organization and monitoring of clinical trials | Homework Help

You are a project manager at Super CRO and have recently been awarded a Phase III North American registration trial by the Perfect Sponsor. The purpose of the trial is to evaluate the safety and efficacy of Wonder Drug vs. placebo in patients 18 yrs– 75 yrs of age with mild to moderate asthma. The study will involve 20 sites in Canada and 20 sites in the USA. Your job is to prepare a plan which identifies the key activities (with responsible persons assigned) that will need to take place prior to the first patient receiving study drug. To do this you are being asked to develop a comprehensive task list for the following phases of the start-up period: 1) Site Selection 2) Investigator meeting 3) Master File set-up and Regulatory Document Collection 4) Protocol Development 5) Case Report Form Development 6) Study Drug Management Be sure to specify which team members will be responsible for what tasks. In aIDition to your task list you are asked to create the following templates: 7) Regulatory document checklist (include relevant regulatory documents required for drug release) Site feasibility assessment 9) Agenda for Investigator Meeting A maximum of 12 pages including title page and references will be accepted. Notes on assignments: Must be academic in style and content Must put forward a specific idea or argument Must have a clear focus Must present the ideas in a logical and well thought-out flow Arguments, analysis and conclusions must be based on clearly identified research and sources Must cite all references from other sources Must be paragraph format Must be double-spaced, and typewritten Must follow APA style