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

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Ship investigational device(s) only to qualified investigator(s) ... Follow investigator agreement, investigational plan, and conditions of approval ... – PowerPoint PPT presentation

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Title: The Sponsor and Sponsor Investigator: Responsibilities in Medical Device Clinical Trials


1
The Sponsor and Sponsor -InvestigatorResponsibi
lities in Medical Device Clinical Trials
Presented by Catherine Parker, RN
Consumer Safety Officer Division of Bioresearch
Monitoring Office of Compliance Center for
Devices and Radiological Health
2
Disclaimer
  • The contents of this presentation are my own,
    and do not necessarily reflect the views and/or
    policies of the Food and Drug Administration or
    its staff as per 21 CFR 10.85.

3
Presentation Topics
  • Regulatory Definitions
  • Sponsor Responsibilities
  • Sponsor-Investigator Responsibilities
  • Lessons Learned

4
A Sponsor Initiates a Study
21 C.F.R. 812.3(n)
5
A Sponsor is a Person
21 C.F.R. 812.3(l)
6
A Clinical Investigator conducts a Study
21 C.F.R. 812.3(i)
  • A Clinical Investigator (CI) is an individual
    who actually conducts a clinical investigation,
    under whose immediate direction the test article
    is administered, dispensed, or used.

6
7
A Sponsor-Investigator does both.
21 C.F.R. 812.3(o)
Initiates
Conducts
8
Presentation Topics
  • Regulatory Definitions
  • Sponsor Responsibilities
  • Sponsor-Investigator Responsibilities
  • Lessons Learned

9
General Sponsor Responsibilities
21 C.F.R. 812.40
  • Select qualified investigators
  • Provide them with the information they need to
    conduct the study

10
General Sponsor Responsibilities
21 C.F.R. 812.40
  • Ensure proper monitoring
  • Ensure IRB review and approval
  • Submit IDE application to FDA
  • Ensure IRB and FDA are informed of significant
    new information about an investigation

11
Sponsor Responsibilities
21 C.F.R. 812.43
  • Ship investigational device(s) only to qualified
    investigator(s)
  • Obtain signed investigator agreements and
    financial disclosure from all investigators
  • Select qualified monitors

12
Monitor
21 C.F.R. 812.3(j)
  • An individual designated by a sponsor or CRO to
    oversee the progress of an investigation
  • It is a sponsors responsibility to select
    monitors that are qualified by training and
    experience

21 C.F.R. 812.43(d)
13
Monitoring
21 C.F.R. 812.3(j)
  • The act of overseeing the progress of an
    investigation.
  • Used to assure the protection of human subjects
    and data integrity
  • Ongoing continuous process
  • The task of monitoring can be delegated but, it
    is ultimately the sponsors responsibility

14
Monitors Review
  • IRB approvals
  • Informed Consent Documents
  • Source documents
  • Case Report Forms (CRF)

15
Monitoring Investigations
21 C.F.R. 812.46
  • Secure investigator compliance
  • Conduct an evaluation of any unanticipated
    adverse device effects
  • Obtain FDA and IRB approval before resuming a
    terminated study

16
Monitoring Investigations
  • Does the sponsor-investigator need to ensure
    adequate monitoring of the investigation at their
    own site?

17
  • YES

18
Monitoring vs. DMC
Data Monitoring Committee (DMC) Sometimes
referred to as a Data and Safety Monitoring Board
  • Monitoring is a different process then oversight
    by a Data Monitoring Committee

19
Data Monitoring Committee
  • A group that reviews data from a trial
  • They advise the sponsor regarding the continuing
    safety of trial subjects
  • Evaluate data for continuing validity and
    scientific merit

20
Sponsor Records
21 C.F.R. 812.140(b)
  • All correspondence with another sponsor, monitor,
    CI, IRB, and FDA
  • Shipment and disposition of the device

21
Sponsor Records
21 C.F.R. 812.140(b)
  • Shipment
  • Name and address of consignee
  • Type and quantity of device
  • Date of shipment
  • Batch number or code
  • Disposition
  • Batch number or code
  • Reasons for
  • Method of disposal

22
Sponsor Records
21 C.F.R. 812.140(b)
  • Signed investigator agreements financial
    disclosure information
  • Non-significant risk device records

21 C.F.R. 812.140(b)(4)
23
Sponsor Records
21 C.F.R. 812.140
  • Adverse device effects and complaints
  • Other records required by FDA

24
Documentation
  • If it is not documented, it never happened!

25
Inspections
21 C.F.R. 812.145
  • Permit access to FDA
  • Permit inspection and copying of documents

26
Sponsor Required Reports
21 C.F.R. 812.150(b)
  • Unanticipated Adverse Device Effects (UADE)
  • Withdrawal of IRB approval
  • Withdrawal of FDA approval

27
Sponsor Required Reports
21 C.F.R. 812.150(b)
  • Investigator list
  • Annual progress report
  • Recall and device disposition
  • Final report

28
Sponsor Required Reports
21 C.F.R. 812.150(b)
  • Use of device without informed consent
  • Significant risk determination
  • Other reports

29
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30
Presentation Topics
  • Regulatory Definitions
  • Sponsor Responsibilities
  • Sponsor-Investigator Responsibilities
  • Lessons Learned

31
CI 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

31
32
CI 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

32
33
Disqualification
21 C.F.R. 812.119
  • An investigators repeated or deliberate failure
    to comply with these requirements may result in
    disqualification from receiving investigational
    devices

33
34
Investigator Records
21 C.F.R. 812.140(a)
  • All correspondence with another investigator,
    Institutional Review Board (IRB), sponsor,
    monitor, or FDA

34
35
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

35
36
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

36
37
Protocols
21 C.F.R. 812.140(a)
  • All IRB approved amendments
  • Including approvals
  • Documentation of protocol deviations and IRB and
    sponsor approvals

37
38
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

38
39
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

39
40
Documentation
  • If it is not documented, it never happened!

40
41
FDA Inspections
21 C.F.R. 812.145
  • Occur at reasonable times and in a reasonable
    manner
  • Permit records to be inspected and copied

http//www.fda.gov/ora/cpgm/default.htmbimo
41
42
Investigator Reports
21 C.F.R. 812.150
  • Unanticipated Adverse Device Effects
  • Withdraw of IRB approval
  • Progress reports
  • Deviations from the investigational plan
  • Informed consent
  • Final report
  • Other

Progress Report 2009
42
43
Adverse Effect
  • Any adverse medical occurrence that may or may
    not be related to the investigational device
  • All adverse effects should be documented

43
44
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

44
45
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 sponsors requirements for reporting
    and recording of AEs and UADEs

45
46
Study Deviations
21 C.F.R. 812.140(a)(4)
  • 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

46
47
Presentation Topics
  • Regulatory Definitions
  • Sponsor Responsibilities
  • Sponsor-Investigator Responsibilities
  • Lessons Learned

48
The FDA inspection results are in
48
49
Top 6 2008 Sponsor Deficiencies
  • Monitor study
  • Secure investigator compliance
  • Analyze and report AE/UADE
  • Inform investigators, FDA, or IRB
  • Control of inv devices
  • Obtain signed Inv Agreement

50
Sponsor- Investigator Deficiencies
  • Follow investigational plan, investigator
    agreement, or protocol
  • Obtain adequate informed consent
  • Submit an IDE application to FDA
  • Monitoring
  • Progress reports to FDA and IRB
  • Accurate, current, and complete records

51
Summary
  • A sponsor initiates the investigation while a CI
    conducts the study and an SI does both
  • The sponsor and CI responsibilities are designed
    to
  • Protect human subjects
  • Promote the collection of quality data
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