CLINICAL
RESEARCH www.bcri.in
Bangalore Clinical
Research Institute
Post Graduate Diploma in clinical Research with SAS
Course Outline
Industry Standard EDC Tools Practical Case Studies & Real-World Scenarios
Hands-on Training LMS Based Learning
Corporate Trainers & Industry Experts Placement Assistance & Career Support
CONTACT US:
FOR MORE INFORMATION +91 94038 90582
#19/19, 2nd Floor, 24th Main Rd, HSR Layout, Sector 1,
Bangalore - 560102. [email protected]
Overview of Clinical Research
Overview of Clinical Research
Clinical Trial Phases
Phase 0 Study and Phase 5 Clinical Trials
1. Exploratory Studies
2. Safety Studies
3. Efficacy and Safety studies
4. Large Scale Trials
5. Post Marketing Studies
Clinical Study vs. Clinical Trials
Conduction of Clinical Studies and Observational Studies
Treatment Trials
Prevention Trials
Diagnostic Trials
Screening Trials
Quality of Life Trials
Fundamentals of Clinical Research & Drug Evaluation
Participants in Clinical Research
Protection and Ethical Considerations for Participation
Active Control Studies
Percentage of Drugs
Do Many Drugs Fail in Clinical Trials
Clinical Research vs. Usual Healthcare
Site and Duration for Clinical Studies
Clinical Research vs. Medical Care
Phases of FDA Approval
Reasons for Conducting Clinical Studies
Microdosing in Clinical Research
Dose Ranging Studies
Single Ascending Dose (SAD)
Multiple Ascending Dose (MAD)
Trial Design: Efficacy vs Effectiveness
Investigational New Drug (IND) & New Drug Application(NDA)
Clinical Data Management
Process flow Study Set-up
Data Management Plan Approved Study Protocol
Study Setup & Database Design Project Management Plan (PMP)
Tracking & Managing Clinical Trial Data Electronic Case Report Form (eCRF)
Data Collection & Management Specifications
Identifying and Managing Discrepancies Visit Form Matrix
Clinical Trial Systems & Technology Database (DB) Design & Development
Choosing Vendor Products Data Validation Specifications (DVS)
Implementing New Systems User Acceptance Testing (UAT)
System Validation & Quality Assurance IxRS (Interactive Response Technology)
Test Plans Integration
Data Migration & Legacy Systems Management Final Sign-Off & Go-Live
Data Management Plan (DMP)
Creating standards
Creating Hierarchies Data Entry in RDC and Discrepancy
SOPs and Guidelines Management in RDC
Working with CROS Auto Coder Algorithms
CRF Design Consideration
Remote Data Entry
Clinical Trail Management
Basic Statistics for Clinical Trials
Clinical Trials in Practice
Reporting and Reviewing Clinical Trials
Protocol Development
Data Entry in RDC and Discrepancy
Management in RDC
Auto coder Algorithms
Trial Designs
Project Management
Regulatory Affairs, GCP and Ethical Guidelines
Data Management
Data monitoring and Interim analyses
Data Reconciliation
DCMs and DCIs
Study Conduct
Data Creation & Collection Modules
CRF Tracking, Design & Data Entry
System Validation
Data Validation & Quality Checks
Testing & Data Base Readiness
User Acceptance Testing (UAT)
Managing Lab Data
Identifying and Managing Discrepancies
Collecting AE Data
SAE Reconciliation
Clinical Data: As per SOPs, Protocol, and Study
Specific Guidelines
Medical Coding
IxRS Reconciliation
Study Conduct Cont.
1. Data Review & Quality Control (QC)
2. Medical Coding & Safety Review
3. Query Resolution & Database Review and Validation
4. Database Lock & Documentation (QC and QA)
5. Data Submission & Archival
Pharmacovigilance
Module 1: Introduction to Drug Discovery and Development
Discovery and Development Phases
Preclinical Research
Clinical Research
Drug Review and Post-Market Surveillance
Module 2: Introduction to Pharmacovigilance
Pharmacovigilance (WHO Definition)
History of Pharmacovigilance
Scope and Purposes of Pharmacovigilance
Basic Concepts: Terms and Definitions
Introduction to essential pharmacovigilance terminology (e.g., AE, ADR, ICSR, PSUR, etc.)
General Overview of Pharmacovigilance and Types of Adverse Event Reporting
Types of Adverse Events (AEs) and the importance of their timely reporting.
Module 3: Types and Sources of Data
Sources of Adverse Event Data
Types of Adverse Events
A comprehensive breakdown of various AE types (e.g., mild,
moderate, severe, serious)
Signal Detection Process
Module 4: Drug Safety Monitoring
Post-Market Surveillance
Drug Recall Process
Module 5: Regulatory Aspects of Pharmacovigilance
WHO-UMC (Uppsala Monitoring Centre)
The role of WHO-UMC in global pharmacovigilance efforts and safety data
management
CIOMS and ICH-GCP Guidelines
European Pharmacovigilance System
Regulatory Authorities
Key regulatory bodies (e.g., FDA, EMA, WHO) and their role in pharmacovigilance
Reporting Criteria and Timelines
Module 6: Pharmacovigilance Data Management
Case Receipt, Verification, and Validity Checks
How adverse event reports are received, verified, and checked for validity
Duplicate Search and Registration
The process of ensuring that cases are unique and properly registered.
Data Entry and Case Linking
Module 7: Coding and Causality Assessment
Coding of Adverse Events and Drugs
Introduction to drug and ADR dictionaries used in pharmacovigilance (e.g.,
MedDRA, WHO-Drug Dictionary, COSTART)
Causality Assessment
Explanation of why causality assessment is important and the systems used (e.g.,
WHO-UMC system)
Expectedness Assessment
Seriousness Criteria and SAE Reporting
Module 8: Special Case Scenarios
Special Case Scenarios
Loss of Efficacy (LOE)
Off-label use
Misuse and overdose
Pregnancy-related cases
Medication errors
Practicing Real-Time Case Scenarios
Module 9: Case Narrative Writing
Overview and Characteristics of Case Narratives
Sections of Case Narrative
Steps in Narrative Construction
Module 10 Aggregate Reporting
Definition and importance of aggregate reports
Aggregate reporting in ensuring drug safety
Types of Aggregate Reports
Periodic Safety Update Report (PSUR)
Development Safety Update Report (DSUR)
PBRER (Periodic Benefit-Risk Evaluation Report)
PADERS (Post-Authorization Drug Evaluation Reports)
Data Sources for Aggregate Reports
Data extraction from clinical trials and post-market surveillance
Adverse event data, risk assessments, and safety signals
Reporting Workflow
How to collect, compile, and analyze data for aggregate reports
Importance of thorough data validation
Identifying trends, patterns, and safety signals
Causality and Expectedness Assessments
Evaluating the relationship between adverse events and the drug
Expectedness assessment for aggregate reporting
Challenges in Aggregate Reporting
Handling incomplete or missing data
Addressing complex cases (e.g., serious AEs, off-label use)
Dealing with multiple data sources and formats
Module 11: Reporting and Submission
Reporting or Submission of Cases
PSUR, DSUR, PBRER, and PADERS Overview
Data Validation and Quality Checks
Additional Resources and Practice
PV Databases and Reporting Formats
Introduction to pharmacovigilance databases like CLINEVO, and the reporting
formats used globally (e.g., E2E)
ADR Classification
Adverse drug reactions are classified according to severity, frequency, and other
characteristics
Regulatory Affairs
1. Introduction to Global Regulatory Authorities for Pharma and Healthcare
Key Global Regulatory Bodies:
WHO: Global health standards and guidelines
FDA (U.S.): Drug and medical device regulation in the U.S
EMA (European Medicines Agency): Drug evaluation and safety in Europe
PMDA (Japan): Regulatory authority for pharma in Japan
TGA (Australia): Regulatory body for healthcare products in Australia
DCGI (India): Drugs Controller General of India overseeing drug regulation in India
2. Regulatory Affairs in Clinical Research
3. Key Global Regulatory Organizations
WHO – UMC (Uppsala Monitoring Centre)
CIOMS
International Council for Harmonisation (ICH)
4. Drug Development Process & Clinical Trials
Phases of Drug Development:
Preclinical Research: Laboratory and animal testing
Clinical Trials: Phases I-IV (human trials) and regulatory compliance
Regulatory Submissions: Preparing dossiers in CTD format for approval
Clinical Trial Norms and Regulations:
Ethical conduct, informed consent, and participant safety
Regulatory compliance during each clinical trial phase
5. Pharmacovigilance Regulations
European Pharmacovigilance System: Ensuring post-market drug safety in the EU
FDA and EMA Reporting Guidelines: Standards for safety reporting and risk management
6. Good Clinical Practice (GCP)
FDA GCP: Ethical and scientific standards for clinical trials in the U.S
ICH GCP Guidelines: Global standards ensuring safety, quality, and integrity in clinical trials
Main GCP Principles
GCP Compliance: Adhering to GCP principles throughout clinical trials
7. Good Manufacturing Practice (GMP) & Other Practices)
GMP: Ensuring quality control and consistent production of pharmaceutical products
GLP (Good Laboratory Practice): Standards for laboratory-based research and testing
GCP (Good Clinical Practice): Guidelines for ethical and scientific integrity in clinical research
Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
Quality Assurance (QA) and Drug Regulations
Data Monitoring Committees (DMC)
European Forum for Good Clinical Practice (EFGCP)
European Medicines Agency (EMA)
Dossier Preparation and Regulatory Submissions
Intellectual Property Rights (IPR) in Healthcare
Pharma & Healthcare Products: Marketing, Import, and Export
Compliance Guidelines and Government Audits
Indian GMP Regulations
Statistical Analysis System (SAS)
Module 1: Introduction to SAS & Clinical Research
Overview of Clinical SAS and its role in Clinical Trials
Module 2: SAS Base Programming
Introduction to SAS Environment
Understanding SAS Interface & Workspace
SAS Program Structure: DATA Step & PROC Step
Creating & managing SAS libraries and datasets
Data Handling & Manipulation
Importing/exporting data (Excel, CSV, TXT, XML)
Creating & modifying datasets using SET, MERGE, UPDATE
Data Cleaning: Handling missing values, duplicates, data validation
Sorting, filtering, and subsetting data
SAS Functions & Conditional Processing
Numeric functions: SUM, MEAN, ROUND, INT
Character functions: SCAN, SUBSTR, INDEX, COMPRESS
Date functions: TODAY, INTNX, INTCK
IF-THEN-ELSE and WHERE conditions
Essential SAS Procedures
Descriptive statistics using PROC MEANS, PROC FREQ, PROC UNIVARIATE
Data exploration using PROC CONTENTS, PROC PRINT, PROC SORT
Transposing & formatting data using PROC TRANSPOSE, PROC FORMAT
Module 3: Advanced SAS Programming
Data Merging & Combining Datasets
Different types of joins: INNER, LEFT, RIGHT, FULL
Merging datasets using SET, MERGE, and UPDATE
Working with BY-GROUP processing
Advanced PROC Procedures
PROC SQL: Joins, Subqueries, Creating Tables & Views
PROC REPORT: Customizing summary tables & Clinical reports
PROC TABULATE: Generating complex summary statistics
SAS Macros & Automation
Introduction to SAS Macros
Macro variables: %LET, %PUT, %GLOBAL, %LOCAL
Writing Macro Programs using %MACRO, %MEND
Using %DO, %IF, %STR for conditional execution
Automating reports & datasets using macros
Error Handling & Debugging
Understanding SAS Log
Identifying and fixing common errors & warnings
Using PUTLOG statement for debugging
Module 4: Clinical Data Analysis & Reporting
Clinical Trial Data Handling
Overview of CDISC SDTM & ADaM standards
Mapping raw clinical data to SDTM domains
Creating subject profiles, adverse event reports, and lab data summaries
Statistical Analysis in Clinical SAS
PROC TTEST, PROC ANOVA, PROC GLM (Comparing treatment effects)
PROC REG & PROC LOGISTIC (Regression modeling)
Kaplan-Meier survival analysis using PROC LIFETEST
Creating Clinical Reports
Generating Tables, Listings, and Figures (TLFs)
Using ODS (Output Delivery System) for reporting
Formatting reports for regulatory submissions (FDA, EMA)
Module 5: CDISC Standards
SDTM (Study Data Tabulation Model)
Understanding SDTM domains
Mapping raw datasets to SDTM format
Generating Define.xml for FDA submission
ADaM (Analysis Data Model)
Creating ADaM datasets for statistical analysis
Generating efficacy and safety analysis reports
Using ADaM datasets for regulatory submissions
Internship Program
Why Choose This Internship?
Hands-on Training in Clinical Trial Operations and EDC Tools
Exposure to Regulatory & Ethical Guidelines (ICH-GCP, FDA, EMA, DCGI)
Experience in Site Management & Patient Recruitment
Learn Clinical Trial Documentation (CRF, ISF, TMF)
Guidance from Industry Experts & Mentorship
CONTACT US:
FOR MORE INFORMATION +91 94038 90582
#19/19, 2nd Floor, 24th Main Rd, HSR Layout, Sector 1,
Bangalore - 560102. [email protected]
