Clinical Trial Results Delayed Submission:

Good Cause Extension

Applicable clinical trials (ACTs) and NIH-funded clinical trials are required to officially submit results to clinicaltrials.gov no later than 1 year after the study’s Primary Completion Date. However, a responsible party may request an extension of the deadline for submitting clinical trial results information for good cause. (See definition of “good cause" in section III.).

A request of Good Cause Extension (GCE) can be submitted via the ClinicalTrials.gov Protocol Registration System (PRS) prior to the date results would be due (i.e., the day before), and must include:

1. A complete description of reason(s) why results information cannot be provided according to deadline, with sufficient detail to justify good cause and to allow for NIH evaluation of the request, AND
2. An estimated date for submission of results information.

Once the request is reviewed, the NIH will issue a determination via email to the responsible parties. There are 3 outcomes of a GCE request:



• Granted: NIH granted the new deadline as requested.
• Granted with modification: NIH identified a submission deadline that is earlier than the requested submission date. In this instance, the responsible party must update the record before the Results Expected Date to reflect the modified submission date.
• Denied: NIH determined that GCE request did not constitute “good cause”. As a result, the responsible party is still bound by the original results reporting deadline with no extension.

NIH-funded awardees should take into considerations that any GCE request could impact other aspects of the contract or grant award. Communicating to your grants manager or contracting officer is strongly encouraged.

For detailed information on the application process, as well as what can be considered a good cause for extension, please read the Good Cause Extension Request Process and Criteria. For assistance with any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.

The Reliance page of the HRPP website has been updated! These updates include the addition of three charts to assist with the submission process of Administrative Review, Advarra IRB and WCG IRB application(s). The charts can be found in the respective sections referenced below on the HRPP Website: Reliance - External IRBs | Rutgers Research



• The Administrative Review Flowchart is designed to help Rutgers University Principal Investigator(s) select the appropriate eIRB submission type when Rutgers University has ceded review of their research study to an external IRB acting as the Reviewing IRB*. The flowchart can be found in the “Administrative Review Submission Guidance” tab.
• The WCG IRB Submission Chart is designed to help Rutgers University Principal Investigator(s) when to submit to eIRB and/or WCG IRB (formerly WIRB) based on the application type. The submission chart can be found in the “WCG IRB Study Submissions” tab.
• The Advarra IRB Submission Chart is designed to help Rutgers University Principal Investigator(s) with the order of submission between eIRB and Advarra IRB based on the application type. The submission chart can be found in the “Advarra IRB Study Submissions” tab.

Reliance Workshop

The Human Research Protections Program (HRPP) is offering a Reliance workshop on Thursday, April 27 from 12:00 pm-1:00 pm. The session will focus on understanding the IRB Reliance Mechanisms. Researchers, faculty and students are invited to learn more about our streamlined reliance processes for Single IRB (sIRB) and Administrative Review submissions to the IRB.

Register at: https://rutgers.zoom.us/meeting/register/tJMtduGorzMvGNVLEXHUOXH_Lyh5wXsSg8O6

What to do if you have a complaint or concern regarding a research study?

The Quality Assurance and Evaluation team, as well as the entire Human Research Protection Program, is concerned about the safety, rights, and welfare of all individuals participating in research at Rutgers and its affiliated sites.

We encourage anyone who has any research-related concerns, complaints, or allegations of any kind to report it to us. Our team is here to assist in resolving any concerns or complaints, as well as investigate any allegations of misconduct.

We take all research concerns or complaints very seriously. We also understand that reporting a concern or a complaint may be difficult, even intimidating at times.  In an effort to respect the privacy and confidentiality of all parties involved, it is our policy to keep any personally identifiable details confidential. Specifically, your identifiable information will never be disclosed to any parties involved in the research, and we will keep any information shared that could be linked to you confidential to the greatest extent possible. Your information would only be accessible by our office to assure that we clearly understand your concern or complaint, and in cases where we may require additional clarification.

If you have a research-related concern or complaint, you can contact our office directly by phone at 732-235-2866 or by sending an email to IRBOffice@research.rutgers.edu.

You can also reach out to the Office of Ethics and compliance hot-line at 833-RU-ETHICS.

For assistance please contact:

Andrea Dragan, Quality Assurance and Evaluation Director

andrea.dragan@rutgers.edu

Barbara LoDico, Quality Improvement Senior Analyst  

Barbara.lodico@research.rutgers.edu

Kathleen Villipiano, Compliance Administrator

Smithk6@research.rutgers.edu