Strategies for Clinical Inves

to Build Quality into Device 

Strategies for Clinical Inves

Strategies for Clinical Inves

to Build Quality into Device 

to Build Quality into Device 

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
What are Source Docu

What are Source Docu

z Hospital recordsz Clinic and office 

charts

z Laboratory reportsz Memorandaz Subjects’

diaries

z Evaluation 

checklists

z Accoun

records

z Automa

instrum

z Microfil

magne

z X-raysz Subjec
What Format? What Format?
What are Elements of Qu

What are Elements of Qu

z

Attributa

z

Legible

z

Contemp

z

Original

z

Accurate
Quality Study Quality Study

Data + Quality 

21 CFR 812.150(b)
Data Life Cycle
Clinical Investigators (C

Clinical Investigators (C
Clinical Investigator Strate

Clinical Investigator Strate

• Obtain FDA/IRB approval• Follow the signed investigator a

investigational plan and protoco

• Obtain Informed Consent • Control investigational devices• Document and report Unanticipa

Device Effects (UADEs)
Obtain Approvals Obtain Approvals

• Obtain FDA/IR

approval prior subject’s participation
Obtain Informed Conse

Obtain Informed Conse

z Include all the basic eleme

any applicable additional e

z Allow adequate time for re

consent 

z Document prior to subjects 

participation

21 CFR Part 50.25 and 50.27
• Evaluate the protocol for f• Know the protocol:

- Inclusion/exclusion crite

windows, study procedureporting criteria and tim

• Know each study staff me

roles and responsibilities

21 CFR Part 812. 100

Ensure Protocol Compli

Ensure Protocol Compl
Ensure Qualified Study P

Ensure Qualified Study 

• Sub-Investigator(s)• Study Coordinator(s)• Data Manager(s)• Any additional study 
Provide Adequate Traini

Provide Adequate Traini

• Specific study exp• Procedures unique 

device or its use in 

• Good Clinical Prac

21 CFR 812.40
• Have written procedures

- Protocol evaluation- IRB communication- Informed Consent- Documentation and repor- Device accountability

Develop Standard Operating P

Develop Standard Operating 
Maintain Device Accoun

Maintain Device Accoun

 Control investigationa- Keep all test article 

accountability records

- Shipping receipts, e

logs, dispensing log

21 CFR Part 812.140(a)(2)
Document and Report 

Document and Report 

 Report within 10 work

after first learning of th

 Know:

 Protocol and investig

definitions and reportrequirements

 Sponsor’s and IRB’s 

requirements

UADE 

REPORT

21 CFR Part 150(a)(1)
• Keep files organized at • Keep ALL corresponde

sponsor, IRB, monitorssubjects

• letters, faxes, e-mails

memos, phone contac

Document Document
Documentation Documentation

If it is not docume

did not occu
What is Quality Assuranc

What is Quality Assuranc

z All those planned and syste

actions that are established that the trial is performed andata are generated, documereported in compliance with Regulatory requirements
What is Quality Control 

What is Quality Control 

z The operational techniques 

activities undertaken to verifrequirements for quality of threlated activities have been 
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 A

Corrective & Preventative A

• Develop and implement a 

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

z Assess the root cause of the z Evaluate the extent of the proz Develop actions to correct thz Implement preventative actio

recurrence

z Incorporate timelines for imp
Summary Summary

z Incorporate the ele

quality throughout lifecycle 

z Implement best pra

the conduct of a “QTrial”

z Develop and imple

corrective and prevaction plan