FDA’s ClinicalTrials.gov Enforcement & Resources 

A Notice of Noncompliance from the FDA to Light Sciences Oncology for late trial results at ClinicalTrials.gov was issued on July 19, 2023. This notification is accessible through the registered record page at ClinicalTrials.gov, under the tab FDAAA 801 Violations. 

The FDA has taken action to enforce the Section 801 of Food and Drug Administration Amendments Act of 2007 (FDAAA801) law on clinical trials results reporting on ClinicalTrials.gov, and has sent approximately 100 Pre-notices to entities noncompliant with results reporting. The first FDA Notice of Noncompliance with results reporting on ClincialTrials.gov was issued April 2021. The latest notification is the 5th Notice of Noncompliance, and four of these 5 notices were issued to industry entities. 

On August 9th 2023, the FDA released webinars titled ClinicalTrials.gov – a Three-Part Series, that provide an overview of ClinicalTrials.gov and examples of compliance and enforcement activities that CDER/FDA has taken to encourage compliance. These videos may be accessed directly through YouTube: 

• ClinicalTrials.gov: Part 1 - Meeting Transparency and Reporting Requirements (12:17) 
• ClinicalTrials.gov: Part 2 - Definitions, Laws, and Regulations (15:32) 

• ClinicalTrials.gov: Part 3 - CDER’s Compliance and Enforcement Activities (16:32) 

The HRPP ClinicalTrials.gov Support team has been working diligently with investigators to reach required compliance and avoid penalties specified in the FDAAA801 law.



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

Changes in WCG IRB Submission Process

Effective September 1, 2023

We are pleased to announce that 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.

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.



7 Ways to Help Prevent Common Non-Compliance Issues

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).

#3: Standard Operating Procedures: 

Standard Operating Procedures (SOPs) are a cornerstone of effective research providing clear guidelines and instructions for consistent practices. 

What is the difference between protocol and SOP in research?

A protocol is a detailed plan outlining the objectives, design, methodology, and procedures of the study. It serves as a blueprint for conducting the research. 

Standard Operating Procedures (SOPs) offer specific instructions for carrying out various tasks in a standardized manner. SOPs are detailed, written plans that outline standard practices and processes within an organization or research setting. They serve as a roadmap, ensuring that everyone involved follows the same steps.

Why are SOPs Important?

The creation of SOPs can assist you and your study team ensure quality, consistency, and compliance with ethical and regulatory standards.

1. SOPs ensure that procedures have been examined and improved to promote operational efficiency.
2. They encourage uniformity and consistency among research team members.
3. They can help prevent noncompliance on a systemic level in a way that a protocol alone cannot.
4. SOPs outline the plan for conducting all studies, rather than a singular specific study.
5. They can also serve as a powerful catalyst for obtaining dependable and high-quality study outcomes.

SOPs typically consist of three key components:

1. Objectives: Clearly state the purpose and scope of the SOP.
2. Procedures: Provide step-by-step instructions for carrying out specific tasks or processes.
3. Responsibilities: Identify the roles and responsibilities of individuals involved in the process.

What are the most common types of SOPs?

1. Informed Consent Process and Documentation
2. Data Management
3. Adverse Event/Serious Adverse Event Reporting
4. Subject Screening and Recruitment
5. Protocol Deviations
6. Regulatory Document Submission Process
7. Drug/Device Storage, Accountability, and Management
8. GCP Training

Example: An SOP for subject screening and recruitment would outline the criteria for selecting participants, the process for obtaining informed consent, and the steps for verifying eligibility.

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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