Diploma in Clinical Research Syllabus

  • Years 1 Years
  • Type Course Post Graduate
  • stream Medical
  • Delivery Mode
Written By universitykart team | Last updated date Jun, 07, 2023
Explore the comprehensive syllabus of the Diploma in Clinical Research program, covering research methodologies, ethics, and clinical trial management.

Syllabus & Subjects of Post Graduate Diploma in Clinical Research  

The Diploma in Clinical Research program offers a comprehensive education in the principles and practices of clinical research. Students embark on a journey through various crucial subjects that form the bedrock of this field. The program commences with an overview, covering historical context, ethical considerations, and regulatory frameworks. A focus on medical terminology follows, essential for clear communication in clinical research settings. Biostatistics and Research Methodology take center stage, encompassing fundamental statistical concepts, data collection methods, and study design principles. This equips students with the ability to analyze and interpret clinical data, a critical skill in the realm of clinical research. Ethics and Regulatory Affairs form another vital module, delving into ethical guidelines, regulatory compliance, and legal aspects of clinical trials. This knowledge ensures the safety and well-being of study participants and upholds the integrity of research endeavors. Clinical Trial Management addresses practical aspects like protocol development, site selection, participant recruitment, and adverse event reporting. It empowers students to proficiently manage diverse aspects of clinical studies. Furthermore, Pharmacovigilance and Drug Safety are explored, emphasizing the detection, assessment, and prevention of adverse effects linked to pharmaceutical products. This module underscores the significance of post-market surveillance in safeguarding drug safety.

Syllabus of Post Graduate Diploma in Clinical Research

S.NoSubjects
1Introduction to Clinical Research Industry and Basics of Clinical Trials
2Pharmacology-Concepts and Application in clinical trials
3Drug Development Process
4Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP)
5Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies
6Outsourcing Clinical Trials, functioning of Clinical Research Organisation
7Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))
8Biostatistics- Concepts and Application in Drug Development and Clinical Research
9Clinical Trials- Phases and Trial Designs
10Documentation and Data Management in Clinical Trials
11Safety Reporting Techniques and Pharmacovigilance
12Quality Control and Clinical Trial Management
13Clinical Trials- Medical Devices
14Protocol Writing and Designing
15Clinical Trials -Latest updates: New Drugs and Clinical Trials Rules, 2019
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