Course Details
Clinical Research – Curriculum Overview
Program Details
- Program Name: Clinical Research Foundation Program (EU‑Focused)
- Duration: 12 Weeks
- Training Hours: 3 Hours/Day (15 Hours/Week)
- Mode of Training: Online – Live Instructor‑Led
- Schedule: Monday to Friday
- Trainers: Clinevia Faculty + Senior Industry Experts (CRA, Study Start‑Up Specialist, Clinical Operations Lead)
- Eligibility: Students & Professionals from Life Sciences, Pharmacy, Biotechnology, Nursing & Allied Health
- Certificate: Clinevia Clinical Research Foundation Certificate (EU‑Aligned)
Clinical Research Foundation Program (EU‑Focused)
The Clinical Research Foundation Program provides a strong, EU‑aligned foundation in
Clinical Operations, preparing learners for roles within CROs, pharmaceutical companies,
hospitals, and academic research centers. The curriculum follows
ICH‑GCP, EU CTR 536/2014, GDPR, and EMA guidelines.
Program Overview
This program focuses on the core operational functions of clinical trials — from study planning and
regulatory submissions to monitoring, documentation, and quality management. It is ideal for individuals
aiming to begin their career in Clinical Operations.
- Clinical Trial Assistant (CTA)
- Clinical Research Coordinator (CRC)
- Study Start‑Up Associate
- Clinical Operations Assistant
- Regulatory & Ethics Submission Assistant
- Clinical Documentation Specialist
- Site Management Support Associate
Curriculum Modules
- Introduction to Drug Development & Clinical Research
- Drug discovery to clinical development
- EMA, Ethics Committees & Competent Authorities
- Overview of Clinical Operations roles
- Fundamentals of Clinical Trials
- Phases I–IV
- Study designs & methodologies
- Low‑intervention trials under EU CTR
- EU Regulations & International Guidelines
- EU Clinical Trials Regulation (EU CTR 536/2014)
- CTIS overview
- ICH GCP E6(R2)/E6(R3), ICH E8(R1)
- Declaration of Helsinki
- GDPR & Data Protection in Clinical Research
- GDPR principles & legal basis
- Pseudonymisation vs anonymisation
- Data subject rights & confidentiality
- Roles & Responsibilities of Key Stakeholders
- Sponsor, CRO, Investigator, Site Staff
- Qualified Person (QP)
- Delegation & oversight under EU CTR
- Preparation & Planning of Clinical Trials
- Protocol development
- Feasibility assessment
- Risk assessment & Quality by Design
- Essential Documents & EU Regulatory Submissions
- Investigator’s Brochure (IB)
- Investigational Medicinal Product Dossier (IMPD)
- Informed Consent Form (EU requirements)
- CTR submission package (Part I & II)
- Substantial modifications
- Study Start‑Up & CTIS Workflows
- Country & site selection
- Ethics Committee coordination
- CTIS submission & transparency
- Clinical Monitoring Essentials
- On‑site, remote & central monitoring
- Risk‑based monitoring (RBM)
- SDV, SDR
- PSV, SIV, MV, COV
- Site Management & Investigator Support
- Site qualification & initiation
- Essential document collection
- Site communication & performance tracking
- Clinical Trial Documentation & TMF Management
- TMF structure & essential documents
- eTMF systems & audit readiness
- Version control & filing standards
- Quality Management, Audits & Archiving
- Risk‑based quality management
- CAPA & inspection readiness
- Archiving & record retention
- Lay summaries & transparency
Certification
Upon successful completion, participants receive a
Clinevia Clinical Research Foundation Certificate, aligned with EU regulatory expectations
and industry standards.
Clinical Data Management – Curriculum Overview
Program Details
- Program Name: Clinical Data Management (CDM) – EU‑Focused
- Duration: 10–12 Weeks
- Training Hours: 3 Hours/Day (15 Hours/Week)
- Mode of Training: Online – Live Instructor‑Led
- Schedule: Monday to Friday
- Trainers: Senior CDM Professionals, EDC Specialists, Clinical Data Leads
- Eligibility: Life Sciences, Pharmacy, Biotechnology, Nursing, Allied Health
- Certificate: Clinevia Clinical Data Management Certificate (EU‑Aligned)
Program Overview
This program provides complete training in the end‑to‑end management of clinical trial data, aligned with
ICH‑GCP, ICH E6(R3), EU CTR 536/2014,
GDPR, and CDISC (CDASH & SDTM) standards.
It prepares learners for CDM roles in CROs, pharmaceutical companies, and biometrics teams.
Typical entry‑level roles include:
- Clinical Data Management Associate
- Data Coordinator / Data Entry Specialist
- EDC Support Associate
- Clinical Data Reviewer
- Query Management Specialist
- Medical Coding Assistant
- Data Quality & Integrity Assistant
Curriculum Modules
- Overview of Clinical Data Management
- Role of CDM in clinical trials
- Data flow in clinical research
- CDM lifecycle overview
- EU CTR expectations for data handling
- Clinical Data Integrity
- ALCOA & ALCOA‑C principles
- Data accuracy, completeness & consistency
- GDPR requirements for clinical data
- Audit trail expectations (EU)
- Data Management Plan (DMP)
- Purpose & structure of DMP
- Data handling workflows
- Roles & responsibilities in DMP execution
- EU‑specific documentation expectations
- Case Report Form (CRF) Design
- CRF principles & standards
- CRF annotation
- CDISC CDASH introduction
- EU regulatory expectations for CRF content
- CRF Tracking
- CRF lifecycle
- Tracking tools & logs
- Version control
- Electronic Data Capture (EDC)
- EDC system overview
- Form building basics
- User roles & permissions
- EU audit readiness in EDC systems
- Data Entry Guidelines
- Data entry standards
- Handling missing & inconsistent data
- GDPR compliance during data entry
- Edit Check Creation, Validation & Programming
- Types of edit checks
- Programming logic
- UAT (User Acceptance Testing)
- EU expectations for edit check documentation
- Discrepancy Management
- Query generation & resolution
- Query workflows
- Communication with sites
- Risk‑based query management (ICH E6 R3)
- Data Transfer in CDM
- External data sources (labs, vendors, imaging, ePRO)
- Data transfer agreements (EU requirements)
- Data import & reconciliation
- Safety data reconciliation with PV teams
- Medical Coding Dictionaries
- MedDRA overview
- WHO‑Drug coding basics
- Coding conventions & quality checks
- EU coding compliance
- Laboratory Tests in Clinical Trials
- Lab data structure
- Normal ranges & flags
- Lab data reconciliation
- Vendor lab data compliance
- Creating Reports
- Data listings
- Metrics & dashboards
- Data review reports
- EU‑required documentation standards
- Adverse Event Reporting & Reconciliation
- AE/SAE data flow
- Safety database vs EDC reconciliation
- Data consistency checks
- Alignment with EU GVP requirements
- Audit Trail
- Regulatory expectations (EU & ICH)
- Audit trail review
- Common findings
- Database Lock
- Soft lock vs hard lock
- Pre‑lock activities
- Final QC & sign‑off
- EU documentation requirements
- Quality Assurance in CDM
- Data quality checks
- Risk‑based data review (ICH E6 R3)
- Issue escalation
- QMS, Audit & Inspection, SOP Compliance
- Quality Management Systems
- Internal & external audits
- SOP adherence
- EU inspection readiness
- Hands‑On Software Training
- EDC navigation
- CRF review & query management
- Practical exercises & simulations
Certification
Upon successful completion, participants receive the
Clinevia Clinical Data Management Certificate, aligned with
ICH‑GCP, ICH E6(R3), EU CTR,
GDPR, and CDISC standards.
Pharmacovigilance – Curriculum Overview
Program Details
- Program Name: Pharmacovigilance (PV) – EU‑Focused
- Duration: 10–12 Weeks
- Training Hours: 3 Hours/Day (15 Hours/Week)
- Mode of Training: Online – Live Instructor‑Led
- Schedule: Monday to Friday
- Trainers: Senior PV Specialists, Drug Safety Physicians, Case Processing Experts
- Eligibility: Life Sciences, Pharmacy, Biotechnology, Nursing & Allied Health
- Certificate: Clinevia Pharmacovigilance Certificate (EU‑Aligned)
Program Overview
The Pharmacovigilance Program provides comprehensive training in drug safety, case processing,
regulatory reporting, signal detection, and risk management. The curriculum is fully aligned with
EU Good Pharmacovigilance Practices (GVP Modules I–XVI),
EU CTR 536/2014,
EMA EudraVigilance requirements,
ICH E2A/E2B(R3)/E2D/E2F guidelines, and
GDPR for safety data handling.
Typical entry‑level roles include:
- Drug Safety Associate
- Pharmacovigilance Case Processor
- Safety Data Reviewer
- ICSR Specialist
- Aggregate Reporting Assistant
- Signal Detection Analyst (Entry Level)
- Risk Management Support Associate
Curriculum Modules
- Overview of Clinical Research
- Basics of clinical trials
- Drug development lifecycle
- Where PV fits in clinical research
- EU CTR safety reporting expectations
- Pharmacology – General Principles
- Mechanism of action
- ADME concepts
- Drug–drug interactions
- Relevance to adverse reactions
- Introduction to Pharmacovigilance
- History & evolution of PV
- Definitions: AE, SAE, ADR, SUSAR
- EU vs US safety frameworks
- Role of EMA & National Competent Authorities
- Pharmacovigilance Regulations (EU‑Focused)
- EU GVP Modules I–XVI (detailed overview)
- EMA & EudraVigilance requirements
- ICH E2A, E2B(R3), E2D, E2F
- EU CTR 536/2014 safety reporting timelines
- GDPR considerations in PV data handling
- Hands‑On Training in Case Processing & Report Generation
- Case intake & triage
- Data entry in safety databases
- MedDRA coding (EU‑compliant)
- Narrative writing (EMA expectations)
- Follow‑up & case closure
- Safety Reporting & ICSR Processing
- ICSR workflow (E2B(R3) compliant)
- Seriousness & causality assessment
- SUSAR reporting timelines (EU CTR)
- Electronic reporting to EudraVigilance
- Aggregate Reports, Signal Detection & Risk Management
- PSUR / PBRER (EU format)
- Signal detection methods (GVP Module IX)
- Risk Management Plans (RMP) – EU requirements
- Safety surveillance & benefit‑risk evaluation
- Documents in Pharmacovigilance
- DSUR (Development Safety Update Report)
- RMP (Risk Management Plan)
- Safety narratives
- Case processing documentation
- PV System Master File (PSMF)
- Audits & Inspections
- PV audit readiness (GVP Module IV)
- EMA inspection expectations
- Common findings & CAPA
- Maintaining compliance with GVP
- Advanced Pharmacovigilance & Analytics
- PV databases overview (Argus, ArisGlobal, Veeva)
- Automation & AI in PV
- Advanced signal analytics
- Future of PV in the EU
Certification
Upon successful completion, participants receive the
Clinevia Pharmacovigilance Certificate, aligned with
EU GVP, EMA, ICH, and
EU CTR safety standards.
SAS Programming – Curriculum Overview
Program Details
- Program Name: SAS Programming for Clinical Research – EU‑Focused
- Duration: 10–12 Weeks
- Training Hours: 3 Hours/Day (15 Hours/Week)
- Mode of Training: Online – Live Instructor‑Led
- Schedule: Monday to Friday
- Trainers: SAS Programmers, Biostatisticians, CDISC Specialists
- Eligibility: Life Sciences, Pharmacy, Biotechnology, Statistics, Data Science
- Certificate: Clinevia SAS Programming Certificate (EU‑Aligned)
Program Overview
This SAS Programming Program prepares learners for statistical programming roles in clinical trials,
aligned with ICH‑GCP, EU CTR 536/2014, GDPR,
and CDISC SDTM/ADaM standards.
The curriculum covers data manipulation, reporting, statistical procedures, and regulatory‑compliant
programming workflows used in EU‑based clinical research.
Typical entry‑level roles include:
- Statistical Programmer (Entry Level)
- SAS Programmer – Clinical Trials
- Biostatistics Programming Assistant
- SDTM/ADaM Programming Support
- Data Analysis & Reporting Programmer
Curriculum Modules
- SAS Introduction
- SAS interface & environment
- EU regulatory expectations for programming outputs
- GDPR considerations in handling clinical datasets
- INFILE Option
- Reading raw data files
- Handling delimiters & missing values
- Data integrity checks (ALCOA‑C)
- Methods to Read Data
- Input styles (column, formatted, list)
- Importing clinical datasets
- EU audit trail expectations for data import
- Import & Export of Data
- PROC IMPORT & EXPORT
- Working with CSV, Excel, and clinical data formats
- GDPR‑compliant data handling
- SET and WHERE Statements
- Combining datasets
- Filtering clinical trial data
- Maintaining traceability (EU CTR)
- Libraries
- Assigning libraries
- Permanent vs temporary datasets
- EU‑compliant folder structures
- IF THEN ELSE Statements
- Conditional logic
- Data derivations for clinical variables
- IF THEN Logic & Loops
- DO loops
- Iterative programming
- Creating derived variables for SDTM/ADaM
- Appending & Adding Data
- PROC APPEND
- Combining clinical datasets
- Maintaining dataset version control
- Merging of Data
- One‑to‑one, one‑to‑many merges
- Handling mismatches
- EU‑compliant merge documentation
- Functions in SAS
- Character, numeric, date functions
- Clinical derivations (AEs, labs, visits)
- CDISC‑aligned variable creation
- Procedures in SAS
- PROC SORT, PRINT, MEANS, FREQ
- PROC TRANSPOSE, PROC FORMAT
- Generating tables & listings for EU submissions
- SQL Overview
- PROC SQL basics
- Joins & subqueries
- Creating analysis datasets
- Macro Overview
- Macro variables & macro programs
- Automating repetitive tasks
- EU‑compliant macro documentation
- ODS (Output Delivery System)
- Generating reports (RTF, PDF, HTML)
- Formatting outputs for regulatory submissions
- Ensuring traceability & reproducibility
- CDISC Standards (EU‑Required)
- Introduction to SDTM
- Introduction to ADaM
- Mapping raw data to SDTM domains
- Creating ADaM analysis datasets
- Biostatistics for Programmers (EU‑Focused)
- Basic statistical concepts
- Generating TLFs (Tables, Listings, Figures)
- Supporting statistical analysis plans (SAP)
Certification
Upon successful completion, participants receive the
Clinevia SAS Programming Certificate, aligned with
ICH‑GCP, EU CTR, GDPR, and
CDISC SDTM/ADaM standards.
Biostatistics – Curriculum Overview
Program Details
- Program Name: Biostatistics & CDISC Standards – EU‑Focused
- Duration: 10–12 Weeks
- Training Hours: 3 Hours/Day (15 Hours/Week)
- Mode of Training: Online – Live Instructor‑Led
- Schedule: Monday to Friday
- Trainers: Biostatisticians, CDISC Experts, Statistical Programmers
- Eligibility: Life Sciences, Pharmacy, Biotechnology, Statistics, Data Science
- Certificate: Clinevia Biostatistics & CDISC Certificate (EU‑Aligned)
Program Overview
This Biostatistics Program provides comprehensive training in statistical principles, CDISC standards,
and regulatory‑compliant data preparation for clinical trials. The curriculum aligns with
ICH E9, ICH E6(R3), EU CTR 536/2014,
EMA submission requirements, and CDISC SDTM/ADaM standards.
Typical entry‑level roles include:
- Biostatistics Assistant
- Statistical Programmer (Entry Level)
- SDTM/ADaM Programming Support
- Data Standards Associate
- Clinical Data Analyst
- Regulatory Submission Support Analyst
Curriculum Modules
- Introduction to CDISC
- CDISC overview & importance in EU submissions
- SDTM, ADaM, CDASH standards
- EMA expectations for CDISC compliance
- Overview of Clinical Trial Protocol, SAP, CRF & TFL Shell
- Protocol structure & statistical considerations (ICH E9)
- Statistical Analysis Plan (SAP) components
- CRF design & mapping to SDTM
- TFL (Tables, Listings, Figures) shell creation
- Sample CRF Annotation Activity
- Annotating CRFs using CDASH
- Traceability from CRF → SDTM → ADaM → TFL
- EU audit expectations for CRF annotation
- Overview of SDTM Implementation Guide
- SDTM domains & structures
- Controlled terminology
- EU regulatory expectations for SDTM datasets
- Overview of ADaM Implementation Guide
- ADaM principles (ADaM IG)
- ADSL, ADAE, ADLB, ADVS datasets
- Traceability & derivations
- Dataset Specification Preparation (SDTM & ADaM)
- Define.xml‑ready specifications
- Variable metadata & controlled terminology
- EU submission‑compliant documentation
- Sample SDTM Creation
- Mapping raw data to SDTM domains
- Creating DM, AE, LB, VS datasets
- Validation using Pinnacle 21
- Sample ADaM Creation
- Creating ADSL & ADAE datasets
- Derivations for analysis variables
- Traceability from SDTM to ADaM
- Creation of .XPT Files for Regulatory Submission
- Why XPT format is required (EMA/FDA)
- Creating XPT files using SAS
- Submission‑ready dataset packaging
- Sample TFL Creation
- Generating Tables, Listings & Figures
- Supporting SAP requirements
- EU‑compliant reporting standards
- Overview of Pinnacle 21 (P21) for Data Validation
- Running SDTM & ADaM validation
- Resolving warnings & errors
- EU submission compliance checks
- Use of University Free SAS Version for Dummy Project
- Hands‑on practice with SAS University Edition
- Building SDTM & ADaM datasets
- Generating TFLs for a mock EU submission
- Overview of Define.xml & Final Regulatory Submission Package
- Define.xml structure & metadata
- Reviewer’s Guide (SDRG/ADRG)
- Preparing a complete EU submission package
Certification
Upon successful completion, participants receive the
Clinevia Biostatistics & CDISC Certificate, aligned with
ICH E9, ICH E6(R3), EU CTR,
EMA, and CDISC SDTM/ADaM standards.
