Assignment -

Scenario: Setup a Mock Phase 3 Clinical Trial for evaluating the efficacy of a Blood Pressure/Weight Loss/ or Muscle Strength Enhancement supplement. Assume that the testing takes place at a physician's office with a nurse taking down the details. Bonus marks of 5 points will be given for students coming up with a Sample Size calculation as to the number of patients/subjects required for a specific effect size.

Part 1: Design a Case Report Form for the above scenario to include demographic and pertinent clinical information. Do include at least two types of data: from physical measurements and from a survey questionnaire. You can use Microsoft Excel or MS Word or any Form Designer software (such as Adobe Acrobat) and submit the document.

Part 2: Design a simple Protocol Document (no more than 5 pages) with a PI and Co-PI and a data management plan based on an existing clinical trial protocol but do cite the source. Submit the Protocol as a MS Word Document. Include a SOP for at least one type of data measurement from the patient/subject.

Part 3: Design and implement a relational database using Microsoft Access or MySQL. Submit the Relationship Diagram and the images of the forms used to capture data from the Case Report Forms in part 1. If you are using Microsoft Access you can also submit the .mdb or .mdbx file instead of the relationship diagram and images.

Part 4: Delineate the project details for the Scenario listed above with the stakeholders, task plan using a WBS and a Gantt Chart for the time duration indicated for the entire project up to submission to the Statistical Analysis Group. You can use and submit a MS Excel Worksheet for both the WBS and the Gantt Chart you have compiled.

Part 5: List the GCP guidelines applicable to the clinical trial you have designed and submit it as a MS Word document.

Part 6: Using the checklist provided in the CONSORT Website: select and compose at least three elements (from the checklist) of relevance to your trial and with some mock results (if needed). Submit the document as a MS Word file.