How to Research Therapeutic Interventions: Preparing the Protocol
Knowledge of methodological issues in clinical trial design.
Knowledge of methods and creation of protocols for clinical trials.
Knowledge of (internal) trial governance issues and how to address them.
Knowledge of statistical issues and how to address them.
Knowledge of and addressing ethical issues in clinical trials - an introduction to research ethics.
Knowledge of data management in clinical trials and how to implement a solution.
Knowledge of (external) clinical trial governance issues and how to address them.
Knowledge of and management of key stakeholders in clinical trial delivery - data managers; trial coordinators; research nurses; and ethics committees.