Quality Review Monitoring of Human Subjects Research

Investigator-initiated trials (IITs) provide an innovative pathway for scientific advancements that »Æ¹Ï¶ÌÊÓƵ strives to support. The Research Integrity & Security Monitoring Service was created to proactively provide risk-based oversight for IITs, and other human research studies, as a method for building a robust network of institutional and investigational compliance.

Overview of Monitoring Service

The Research Integrity & Security Monitoring Service aims to:

  • assess and promote compliance with the laws, regulations, policies, and protocols
  • protect the rights and safety of research participants
  • encourage data integrity
  • support and encourage research excellence in human subjects research at »Æ¹Ï¶ÌÊÓƵ

Monitoring reviews will be implemented routinely throughout the course of human research studies at »Æ¹Ï¶ÌÊÓƵ, with the highest priority being given to IITs, particularly those without independent monitors. For FDA-regulated trials, monitoring will often begin once the first subject is enrolled.

This program is complimentary to and does not replace the essential roles of AU’s Human Research Protection Program or the Institutional Review Board (IRB) of record for your study. Furthermore, these reviews are not intended to replace standard quality assurance reviews by the PI and their research team.

Research Integrity & Security (RIS) Monitoring Service will provide reviews of multiple factors, including (but not limited to) regulatory documents and subject cases.

REGULATORY REVIEW

  • IRB approval and compliance with approved protocol
  • Documentation of Investigator and Staff Credentialing and Training; Delegation of Duties Log
  • IND/IDE Holder Requirements
  • Verification of appropriate and timely reporting of reportable events
  • Compliance with PRMC and DSMC reviews
  • Device Accountability
  • Documentation of Monitoring/Auditing
  • Compliance with Security and Confidentiality Requirements
  • Oncore Compliance

SUBJECT CASE REVIEW

  • Informed Consent
  • Eligibility
  • Treatment/Intervention
  • Response/Outcome
  • Toxicity
  • Data Quality
  • Follow-Up
  • Billing Compliance
  • Oncore Compliance

FDA-Regulated Clinical Trials

In the United States, the Food and Drug Administration (FDA) is charged with the governance, oversight, and regulation of clinical trial conduct and public health protection. The agency’s regulations and guidance aim to promote safe and effective development and approval of medical drugs, biologics, and devices. A key component of these goals surrounds the approval processes for investigational drugs and devices. Investigational drugs and investigational devices are approved for experimental use by the FDA under 21 CFR 312 (Investigational New Drug Application) or 21 CFR 812 (Investigational Device Exemptions).

Below outlines current FDA regulations governing human subject protection and the conduct of clinical trials:

DRUGS OR DEVICES

  • 21 CFR 11- Electronic Records and Electronic Signature
  • 21 CFR 50- Protection of Human Subjects (Informed Consent)
  • 21 CFR 54- Financial Disclosure by Clinical Investigators
  • 21 CFR 56- Institutional Review Boards

DRUGS OR BIOLOGICS

  • 21 CFR 210- Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
  • 21 CFR 211- Current Good Manufacturing Practice for Finished Pharmaceuticals
  • 21 CFR 312- Investigational New Drug Application
  • 21 CFR 314- Applications for FDA Approval to Market a New Drug
  • 21 CFR 320- Bioavailability and Bioequivalence Requirements
  • 21 CFR 330- Over-The-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
  • 21 CFR 601- Biologics Licensing
  • Determining Whether Human Research Studies Can Be Conducted Without an IND (FDA Guidance)

DEVICES

  • 21 CFR 807- Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
  • 21 CFR 812- Investigational Device Exemptions
  • 21 CFR 814- Premarket Approval of Medical Devices
  • 21 CFR 820- Quality System Regulation
  • 21 CFR 860- Medical Device Classification Procedures
  • Significant Risk and Nonsignificant Risk Medical Device Studies (FDA Guidance)

Contact Us

Laura A. Meyer Chapman, MA, RBP

706-446-1459

LMEYER@augusta.edu

1120 15th Street CJ-1033 Augusta, GA 30912

Sponsor-Investigator Requirements

A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug or device is administered or dispensed. Sponsor investigators are responsible for satisfying the regulatory requirements of both an investigator and a sponsor.

Sponsor Responsibilities (21 CFR 312 & 21 CFR 812)

Oversight

  • Selecting Qualified Investigators and Monitors
  • Drug/Device Control (supply & shipping)
  • Informing Investigators (i.e. Investigator Brochure and new safety updates)
  • Review of Ongoing Investigation (monitoring and ongoing interim safety/data evaluations)

Record Keeping and Retention

  • Drug/Device Accountability (records showing receipt, shipment, or other disposition & reservations of test articles/reference standards)
  • Clinical Protocol
  • Investigator Statement(s) and Curriculum Vitae(s)
  • Financial Disclosure Information
  • Documentation of Correspondence

Reporting Requirements (to FDA)

  • IND/ IDE Approval
  • Protocol Amendments (new protocols, changes in the protocol, new investigators, etc.)
  • Safety Reports (See FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies)
  • Annual Reports
  • Registration & Updates (42 CFR 11)

 Investigator Responsibilities (21 CFR 312 & 21 CFR 812)

Oversight

  • Assurance of IRB Review
  • Selecting/Training Qualified Research Staff
  • Trial Implementation & Compliance
  • Drug/Device Control (limiting distribution/use/ administration to research subjects & ensuring proper disposition)

Record Keeping and Retention

  • Drug/Device Accountability (record of use and disposition)
  • Case Histories (signed consent forms, applicable medical records, and other research source documents)
  • Documentation of Correspondence

Reporting Requirements (to Sponsor)

  • Progress Reports
  • Safety Reports (adverse events/effects)
  • Final Report
  • Financial Disclosure Reports

Frequently Asked Questions (FAQs)

How are research studies selected for Research Integrity & Security review?

The RIS Monitoring Service will prioritize research studies with high-risk characteristics. Highest priority will be given to IITs without independent monitors. Other studies that may be prioritized include studies where investigators hold the IND/IDE, phase I clinical trials, high enrolling clinical trials, multi-site clinical trials, studies with vulnerable populations, and federally funded studies without external monitoring. RIS Monitoring is applicable to all human research studies conducted at »Æ¹Ï¶ÌÊÓƵ but is not required to include all studies meeting criteria for possible review.

What will an investigator gain from Research Integrity & Security review?

RIS reviews aim is to build a robust network of institutional and investigational compliance. RIS monitor(s) apply a regulatory and compliance perspective during these reviews creating an environment for increased knowledge and understanding of applicable human subjects research regulations and »Æ¹Ï¶ÌÊÓƵ policies.

How should an investigator prepare for a Research Integrity & Security review?

RIS monitor(s) will contact the principal investigator (PI) to schedule an RIS review. The PI should make every effort to schedule the review with timely responses. After the review has been scheduled, the PI will be notified of the necessary review preparations. Briefly, study records will need to be assembled for review. For remote reviews, RIS monitor(s) will need to be able to access required documents. For in-person reviews, the PI/study team will need to reserve a quiet space for the review to occur.

What should an investigator expect for a Research Integrity & Security review?

The scope of RIS reviews may vary and will be tailored to the scope, nature, and complexity of the research studies being reviewed. A study representative should be available to respond in a timely manner during the review. A close-out meeting will be held to discuss any findings and the PI will receive a copy of the final report. The PI is responsible for correcting any identified items and submitting the appropriate notifications of protocol deviations or violations to the IRB of record. Please note: RIS review is not intended to be comprehensive for all subjects and all items, and it does not replace standard quality assurance reviews by the PI and their research team.

Is the Research Integrity & Security Monitoring Service part of the IRB?

No, the RIS Monitoring Service is independent of the IRB. This program is complimentary to and does not replace the essential roles of the IRB of record for your study, or AU’s Human Research Protection Program. The Monitoring Service is designed to provide early-intervention and proactive monitoring for human subjects research at Augusta University.