GUIDELINE FOR GOOD CLINICAL PRACTICEBASIC 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
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 protectedFollow when conducting a trial: Intended for submission to a regulatory agency in an ICH region Any trial being conducted under a Clinical Trials Application.
2. GCP: Principles2.1ethical principles2.2 benefits/risk 2.8 qualified individuals conduct trials2.3 rights/safety of subjects most 2.9 free informed consentimportant2.4 drug info supports trial 2.10 data accurate etc2.5 trial scientifically sound, protocol 2.11 confidentiality2.6 protocol REB approved 2.12 drugs: GMP/protocol2.7 medical care by a qualified physician 2.13 quality assurance
3. GCP: IRB(Independent review board) Responsibilities3.1Composition, function and procedures3.2Documents to obtain & review3.2Records
4.GCP: Investigator Responsibilities4.1Qualifications & resources4.2Care of subjects4.3Communication with REB4.4 Investigator product4.5Patient consent process4.6Records/reports4.7Safety reporting
5. GCP: Sponsor Responsibilities5.1Quality assurance and 5.6Informed consentquality control requirements5.2Trial management, data 5.7Monitoring & Auditinghandling and record keeping patients rights/well-being protected data is accurate, complete, verifiable5.3Investigator selection 5.8SAE (SERIOUS ADVERSE EFFECT) REPORTING5.4Regulatory submissions 5.9Conduct of trial by everyone is GCP compliant5.5Confirmation of IRB review 5.10DRUG
6. Protocol and Amendments6.1 General information 6.10 Direct access to source data6.2 Background information And documents6.3 Trial objectives and 6.11 Quality control and Q.Apurpose6.4 Trial design 6.12 Ethics6.5 Selection and withdrawal 6.13 Data handling andof subject record keeping6.7 Assessment of Efficacy 6.14 Finance and insurance6.8 Assessment of safety 6.15 Publication policy6.9 Statistics
Cntd……7.3 Contents of the investigetris Brochure it include:---7.3.1 summary7.3.2 introduction7.3.3 Physical ,chemical and pharmaceuticalproperties7.3.4 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 DOCUMENTS8.1 Introduction8.2 Before the Clinical Phase of the TrailCommences8.3 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 documents Maintain essential documents (GCP) Maintain confidentiality Ensure 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 analysisReference :- www.ich.org,NCIC clinical trial group.
ThanksAshwani kumar singhMsc clinical research and experimental medicine Chettinad university , Chennai. email- email@example.com