Clinical Research Administration - Assignment Example

Root Cause Analysis Worksheet (starting point Use this template or prepare your own with pen and paper. YOU SHOULD ADD OR DELETE LAYERS AS APPROPRIATE BASED ON YOUR ANALYSIS Action Plan Template Purpose: To create a “script” for your improvement effort and support implementation. Directions: 1. Using this form as a template develop a work plan for each goal identified through the needs assessment process. (Modify the form as needed to fit your unique context.) 2. Distribute copies of each work plan to the members of the collaboration. 3. Keep copies handy to bring to meetings to review and update regularly. You may decide to develop new work plans for new phases of your reform effort. Goal: To increase patient enrollment per site to 5 patients per month (from May through July) after modifying the informed consent form to 8th grade reading level Results/Accomplishments: Action Steps What Will Be Done? Responsibilities Who Will Do It? Timeline By When? (Day/Month) Resources A. Resources Available B. Resources Needed (financial, human, political & other) Potential Barriers A. What individuals or organizations might resist? B. How? Communications Plan Who is involved? What methods? How often? Step 1: Modify the informed consent form to make it more patient friendly Local IRB site directors and the central IRB site directors By April 31, 2015 A. Computers, printers and required software B. Printing material, human support A. Healthcare oversight organizations B. Adjusting the inclusion and exclusion criteria could open avenue for patients who do not meet project requirement Local and central IRB site directors and overall project manager. Site meetings, emails, calls during the whole period Step 2: Providing additional patient education materials Local IRB site staff and central IRB site staff May through to July A. Human personnel resources, printers, computers, research materials B. Printing materials, human personnel to provide awareness A. None B. None Local and central IRB site directors, awareness campaign personnel Site meetings, emails, calls Mondays and Fridays during the period Evidence Of Success: Increase in enrollment for the for the period from May through July. The benchmark will be at least 3 patient enrollment per month Evaluation Process: We will determine that the goal has been reached when the target enrollment is achieved. This will be measured by assessing daily and weekly recruitment rate with the progress evaluated monthly. Read More