biomedical 3

Excelling in Clinical Trial Design and Management: From Concept to Completion

“From Concept to Completion: Mastering Clinical Trial Design and Management”

About Program:

Aim: This program aims to equip participants with the knowledge and skills required to design and manage successful clinical trials. Participants will gain an in-depth understanding of the clinical trial lifecycle, including protocol development, site selection, patient recruitment, data collection, monitoring, and regulatory compliance.

Program Objectives:

  • Understand the key components of clinical trial design, including study endpoints, randomization, blinding, and control groups.
  • Learn best practices for protocol development, including the selection of study population, intervention, and outcome measures.
  • Gain insights into site selection, patient recruitment, and retention strategies to ensure successful trial implementation.
  • Understand the principles of data collection, quality control, and regulatory compliance in clinical trials.
  • Learn the fundamentals of clinical trial monitoring, adverse event reporting, and ethical considerations in trial conduct.

What you will learn?

Week 1: Introduction to Clinical Trials

  • Overview of clinical trials and their significance in medical research
  • Understanding the different phases of clinical trials and their objectives

Week 2: Ethical Considerations and Regulatory Framework

  • Ethical guidelines and regulations governing clinical trials
  • Informed consent process and protection of human subjects

Week 3: Study Protocol Development

  • Elements and structure of a clinical trial protocol
  • Inclusion and exclusion criteria, endpoints, and study procedures

Week 4: Randomization and Blinding in Clinical Trials

  • Principles and methods of randomization
  • Importance of blinding and strategies for maintaining blinding integrity

Week 5: Patient Recruitment and Retention

  • Strategies for effective patient recruitment and retention
  • Addressing challenges and enhancing patient engagement in clinical trials

Week 6: Data Collection and Management

  • Data collection methods and tools in clinical trials
  • Ensuring data quality, accuracy, and completeness

Week 7: Adverse Event Reporting and Safety Monitoring

  • Understanding adverse event reporting requirements
  • Safety monitoring, data safety monitoring boards, and pharmacovigilance

Week 8: Statistical Analysis and Data Interpretation

  • Principles of statistical analysis in clinical trials
  • Interpreting and reporting study results

Week 9: Regulatory Submissions and Approvals

  • Preparation and submission of regulatory documents
  • Interaction with regulatory authorities and obtaining approvals

Week 10: Good Clinical Practice (GCP) Guidelines

  • Overview of GCP guidelines and their importance in clinical research
  • Compliance with GCP standards and quality assurance

Week 11: Trial Site Management and Monitoring

  • Site selection, initiation, and monitoring visits
  • Ensuring compliance, data accuracy, and protocol adherence at trial sites

Week 12: Trial Closure and Reporting

  • Steps involved in trial closure and database lock
  • Final study report preparation and dissemination of trial results

Fee Plan

INR 1999 /- OR USD 50

Get an e-Certificate of Participation!

unnamed 1

Intended For : Graduates, Post Graduates, Research Scholars, Academicians, Industry Professionals, Clinical Researchers, Clinical trial Coordinators, Project Managers, Data Managers, Biostatisticians

Career Supporting Skills

Clinical Trial Design and Management Randomization and Blinding Patient Recruitment and Retention Statistical Analysis and Interpretation Trial Site Management and Monitoring Data Collection and Quality Management

Program Outcomes

  • In-depth understanding of clinical trial design, implementation, and management.
  • Knowledge of ethical considerations, regulatory requirements, and good clinical practice guidelines.
  • Competence in developing study protocols, randomization, and blinding strategies.
  • Skills in patient recruitment, data collection, and adverse event reporting.
  • Proficiency in data analysis, interpretation, and reporting of clinical trial results