Clinical Research For Researchers

Clinical Research Training Program

MODULE I: Clinical Research

1.1. Introduction to Clinical Research and Good Clinical Practice (ICH-GCP)

1.2. Legislation Applicable to Clinical Research

1.3. General Data Protection Regulation

1.4. Designing Clinical Studies and Writing a Clinical Research Protocol

1.5. Submission of Clinical Studies to Competent Entities

1.6. The Role of a Monitor in a Clinical Study

1.7. Data Management

MODULE II – Biostatistics

2.1. General Notions of Biostatistics and Introduction

2.2. Exploratory Data Analysis

2.3. Theory of Hypotheses

2.4. Student's t-tests and Analysis of Variance (ANOVA)

2.5. Pearson Correlation

2.6. Simple and Multiple Linear Regression