Organizing a clinical trial for the new investigator

Background and purpose: Clinical trials organization can be daunting especially when orienting to a new system. The steps to a successful clinical trial are not concrete and vary based on the system. Methods: In this section the discussion centers on how to shape the question for the clinical trial which is rational and feasible to answer within the planned study design. Findings: Senior mentorship, collaboration and early involvement of stakeholders can help shape a successful clinical trial. Keeping in mind ethics and the processes within a system will make planning easier. Questions about key elements of the trial should be answered early to prevent delays of study initiation. Conclusion: Clinical trial development and implementation can be very rewarding, but successful outcomes require careful planning and considerations.