DAIDS Guidelines for Good Clinical Laboratory Practice ...
DAIDS
Bethesda, MD USA
Manual
DAIDS Guidelines for Good Clinical Laboratory Practice Standards
Effective Date: 09/28/19
Document No.: MAN-A-OD-001.00
DAIDS Guidelines for
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Good Laboratory Practice Standards
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DAIDS
Bethesda, MD USA
Manual
DAIDS Guidelines for Good Clinical Laboratory Practice Standards
Effective Date: 09/28/19
Document No.: MAN-A-OD-001.00
Public Health Services
National Institutes of Health
Bethesda, Maryland 20892
Dear Site Principal Investigator and Laboratory Director:
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All National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDSsupported clinical trials involving human subjects must ensure compliance with federal regulations
including procedures to protect the safety of all participants. These studies must be conducted in a manner
to assure the sponsor and regulatory agencies that all data submitted are a true reflection of the results
obtained during a study and that this data can be relied upon when making risk and/or safety assessments
of study products.
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DAIDS has determined that Good Clinical Laboratory Practices (GCLP) are the minimal requirements that
clinical research laboratories should follow, as GCLP embraces both the research/pre-clinical and clinical
aspects of Good Laboratory Practices (GLP). Complying with GCLP is an ongoing process that is central
to optimal clinical research laboratory operations. DAIDS will monitor the progress toward GCLP
compliance through annual audits and/or site visits for most laboratories. GCLP compliance will ensure
that consistent, reproducible, auditable, and reliable laboratory results that support clinical trials will be
produced in an environment conducive to study reconstruction.
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To support the many laboratories that conduct quality laboratory testing for clinical trials around the world,
DAIDS has developed, in collaboration with PPD, the attached ¡°DAIDS Guidelines for Good Clinical
Laboratory Practice (GCLP) Standards.¡± This guidance document is provided to clearly define the
standards that encompass GCLP to include applicable portions of 21 Code of Federal Regulations (CFR)
part 58, or GLP, and 42 CFR part 493, or Clinical Laboratory Improvement Amendment (CLIA) rules. Due
to the ambiguity of some parts of these regulations, the attached document also includes guidance from
accrediting bodies such as the College of American Pathologists and South African National Accreditation
System. These GCLP standards should be applied to all laboratories performing testing that supports a
clinical trial sponsored by DAIDS. Institutions must also meet sponsor-specific requirements as outlined in
the Sponsor Statement of this document.
The first 69 pages of the document provide the GCLP standards. The next 72 pages are appendices that
offer additional information and guidelines on how to implement some of these standards. This document
can also be accessed on the DAIDS Clinical Research Policies and Standard Procedures Documents
().
I hope these GCLP standards become a useful resource for your clinical research laboratory operations.
This document has been vetted through the DAIDS Management Group, Regulatory Affairs Branch, Office
of Policy for Clinical Research Operations, DAIDS Clinical Laboratory Oversight Team (DCLOT), and the
Cross Network Laboratory Groups. If you have any questions about the content of this document please
contact your Network Coordinator or the DAIDS Clinical Lab Oversight Team (DCLOT¡¯s e-mail:
NIAIDDCLOT@niaid.).
Sincerely,
Carl W. Dieffenbach, Ph.D.
Director, Division of AIDS, NIAID, NIH
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DAIDS
Bethesda, MD USA
Manual
DAIDS Guidelines for Good Clinical Laboratory Practice Standards
Effective Date: 09/28/19
Document No.: MAN-A-OD-001.00
DAIDS Guidelines
for
Good Clinical Laboratory Practice Standards
The development of these GCLP standards was a collaborative effort between
PPD and the Division of AIDS (DAIDS). The authors that have contributed to
this document are listed below:
DAIDS:
DAIDS Clinical Laboratory
Oversight Team
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PPD, Inc.:
Global Government and Public
Health Services, Laboratory
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The authors would also like to thank the following groups for their review and comments:
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Network Laboratory Groups
Patient Safety Monitoring in International Laboratories (pSMILE)
Development of this document was funded by the HIV Clinical Research Support
Contract Number N01-AI-50022
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Table of Contents
1.
Sponsor Statement ........................................................................................................ 1
Introduction ................................................................................................................................ 1
Food and Drug Administration¡¯s Form FDA 1572....................................................................... 2
Study Plans and Analytical Plans ................................................................................................ 3
Enrollment in External Quality Assurance Programs ................................................................. 3
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Retention of Records .................................................................................................................. 4
Performance Specifications ¨C Validation of Test Methods ........................................................ 4
Good Clinical Laboratory Practice .............................................................................................. 5
Organization andPersonnel ............................................................................................ 5
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Introduction to Organization and Personnel ...................................................................... 5
B.
Standards for Organization and Personnel ......................................................................... 5
Documentation .................................................................................................................. 5
Staff Education and Evaluations: ....................................................................................... 7
Job Introduction Program: ................................................................................................. 7
GCLP Training ..................................................................................................................... 9
Staff Identification ........................................................................................................... 10
C.
Record Retention ............................................................................................................... 10
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Equipment ................................................................................................................... 10
A.
Introduction to Equipment ................................................................................................ 10
B.
Standards for Equipment .................................................................................................. 11
Documentation Guidelines .............................................................................................. 11
General Guidelines ........................................................................................................... 11
Temperature monitoring ................................................................................................. 12
Backup instruments/ Correlation Testing ........................................................................ 12
Service Guidelines ............................................................................................................ 13
4.
Testing Facility Operation ............................................................................................ 16
A.
Introduction to Testing Facility Operation ........................................................................ 16
B.
Standards for Testing Facility Operation .......................................................................... 16
SOP Format ...................................................................................................................... 16
SOP Distribution ............................................................................................................... 17
MAN-A-OD-001 Good Clinical Laboratory Practice Standards
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Document Control Plan .................................................................................................... 18
SOP Categories ................................................................................................................. 18
C.
5.
Record Retention ............................................................................................................... 20
Test and Control .......................................................................................................... 20
Introduction to Test and Control ....................................................................................... 20
B.
Standards for Test and Quality Control............................................................................. 20
Quality Control Program .................................................................................................. 20
Evaluation Criteria............................................................................................................ 20
Frequency of Quality Control Testing and Types of Control Materials ........................... 21
Review of Quality Control Data ....................................................................................... 22
Quality Control Logs ......................................................................................................... 22
Corrective Action Logs ..................................................................................................... 23
Supervisor Review of Quality Control Documentation.................................................... 23
Quality Control Record Retention.................................................................................... 23
Labeling and Storage of Quality Control Materials and Reagents ................................... 24
Inventory Control ............................................................................................................. 25
Parallel Testing, lot release and reagent equivalency ..................................................... 25
Water Quality Testing ...................................................................................................... 27
6.
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Test Method Validation and Verification ...................................................................... 27
Introduction to Test Method Validation and Verification ................................................. 27
B.
Standards for Performance Specifications ........................................................................ 29
7.
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Records and Reports .................................................................................................... 34
A.
Introduction to Records and Reports ................................................................................ 34
B.
Standards for Records and Reports................................................................................... 35
Record and Report Tracking ............................................................................................ 35
Record Retention ............................................................................................................. 35
Data Integrity ................................................................................................................... 36
Report Format .................................................................................................................. 37
Pertinent Reference Ranges ............................................................................................ 38
Laboratory Assays and Performance Specifications ........................................................ 38
Assay Results .................................................................................................................... 38
Result Modification Log and Errors in Test Results ......................................................... 40
Archiving Reports or Records........................................................................................... 41
8.
Physical Facilities ......................................................................................................... 41
A.
B.
Introduction to Physical Facilities ..................................................................................... 41
Standards for Physical Facilities ........................................................................................ 42
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