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