Clinicaltrials.gov Registration and Reporting
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.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. The site is administered by the National Library of Medicine meant to provide increased stewardship, transparency, and access to research and research results. For assistance registering at clinicialtrials.gov, see these instructions and check out the ClinicalTrials.gov Infosheet.
Voluntary Registration and Registration for Publication
While "applicable clinical trials" (ACT) must be registered at clinicaltrials.gov, an investigator can voluntarily register any study. Many journals follow the recommendations of the International Committee of Medical Journal Editors (ICMJE) and have policies regarding clinicaltrials.gov registration. 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. Even journals that do not adopt ICMJE recommendations may still have an editorial policy for clinicaltrials.gov registration.
As a condition of publication of clinical trial results, many journals require inclusion of a Data (Individual Participant Data, IPD) Sharing Statement for clinical trial registration. See the Understanding Data Sharing Statements (IPD Tool) which outlines the process of entering the IPD Sharing Statement in a trial’s ClinicalTrials.gov registration, including examples and instructions for completion.
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.
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 it may contain information that could identify participants.
Registration Guidance
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. See our ClinicalTrials.gov Registration Guide for detailed guidance on how to register your study. Clinicaltrials.gov offers a number of instructional and training materials and their guided tutorial on study registration can be found here. When registering, please follow ORP requirements for the registration data elements below.
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?"
Compliance Deadlines
| Event | Action Needed in ClinicalTrials.gov |
|---|---|
| You submitted a study for IRB approval. | When registration is required by law or NIH policy, the record must be registered and an NCT # obtained prior to 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. |
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.