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Clinical Trial Services Course: (6 Modules)

1. Introduction to Clinical Trial Support Services

a. Pharma World & Companies

b. Pre-clinical Phase

c. Clinical Phase

d. Post-Marketing Phase (RWE)

2. Documents for EC approval

a. Clinical Study Protocol

b. Informed Consent Document (ICD)

c. Case Report Form (CRF)

d. Ethics Committee Proposal Package

e. CTRI Database Registration

3. Trial Support Services

a. Site-inspection and Monitoring

b. CRA deputation

c. Medical Monitoring

d. Site inspection Reports

4. Data Monitoring

a. Data Entry & Registration

b. Online Databases

c. Data Storage

d. Pharmaco-Vigilance support

5. Data Management

a. Statistical Analysis Plans

b. Statistical Data Analysis

c. Preparation of TLFs

d. Statistical Report

6. Trial Outcome

a. Clinical Study Reports (CSR)

b. Structures and Components

c. Filing of CSR to Regulators

d. Regulaotry Approvals

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