Advanced Post Graduate Diploma in Clinical Research

MODULE I

Introduction
Introduction to Clinical research. Need and types of clinical trial. Drug development,nce development, steps in drug development,ind application. phases of drug development,pre-clinical studies Clinical research terminology Overview of formats/disciplines for clinical research

Clinical Trial Development Phases:

Defining phases 1-4, post marketing New drug development and marketing approval process Drug, device, biologic, radio-logic development considerations Clinical trial originations: Federal, sponsor, PI, WHO, etc Historical Case Studies in Human Subject Research; Ethical Considerations:

Discuss articles brought in about clinical trials: are they or arent they research Historical Case Studies: Tuskegee Experiments, Thalidomide, Jewish Chronic Disease, Willowbrook, San Antonio Contraception, Jesse Hellinger, etc.

Developing Ethical Research Principles, regulations, guidelines:

Nuremberg Code 1949 National Research Act 1974/81 (DHHS 45CFR46) Declaration of Helsinki 1975 Belmont Report 1979 FDA (21CFR50/56) Common Rule definition, applications Definitions of the Basic Ethical Research Principles Development of Institutional Review Boards, Data Safety Monitoring Boards, Ethical Review Committees:

Dept. Health & Human Services Office of Human Research Protections; Federal Research Oversight Institutional Review Board; roles, responsibilities, membership Data Safety Monitoring Boards; roles, responsibilities

MODULE II

Good Clinical Practice Guidelines (GCP) and International Committee on Harmonization (ICH) Guidelines:

GCP & ICH historical development Review of guidelines GCP & ICH Indian GCP SCHEDULE Y AND PROVISIONS DRUG AND COSMETIC ACT ICMR Principles. International research guideline(FDA,EMEA,MHRA etc)

MODULE III Clinical trial design

Classification of trial, Observational trials, Interventional trial ,Trial design,Randomisation,bliniding,parallel,cross over,case control.

Defining the Research Team; roles, responsibilities, org. structure: Principal Investigator, Co-PI, Sub-PI Medical officer/writer CRC, technicians Research Pharmacist Statistician Regulatory manager, monitor/auditor Data manager Scientific writer/publisher

Essential Documentation in Clinical Research & Regulatory Submissions

Protocol, Design and Components Investigator brochure Design and Components Informed Consent-Form, Process, LAR, Impartial witness CRF Design(Paper/e-crf) and Components Sops Other CT related Documents
MODULE IV Clinical trial Execution

Selection of site and PI,Investigator meeting, Site initiation Patient Screening and enrollment Routine monitoring, site close out visit CRF completion, source document verification misconduct and fraud Auditing and monitoring Audit of trial site, routine audit for cause audit, Audit plan QA QC

MODULE V

Ba/be studies-approval of generic drugs,ANDA Pharmacovigilance definition and needs, tools, techniques and PV in India

Overview of Data Management Importance of statistics in clinical research Statistical considerations at the design, analysis and reporting stage. Data management plan Data Capture, collection, Entry, Data validation SAE reconciliation Query management Software considerations