Clinical Data Management

This course equips participants with the essential technical skills, regulatory knowledge, and hands-on expertise required to ensure high-quality, compliant, and reliable clinical trial data. Participants will gain practical exposure to database setup, data validation, query resolution, SAE reconciliation, medical coding, and database lock procedures—all critical components of clinical data management.

Key Learning Modules: Module

1: Introduction to Clinical Research & Data Management

✔ Fundamentals of Clinical Research & Clinical Data Management (CDM)

✔ Roles & Responsibilities of key stakeholders in data management

✔ Standard Operating Procedures (SOPs) in clinical data handling

✔ Overview of study setup, conduct, and close-out phases Module

2: Study Setup Phase

✔ Study Design & Database Development

✔ Protocol Orientation & Creation of Study Setup Documents

✔ Development of Data Management Plan (DMP) & Data Handling Plan (DHP)

✔ Case Report Form (CRF) Design & Annotation

✔ Data Validation Plan (DVP) & Edit Check Specifications

✔ Database Design & User Acceptance Testing (UAT)

✔ Third-Party Data Specifications & Testing (Lab, ECG, Imaging, etc.)

✔ Medical Coding Specifications & Testing

✔ SAE Reconciliation Specifications & Self-Evident Corrections (SEC)

✔ Development of Custom Reports & Data Export Specifications Module

3: Study Conduct Phase

✔ Tracking CRF Data & Query Resolution

✔ Data Entry & Remote Data Capture (EDC Systems)

✔ Medical Coding (MedDRA, WHO-DD) & Lab Data Management

✔ Serious Adverse Event (SAE) Reconciliation

✔ Managing Post-Production Changes (PPC)

✔ Handling Self Evident Corrections (SEC)

✔ Generating & Analyzing Reports Module

4: Study Close-Out Phase

✔ Database Listings & Quality Control (QC) Review

✔ Ensuring Data Completeness & Final QC

✔ Database Lock Process & Compliance Checklist

✔ Archival of Study Data & Data Transfer Procedures Module

5: Case Studies & Hands-on Practice

✔ Real-world CDM case studies for practical understanding

✔ Hands-on training in data review, query handling, and database setup Who Should Attend?

✅ Clinical Research & Data Management Professionals

✅ Life Sciences, Pharmacy, and Healthcare Graduates

✅ Biostatisticians & Medical Coders

✅ Regulatory & Quality Assurance Professionals

✅ Aspiring CDM Professionals Looking for Career Advancement