Clinical Trials Unit (CTU)

Vision and Mission
Principal Message
Faculty Details
Departmental Profile
Courses Outlines
Academic Time Tables
Address & Contact Details
Location Map

Courses Outlines (Clinical Research Certified Professional (CRCP))

1. Introduction to Clinical Research Certificate Program, Pharma Industry Review, Group Formations
2. Introduction to Clinical Research (Pre-Clinical Research, Phases of Clinical Trials)
3. International Conference on Harmonization and Good Clinical Practices Guidelines (ICH-GCP Guidelines).
4. Ethics in Clinical Research (ERC formulation, documents reviewed by ERC, ERC authorities & decisions, Ethical Dilemma and Issues)
5. Review and Approval Processes of Investigational New Drug/New Drug Application (IND, NDA, Canadian and MOH approval processes)
6. Study design & Documents (Study Protocol, IB, ICF, CRF & eCRF, Patient Diaries, Financial disclosure, Form 1572, Site Staff Signature sheet, Source document agreement, Confidentiality agreement, Site Visits log, Drug accountability log, Drug destruction log, Monitoring visit log, Contact Visits log& Essential Documents)
7. Clinical Site Selection, Site Staff Roles & Responsibilities, establishment of an ideal site (site infrastructure, site staff capabilities, recruitment strategies and related topics)
8. CRA responsibilities & activities-I (Budgeting, Pre, During & Post study activities, Computerized systems used in clinical trials-IVRS, eCRF)
9. CRA responsibilities & activities- II (Planning, SDV, Discussion with site staff, Post monitoring FU letter, CTM, Archiving)
10. Safety & Pharmacovigilance and QA audit
11. Basics & descriptive Biostatistics, Probability Theory, Properties of Continuous Probability Distribution, Hypothesis Testing, Normal Distribution Probability and Sampling Techniques Estimation of a parameter.
12. Basic Research Design, Introduction to Epidemiology, A brief Introduction to epidemiology, Sampling Methodology, Screening
Introduction to the Principles and Practice of Clinical Research (IPPCR) NIH, USA
S.No Module I, Statistical Methods S.No Module III, Monitoring Patient-Oriented
Research and Regulatory Issues
1.  Design of Epidemiologic Studies 1. Data Management in Clinical Trials
2.  Issues in Randomization 2. Information Resources for Clinical Research
3.  Measures 3. Quality of Life
4. Participant Selection 4. Scientific Conduct
5. Overview of Hypothesis Testing 5. NIH Peer Review Process
6. Secondary Data/Meta Analysis S.No Module lV, Preparing and Funding
a Clinical Research Study
7. Sample Size and Power
8. Conceptual Approach to Survival Analysis 1. Quality Control in Clinical Trials
9. Study Development 2. Clinical Research from the Patient's Perspective
10. Designing and Testing Questionnaires 3. Design of Case Report Forms
11. Efficient Clinical Trials 4. ProtoType and Protocol Mechanics
12. Research with Vulnerable Participants 5. Technology Transfer
13. Ethical Principles in Clinical Research 6. Inclusion of Women and Minorities in
Clinical Trials


Module II, Ethical Issues and
Regulation of Human Subjects Research

7. Evaluation of Alternative and Complementary
8. Health Disparities Research
1. Legal Issues in Clinical Research 9. Community-Based Participatory Research
2. Concepts in the Management of Projects    
3. Evaluation of a Protocol Budget    
4. Human Genome Project and Clinical Research    
5. Data and Safety Monitoring Boards    
6. The Clinical Researcher and the Media    
7. Product Development: Moving from the Bench
to the Clinic
8. FDA Product Regulation