Overview of Clinical Data ManagementUnderstanding Clinical Data in Healthcare Types of Clinical Data (e.g., patient records, trial data)
Methods for Data Collection (EHRs, Clinical Trials) Electronic Data Capture (EDC) Systems Data Entry Best Practices
Ensuring Data Accuracy and Integrity Data Validation Techniques Handling Data Discrepancies and Errors
Data Collection and Entry
Data Quality Management
Introduction to Clinical TrialsOverview of Clinical Trial Processes Types of Clinical Trials and Their Phases
Creating and Managing Clinical Study Protocols Defining Objectives, Methodologies, and Endpoints
Selecting Clinical Trial Sites Subject Recruitment and Retention Strategies Managing Informed Consent Processes
Monitoring Trial Progress and Compliance Generating Reports on Trial Data Handling Adverse Events and Safety Reporting
Study Design and Protocol Development
Site and Subject Management
Monitoring and Reporting
Overview of Data AnalyticsImportance of Data Analytics in Clinical Research Types of Analytics (Descriptive, Predictive, Prescriptive)
Utilizing SAP Analytics Cloud for Visualization Creating Dashboards and Reports for Clinical Data
Introduction to Statistical Methods Used in Clinical Trials Utilizing Statistical Software for Data Analysis
Data Visualization Techniques
Statistical Analysis
Understanding Regulatory RequirementsOverview of Regulatory Bodies (FDA, EMA, etc.) Importance of Compliance in Clinical Research
Handling Patient Data with Compliance to HIPAA and GDPR Data Security Best Practices
Understanding GCP Guidelines Implementing GCP in Clinical Trials
Data Privacy and Security
Good Clinical Practice (GCP)
System ConfigurationConfiguring SAP Clinical Applications Integration with Other SAP and Non-SAP Systems
Managing Change during Implementation Training Staff and Stakeholders on SAP Clinical Solutions
Monitoring System Performance Continuous Improvement Strategies
Change Management
Post-Implementation Support
