This ppt contain basic structure of good clinical practice (GCP) that is necessary fro conducting clinical trails for developing a new drug.

1. GUIDELINE FOR GOOD CLINICAL
PRACTICE
BASIC STRUCTURE OF I.C.H
G.C.P
Prepared By :- Ashwani Kumar Singh
MSc( clinical research &
experimental medicine) C.H.R.I
Submitted to:- Dr.Arun kumar

2. ICH Good Clinical Practice Guideline(GCP)
 International ethical and scientific quality standard for trials
involving humans. It adresses:
 Design; conduct; recording; reporting.
 Compliance with this standard provides public assurance
that the rights, safety and well-being of trial subjects are
protected
Follow when conducting a trial:
 Intended for submission to a regulatory agency in an ICH
region
 Any trial being conducted under a Clinical Trials Application.

3. GCP: Basic Structure
1. Glossary
2. Principles
3. IRB responsibilities
4. Investigator responsibilities
5. Sponsor responsibilities
6. Protocol and amendments
7. Investigator Brochure
8. Essential Documents

4. TABLE CONTENTS OF ICH G.C.P
1.GLOSSARY 2.PRINCIPELS
1.1ADR (ADVERSE DRUG 1.9 C.R.O (CONTRECT 3.REB (RESEARCH
REACTION) RESEARCH ETHICS BOARD)
ORGENIZATION) RESPONSBILITIES
1.2 AE 1.10BLINDING 4. INVESTIGATER
(ADVERSE EVENT) RESPONSBILITY
1.3 AMENDMENT 1.11 CASE REPORT 5.SPONSER
FORM RESPONSBILITY
1.4 APPROVEL 1.12INVESTIGATOR 6.PROTOCOL &
AMENDMENT
1.5 AUDIT 1.13DOCUMENTATION 7.INVESTIGATOR
BROUCHER
1.6 AUDIT CERTIFICAT 1.14 INDEPENDENT EHICS 8.ESSENTIAL
COMMITTEE DOCUMENTS
1.7 AUDIT REPORT 1.15IMPARTIAL WITNESS
1.8 AUDIT TRAIL 1.16INFORMED CONSET Cont..

5. Glossary Cont..
1.17 INSPESCTION (25)CLINICAL TRIAL (33)G.C.P
STUDY
1.18 INDEPENDENT DATA 1.26 QUALITY ASSURANCE 1.34 SPONSER
MONITORING COMMITTEE
(IDMC)
1.19 INSTITUTION(MEDICAL) 1.27 QUALITY CONTROL 1.35 SPONSER
INVESTIGATOR
1.20 IRB 1.28 RAGULATORY 1.36 SOPs (STANDERD
(INSTITUTIONAL AUTHORITIES OPRATING PROCEDURE)
REVIEWBOAD )
1.21 INVESTIGATIONAL 1.29 RANDOMIZATION 1.37 SUBINVESTIGATOR
PRODUCT
1.22 MONITERING 1.30 SERIOUS A.E & 1.38 TRIAL SUBJECT
SERIOUS A.D.R
1.23 MULTICENTER TRIAL 1.31SOURCE DATA 1.39 UNEXPECTED A.D.R
1.24 PROTOCOL 1.32 SOURCE DOCUMENT 1.40 VULNERABLE
SUBJECTS

6. 2. GCP: Principles
2.1ethical principles
2.2 benefits/risk 2.8 qualified individuals conduct trials
2.3 rights/safety of subjects most 2.9 free informed consent
important
2.4 drug info supports trial 2.10 data accurate etc
2.5 trial scientifically sound, protocol 2.11 confidentiality
2.6 protocol REB approved 2.12 drugs: GMP/protocol
2.7 medical care by a qualified physician 2.13 quality assurance

7. 3. GCP: IRB(Independent review
board) Responsibilities
3.1Composition, function and procedures
3.2Documents to obtain & review
3.2Records

8. 4.GCP: Investigator Responsibilities
4.1Qualifications & resources
4.2Care of subjects
4.3Communication with REB
4.4 Investigator product
4.5Patient consent process
4.6Records/reports
4.7Safety reporting

9. 5. GCP: Sponsor Responsibilities
5.1Quality assurance and 5.6Informed consent
quality control requirements
5.2Trial management, data 5.7Monitoring & Auditing
handling and record keeping patients rights/well-being
protected
data is accurate, complete,
verifiable
5.3Investigator selection 5.8SAE (SERIOUS ADVERSE
EFFECT)
REPORTING
5.4Regulatory submissions 5.9Conduct of trial by everyone is
GCP compliant
5.5Confirmation of IRB review 5.10DRUG

10. 6. Protocol and Amendments
6.1 General information 6.10 Direct access to
source data
6.2 Background information And documents
6.3 Trial objectives and 6.11 Quality control and Q.A
purpose
6.4 Trial design 6.12 Ethics
6.5 Selection and withdrawal 6.13 Data handling and
of subject record keeping
6.7 Assessment of Efficacy 6.14 Finance and insurance
6.8 Assessment of safety 6.15 Publication policy
6.9 Statistics

11. 7. INVESTIGATORIS BROCHURE
7.1 Introduction
7.2 Genral consideration
Confidentiality
Title page statments

12. Cntd……
7.3 Contents of the investigetris Brochure
it include:---
7.3.1 summary
7.3.2 introduction
7.3.3 Physical ,chemical and pharmaceutical
properties
7.3.4 Nonclinical Studies
7.3.5 Nonclinical Pharmacology
7.3.6 Toxicology
7.3.7 Effects in humans
7.3.8 Safety and Effacacy
7.3.9 Marketing experience

13. 8. ESSENTIAL DOCUMENTS
8.1 Introduction
8.2 Before the Clinical Phase of the Trail
Commences
8.3 During The Clinical Conduct of the Trail
8.4 After Completion or Termination of The Trail

14. During the Trial
 Informed consent prior to trial specific procedures
 Comply with the protocol, document.
 Source documents
 Maintain essential documents (GCP)
 Maintain confidentiality
 Ensure drug reconciliation .
 Ongoing annual approval.
 REB approval for amendments.

15. End of the Trial
 Inform REB when trial closes
 Submit Final report to REB
 Monitor long term safety : inform patients and REB as needed
 Retain records (included source documents and radiology)
according to regulations (25 years for CTA trial)
 Audits/inspections may occur during trial or after final
analysis
Reference :- www.ich.org,NCIC clinical trial group.

16. Thanks
Ashwani kumar singh
Msc clinical research and experimental
medicine
Chettinad university , Chennai.
email- aksingh.kumar2009@gmail.com