As we all know, meeting recruitment goals is paramount to ensuring long term success of a clinical trial site. As the manager of a clinical trial site, one of your responsibilities is to evaluate trials that are a good fit for your clinical trial site, and to identify resources that could assist you in enrollment and retention of study subjects. For this assignment you will be required to develop a recruitment plan and a retention plan using the clinical trial you identified in Class 3/Exercise 1. For the recruitment plan: include timelines: how many subjects you expect to enroll and the rate of enrollment on a monthly basis in a recruitment graph. Be realistic based on the patient population, protocol and disease that is being studied. Identify 3 methods of recruitment that may be successful with the type of subjects you are recruiting and specify why these methods should be successful. One of the methods must include an ad campaign for which you will develop the materials (can be used in TV, radio, social media, or print/newspaper). Be creative, but ensure it meets the guidelines for acceptable advertisement in clinical trials. (https://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm). For the retention plan: identify 2 methods that can be used to ensure the recruited subjects remain in the trial. This does not include those who meet exit criteria as described in the protocol, encounter a SAE, or who is withdrawn for any other protocol-designated reason, e.g., disease progression. The format for this assignment does not have to be traditional paper style. However it must include exhibits to the required information, perhaps a grid is useful or presentation format. Please make sure the content is there. Please use the rubric to ensure all components are met.
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