ClinicalTrials.gov Content Migration Plan

The modernized version of the ClinicalTrials.gov public website has served as the primary site since June 2023. As the ClinicalTrials.gov Modernization effort continues, information about regulations and policies related to clinical trial registration and results reporting is being moved from the classic website to the modernized website. Once this content has been migrated, users who intend to view the information on the classic website will be automatically redirected to the equivalent information on the modernized site or will encounter alerts containing links to the most up-to-date information.  

During the migration process, some content may undergo significant restructuring or revision; however, all the essential information will be available on the modernized website before the classic website is retired. 

Webpages containing more general information, such as the ClinicalTrials.gov Modernization and What's New pages, have also been migrated to the modernized website. (Note: The What's New page was renamed "News and Updates.") These pages are still available on the classic website but are no longer being updated. A banner at the top encourages users to visit the modernized pages for the latest information will show. 

The classic website will remain available until its planned retirement in 2024, but only the modernized website will be updated. To access current information, please visit the modernized ClinicalTrials.gov.  

It is a great idea to update your bookmarks to the corresponding pages on the modernized ClinicalTrials.gov site.

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, January 9th,
• Tuesday, January 16th,
• Tuesday, January 23rd
• Tuesday, January 30th

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) Spring Reliance Workshop is tentatively scheduled for May 2024. Further details will be shared at a later date.



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).

#7: Reporting

An essential element of human subjects protection is identifying, analyzing the causes of, and responding appropriately to expected and unexpected events, as well as unanticipated problems involving risks to participants or others. In addition, investigators must inform the IRB promptly of any protocol deviations and/or violations. The IRB is required to make independent judgments concerning the significance of events and information in the context of the research project and the need for changes to the study protocol and/or informed consent process to protect research subjects.

During the course of the research, investigators may encounter any of the above occurrences or situations. When any of these events happen, or are suspected to happen, to the IRB-approved research plan occur, the investigator must act quickly to ensure subject safety as well as report to sponsor and/or IRB according to each policy and procedures.

Types of Events to be Reported to the IRB:

• A protocol violation is a failure to comply with the study protocol as approved by the IRB.  It is a deviation from the IRB approved protocol that may affect the subject's rights, safety, or well-being and could affect the completeness, accuracy and reliability of the study data. A violation can be serious non-compliance that can result in the exclusion of a participant or their results in the study and in some cases a charge of research misconduct. Protocol violations must be submitted to t the IRB for review.

• A protocol deviation is a less serious non-compliance with the approved study protocol. It can be any change, divergence, or departure from the study design or procedures of a research protocol that is under th Adverse e investigator's control and that has not been approved by the IRB. Upon discovery, the Principal Investigator is responsible for reporting protocol deviations to the IRB.

• Unanticipated Problems  are any problem or event which, in the opinion of the researcher, was unanticipated, reflects new or increased risk to the subjects and was possibly related to the research procedures.

• Adverse Events are defined as: (1) any medical, physiological, psychological, behavioral, social or economic event that is undesirable and unintended, although not necessarily unexpected; (2) an event in which the outcome is fatal or life threatening, causes permanent disability, causes hospitalization or prolongation of hospitalization. events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, but they can occur in the context of social and behavioral research. 

Please visit our website for information about how and when to report such events to the IRB:

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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