GCLP Standards - DAIDS Learning Portal

Report
Introduction to Good Clinical
Laboratory Practices (GCLP)
Version 5.0, August 2012
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services,
under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research
Support Services (CRSS).
Workshop Approach
Objectives
Didactic Presentation
Activities and Discussion
2
Workshop Materials
DAIDS GCLP Standards
Booklet
Module Handouts
Reference Materials
ARS Key Pads
3
Audience Response System (ARS)
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4
Respond to Questions
Change an Answer
Responses are Anonymous
Question cue is a
on preceding slide
 Ensure remote is on by
pressing and holding the
“On/Off” button
Please leave remotes on the
tables
Choose
your
answer
Send or
change
your
answer
Audience Response System
(ARS) (con’t)
Good Documentation Practices include
following the principles of:
A. Electronic Record Management
B. “ALCOA”
C. Electronic Signatures
Choose
your
answer
Send or
change
your
answer
5
Audience Response System
(ARS) (con’t)
Name one of the words that is
applied within the acronym
“ALCOA.”
Choose
your
answer
Send or
change
your
answer
6
Survey
What position do you hold in your facility?
A. Laboratory Technician
B. QA/QC Coordinator
C. Laboratory Manager
D. Laboratory Director
E. Other (laboratory)
F. Other (nonlaboratory)
7
Survey (con’t)
How many years of research experience do you have?
A. None
B. < 1
C. 1 – 5
D. 6 – 10
E. >10
8
Objectives
9

Explain what GCLP is and why it is important

List GCLP standards

List the key entities involved in ensuring GCLP

Explain the role that audits play in ensuring GCLP
Pre-Assessment Question #1
Good Clinical Laboratory Practices are important for which
of the following reasons?
A. To ensure accurate laboratory testing results
B. To allow for reconstruction of the study
C. To define the performance of specific laboratory
functions
D. A and B only
E. A, B and C
10
Pre-Assessment Question #2
According to GCLP, accurate documentation is important
for which of the following reasons?
A. To allow for reconstruction of a study
B. To ensure that data are reliable, and accurately
recorded
C. To explain why, how, and by whom an activity was
performed
D. All of the above
11
Pre-Assessment Question #3
Which organization generates action plan documents after
international audits and supports Corrective Action and
Preventive Action (CAPA), External Quality Assurance
(EQA) / Proficiency Testing (PT)?
A. DAIDS
B. Patient Safety Monitoring in International Laboratories
(SMILE)
C. DAIDS Clinical Laboratory Oversight Team (DCLOT)
D. CRSS
12
Pre-Assessment Question #4
Site monitors ensure compliance to GCLP standards by
conducting __________________.
A. Site visits
B. Data entry
C. Laboratory audits
D. A and B only
E. A and C only
F. None of the above
13
Laboratory Oversight Relationships
DAIDS
DCLOT
SMILE
CRSS
WESTAT
FHI
DCLOT and SMILE generate action plan
documents after
audits;
-SMILE supports
CAPA, EQA/PT.
14
Clinical
Operations
Clinical
Support
- Oversee
Laboratory Audits
LABORATORIES &
REPOSITORIES
DAIDS Guidelines for GCLP Standards
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Outlines the minimal requirements clinical research
laboratories should follow
Encompass elements of:
 GLP (21CFR Part 58),
 CLIA (42CFR Part 493), and
 Guidance from ISO and CAP
Deployed globally
Compliance is an ongoing process
Monitoring of compliance by the DAIDS through site
visits and laboratory audits
GCLP Standards
Provide for…

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
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Sufficiently trained, experienced, and competent staff
Appropriate and adequate facilities
Optimal functioning equipment
Adequate reagents and materials
Relevant standard operating procedures (SOPs) that are approved
and in place for use by laboratory personnel
And ensure that…
 Analytical Plans exist
 Quality Assurance and Quality Control programs are in place
 Specimen integrity is maintained
16
Why GCLP?
To ensure quality, reliability, and integrity of study
data
To ensure comparability of study data
To allow for reconstruction of the study
To achieve uniformity of the performance of specific
functions across all laboratories worldwide
17
Elements of GCLP
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Organization and Personnel
Safety
Facilities and Equipment
Verification of Performance Specifications
Laboratory Information Systems (LIS)

Testing Facilities Operation
Test and Control Articles
Records and Reports
Specimen Management and Tracking

Quality Management
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Documentation
“If it is not
documented, it
never happened!”
Maintenance of
prompt, accurate, and
complete records
Why, how, when, and
by whom was the test
performed
“Write down what you do, do what is written down!”
19
Study Data
FDA expects data acquired during a clinical study to be:
A
L
C
O
A
20
ttributable
egible
ontemporaneous
riginal
ccurate
GCLP Standards
Compliance to GCLP standards will ensure
that data reported is:
Consistent
Reproducible
Auditable
Produced in an
environment conducive
to study reconstruction
21
Additional Training Resources

DAIDS Learning Management System (DLMS):
https://daidslms.plateau.com/learning/user/login.do
 Laboratory Curriculum
 GCLP Online Review Courses
 Quality Management Curriculum
 CAPA for Laboratory Staff
 FSTRF Training
 Laboratory Data Management System (LDMS)
Courses

22
Comprehensive GCLP Workshop
DAIDS Laboratory Audits
General
Laboratory
Audit
Central
Laboratory
Audit
Histology
Audit
Types
of
Audits
PBMC
Laboratory
Audit
Repository
Audit
TB
Laboratory
Audit
23
DAIDS-Sponsored Programs
GCLP
Standards
GCLP
Training
24
GCLP
Audits
Skill Check
A DAIDS audit has just been announced in your laboratory.
How should your laboratory respond?
A. The QA/QC Coordinator should sign and predate all
temperature charts that were not reviewed the previous
year
B. Send all staff without complete personnel records on
forced vacation
C. Embrace the audit and use the opportunity to improve
your systems
D. Move all equipment without documented maintenance out
of the laboratory and bring it back as soon as the auditor
has left
E. None of the above
25
Teamwork
Teamwork is the ability to work together toward a common
vision—the ability to direct individual accomplishments
toward organizational objectives. It is the fuel that allows
common people to attain uncommon results.
Andrew Carnegie
26
Post-Assessment Question #1
Good Clinical Laboratory Practices are important for which
of the following reasons:
A. To ensure accurate laboratory testing results
B. To allow for reconstruction of the study
C. To define the performance of specific laboratory
functions
D. A and B only
E. A, B and C
27
Post-Assessment Question #2
According to GCLP, accurate documentation is important
for which of the following reasons?
A. To allow for reconstruction of a study
B. To ensure that data are reliable, and accurately
recorded
C. To explain why, how, and by whom an activity was
performed
D. All of the above
28
Post-Assessment Question #3
Which organization generates action plan documents after
international audits and supports CAPA, EQA/PT?
A. DAIDS
B. SMILE
C. DCLOT
D. CRSS
29
Post-Assessment Question #4
Site monitors ensure compliance to GCLP standards by
conducting __________________.
A. Site visits
B. Data entry
C. Laboratory audits
D. A and B only
E. A and C only
F. None of the above
30
Wrap Up
31

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