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Protocol design and Capturing of Protocol Content (CDISC-PRM)
CRF Design (CDISC-CDASH) Data Management Plan (DMP) Data Validation Plan (DVP)
User Acceptance Tests (UAT)
Edit Checks design and validation
System Validation Plan (SVP)
Annotated Case Report Form (aCRF)
Annotated Case Report Tabulations (aCRT)
Data Tabulation (CDISC-SDTM)
CRF Completion Guidelines (CCG)
Importing and Validation of external data
Data Entry (pCRF): single/double data entry
Data Cleaning
Data Dictionaries: MedDRA, WHO-DRUG
Safety Reconciliation
Database closure


Study design
Protocol development
Sample size and Power calculation
Statistical analysis plan (SAP)
Subject randomization
Data analysis and reports generation
Data conversion from legacy datasets to CDISC-SDTM compliant datasets
Exploratory and Descriptive analysis
Risk factors
Safety and Efficacy analysis of study data
Pharmacokinetic and pharmacodynamic data analysis and modeling
Clinical Statistical Report (CSR): Reporting based on ICH E3: Guideline for Structure and Content of Clinical Study Reports


Developing Clinical Trial Designs
Overall Approach to a Clinical Trial
Formulating an Approach to Developing a Protocol
Bias and Confounding Factors
Classification and Description of Clinical Trials / Postmarketing Study Designs
Randomization Procedures
Study Epochs
Patient Populations
Defining Inclusion Criteria
Identifying Efficacy Parameters and Safety Parameters
Time and Events Schedules
Collecting Safety Information
Informed Consent
Ethical Considerations

Fundamentals of Statistics and Data Processing
Developing and Overall Approach to Statistical Analysis
Statistical Issues
CRF Design and Validation
User Assessment Tests
Edit Checks: design and validation
Data cleaning
Management and reconciliation of Safety Data
Database closure
Collecting Data: CDISC-CDASH
Electronic Case Report Form
Data Tabulation: CDISC-SDTM

Evidence-Based Medicine (EBM)
Evidence-Based Medicine: guidelines and policies
Evidence: Identifying and Choosing
Assessing the quality of evidence
Measurements, Frequencies, Risk, Validation
Diagnostic tests: performance evaluation
Interventional designs
Secondary and integrative studies
Application in clinical settings
EBM: Limitations