BASIC STRUCTURE OF I.C.H

G.C.P

GUIDELINE FOR GOOD CLINICAL PRACTICE

Prepared By :- Ashwani Kumar Singh MSc( clinical research & experimental medicine) C.H.R.ISubmitted to:- Dr.Arun kumar

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

regionAny trial being conducted under a Clinical Trials Application.

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

TABLE CONTENTS OF ICH G.C.P

1.GLOSSARY 2.PRINCIPELS

1.1ADR (ADVERSE DRUG REACTION)

1.9 C.R.O (CONTRECT RESEARCH ORGENIZATION)

3.REB (RESEARCH ETHICS BOARD) RESPONSBILITIES

1.2 AE (ADVERSE EVENT)

1.10BLINDING 4. INVESTIGATER RESPONSBILITY

1.3 AMENDMENT 1.11 CASE REPORT FORM

5.SPONSER 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 COMMITTEE

8.ESSENTIAL DOCUMENTS

1.7 AUDIT REPORT 1.15IMPARTIAL WITNESS

1.8 AUDIT TRAIL 1.16INFORMED CONSET

Cont..

Glossary Cont..

1.17 INSPESCTION (25)CLINICAL TRIAL STUDY

(33)G.C.P

1.18 INDEPENDENT DATA MONITORING COMMITTEE (IDMC)

1.26 QUALITY ASSURANCE

1.34 SPONSER

1.19 INSTITUTION(MEDICAL)

1.27 QUALITY CONTROL

1.35 SPONSER INVESTIGATOR

1.20 IRB(INSTITUTIONAL REVIEWBOAD )

1.28 RAGULATORY AUTHORITIES

1.36 SOPs (STANDERD OPRATING PROCEDURE)

1.21 INVESTIGATIONAL PRODUCT

1.29 RANDOMIZATION 1.37 SUBINVESTIGATOR

1.22 MONITERING 1.30 SERIOUS A.E &SERIOUS A.D.R

1.38 TRIAL SUBJECT

1.23 MULTICENTER TRIAL 1.31SOURCE DATA 1.39 UNEXPECTED A.D.R

1.24 PROTOCOL 1.32 SOURCE DOCUMENT

1.40 VULNERABLE SUBJECTS

2. GCP: Principles2.1ethical principles

2.2 benefits/risk 2.8 qualified individuals conduct trials

2.3 rights/safety of subjects most important

2.9 free informed consent

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

3. GCP: IRB(Independent review board) Responsibilities

3.1Composition, function and procedures

3.2Documents to obtain & review

3.2Records

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

5. GCP: Sponsor Responsibilities

5.1Quality assurance and quality control

5.6Informed consent requirements

5.2Trial management, data handling and record keeping

5.7Monitoring & Auditingpatients rights/well-being protecteddata 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

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 purpose

6.11 Quality control and Q.A

6.4 Trial design 6.12 Ethics

6.5 Selection and withdrawal of subject

6.13 Data handling and record keeping

6.7 Assessment of Efficacy

6.14 Finance and insurance

6.8 Assessment of safety 6.15 Publication policy

6.9 Statistics

7. INVESTIGATORIS BROCHURE

7.1 Introduction

7.2 Genral consideration

Title pageConfidentiality

statments

Cntd……

7.3 Contents of the investigetris Brochure it include:---7.3.1 summary7.3.2 introduction7.3.3 Physical ,chemical and pharmaceutical properties7.3.4 Nonclinical Studies7.3.5 Nonclinical Pharmacology7.3.6 Toxicology7.3.7 Effects in humans7.3.8 Safety and Effacacy7.3.9 Marketing experience

8. ESSENTIAL DOCUMENTS

8.1 Introduction8.2 Before the Clinical Phase of the Trail Commences8.3 During The Clinical Conduct of the Trail8.4 After Completion or Termination of The Trail

During the Trial

Informed consent prior to trial specific procedures

Comply with the protocol, document.Source documentsMaintain essential documents (GCP)Maintain confidentialityEnsure drug reconciliation .Ongoing annual approval.REB approval for amendments.

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.

Thanks

Ashwani kumar singh Msc clinical research and experimental medicine Chettinad university , Chennai. email-

aksingh.kumar2009@gmail.com