record.

By federal law, some FDA-regulated studies voluntarily registered may be subject to further requirements.

Creating an Account

If you do not have a clinicaltrials.gov account, you can create one by emailing ORP-QM@psu.edu. Please send the email from your Penn State email and include your office phone number.

Registration Guidance

Please see our Clinicaltrials.gov Registration Guide for detailed guidance on how to register your study.

Secondary ID: If the study is NIH-funded, use the NIH grant/contract award number. Include the activity code, institute code, and 6-digit serial number. Other components of the full award number are optional.
Primary Completion Date: This is not the date when analysis is complete or when the study is closed with the IRB. It is the date of the last data collection for the primary outcome.

Study Completion Date: This field is referring to the last data collection date for the entire study. The two completion dates may be the same.

Primary Outcomes: Enter a description of each primary outcome. If results reporting is required, you will have to provide results for each primary outcome. These should be exactly the same as the “Primary Study Endpoints” in your IRB protocol.
Secondary Outcomes: Enter a description of each secondary outcome(s), if any. If there are secondary outcomes and results reporting is required by law or NIH policy, you must include any secondary outcomes. These should be exactly the same as the “Secondary Study Endpoints” in your IRB protocol.
Important: If results reporting is required, you will have to report results for all primary and secondary outcomes. According to clinicaltrials.gov, though a study can have more, "[m]ost clinical studies have one primary outcome measure.”

Penn State Required Record Data

When registering, please follow ORP requirements for the registration data elements below. Please also see our detailed guidance on registering with clinicaltrials.gov.

Responsible Party:  Select "Principal Investigator."

Sponsor: Penn State

For investigator-initiated studies at Penn State, the Responsible Party is the PI on the grant or the IRB submission. The Responsible Party is the party who is responsible for ensuring the the study record is complete, accurate, and in compliance. See more in the Investigator Manual under "Who is responsible for meeting requirements to register and report results for clinical trials?"

Approval Number: Please include the the full CATS IRB study number (e.g., STUDY000123).
 
Board Name: Institutional Review Board
Board Affiliation: The Pennsylvania State University
Phone: 814-865-1775
Address: The 330 Building, Suite 205/University Park, PA 16802
Do not list the IRB as a contact.

Compliance Deadlines

Event Action Needed in Clinicaltrials.gov
You have received IRB approval. When registration is required by law or NIH policy, register within 21 days of IRB approval. This is ORP policy.
You are preparing to recruit. Register before the first subject is enrolled if seeking to fulfill ICMJE requirements.
The recruitment status of the study has changed. Update the “Overall Recruitment Status” in the “Study Status” protocol section within 30 days.
The study is not yet complete, and it has been 11 months since you have looked at the record. Review the record, even if there have been no changes to the study. If there are no changes, update the “Record Verification Date” in the “Study Status” protocol section. Check whether anticipated study completion dates need to be extended. If there are changes, update the record, approve it, and release it. You must update/verify the record no less than every 12 months while active
You have collected the last data for your primary outcome(s). Within 30 days, update the Primary Completion Date from the anticipated to the actual completion date. Report results within 12 months.
Other information related to the record changes, such as study modifications. Update within 30 days. If the change is a change in FDA clearance or approval of a device, update the record within 15 days.

Results Reporting

Researchers do not have to report the results of studies they have registered voluntarily. The ICMJE does not ask that result reporting be required, but some journals following ICMJE recommendations may still require it.

Researchers must report the results of ACTs and NIH-funded studies meeting the NIH definiton of a clinical trial. When required by law or NIH policy, first results and adverse event must be entered within 12 months after the "primary completion date," the date of the last data collection for the study's primary endpoint. All results for the primary and secondary outcomes must be reported. The results information required in clinicaltrials.gov may be more than results information in a publication.  All results are entered in tabular format, not written. The government estimates 40 hours for results reporting. 

When reporting results for studies with at primary completion date on or after January 18, 2017, you must upload the up-to-date study protocol and statistical analysis plan. If you chose to upload the protocol submitted to the IRB, please contact our office if the it may contain information that could identify participants.

More Information About The Clinicaltrials.gov Registration and Reporting

Please see our Clinicaltrials.gov Registration Guide.

If you have questions, please contact the Office for Research Protections Quality Management program at  ORP-QM@psu.edu or 814-865-1775.

Also, clinicaltrials.gov offers a number of instructional and training materials at https://www.clinicaltrials.gov/ct2/manage-recs.

PRS Administrators and New Faculty

Penn State expects active records to stay with the sponsor as defined by clinicaltrials.gov (primary organization conducting study and associated data analysis).  To transfer a record to Penn State, please contact us at ORP-QM@psu.edu or 814-865-1775.