ICH GCP GUIDELINES FOR CONDUCT OF TRIAL

ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
Mohammed Faheem khan
MBA-Pharmaceutical Management,
Jamia Hamdard, New Delhi

Good Clinical Practices (GCPs)
• Good Clinical Practices (GCP) is an international
ethical & scientific quality standard for designing,
conducting, performing, monitoring, auditing,
recording, analyzing, and reporting clinical trials.
Why is it needed?
• To ensure the rights, safety and well being of the trial
subjects are protected.
• Ensure the credibility of clinical trial data.

Principles of GCP
• Clinical Trials should be conducted in accordance with
the ethical principles consistent with GCP and applicable
regulatory requirements.
• Before a trial is initiated, foreseeable risks &
inconveniences should be weighed against anticipated
benefit for the trial subject & society.
• The rights, safety, and well being of the trial subjects are
the most important considerations & should prevail over
interests of science and society.
• The available nonclinical & clinical information on an
investigational product should adequately support the
proposed clinical trial.

Who is Responsible for
GCP Compliance?
• Clinical Investigators
• Sponsors
• Independent Ethics Committees/Institutional Review
Boards Contract Research Organizations
• Research Clinical Coordinators
• Clinical Research Associates
• Medical monitors
• Data entry personnel
• Others study team members

What is ICH?
International conference on harmonization
• It is a joint initiative involving regulators &
industry as equal partners in the scientific &
technical discussions of the testing procedures
which are required to ensure and assess the
safety, quality & efficacy of medicines.

A Unique Approach
• International Conference on Harmonization
(ICH) was created in 1990
• Agreement between the EU, Japan and the USA
to harmonize different regional requirements for
registration of pharmaceutical drug products
• Unique because joint effort by regulators and
associated pharmaceutical industry trade
associations

MISSION
• To make recommendations towards achieving
greater harmonization in the interpretation and
application of technical guidelines and
requirements for pharmaceutical product
registration, there by reducing duplicating of
testing carries out during the research &
development of new human medicines.

Purpose of ICH
• Harmonization of technical requirements
• Ensure safety, efficacy and quality of medicines
• Prevent duplication of clinical trials in humans
• Minimize the use of animal testing without
compromising safety and effectiveness

Structure of ICH
Regulatory bodies
• EU- European Union
• EFPIA- European federation of pharmaceutical industries’
associations
• US FDA- US Food & Drug Administration
Industry
• MHLW- Ministry of health, Labor and welfare, Japan
• JPMA- Japan Pharmaceuticals manufacturers Association
• PhRMA- Pharmaceutical Research & Manufactures of America
• Observers : WHO, TPP( Canada)
• International federation of Pharmaceutical manufacturer’s
association

ICH Working Groups
• EWG: developing a harmonized guideline that
meets the objectives in the Concept Paper and
Business Plan
• IWG: develop Q&As to facilitate
implementation of existing guidelines
• INWG: developing/finalizing a Concept Paper,
as well as developing a Business Plan
• DG: discuss specific scientific considerations or
views

Sections of ICH-E6 (GCP)
1. Glossary
 2. Principles of GCP
 3. EC/IRB Responsibilities
4. Investigator Responsibilities
 5. Sponsor Responsibilities
6. Protocols and Amendments
7. Investigator’s Brochure
 8. Essential Documents

Section 1- Glossary of various terms
 Adverse drug reaction & Adverse Event
 Case report form & Clinical Study Report
 Coordinating Committee & Contract Research Organization
 Independent Ethics Committee & Institutional Review Board
 Investigator & Investigator’s Brochure
 Monitoring & Monitoring report
 Protocol & Protocol Amendment
 Serious Adverse Event
 Source data & Source documents
 Sponsor & Sponsor investigator
 Standard Operating Procedures
 Vulnerable subjects

Section 2- Principles of GCP
 Clinical Trials should be conducted in accordance with the ethical principles
consistent with GCP and applicable regulatory requirements
 Before a trial is initiated, foreseeable risks & inconveniences should be
weighed against anticipated benefit for the trial subject & society
 The rights, safety, and well being of the trial subjects are the most important
considerations & should prevail over interests of science and society
 The available nonclinical & clinical information on an investigational product
should adequately support the proposed clinical trial
 Clinical trials should be scientifically sound, & described in a clear, detailed
protocol; which has received prior IRB/IEC approval
 The medical care and medical decisions for subjects should be the
responsibility of a qualified physician
 Each individual involved in conducting a trial should be qualified by
education, training & experience to perform his respective task

Section 3- EC / IRB Responsibilities
 Should safeguard the rights, safety & well being of all trial subjects
 Review Protocol / Informed Consent Document / Recruitment Procedures /
Investigator’s Brochure / Remunerations
 Ongoing Progress/Adverse events
RB/IEC Composition
 At least 5 members
 At least one non scientific member
 At least one independent member
 Maintain list of members and qualifications
 Only independent members to vote
 Quorum to be present

Section 4- Investigator Responsibilities
 Qualified (documented) by education, training & experience to
assume responsibility for proper trial conduct
 Should be familiar with the appropriate use of the investigational
product, IB, and other information provided by sponsor
 Should be aware of & should comply with GCP and the applicable
regulatory requirements
 To permit monitoring, auditing and inspection
 Delegation of duties to appropriately qualified persons
 Potential for recruitment of required number of subjects
 Sufficient time for trial conduct and completion
 Staff, facilities
 Ensure training to staff

Section 5- Sponsor Responsibilities
An individual, company, institution, or organization
which takes responsibility for the initiation, management,
and/or financing of a clinical trial
 Implementing & maintaining QA and QC systems with
written SOPs to ensure GCP compliance
 Securing agreements from all sites for monitoring,
auditing, and inspections
 QC of data handling
 Payment agreements

Section 6- Protocol and Amendments
 Document describing all aspects of the study
 Well designed and thoroughly considered
 Complete & Well structured
General Information:
 Protocol Title, identifying number , date, Amendment number
 Contact names, addresses
 Name and title of Authorized signatory
 Institution(s), Laboratories, department contact

Section 7- Investigator’s Brochure
 The information should be presented in a concise, simple,
objective, balanced, and non-promotional form that enables a
potential investigator, to understand it and make his/her own
unbiased risk-benefit assessment of the appropriateness of the
proposed trial
 Compilation of the clinical and nonclinical data on the
investigational product(s) that are relevant to the study of the
product(s) in human subjects.
 Provide the investigators and others involved in the trial with the
information to facilitate their understanding of the rationale for,
and their compliance with, many key features of the protocol, such
as the dose, dose frequency/interval, methods of administration:
and safety monitoring procedures.

Section 8- Essential Documents for the Conduct of a
Clinical Trial
 Documents which individually and collectively permit evaluation of the conduct
of a trial and the quality of the data produced
 These documents serve to demonstrate the compliance of the investigator,
sponsor and monitor with the standards of Good Clinical Practice and with all
applicable regulatory requirements
 Various documents are grouped in three sections according to the stage of the
trial during which they will normally be generated:
 Before the clinical phase of the trial commences
 During the clinical conduct of the trial
 After completion or termination of the trial

ICH GCP GUIDELINES FOR CONDUCT OF TRIAL

ICH GCP GUIDELINES FOR CONDUCT OF TRIAL

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ICH GCP GUIDELINES FOR CONDUCT OF TRIAL