ClinicalTrials.gov Tips for NIH Awardees 

The NIH Award Notice includes a "Clinical Trial Indicator" in Section IV which specifies whether the award supports any NIH defined clinical trials. 

• If the Clinical Trial Indicator specifies "No", then your study does NOT meet the NIH definition of a clinical trial, and therefore, does not need to be registered on Clincaltrials.gov. 

• If the Clinical Trial Indicator specifies "Yes", then your study meets the NIH definition of a clinical trial and must be registered and report results on Clincaltrials.gov. 

NIH Research Performance Progress Report (RPRR): 

Be proactive and panic-free! Utilize the template below to craft the required statement for the next Research Performance Progress Report (RPPR) of your NIH-funded clinical trial. 

In addition to the comments above, please note that this project involves the clinical trial number XXXXXXXX (i.e., NCT number). Due to validations implemented by the NIH, the information in the RPPR, particularly the primary completion date and study completion date, must be consistent with the data in the corresponding ClinicalTrials.gov record. To view the information in the ClinicalTrials.gov record and ensure consistency with the RPPR, navigate to www.clinicaltrials.gov and search for the record using the NCT #.  

For assistance with any ClinicalTrials.gov questions, contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu. 

SMART IRB

Over the past several years, SMART IRB leadership has been working with the SMART IRB Harmonization Steering Committee, the National Center for Advancing Translational Sciences (NCATS) and other federal agency representatives, and members of the SMART IRB community to discuss possible changes to the current SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement. The proposed SMART IRB Reliance Agreement Version 3.0 is a significant amendment of the current SMART IRB Agreement. Key changes can be found in the Executive Summary.

These changes are intended to:

• Address feedback from current and potential Participating Institutions
• Fully reflect changes to IRB review requirements in the 2018 Common Rule; and
• Allow additional federal agencies to participate in the agreement.

Availability During Virtual IRB Office Hours

The Reliance Team is excited to announce that we are available during Virtual IRB Office Hours during select Tuesday sessions.

We are joining Virtual Office Hours on the following dates:

• Tuesday, December 5th
• Tuesday, December 12th
• Tuesday, December 19th

If you'd like to connect with us on one of these select dates, please join using the general Office Hours Zoom Link | Passcode: 133269. When you join, please let us know that you'd like to meet with the Reliance Team so that you can be placed appropriately for consultation.

Reliance Workshop

The Human Research Protections Program (HRPP) Reliance workshop presented on Thursday, November 16, 2023 was a success! To obtain the recorded slides, please contact the IRB Reliance Team at irbrelianceteam@research.rutgers.edu.

Reliance Document(s) Update

Exciting News! The former reliance documents (i.e., HRP 1812A/B, HRP 830, and HRP 811 forms) have been completely redesigned to reduce the number of document(s) required to establish a reliance agreement. Three forms have been condensed into ONE document referenced as the “Relying Site Local Context.”

The “Relying Site Local Context” is available in the “External IRB” tab of our webpage.

WCG IRB Submission Process

As a friendly reminder, effective September 1, 2023, Principal Investigators (PIs) at Rutgers University may submit Initial WCG IRB applications directly to WCG. This change aims to streamline the submission process and enhance efficiency.

All initial applications must still undergo a preliminary review by the Rutgers IRB office before they can be accepted by WCG IRB. It is essential to adhere to this step, as WCG IRB will not consider any initial applications without the completion of the preliminary review by the Rutgers IRB. The Rutgers IRB reliance team completes this preliminary review in 3 business days and allows our office to confirm the local context required by WCG IRB.

The revised process requires Rutgers Principal Investigator(s) to submit an eIRB WCG IRB application to the Rutgers IRB first and obtain local institutional clearance from Rutgers IRB for their WCG IRB submission. Once the submission is ready for WCG IRB review, a clearance memo will be issued to the Principal Investigator (PI). This memo should be uploaded as the local institutional requirement document when submitting directly to WCG IRB.

Additionally, we would like to inform you that Progress Reports and/or Final Reports should now be submitted to Rutgers IRB for administrative review after the WCG IRB Continuing Approval and/or Notice of Closure has been submitted directly to WCG IRB for their review.

For your convenience, we have updated the WCG IRB Submission chart on our website to reflect the new process. 

For any inquiries or further information regarding the submission process, we encourage you to contact the IRB Reliance Team at irbrelianceteam@research.rutgers.edu. They will be more than happy to assist you with any questions you may have.

The Quality Assurance and Evaluation (QA&E) Team continues its series on the seven most common pitfalls identified during Post Approval Monitoring (PAM) Reviews.

The May issue of the HRPP/IRB Bulletin introduced our series, "7 Ways to Help Prevent Common Non-Compliance Issues" and listed seven common compliance pitfalls:

1. Assess Your Research Plan Feasibility
2. Data Collection Forms and Checklists
3. Standard Operating Procedures (SOPs)
4. Resource Availability
5. Training
6. Documentation
7. Reporting

If you missed any of the previous articles in this series, please visit the Newsletter section of our website (Net ID required to access).

#6: Documentation

One of the most common PAM findings is a lack of accurate and adequate documentation. The importance of good documentation practice needs to be emphasized because it ensures that the study is built on the foundation of both credible and valid data, as well as to ensure proper protocol compliance.

The purpose of proper documentation is to be able to reconstruct the study as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide a trail of how the study was conducted and each participant’s role from the beginning to the end of the study.

Source documentation is the record of the subject before, during, and after the study. It documents the progress of the participant from consent through completion of the study.

Why is study documentation important?

• It provided evidence that the rights, safety and well-being of participants were protected. 
• It ensures data integrity and compliance.

Examples of findings of inadequate documentation:

• Inadequate/inaccurate case histories.
• Unsigned and dated notes to file, data collection sheets, etc.
• Use of white out.
• Documents signed by someone other than participant or approved study team member.
• Inadequate documentation of consent (missing dates and/or signatures).
• Missing documentation of study visits and/or missed study procedures.
• Missing or incomplete questionnaire, incomplete assessments, missing source documents.

Examples of good documentation practice

• Attributable: It should be clear who has documented the data.
• Legible: Readable and signatures identifiable.
• Contemporaneous: The information should be documented in the correct time frame along with the flow of events. If a clinical observation cannot be entered when made, chronology should be recorded.
• Original: Should be original copy; the first record made by the appropriate person. The investigator should have the original source document.
• Accurate: Accurate, consistent and real representation of facts.

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

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