Presentation: The Clinical Investigator: Responsibilities in Medical Device Clinical Trials

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

Presented by Catherine Parker, RN

Consumer Safety Officer
Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and Radiological Health

Objectives

• Define a medical device clinical investigator
• Explain the general and specific responsibilities of investigators
• Describe records and reporting requirements of investigators

Presentation Topics

• General responsibilities
• Specific responsibilities
• Records
• Inspections
• Reports

What is a Clinical Investigator (CI)?

• An individual who actually conducts a clinical investigation, under whose immediate direction the test article is administered, dispensed, or used.

General Responsibilities - 21 C.F.R. 812.100

• Follow the investigator agreement, the investigational plan, and applicable regulations
• Protect the rights, safety, and welfare of subjects
• Control devices under study
• Obtain informed consent

Specific Responsibilities - 21 C.F.R. 812.110

• Obtain IRB and FDA approval
• Follow investigator agreement, investigational plan, and conditions of approval imposed by IRB or FDA
• Supervise device use
• Disclose financial interests
• Dispose of device

Disqualification - 21 C.F.R. 812.119

• An investigator’s repeated or deliberate failure to comply with these requirements may result in disqualification from receiving investigational devices

Investigator Records - 21 C.F.R. 812.140(a)

• All correspondence with another investigator, Institutional Review Board (IRB), sponsor, monitor, or FDA

Device Records - 21 C.F.R. 812.140(a)

• Records of receipt, use, and disposition of device including:
  • Type and quantity of the devices, dates of receipt, and batch number or code mark
  • Name of all persons who received, used, or disposed of each device
  • Why and how many devices have been returned, repaired, or other wise disposed of

Case Histories - 21 C.F.R. 812.140(a)

• Exposure to the device
• CRFs and supporting data
  • Informed consent documents
  • Adverse device effects
  • Any relevant observations

Protocols - 21 C.F.R. 812.140(a)

• All IRB approved amendments
  • Including approvals
• Documentation of protocol deviations and IRB and sponsor approvals

Record Retention - 21 C.F.R. 812.140(d)

• Two years after study termination or completion
• Two years after records are no longer required to support marketing application

Records Custody - 21 C.F.R. 812.140(e)

 Withdraw responsibility to maintain records
 Transfer custody to any other person who will accept responsibility
 Notice of transfer to FDA not later than 10 working days

Documentation

If it is not documented, it never happened!

FDA Inspections - 21 C.F.R. 812.145

• Occur at reasonable times and in a reasonable manner
• Permit records to be inspected and copied

Investigator Reports - 21 C.F.R. 812.150

• Unanticipated Adverse Device Effects
• Withdrawal of IRB approval
• Progress reports
• Deviations from the investigational plan
• Informed consent
• Final report
• Other

Adverse Effect

• Any adverse medical occurrence that may or may not be related to the investigational device

All adverse effects should be documented

Unanticipated Adverse Device Effect - 21 C.F.R. 812.3(s)

• Any serious adverse effect that is possibly caused by or related to the investigational device:
  • Not previously identified in nature, severity, or degree, or
  • Any other unanticipated serious problem associated with a device

Investigator Responsibilities-AEs and UADEs

• Report Unanticipated AEs to the sponsor and IRB within 10 working days
• Maintain records of all AEs (anticipated or unanticipated)
• Follow the sponsor’s requirements for reporting and recording of AEs and UADEs

Study Deviations - 21 C.F.R. 812.140(a)

• Document dates and reasons for any deviations from the study protocol
• Emergency deviations must be reported to the sponsor and IRB within 5 days
• Obtain prior approval from the sponsor, IRB, and FDA for changes or deviations from the investigational plan

Summary

• A clinical investigator conducts a clinical investigation.
• CI responsibilities are designed to:
  • Protect human subjects
  • Promote the collection of quality data