5.1 Clinical Research

1. Drug Development Process

a. Introduction

b. Various Approaches to Drug Discovery

i. Pharmacological

ii. Toxicological

iii. IND Application

iv. Drug Characterization

v. Dosage Form

2. Clinical Development of Drug

a. Introduction to Clinical Trials

b. Various Phases of Clinical Trial

c. Methods of Post Marketing Surveillance

d. Abbreviated New Drug Application Submission

e. Good Clinical Practice

i. ICH

ii. GCP

iii. Central Drug Standard Control Organisation (CDSCO) Guidelines

f. Challenges in the Implementation of Guidelines

g. Ethical Guidelines in Clinical Research

h. Composition, Responsibilities, Procedures of IRB / IEC

i. Overview of Regulatory Environment in USA, Europe and India

j. Role and Responsibilities of Clinical Trial Personnel as per ICH GCP

i. Sponsor

ii. Investigators

iii. Clinical Research Associate

iv. Auditors

v. Contract Research Coordinators

vi. Regulatory Authority

k. Designing of Clinical Study Documents

i. Protocol

ii. CRF

iii. ICF

iv. PIC

l. Informed Consent Process

m. Data Management and its Components

n. Safety Monitoring in Clinical Trials