Anna University                     Apollo Hospitals Educational &                Auroville HealthCare

  AU-KBC Research Centre       Research Foundation (AHERF)                 R & D Private Limited (AHC)

The following modules will be covered in four months under Contact Sessions and Distance Learning Sessions

MODULE - 1: INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT

o  Introduction to Drug discovery and development

o  History of clinical research

o   Importance of clinical research to human society

o   Terminologies in clinical research

o   Fields in clinical research

MODULE - 2: TYPES OF CLINICAL RESEARCH AND PHASES IN CLINICAL TRIAL

o   Types of clinical research-interventional & observational

o   Bioavailability and Bioequivalence studies

o   Phases of clinical trial

2.     MODULE - 3: GOOD CLINICAL PRACTICES

o   Importance of good clinical practice - ICH GCP guidelines

o   Roles and responsibilities of CRA and CRC

MODULE - 4: ETHICS IN CLINICAL RESEARCH

o   Ethical standards for Human subjects

o   ICMR guidelines

o   Informed consent and protection of vulnerable subjects

MODULE - 5: PRE CLINICAL RESEARCH

o   pre clinical research requirements and GLP

o   Toxicity studies

o   Translational Pharmacology

MODULE - 6: NATIONAL AND INTERNATIONAL REGULATIONS IN CLINICAL RESEARCH

o   CDSCO – Schedule Y

o   FDA – 21 CFR

o   Global regulatory bodies

MODULE - 7: REGULATORY AFFAIRS IN CLINICAL RESEARCH

o   Importance of Regulatory affairs in clinical research

o   Clinical trial approval procedures in various regions (US, EU and India etc.)

o   Guidelines(ICH M 4) for preparing regulatory dossier

MODULE - 8: PLANNING, DESIGNING AND DOCUMENTATIONS IN CLINICAL TRIAL

o   Project planning and time management

o   Essential documents in clinical research

o   Clinical trial design

o   Randomization and blinding

o   Clinical trial budgeting and insurance

MODULE - 9: MANAGEMENT OF CLINICAL TRIAL

o   Agreements involved in clinical trials

o   Documentation and filing (TMF and ISF)

o   Clinical trial Management

MODULE - 10: QUALITY ASSURANCE AND QUALITY CONTROL IN CLINICAL TRIAL

o   Introduction to quality assurance and quality control in clinical research

o   Methods of quality assurance and quality control

o   Implementation of Standard operating procedure in clinical research

o   Audit & Inspection

MODULE - 11: CLINICAL DATA MANAGEMENT AND BIOSTATISTICS

o   Introduction to data management in clinical research

o   Data entry and data validation

o   Basics of biostatistics in clinical research

o   Importance of statistical analysis plan

o   Statistical analysis methods

MODULE - 12: SAFETY REPORTING and PHARMACOVIGILANCE

o   Introduction to Pharmacovigilance

o   Adverse event reporting forms

o   Signal detection

o   Adverse event coding procedure (MedDRA,WHO ART etc.)

PART –III: Observership – 5 Days

* In general, the interns will expose to the the following activities:

i. Site selection

ii. Ethics committee Process

iii. Site Initiation

iv. Patient recruitment

v. Documentation

vi. Monitoring

vii. Trial closure