Presentation: Strategies For Sponsors to Build Quality into Device Research

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

Presented by Donna Headlee, RN BSN CCRP

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

Objectives

• Identify the elements of quality throughout the data life cycle of a clinical trial.
• Recognize best practices for implementing a quality study.
• Identify the elements of a corrective and preventative action plan.

Topics

• Data, quality data, data lifecycle, and quality studies
• Suggestions for the conduct of “Quality Studies”
• A quality systems approach to the conduct of a clinical study

Source Data

• All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the study

What are Documents?

• Hospital records
• Clinic and office charts
• Laboratory reports
• Memoranda
• Subjects’ diaries
• Evaluation checklists
• Accountability records
• Automated instrument data
• Photographic negatives
• X-rays
• Subject files

What are Elements of Quality Data?

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

Guidance for Industry
Computerized Systems Used in Clinical Investigations

Quality Study

Data + Quality = Quality Study

21 CFR 812.150(b)

Data Life Cycle

Sponsor Strategies

• Obtain protocol feedback
• Select qualified investigators
• Select qualified clinical sites
• Provide adequate training
• Ensure adequate monitoring
• Secure investigator compliance

Obtain Protocol Feedback

• When planning a study, consult potential investigators, scientific experts and FDA reviewers
  • Inclusion & exclusion criteria
  • Testing appropriate for endpoints
  • Case Report Forms

Select Qualified Investigators

• Knowledge, training, & experience
  • appropriate for the device
  • specific use in the study
• Commitment to research
  • clinician vs. researcher

21 CFR 812.43(a)

• Compliance history
  • FDA 483
  • Warning Letters
  • Untitled Letters
  • IRB Suspensions

Select Adequate Study Sites

• Availability
• Personnel
• Resources
• Equipment

Ensure Qualified Study Personnel

• Sub-Investigator(s)
• Study Coordinator(s)
• Data Manager(s)
• Study Monitor(s)

Provide Adequate Training

• Before study & when essential staff replaced
  • Specific study expectations
  • Procedures unique to the device or its use in the study
  • Regulatory requirements
    • Importance of the informed consent process
  • Clinician versus Investigator

21 CFR 812.40

Provide Retraining

• Retrain when necessary
  • Significant changes in device or protocol
  • Monitoring reveals problems

21 CFR 812.46(a)

Ensure Adequate Monitoring

• Early & frequent enough for specific study
• Systemic issues can be corrected before study integrity is jeopardized
• Regular data audits avoid numerous queries and late database cleanup

21 CFR 812 40 and 812.46

Secure Investigator Compliance

• Predetermined strategy
• Expeditious review of monitoring reports
• Immediate actions to correct noncompliance
  • device shipments halted until evidence of compliance
  • terminate site’s participation in study

21 CFR 812.46(a)

Quality Systems Approach

• Build quality into every step
• Evaluate the process at every stage in the data lifecycle
• Ensure accurate, complete, and current data at every stage in the data lifecycle

Corrective & Preventative Action Plan

• Develop and implement a corrective and preventative action plan (CAPA) to ensure quality data

CAPA Steps

• Assess the root cause of the problem
• Evaluate the extent of the problem
• Develop actions to correct the problem
• Implement preventative actions to avoid recurrence
• Incorporate timelines for implementation
• Document steps taken

Summary

• Incorporate the elements of quality throughout the data lifecycle
• Implement best practices for the conduct of a Quality Trial
• Develop and implement a corrective and preventative action plan