The Clinical Investigator: The Clinical Investigator: - - PowerPoint PPT Presentation

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The Clinical Investigator: The Clinical Investigator: - - PowerPoint PPT Presentation

Dec 21, 2023 155 likes •379 views

The Clinical Investigator: The Clinical Investigator: Responsibilities in Medical Responsibilities in Medical Device Clinical Trials Device Clinical Trials Presented by Catherine Parker, RN Presented by Catherine Parker, RN Consumer Safety

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

Presented by Catherine Parker, RN Presented by Catherine Parker, RN

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

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Objectives Objectives

  • Define a medical device clinical

investigator

  • Explain the general and specific

responsibilities of investigators

  • Describe records and reporting

requirements of investigators

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Presentation Topics Presentation Topics

General

responsibilities

Specific

responsibilities

Records Inspections Reports

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What is a Clinical Investigator (CI)? 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.

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General Responsibilities General Responsibilities

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

21 C.F.R. 812.100 21 C.F.R. 812.100

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Specific Responsibilities Specific Responsibilities

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

21 C.F.R. 812.110 21 C.F.R. 812.110

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Disqualification Disqualification

An investigator’s repeated or deliberate

failure to comply with these requirements may result in disqualification from receiving investigational devices

21 C.F.R. 812.119 21 C.F.R. 812.119

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Investigator Records Investigator Records

All correspondence

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

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

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Device Records Device Records

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

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

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Case Histories Case Histories

Exposure to the device CRFs and supporting data

–Informed consent documents –Adverse device effects –Any relevant

  • bservations

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

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Protocols Protocols

All IRB approved amendments

–Including approvals

Documentation of protocol deviations

and IRB and sponsor approvals

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

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Record Retention Record Retention

Two years after

study termination or completion

Two years after

records are no longer required to support marketing application

21 C.F.R. 812.140(d) 21 C.F.R. 812.140(d)

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Records Custody Records Custody

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

21 C.F.R. 812.140(e) 21 C.F.R. 812.140(e)

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Documentation Documentation

If it is not documented, it never happened! If it is not documented, it never happened!

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FDA Inspections FDA Inspections

Occur at reasonable

times and in a reasonable manner

Permit records to be

inspected and copied

21 C.F.R. 812.145 21 C.F.R. 812.145

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Investigator Reports Investigator Reports

Unanticipated Adverse

Device Effects

Withdrawal of IRB approval Progress reports Deviations from the

investigational plan

Informed consent Final report Other

21 C.F.R. 812.150 21 C.F.R. 812.150

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Adverse Effect Adverse Effect

Any adverse medical occurrence that

may or may not be related to the investigational device

All adverse effects should be documented

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Unanticipated Adverse Device Effect Unanticipated Adverse Device Effect

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

21 C.F.R. 812.3(s) 21 C.F.R. 812.3(s)

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Investigator Responsibilities- AEs and UADEs Investigator Responsibilities- AEs and UADEs

Report Unanticipated AEs to the

sponsor and IRB within 10 working days

Maintain records of all AEs (anticipated

  • r unanticipated)

Follow the sponsor’s requirements for

reporting and recording of AEs and UADEs

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Study Deviations Study Deviations

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

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

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Summary Summary

A clinical investigator conducts a clinical

investigation.

CI responsibilities are designed to:

– Protect human subjects – Promote the collection of quality data