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Good Clinical Practices


Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Compliance with this standard provides assurance to public that the rights, safety and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki and ensures that clinical trial data are credible.  

It has been widely recognized that India offers unique opportunities for conducting clinical trials in view of the large patient pool, well- trained and enthusiastic investigators and premiere medical institutes available in the country along with considerable low per patient trial cost, as compared to developed countries.

A need was, however, felt to develop our own Indian Guidelines to ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population. An Expert Committee set up by Central Drugs Standard Control Organisation (CDSCO) in consultation with clinical expert has formulated this GCP guideline for generation of clinical data on drugs. 

The Drug Technical Advisory Board (DTAB), the highest technical body under D&C, Act, has endorsed adoption of this GCP guideline for streamlining the clinical studies in India.


Contents 

 
            Introduction
1.            Definitions
2.                  Pre-requisites for the study
2.1.           Investigational Pharmaceutical Product
2.2.           Pre-Clinical supporting data
2.3.           Protocol
2.3.1.     Relevant components of Protocol
2.3.1.1.          General Information
2.3.1.2.          Objectives and Justification
2.3.1.3.          Ethical Considerations
2.3.1.4.          Study design
2.3.1.5.          Inclusion, Exclusion & Withdrawal of Subjects
2.3.1.6.          Handling of the Product(s)
2.3.1.7.          Assessment of Efficacy
2.3.1.8.          Assessment of Safety
2.3.1.9.          Statistics
2.3.1.10.      Data handling and management
2.3.1.11.      Quality control and quality assurance
2.3.1.12.      Finance and Insurance
2.3.1.13.      Publication policy
2.3.1.14.      Evaluation
2.3.2.     Supplementaries and appendices:

2.4.           Ethical & Safety Considerations
2.4.1.     Ethical Principles
2.4.2.     Ethics Committee
2.4.2.1.          Basic Responsibilities
2.4.2.2.          Composition
2.4.2.3.          Terms of Reference
2.4.2.4.          Review Procedures
2.4.2.5.          Submission of Application
2.4.2.6.          Decision Making Process
2.4.2.7.          Interim Review
2.4.2.8.          Record Keeping
2.4.2.9.          Special Considerations
2.4.3.     Informed Consent Process
2.4.3.1.          Informed Consent of Subject
2.4.3.2.          Essential information for prospective research subjects
2.4.3.3.          Informed Consent in Non-Therapeutic Study
2.4.4.     Essential Information on Confidentiality for Prospective Research Subjects
2.4.5.     Compensation for Participation
2.4.6.     Selection of Special Groups As Research Subject
2.4.6.1.          Pregnant or nursing women
2.4.6.2.          Children
2.4.6.3.          Vulnerable groups
2.4.7.     Compensation for Accidental Injury
2.4.7.1.          Obligation of the sponsor to pay
3.                  Responsibilities
3.1.           Sponsor
3.1.1.     Investigator and Institution Selection
3.1.2.     Contract
3.1.3.     SOP
3.1.4.     Allocation of duties and responsibilities
3.1.5.     Study management, data handling and record keeping
3.1.6.     Compensation for Participation
3.1.7.     Confirmation  of review by the Ethics Committee
3.1.8.     Information on Investigational Products
3.1.9.     Supply, storage and handling of Pharmaceutical Products
3.1.10  Safety Information
3.1.11  Adverse Drug Reaction Reporting
3.1.12  Study Reports
3.1.13  Monitoring
3.1.14  Audit
3.1.15  Multicentre Studies
3.1.16  Premature Termination or Suspension of a Study
3.1.17  Role of Foreign Sponsor
3.2.           The Monitor
3.2.1.     Qualifications
3.2.2.     Responsibilities
3.3.           Investigator
3.3.1.     Qualifications
3.3.2.     Medical Care of the Study Subjects
3.3.3.     Monitoring and Auditing of records
3.3.4.     Communication with Ethic Committee
3.3.5.     Compliance with the Protocol
3.3.6.     Investigational Product(s)
3.3.7.     Selection and recruitment of Study Subjects
3.3.8.     Records/Reports
4.                  Record Keeping and Data Handling
4.1.           Documentation
4.2.           Corrections
4.3.           Electronic Data Processing
4.4.           Validation of Electronic Data Processing Systems
4.5.           Language
4.6.           Responsibility of Investigator
4.7.           Responsibilities of Sponsor and Monitor
5.         Quality Assurance
6.                  Statistics
6.1.           Role of Biostatistician
6.2.           Study design
6.2.1.     Randomisation and Blinding
6.3.           Statistical Analysis
7.      Special Concerns
7.1.           Clinical Trials of Vaccines
7.1.1.     Phases of Vaccine Trials
7.1.2.     Guidelines
7.2.           Clinical Trials of  contraceptives
7.3.           Clinical Trials with Surgical Procedures / Medical devices.
7.3.1.     Definitions
7.3.2.     Guidelines
7.4.           Clinical Trials for Diagnostic agents - Use of radioactive materials and X-rays
7.4.1.     Guidelines
7.5.           Clinical Trials of Herbal Remedies and Medicinal Plants
7.5.1.     Categories of Herbal Product
7.5.2.     Guidelines
 
Appendices
Appendix I: Declaration of Helsinki
Appendix II: Schedule Y
Appendix III: Format for submission of Pre-clinical and clinical data for r-DNA based vaccines, diagnostics and other biologicals.
Appendix IV: Investigator's Brochure
Appendix V: Essential Documents

Good Clinical Practice Guidelines...continue reading here:  http://cdsco.nic.in/html/gcp1.html

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