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U.S. Department of Health and Human Services

Training and Continuing Education

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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


  • 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


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


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