Strategies for Sponsors 

Quality into Device Rese

Strategies for Sponsors Quality into Device Rese

Presented by Donna Headlee, RN 

Presented by Donna Headlee, RN 

Consumer Safety OfficerDivision of Bioresearch MonitoringOffice of ComplianceCenter for Devices and Radiological Health

Consumer Safety OfficerDivision of Bioresearch MonitoringOffice of ComplianceCenter for Devices and Radiological Health
Objectives Objectives

z Identify the elements of q

throughout the data life cclinical trial.

z Recognize best practices 

implementing a quality s

z Identify the elements of a 

and preventative action p
Topics

z Data, quality data, data life

and quality studies

z Suggestions for the condu

“Quality Studies”

z A quality systems approac

conduct of a clinical study
Source Data Source Data

z All information in original 

and certified copies of origrecords of clinical findingsobservations, or other acta clinical trial necessary foreconstruction and evaluathe study
What are Documents? What are Documents?

z Hospital recordsz Clinic and office 

charts

z Laboratory notesz Memorandaz Subjects’

diaries

z Evaluation 

checklists

z Accoun

records

z Automa

instrum

z Photogr

negativ

z X-raysz Subject 
What are Elements of Qua

What are Elements of Qua

z Attributaz Legiblez ContempzOriginalz Accurate

Guidance for IndustryComputerized Systems Used in Clinical Investig
Quality Study Quality Study

Data + Quality 

21 CFR 812.150(b)
Data Life Cycle
Sponsor Strategies Sponsor Strategies

• Obtain protocol feedback• Select qualified investiga• Select qualified clinical s• Provide adequate training• Ensure adequate monito• Secure investigator comp
Obtain Protocol Feedb

Obtain Protocol Feedb

• When planning a study, co

potential investigators, scieexperts and FDA reviewers

- Inclusion & exclusion crite- Testing appropriate for en- Case Report Forms
Select Qualified Investiga

Select Qualified Investiga

• Knowledge, training, & exp

• appropriate for the device • specific use in the study

• Commitment to research

• clinician vs. researcher

21 CFR 812.43(a)
Select Qualified Investigato

Select Qualified Investigato

Select Qualified Investigato

• Compliance history

- FDA 483- Warning Letters- Untitled Letters- IRB Suspensions

W
Select Adequate Study 

Select Adequate Study 

• Availability• Personnel• Resources• Equipment
Ensure Qualified Study 

Ensure Qualified Study 

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

Provide Adequate Train

• Before study & whe

essential staff repla

- Specific study expect- Procedures unique to 

its use in the study

- Regulatory requireme

- Importance of the info

process

- Clinician versus Inves

21 CFR 812.40
Provide Retraining Provide Retraining 

• Retrain when necessary

- Significant changes in de

protocol

- Monitoring reveals probl21 CFR 812.46(a)
Ensure Adequate Monitor

Ensure Adequate Monitor

 Early & frequent en

specific study

 Systemic issues ca

corrected before stis jeopardized

 Regular data audit

numerous queries database cleanup

Monitor

21 CFR 812 40 and 812.46
Secure Investigator Com

Secure Investigator Com

• Predetermined strategy • Expeditious review of monitor• Immediate actions to correct 

noncompliance

- device shipments halted un

of compliance

- terminate site’s participatio

21 CFR 812.46(a)
Quality Systems Approa

Quality Systems Approa

z Build quality into every stez Evaluate the process at ev

stage in the data lifecycle

z Ensure accurate, complete

current data at every stage data lifecycle
Corrective & Preventative 

Corrective & Preventative 

• Develop and implement a 

corrective and preventatiplan (CAPA) to ensure q
CAPA Steps CAPA Steps

z Assess the root cause of the pz Evaluate the extent of the proz Develop actions to correct the z Implement preventative action

recurrence

z Incorporate timelines for implez Document steps taken
Summary Summary

z Incorporate the ele

quality throughout lifecycle 

z Implement best pra

the conduct of Qua

z Develop and imple

corrective and prevaction plan