Clinical Trial Planning: Design, Protocol Development, Data Management and Clinical Site Activities
16 Contact Hours - 4 Days
The aim of this training is to explore all aspects of clinical trials including study design, set up and on-going management, the roles and responsibilities of Principal or Chief Investigator, processes and procedures inherent to planning clinical trials, protocol development, case report form design, IRB submission, site selection, developing and negotiating site contracts and budgets, pre-study visits, statistics in clinical trials, data management and capture, and electronic records.

At the end of the training, participants will:
  • Be introduced to terminology used in clinical trials and the several common designs used for clinical trials, such as parallel and cross-over designs
  • Understand the different types and stages of a clinical trial
  • Describe the main features of a study protocol
  • Appreciate the importance of randomization, allocation concealment, and blinding
  • Recognize the importance of ethical issues involved in conducting a clinical trial
  • Understand the different data management methods used in clinical trials
  • Understand the types of adverse events in clinical trials and methods of monitoring them
  • Discuss methods of measuring/monitoring adherence
  • Understand the process of analyzing, reporting and interpreting results of a clinical trial