DMP should be developed for each study and early during the setup of the study A data management plan or DMP is a document detailing all procedures, tasks, milestones, and deliverables throughout the CDM lifecycle. It gives a roadmap on how to work with information and handle possible risks. Another important function is to clearly communicate what happens in the course of the trial to each stakeholder. INTRODUCTION 1.1 Purpose of the Data Management Plan (DMP) 1.2 Scope 2. SOPs 3. Data management Tasks 4. CORE/Primary project team members 5.Communication 5.1 Meetings 5.2 Status Reports/Metrics 6. clinical database used for project 7. Training 8. Data entry 8.1 Audit Trail 9. CRF Completion Guidelines 10. Clinical Database Design and Testing 10.1 Clinical Database Specifications 10.2 Clinical Database Development 10.3 User Acceptance Testing(UAT) 11. edit checks...
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CLINICAL DATA MANAGEMENT Clinical data management ( CDM) is a set of practices that handle information generated during medical research. It aims to ensure data quality , integrity, and compliance with internal protocols and state regulations. Also, the CDM process helps keep key clinical trial stakeholders on the same page : 1. Sponsors — pharmaceutical companies, institutions, and other organizations that initiate, monitor, and finance the trial. 2. CROs (control research organizations) — an organization contracted by another company to take the lead in managing that company's trials and complex medical testing responsibilities . CRF design-Data manager Database design-Database designer Data capture-Data entry associate Data validation-medical coder Database lock-Quality control associate Protocol review:r eviewed done by the company team including data manager along with other team mem...