Studies must be registered with ClinicalTrials.gov if:

• The study is an FDA Regulated Applicable Clinical Trial (ACT) that was initiated after 9/27/2007, or initiated before 9/27/2007, but were ongoing as of 12/26/2007. An ACT is a controlled clinical-investigations (with one or more arms) of Food and Drug Administration (FDA) regulated drugs, biologics, or devices, that meet one of the following conditions:
  • The trial has one or more sites in the United States
  • The trial is conducted under an FDA investigational new drug application (IND) or investigational device exemption (IDE)
  • The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research.

*ClinicalTrials.gov provides a checklist to help you determine if your study is an ACT.

• The study is fully or partially funded by the National Institutes of Health (NIH), including phase 1 clinical trials and trials that do not involve any FDA regulated product such as trials involving only behavioral interventions.

*NIH definition of clinical trial can be found here.

• The Investigator intends to publish in an International Committee of Medical Journal Editors (ICMJE) Member Journal or in a Surgery Journal Editors Group (SJEG) journal.
• The study is Qualifying Clinical Trial as designated by the Center for Medicare and Medicaid Services (CMS).

The Responsible Party must review and update, as applicable, an active study record at least annually. Failure to do so will result in the record being designated as a problem record, having problems that needs to be addressed.

Additionally, updates should be made within 30 days of any change to clinicaltrials.gov data elements or IRB changes to the protocol.

Federal regulations and NIH policy require the Responsible Party to report results information for the clinical trial no later than one (1) year after the Primary Completion Date indicated in the registration record. The Responsible Party is required to enter results information even if the study terminated.

ClinicalTrials.gov provides step-by-step guided tutorials to assist you with results reporting: https://clinicaltrials.gov/submit-studies/prs-help/prs-guided-tutorials

Note: other funding agencies may require results reporting, check with your funder to determine obligations.

Statement  in the consent

The following statement must be included in the consent form:

"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

Posting

Posting of Clinical Trial consent forms is required for all federally funded clinical, educational, and social-behavioral research meeting the NIH Definition of a Clinical Trial. The informed consent form must be posted after the close of recruitment and no later than 60 days after the last study visit.

Additional information can be found in the Temple ClinicalTrials.gov guidance document.

Study teams should register their studies in the Protocol Registration and Results Reporting System (PRS) at https://register.clinicaltrials.gov/.

Temple is committed to full compliance with registration requirements. If you are noncompliant, the Office of Clinical Research and/or the LKSOM CRORA will contact you and potentially your department or research chair. University officials may administratively suspend your study, hold new IRB submissions or take additional actions.

Important Reminders

As a reminder, the NIH has enhanced its monitoring and oversight of the electronic Research Administration (eRA) Research Performance Progress Report (RPPR) system to ensure that NIH grant and cooperative agreement recipients conducting clinical trials are complying with their clinical trial registration and results reporting requirements as per 42 CFR Part 11 and NIHGPS section 4.1.3.1 - NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.

Investigators submitting a RPPR will receive registration and/or results reporting errors that will prevent RPPR submission if their clinicaltirials.gov registration is incomplete or if results are due.  To resolve registration errors, the recipient will be required to either provide the NCT number issued by ClinicalTrials.gov, or provide the ClinicalTrials.gov registration receipt that is received upon submission of the trial registration information to ClinicalTrials.gov. To address delinquent clinical trial results reporting errors, the recipient will need to submit the trial results information to clinicaltrials.gov.