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U.S. Department of Health and Human Services

Training and Continuing Education

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Presentation: The Sponsor: Responsibilities in Medical Device Clinical Trials Objectives

(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 “medical device research sponsor.”
  • Identify the 10 sponsor responsibilities discussed in the presentation.
  • Contrast the role of monitoring with the role of a Data Monitoring Committee.
  • Identify the six categories of records sponsors may be required to maintain.

Presentation Topics

  • Regulatory Definition of a Sponsor
  • Sponsor Responsibilities
  • Monitoring
    • Monitoring vs. Data Monitoring Committee
  • Sponsor Records
  • Documentation
  • Inspections
  • Sponsor Reports

A Sponsor Initiates a Study - 21 C.F.R. 812.3(n)

A Sponsor is a Person - 21 C.F.R. 812. 3(l)

General Sponsor Responsibilities - 21 C.F.R. 812.40

  • Select qualified investigators
  • Provide them with the information they need to conduct the study
  • 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

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

Monitor - 21 C.F.R. 812.3(j), 21 C.F.R. 812.43(d)

  • An individual designated by a sponsor or CRO to oversee the progress of an investigation
  • It is a sponsor’s responsibility to select monitors that are qualified by training and experience

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 sponsor’s responsibility

Monitors Review

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

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

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

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

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
  • 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
  • Signed investigator agreements & financial disclosure information
  • Non-significant risk device records - 21 C.F.R. 812.140(b)(4)

Sponsor Records - 21 C.F.R. 812.140

  • Adverse device effects and complaints
  • Other records required by FDA
  • Retention period is 2 years after
    • end of the study
    • pre-market approval application
  • Custody can be transferred

Documentation

If it is not documented, it never happened.

Inspections - 21 C.F.R. 812.145

  • Permit access to FDA
  • Permit inspection and copying of documents

Sponsor Required Reports - 21 C.F.R. 812.150(b)

  • Unanticipated Adverse Device Effects (UADE)
  • Withdrawal of IRB approval
  • Withdrawal of FDA approval
  • Investigator list
  • Annual progress report
  • Recall and device disposition
  • Final report
  • Use of device without informed consent
  • Significant risk determination
  • Other reports

Summary

  • A sponsor initiates the investigation
  • Sponsor responsibilities are designed to:
    • Protect human subjects
    • Promote the collection of quality data