Course

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

“Driving Innovation in Clinical Trials: Seamless Design and Management from Concept to Success”

About Course:

Aim: This course 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.

Course 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

Intended For : Graduates, Post Graduates, Research Scholars, Academicians, Clinical Research Professionals, Medical and Scientific Professionals: Physicians, medical researchers, and Scientists

Career Supporting Skills

A

Course 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