GCP, GLP and GCLP are international guidelines for clinical trials, non-clinical studies, and clinical laboratory testing. GCP ensures the rights, safety and well-being of clinical trial subjects. GLP provides standards for non-clinical laboratory studies to ensure reliable data. GCLP bridges GCP and GLP by providing quality standards for analytical laboratories involved in clinical trials to ensure reliable and traceable data. Adherence to these guidelines helps ensure ethical and scientific standards in research and regulatory acceptance of study results.

1. GCP, GLP and GCLP guidelines
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Dr. Ssuna Bashir
Clinical Epidemiology and Biostatistics
MBCh.B (MUST) Msc. (MAK)
Fellowship in Mixed methods Research (MAK)
Email: sbn144@gmail.com Mob. +256775655562

2. GCP: Good Clinical practice
ICH: International Conference on Harmonization
GLP: Good Laboratory Practice
GCLP: Good Clinical Laboratory Practice
OECD – Economic Co-operation and Development
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3. GOOD CLINICAL PRACTICE (GCP)
• Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording and reporting trials that involve
the participation of human subjects.
• Compliance with this standard provides public assurance that the rights, safety
and well-being of trial subjects are protected, consistent with the principles
that have their origin in the Declaration of Helsinki, and that the clinical trial
data are credible
INTRODUCTION
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4. • To Provide a unified standard for Europe, Japan and US
• To facilitate the mutual acceptance of clinical data
Note:
• This guideline should be followed when generating clinical trial data that
are intended to be submitted to regulatory authorities.
• May also be applied to other clinical investigations that may have an
impact on the safety and well-being of human subjects
OBJECTIVES OF ICH-GCP
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5. ICH GCP CONT…
• Good Clinical Practice guidelines include protection of human rights as a
subject in clinical trial. It also provides assurance of the safety and efficacy of
the newly developed compounds.
• Good Clinical Practice Guidelines include standards on how clinical trials should
be conducted, define the roles and responsibilities of clinical trial sponsors,
clinical research investigators, and monitors.
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6. • Nuremberg Code, 1946 – voluntary consent of the human subject is absolutely essential,
animal experimentation results and a knowledge of the natural history of the disease
• Kefauver Amendments, 1962 (Thalidomide) – Drug manufacturers should prove to the
FDA the effectiveness of their products before marketing them
• Declaration of Helsinki, 1964 – The fundamental principle is respect for the individual,
their right to self determination and the right to make informed decisions regarding
participation in research, both initially and during the course of the research.
• National Research Act, 1974 - Tuskegee Syphilis Study (1932-1972)
• Belmont Report, 1979 – respect for persons, beneficence, and justice
HISTORY OF ICH GCP
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7. THE PRINCIPLES OF ICH GCP
• Conduct trials according to GCP
• Weigh risks vs benefits
• Protect the subjects (rights, safety
and wellbeing of participants)
• Have adequate information to justify
trial (nonclinical and clinical)
• Write a scientifically sound protocol
• Receive IRB/IEC approval
• Use qualified physicians
• Use qualified support staff
• Obtain informed consent
• Record information
appropriately
• Protect confidentiality
• Handle investigational products
appropriately
• Implement quality systems7

8. THE INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS
COMMITTEE (IRB/IEC)
• An independent body constituted of medical, scientific, and non-scientific
members
• Main responsibility – To ensure the protection of the rights, safety and well-
being of human subjects involved in a trial
• IRB also reviews, approves, and provides continual review of trial protocol and
amendments and of the methods and material to be used in obtaining and
documenting informed consent of the trial subjects.
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9. KEY PERSONS/TERMS IN A TRIAL
• Investigator – A person responsible for the conduct of the clinical trial at a trial site. If a trial is
conducted by a team of individuals at a trial site, the investigator is the responsible leader of
the team and may be called the principal investigator
• Sponsor – An individual, company, institution, or organization which takes responsibility for
the initiation, management, and/or financing of a clinical trial
• Protocol – A document that describes the objective(s), design, methodology, statistical
considerations, and organization of a trial.
• Independent Data-Monitoring Committee (IDMC) – An independent data-monitoring
committee that may be established by the sponsor to assess at intervals the progress of a
clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the
sponsor whether to continue, modify, or stop a trial
• Essential documents – Documents which individually and collectively permit evaluation of the
conduct of a study and the quality of the data produced. 9

10. GOOD LABORATORY PRACTICE (GLP)
• GLP is a quality system concerned with the organizational process and the
conditions under which non-clinical health and environmental safety studies
are planned, performed, monitored, recorded, archived and reported.
(OECD GLP Guideline).
INTRODUCTION
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11. OBJECTIVES OF GLP:
• GLP makes sure that the data submitted are a true reflection of the results that
are obtained during the study.
• GLP makes sure that data is traceable.
• Promotes international acceptance of tests.
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12. • The formal regulatory concept of “Good Laboratory Practice” (GLP)
originated in the USA in the 1970’s
• The FDA’s publication of Proposed Regulations on GLP in 1976, with
establishment of the Final Rule in June 1979 .
• In 1981, OECD produced GLP principles that are international standard.
GLP - HISTORY
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13. • In the early 70’s FDA became aware of cases of poor laboratory practice
(PLP) all over the United States.
• FDA decided to do an in-depth investigation in 40 toxicology labs.
• They discovered a lot fraudulent activities and a lot of poor lab practices.
WHY GLP WAS CREATED
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14. Personnel
 Sponsor
 Management
 Study director
 Quality Assurance
Facility
 Laboratory Operation
 Characterization
 Animal care
 Equipment
 Reagents
BASIC ELEMENTS OF GLP
Documents
 Standard operating procedures (SOPs)
 Protocols
 Reports
 Archiving
Test and Control Articles
 Characterization
 Handling
 Storage
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15. GOOD CLINICAL LABORATORY PRACTICE (GCLP)
• GCLP applies those principles established under GLP for data generation used
in regulatory submissions relevant to the analysis of samples from a clinical
trial.
• At the same time it ensures that the objectives of the GCP principles are
carried out.
• This ensures the reliability and integrity of data generated by analytical
laboratories.
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16. • Provides a bridge between GCP and GLP
• Provides framework to organisations on facilities, systems and procedures
• Ensures the reliability, quality and integrity of the work and results
• Satisfies GCP expectations.
GCLP
• Principles should be interpreted and applied to any laboratory that analyses
samples generated during the conduct of a clinical trial
SCOPE OF GCLP
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17. THE GCLP PRINCIPLES
• Organisation and Personnel
• Facilities
• Equipment, materials and reagents
• Standard Operating Procedures (SOPs)
• Planning, conduct and reporting
• Quality Control and Quality audits
• Retention of study records and reports.
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18. ORGANISATION & PERSONNEL
• Facility management
• Analytical Project Manager
• Analytical staff
• Archivist
• Quality Audit personnel
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19. FACILITY MANAGEMENT
• Ensures that the principles of GCP,GCLP are complied with
• Provide sufficient, trained staff
• Appropriate & available facilities, equipment & materials
• SOPs are approved and in place
• Ensure Analytical Plan exists
• Quality audit and QC programs are in place
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20. ANALYTICAL PROJECT MANAGER
• Responsible for the overall conduct of the analytical work
• Approve analytical plan & ensure plan is followed
• Ensure authorisation for any modification is obtained & documented
• Ensure results are accurately recorded
• Approve the issue of analytical results
• Ensure data are archived
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21. ANALYTICAL STAFF
• Maintain awareness of GCP, GCLP which apply to their work
• Perform trial requirements in accordance with Trial Protocol,
Analytical Plan & Standard Operating Procedures.
• Maintain prompt, accurate and complete records
• Responsible for the quality of their work & data
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22. QUALITY AUDIT STAFF
• Independent monitoring of facility
• Performs quality audits
• review all aspects of the facility and work performed
• Reports findings to Analytical Project Manager and Facility Management
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23. FACILITIES, EQUIPMENT & REAGENTS
• Demonstrably fit for purpose
• Facilities
• suitable size, structure and location
• space to avoid sample mix-up or contamination
• separation of activities
• limited access?
• storage areas
• temperature controlled, monitored, limits set, alarmed, back up
• good housekeeping 23

24. FACILITIES, EQUIPMENT & REAGENTS
• Equipment
• acceptance testing prior to use
• appropriately maintained & calibrated
• with records to demonstrate this
• trend analysis of calibration checks?
• validated computer systems in use
• may need to keep records of usage
• Reagents
• suitably labelled and stored 24

25. STANDARD OPERATING PROCEDURES
• Function of SOPs
• To establish standard procedures which will ensure quality and integrity of
the data
• To communicate these procedures to those who will undertake them and
underpin training
• To leave a permanent record of the methodology employed.
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26. SOPs CONT…
• Approved by Management
• Controlled with historical file maintained
• To cover areas such as:
• Format, control and review of SOPs
• Sample handling- receipt, chain of custody, storage, repeat analysis, etc
• Methods or control of methods
• Equipment use and maintenance
• Record keeping
• QC procedures & Audit procedures
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27. PLANNING
• Documented and approved plan for the work
• May form part of the contractual agreement with the sponsor
• Should reflect the requirements of the clinical protocol
• Should contain sufficient detail to provide clear instruction to staff
• Amendments and deviations documented
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28. CONDUCT
• In accordance with the plan
• Data and results recorded
• promptly, indelibly, legibly, signed & dated
• Methods validated
• Uniform analytical platforms
• Definition of raw (source) data
• Documented procedure for repeat analysis
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29. REPORTING
• Two types of report
• Analytical report: A formal report which may be issued on completion of
the work detailed in the analytical plan.
• Analytical results: A document(s) containing just the results which is
usually issued rapidly on completion of sample analysis on a given day
• Contain information as required by GCLP, Analytical plan and Sponsor
• clinical trial number, identity of the facility and APM, dates, results etc.
• QC to ensure accuracy
• Approved for issue 29

30. STORAGE AND RETENTION OF DATA
• Trial data, Analytical plan & Analytical results/reports
• Supporting data or information
• Organisation charts
• Staff records (training, job descriptions, CVs)
• Equipment records( maintenance & calibration)
• System validation records
• Historical file of SOPs
• Quality Audit reports
• Stored in appropriate facilities 30

31. SUMMARY -GCLP
• GCLP is concerned with producing reliable results which can be
supported and are reconstructable
• To meet the challenge of GCP compliance
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