Tip: Submitting Results for a Terminated Study 

How do I submit results information if the trial is terminated (that is, stopped prematurely) and no participants were enrolled in the trial?  

If no participants were enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no results information will need to be submitted.  

How do I submit results information if the trial is terminated (that is, stopped prematurely) and participants were enrolled in the trial, but no data were collected for one or more Outcome Measures?  

If participants were enrolled before trial termination but no data were collected for one or more Outcome Measures, specify zero ("0") in the relevant Number of Participants Analyzed data element and leave the data fields blank for each Arm/Group. In this case, use the Analysis Population Description data element to explain that the trial was terminated before the outcome measure data were collected and, if appropriate, provide additional details in the Limitations and Caveats module. All other required results information collected for the enrolled participants will need to be submitted in each results module even though no data were collected for one or more Outcome Measures.  

Log-in to view your records at https://register.clinicaltrials.gov/.

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

Updates to Reliance Documents

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

Effective October 1, 2023, the “Relying Site Local Context” will be made available for download in the “External IRB” tab.

WCG IRB Submission Process Updates

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 to reflect the new process. You can find the updated chart and further guidance on our website at Reliance | Rutgers Research.

We appreciate your cooperation and understanding during this transition. These changes are aimed at ensuring a smoother and more effective IRB submission process for all researchers at Rutgers University.

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, October 3rd
• Tuesday, October 17th
• Tuesday, October 31st

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.

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).

#4: Resource Availability 

Having adequate resource availability means the PI has ensured that all research team members have readily available access to training materials, research plan(s), checklists, and other documentation along with the supplies necessary to conduct the research and that these resources are regularly updated as needed. Study team members should also know where to go to when questions about study implementation arise.

Principal Investigators (PIs) and research teams are tasked with a myriad of responsibilities. Ultimately, it is the responsibility of the PI to ensure all affiliated research personnel are compliant with the protocol.

It is often the research team who facilitates and coordinates the daily activities and the conduct of the study. In collaboration with the PI, they assist with protocol and consent form development, recruiting subjects, administration of the study, and the collection and maintenance of data.

Why is having availability to adequate resources important?

Keeping regulatory documents accessible and accurate is critical in being able to reconstruct the study as it happened for each participant. Maintaining and storing these study documents will also ensure the quality of the data. The PI should retain these essential documents/records in a way that ensures that they remain complete, readable, readily available and are directly accessible upon request.

Tips to Help Maintain Access to Study Materials and Documentation

Each research team should have a “Site Master File” that contains all essential study documents.

• Regulatory and protocol related documents: Access to the most recently approved protocol, consent forms, recruitment scripts, screening logs, surveys, and/or questionnaires will ensure everyone is using the correct versions of documents. Also, all protocol deviations, reportable events, and/or modifications should be retained in a central location and made available to the study team.

• Participant specific (source) documents: Maintain records of all data and observations pertinent to the research subject. Examples include screening tools, eligibility logs, consent forms, treatment logs, survey answers, and interview transcriptions.

These documents can be stored in a binder or online, but the key is that ALL affiliated study team members are aware where they are located and have access to all current documents to use as needed.

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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