Case Study
The overall goal of this assignment is to familiarize students with the main categories commonly found in a Data Management Plan (DMP). Students will review a sponsor’s data management plan and then create a 5 – 6 page DMP for the study site (Good Clinical Trials). The DMP will be based on A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Clinical Study to Compare the Efficacy and Safety of XYZ Versus Corticosteroid for the Treatment of Lateral Epocondylitis. For this assignment, all data capture is electronic.
Please do not “cut and paste” from the SWP Data Plan example into the template; use your own words. You will be penalized if you “cut and paste” from someone else’s work.
Attached to the end of this assignment are:
Data management plan overview for your review
Sponsor’s DMP
A Template for the Site DMP
Use the following format and sections in your site DMP:
DMP Title
Protocol Title
Overview (1 – 2 paragraphs) (15 points)
Data Management Staff Roles and Responsibilities (Table Format) (15 points)
Site Policies: related to SOPs and staff training (15 points)
Data Access: access by staff role, security and safety measures; assigning and using passwords, etc.; entry and exit of data management systems (15 points)
Data Entry & Cleaning: prerequisites for data entry (required training & access), granting access, entering data, data security, quality control functions & procedures, and query generation. (15 points)
Monitoring Visits: preparing for monitor visits, protecting data, managing queries, responding to issues. (10 points)
Database closure checks, quality assurance at closure and database lock, and database unlock. (10 points)
Data Archiving, Record Storage, Retention, and Transfer of final Materials: how and where records will be stored, access to records; length of retention, and how they will be destroyed (10 points)
Adverse & Serious Adverse Events: management of, reconciliation, process and who is responsible for what task related to documenting and reporting (15 points)
