2026 · 12 courses · 161 modules
Clinical research course syllabus, module by module.
The complete 2026 curriculum for every clinical course — duration, modules, and the hands-on platform work behind each. New to the field? Start with the guide to clinical courses in India, or find the right course in two minutes.
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- Certificate in Clinical Research 3 months
- Certificate in PV & Regulatory Affairs 3 months
- ICH-GCP 1 month
- Certificate in Biostatistics 3 months
- Certificate in Clinical Data Management 3 months
- Certificate in Medical Coding 3 months
- Certificate in Clinical SAS 3 months
- Certificate in Bioinformatics 3 months
- Certificate in Medical Writing 3 months
- PG Diploma in Clinical Research 6 months
- PG Diploma in CDM 6 months
- PG Diploma in PV & RA 6 months
3 months · hybrid · ₹40K
Certificate in Clinical Research — syllabus
-
01 Introduction to Clinical Research
- Definition and history — the basics
- Structure of the clinical research industry
- Clinical research vs. clinical trials
- Clinical research terminology
- General medical terminology
-
02 General Pharmacology & Mechanism of Drug Action
- Basics of pharmacology; branches of pharmacy
- History of pharmacy
- The Indian pharmaceutical industry
- Pharmacodynamics and pharmacokinetics
- Routes of administration and dosage forms
-
03 Drug Discovery & Drug Development
- History of drug discovery
- The drug discovery process
- Target identification
- Lead identification and lead optimisation
- Discovery genomics; preclinical studies
-
04 Historical Perspectives of Clinical Research
- Evolution of the ethical & regulatory framework
- Nuremberg Code, 1946
- Declaration of Helsinki
- Thalidomide tragedy; Belmont Report
- Schedule Y, Drugs & Cosmetics Act 1945; history of ICH
-
05 Ethical Issues & Global Regulations
- ICH guidelines — ICH-GCP E6(R2) and E6(R3)
- ICMR ethical guidelines
- Ethics on the use of placebo in clinical trials
- CDSCO and ICMR, India
- USFDA (USA), EMA (Europe), MHRA (UK), TGA (Australia)
-
06 Stakeholders & Core Team: Roles and Responsibilities
- Investigator — roles and responsibilities
- Sponsor — roles and responsibilities
- Contract Research Organisation (CRO)
- Ethics committee (IRB / IEC); regulatory agencies
- Clinical Research Coordinator (CRC) and Associate (CRA)
-
07 Clinical Research Documentation
- Essential documents before, during and after the trial (ICH-GCP)
- Protocol
- Informed consent documents
- Investigator's Brochure; Case Report Form
- Clinical Study Report
-
08 Research Methodology & Applied Biostatistics
- Defining the research problem
- Sampling design
- Hypothesis testing
- Parametric and non-parametric tests
- Scientific writing
-
09 Types & Designs Used in Clinical Research
- Diagnostic and treatment trials
- Interventional and observational studies
- Case-control and cohort studies
- Randomised controlled trials
- Quasi-experiments
-
10 Clinical Trial Data Management
- Introduction to data management
- Electronic data records
- eCRF and Interactive Web Response Systems
- Database locking and unlocking
- Good documentation practices
-
11 Pharmacovigilance & Safety Monitoring
- Adverse drug reactions
- Serious adverse events (SAE) and reporting timelines
- Pharmacovigilance methods
- Signal detection and data mining
- PvPI; risk management plan
-
12 Quality Assurance & Quality Control in Clinical Trials
- Introduction to the quality management system
- Quality assurance
- Quality control
- Audits and inspections; types of audits
- General audit observations
-
13 Pharmacoepidemiology & Pharmacoeconomics
- Pharmacoepidemiology — methods
- Clinical application of pharmacoepidemiology
- Principles of pharmacoeconomic analysis
- Pharmaceutical outcomes evaluations
-
14 Medical Device Clinical Trials (MDCTs)
- Medical Devices Rules, 2017
- Classification of medical devices
- Materiovigilance
- Phases of medical device clinical trials
-
15 Medical Writing for Trials & Regulatory Submission
- Case reports and article writing
- Designing a clinical trial protocol
- CRF designing
- Informed consent documents
- Clinical study reports
-
16 Virtual Clinical Trials (Role of AI and ML)
- e-Consent (audio-visual consent)
- e-Patient Reported Outcomes (e-PRO)
- IWRS; telemedicine
- Patient e-diaries
- Remote patient monitoring
-
17 Clinical Trials — Latest Updates (2019 to date)
- ICH-GCP E6(R3)
- NDCT Rules 2019 and the 2023 amendment
- ICMR-HMSC
- Recent CDSCO notices
- NABH ethics committee standards
-
18 AI in Clinical Research
- Introduction to AI; evolution of AI in healthcare
- Machine learning basics; deep learning
- Types of healthcare data, databases and software
- Modern clinical trial design
- Application of AI in clinical research
-
19 Placement Mastery
- Résumé building for clinical research roles
- Communication skills, aptitude and soft skills
- Corporate etiquette
- Interview preparation
- Four mock interviews with practising professionals
-
20 Industry-Based Case Studies
- Real trial scenarios drawn from partner CROs and sponsors
- Protocol deviation and CAPA walkthroughs
- Site-level problem solving and escalation
- Group presentation and faculty critique
-
21 Capstone Project
- End-to-end project applying the full curriculum
- Documentation set: protocol synopsis, ICD, CRF, safety plan
- Mentor-guided review cycles
- Final submission and viva — forms your interview portfolio
3 months · hybrid · ₹40K
Certificate in PV & Regulatory Affairs — syllabus
-
01 Pharmacology, Clinical Trials & Pharmacoepidemiology
- Basics of pharmacology and the clinical research industry
- Phases of clinical trials
- Pharmacovigilance methods
- Clinical application of pharmacoepidemiology
-
02 Adverse Drug Reactions & Safety Reports
- AE versus ADR and classification of ADRs
- SAE reporting
- Side effects and medication errors
-
03 Methodologies & Benefit Assessment
- Passive reporting and case series
- Active surveillance
- Targeted clinical investigations
- Descriptive studies
-
04 Seriousness, Expectedness & Causality
- Expectedness assessment
- Causality assessment
- The Naranjo algorithm and Hill's criteria
-
05 ICSR Processing & Case Management
- Case intake, triage and prioritisation
- Data entry and narrative writing
- Quality review
- Reconciliation and submission
-
06 Drug Dictionaries & Coding
- MedDRA hierarchy and coding conventions
- WHO Drug Dictionary
- MedWatch
- Version migration scenarios
-
07 Safety Database Training
- Hands-on Argus, ARISg (by ArisGlobal) and ABcube
- Case entry and workflow management
- Querying and periodic report generation
-
08 Aggregate Safety Reports
- DSUR, PADER, PBRER and PSUR
- Structure and data sources
- Authoring conventions and review
-
09 Signal Detection & Data Mining
- Data sources and tools for signal detection
- Statistical techniques
- Data-mining methodologies
- Risk identification
-
10 AI & Automation in Pharmacovigilance
- Machine learning for case intake and triage
- NLP-based literature screening and duplicate detection
- AI-assisted MedDRA coding and narrative drafting
- ML approaches to signal detection
- Validation and GxP expectations that govern AI in a regulated safety system
-
11 Materiovigilance Across the Globe
- Materiovigilance Programme of India
- US FDA device vigilance
- MHRA manufacturer guidance
- EU and non-EU practice
-
12 Global Regulatory Framework & Risk Communication
- CDSCO India, USFDA, EMA Europe, MHRA UK and TGA Australia
- Reporting obligations
- Medicines risk communication
-
13 Regulatory Affairs Essentials
- CTD and eCTD architecture
- Dossier compilation
- Submission pathways across CDSCO, USFDA and EMA
- Lifecycle maintenance
-
14 AI in Regulatory Affairs & Regulatory Intelligence
- AI-assisted dossier authoring and document management
- Automated regulatory intelligence and change monitoring
- Structured product data and IDMP
- Evolving CDSCO, USFDA and EMA positions on AI across the product lifecycle
-
15 Pharmacovigilance Programme of India (PvPI)
- IPC services
- ADR reporting in India
- PV System Master File and capacity building
- Recent developments
-
16 Compliance, Audits & Inspections
- Good Pharmacovigilance Practices
- NMRA inspection guidelines
- Audit readiness and common findings
- PV of herbal medicines
-
17 Industry Case Studies & Capstone Project
- Real-world scenarios drawn from partner CROs
- Assessed capstone project
- Bonus: PV-specific resume, LinkedIn optimisation and mock interviews simulating pharma and CRO hiring rounds
1 month · hybrid · ₹15K
ICH-GCP — syllabus
-
01 Foundations & History of GCP
- History and purpose of Good Clinical Practice
- The Declaration of Helsinki and its ethical foundations
- What ICH-GCP E6(R3) is and how it updates E6(R2)
- The 13 core principles of ICH-GCP
-
02 Roles & Responsibilities
- Sponsor responsibilities and oversight obligations
- Investigator responsibilities and delegation of duties
- Monitor (CRA) responsibilities and monitoring approaches
- IRB/IEC composition, functions, and responsibilities
-
03 Informed Consent & Ethics in Practice
- The informed consent process, elements, and documentation
- Consent in vulnerable populations and emergency situations
- Re-consent following protocol or safety updates
- Ethical review, approvals, and continuing oversight
-
04 Essential Documents & the Trial Master File
- The essential document set and why each is required
- Structure and maintenance of the Trial Master File (TMF)
- Protocol, Investigator's Brochure, and source documentation
- ALCOA+ data integrity principles in practice
-
05 Protocol Compliance & Safety Reporting
- Protocol compliance, deviations, and corrective actions
- Adverse events, serious adverse events, and SUSAR reporting
- Safety reporting timelines and sponsor/investigator duties
- Quality management and risk-based thinking under E6(R3)
-
06 Audits, Inspections & Indian Regulations
- Sponsor audits and regulatory inspections — how to prepare
- Inspection readiness at the site and common findings
- The New Drugs and Clinical Trials Rules 2019 (India)
- CDSCO oversight and how GCP maps to Indian requirements
3 months · hybrid · ₹25K
Certificate in Biostatistics — syllabus
-
01 Introduction to Biostatistics & Study Design
- Role of biostatistics in clinical research and health sciences
- Types of clinical studies: observational vs experimental
- Study design principles: controls, randomisation, blinding
- Sample size determination and statistical power calculations
- Protocol statistical sections and analysis plan overview
-
02 Research Types & Methodology
- Descriptive, analytical, and interventional research designs
- Cross-sectional, cohort, case-control, and RCT designs
- Bias types: selection bias, information bias, confounding
- Systematic reviews and meta-analysis overview
- Epidemiological measures: incidence, prevalence, relative risk, odds ratio
-
03 Foundations of Statistical Theory
- Statistical terminology and measurement scales
- Population vs sample: parameters and statistics
- Statistical estimation: point and interval estimates
- Normal distribution and the Central Limit Theorem
- Confidence intervals and their clinical interpretation
-
04 Data Types, Data Organization & Data Visualization
- Data types: continuous, categorical, ordinal, nominal
- Data collection instruments and coding schemes
- Frequency tables, crosstabulations, and data validation
- Graphical displays: histograms, box plots, scatter plots, bar charts
- Handling missing data and data cleaning principles
-
05 Descriptive Statistics
- Measures of central tendency: mean, median, mode
- Measures of dispersion: variance, standard deviation, IQR, range
- Skewness, kurtosis, and distribution shape
- Percentiles and quartiles
- Summary statistics reporting in clinical research format
-
06 Probability & Sampling
- Probability theory: basic rules and conditional probability
- Probability distributions: binomial, Poisson, normal
- Sampling techniques: simple random, stratified, cluster
- Sampling error and precision
- Randomisation methods in clinical trials
-
07 Statistical Inference & Hypothesis Testing
- Null and alternative hypotheses: Type I and Type II errors
- p-value, significance level, and statistical power
- t-tests: one-sample, independent samples, and paired
- Chi-square test and Fisher's exact test
- ANOVA: one-way and two-way analysis of variance
- Non-parametric tests: Mann-Whitney U, Kruskal-Wallis, Wilcoxon signed-rank
-
08 Regression & Advanced Analysis
- Simple and multiple linear regression
- Logistic regression for binary outcomes
- Survival analysis: Kaplan-Meier curves and log-rank test
- Cox proportional hazards model
- Correlation: Pearson and Spearman coefficients
- Repeated measures and longitudinal data overview
-
09 Statistical Software & Proficiency
- SAS: PROC MEANS, PROC FREQ, PROC TTEST, PROC LOGISTIC hands-on
- R: data manipulation with dplyr, visualisation with ggplot2, statistical functions
- SPSS: data entry, descriptive analysis, and hypothesis testing workflows
- Hands-on datasets from clinical trial and public health scenarios
- Interpreting and presenting software output for clinical reports
-
10 Corporate Etiquette, Aptitude & Communication Skills
- Professional communication in clinical research environments
- Statistical reporting for non-statistical audiences
- Quantitative aptitude and logical reasoning for placement tests
- Resume preparation for biostatistics and data analysis roles
- Mock interviews and technical assessment preparation
3 months · hybrid · ₹40K
Certificate in Clinical Data Management — syllabus
-
01 Introduction to Clinical Data Management
- The Clinical Data Management process and its objectives
- CDM team structure: data manager, coordinator, programmer
- Introduction to CDM tools and software
- Role of CDM within the clinical trial lifecycle
- Indian and global CDM landscape and career pathways
-
02 Guidelines & Data Standards for CDM
- Documentation scenario for data collection and management
- International studies and data privacy requirements
- Guidance for industry: ISO, ICH, HL7, CDISC and CDASH
- Electronic source data in clinical investigations
-
03 Study Setup & CRF Design
- Protocol-to-CRF mapping and design principles
- Edit check specification and validation logic
- User acceptance testing (UAT) and go-live procedures
- Annotated CRF (aCRF) and CRF Completion Guidelines
- EDC study build: Medidata Rave hands-on
-
04 Data Entry & Discrepancy Management
- Data entry workflows in EDC systems
- Manual review vs automated edit check resolution
- Data review metrics and site performance tracking
- Discrepancy identification and the query lifecycle
- Site communication for query resolution
-
05 Standard Coding & Safety Reporting
- MedDRA coding: hierarchy, conventions and version migration
- CDISC standards: CDASH, SDTM and ADaM overview
- WHO-DD drug coding and dictionary management
- Coding consistency and quality control
-
06 Data Review & Data Transfer
- External data reconciliation: lab, ECG, IRT, ePRO
- Listings review and data cleaning sign-off
- Data transfer specifications and integration standards
- CDISC Define-XML and Reviewer's Guide preparation
-
07 SAE Reconciliation
- SAE reporting workflow: site to sponsor to safety database
- Discrepancy identification and resolution between databases
- CDM–safety database reconciliation process
- Regulatory reporting timelines and CDM's role
-
08 Database Closure & Archiving
- Pre-lock checklist and quality review procedures
- Post-lock unlock procedures and documentation
- Long-term data retention and regulatory requirements
- Database lock protocols and authorisation workflow
- Trial Master File (TMF) archiving requirements
-
09 Quality Control (QC) & Quality Assurance (QA)
- QC vs QA: definitions and scope in CDM
- Audit trail review and data integrity checks
- Inspection readiness for CDM systems and processes
- Risk-based data monitoring principles
- GCP compliance in data management operations
-
10 Tools: Medidata Rave, Oracle Clinical, CDISC
- Medidata Rave: study build, forms, edit checks and reporting
- CDISC SDTM mapping exercises
- Veeva Vault EDC overview and industry adoption
- Oracle Clinical / InForm: overview and when it is used
- SAS programming basics for CDM: data steps and PROC SQL
-
11 AI in Clinical Research
- Introduction to AI, machine learning and deep learning basics
- Modern and adaptive clinical trial design
- Remote patient monitoring and patient e-diaries
- Evolution of AI across healthcare and the drug development lifecycle
- Virtual and decentralised trials: e-consent, ePRO, IWRS, telemedicine
-
12 AI in Managing Clinical Data
- Types of healthcare data, databases and AI-enabled platforms
- NLP for automated coding and unstructured clinical narratives
- Governance, validation and 21 CFR Part 11 expectations for AI tools
- ML-assisted CRF design and risk-based data review
- Anomaly detection and central statistical monitoring
-
13 Career Readiness & Placement Prep
- CDM resume building for freshers and career-changers
- Industry roles and entry paths in clinical data management
- Mock interviews with practising clinical data managers
- Certification pathways and next steps after the certificate
3 months · hybrid · ₹40K
Certificate in Medical Coding — syllabus
-
01 Medical Terminology, Anatomy & Physiology
- Medical terminology: prefixes, suffixes, root words
- Body systems overview: cardiovascular, respiratory, GI, MSK, neuro
- Anatomy fundamentals relevant to coding specialties
- Physiology basics for understanding diagnoses and procedures
- Common diagnostic tests and laboratory procedures
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02 Introduction to Medical Coding
- Healthcare reimbursement ecosystem: US, UK, India
- Revenue cycle management and the claim cycle
- Roles: coder, auditor, denials specialist, CDI specialist
- Compliance frameworks: HIPAA, OIG, Anti-kickback statute
- Career pathways: in-house, MNC, freelance/remote
-
03 ICD-10-CM (Diagnosis Coding)
- ICD-10-CM structure: chapters, blocks, categories, codes
- Official Coding Guidelines and conventions
- Coding by body system with hands-on case studies
- Z-codes, V-codes, and external cause codes
- Sequencing principal vs secondary diagnoses
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04 CPT (Procedure Coding)
- CPT structure: Categories I, II, III
- E/M services coding with 2021 and 2023 guideline updates
- Surgery section: integumentary, MSK, cardiovascular, GI
- Modifier usage: -25, -26, -59, -76, -78, -79
- Anesthesia, radiology, pathology, and laboratory coding
-
05 HCPCS Level II
- HCPCS structure and permanent vs temporary codes
- J-codes for injectable drugs and drug administration
- DME (durable medical equipment) coding
- HCPCS-specific modifiers and their application
-
06 Coding Guidelines & Compliance
- Bundling and unbundling concepts
- National Correct Coding Initiative (NCCI) edits
- Specialty coding: ED, inpatient, and outpatient differences
- Risk Adjustment / HCC coding overview
- Documentation integrity and CDI
-
07 Denial Management & Reimbursement
- Common denial types: coding, eligibility, timely filing
- Denial analysis and root cause identification
- Appeal writing and resubmission strategies
- Payer-specific guidelines and local coverage determinations
- Revenue cycle KPIs: denial rate and clean claim rate
-
08 CPC Certification Prep
- AAPC CPC exam structure: 100 questions, 4 hours
- Time-management and exam-taking strategies
- Full-length practice exams under timed conditions
- Weak-area review and targeted practice
- AAPC membership, credential maintenance, and job board access
3 months · hybrid · ₹40K
Certificate in Clinical SAS — syllabus
-
01 Foundations of Base SAS Programming
- The SAS programming environment, libraries, and dataset structure
- Reading and importing clinical data from Excel, CSV, and databases
- The SAS DATA step: reading, creating, and transforming datasets
- SAS functions, formats, informats, and conditional logic
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02 Data Manipulation & PROC Steps
- Sorting, merging, and concatenating clinical datasets
- PROC SQL for querying and joining trial data
- PROC TRANSPOSE, PROC FORMAT, and restructuring datasets
- Handling missing values, duplicates, and data cleaning in SAS
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03 SAS Macros & Automation
- Macro variables, macro programs, and parameter passing
- %DO loops, %IF conditions, and iterative macro logic
- Building reusable macros for repetitive clinical programming tasks
- Debugging macros with the SAS log and system options
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04 CDISC Standards — SDTM & ADaM
- The CDISC framework and why sponsors mandate it
- SDTM domain structure, variables, and mapping raw data
- ADaM datasets (ADSL, BDS, OCCDS) and derivation logic
- Define.xml, controlled terminology, and compliance checks
-
05 Statistical Procedures & TLF Generation
- Descriptive statistics with PROC FREQ and PROC MEANS
- Inferential testing with PROC TTEST and PROC GLM
- Generating Tables, Listings, and Figures (TLFs) for CSRs
- PROC REPORT and ODS for regulatory-ready output
-
06 Validation, QC & Career Readiness
- Double programming and independent QC of SAS output
- Log review, validation documentation, and audit readiness
- Clinical SAS resume building and mock interviews
- Career pathways into statistical programming and biostatistics teams
3 months · hybrid · ₹40K
Certificate in Bioinformatics — syllabus
-
01 Fundamentals of Biology
- Cell biology: cell structure, organelles, and function
- Molecular biology: DNA, RNA, protein synthesis
- Genetics: Mendelian inheritance, mutations, and gene expression
- Central dogma and its implications for bioinformatics
- Introduction to omics: genomics, transcriptomics, proteomics
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02 Bioinformatics Databases & Tools
- NCBI: GenBank, PubMed, RefSeq, and database navigation
- BLAST: sequence similarity searching and result interpretation
- UniProt, PDB, and protein structure databases
- Ensembl and genome browser tools
- Biological ontologies: Gene Ontology (GO) and KEGG pathways
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03 Programming & Statistical Analysis
- Python for bioinformatics: Biopython library and data manipulation
- R for bioinformatics: Bioconductor packages and statistical analysis
- Command-line Linux basics for bioinformatics pipelines
- Statistical concepts: distributions, hypothesis testing, multiple testing correction
- Data visualisation: heatmaps, volcano plots, principal component analysis (PCA)
-
04 Advanced & Specialized Modules
- Introduction to machine learning concepts in bioinformatics
- Network biology and pathway enrichment analysis
- Comparative genomics and genome evolution
- Drug target identification using bioinformatics approaches
- Integrative multi-omics analysis overview
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05 Structural Bioinformatics
- Protein 3D structure: primary, secondary, tertiary, quaternary levels
- Structure visualisation tools: PyMOL and UCSF Chimera
- Homology modelling and structure prediction (AlphaFold)
- Molecular docking basics for drug discovery
- Structure-based drug design principles
-
06 Sequence Alignment
- Pairwise alignment: global (Needleman-Wunsch) and local (Smith-Waterman)
- BLAST algorithms: blastn, blastp, tblastx applications
- Multiple Sequence Alignment (MSA): ClustalW, MUSCLE, MAFFT
- Scoring matrices: PAM and BLOSUM
- Alignment interpretation and biological significance
-
07 Phylogenetics
- Evolutionary distance and nucleotide substitution models
- Tree-building methods: Neighbour-Joining, maximum parsimony, maximum likelihood, Bayesian
- Bootstrap analysis and tree confidence
- Tools: MEGA, IQ-TREE, PhyML
- Applications: molecular evolution, outbreak tracing, gene family analysis
-
08 Next-Generation Sequencing (NGS)
- NGS platforms: Illumina, PacBio, Oxford Nanopore
- NGS library preparation and sequencing chemistry
- Quality control: FastQC and Trimmomatic
- Read alignment: BWA, STAR, HISAT2
- Variant calling and annotation: GATK, ANNOVAR
- RNA-seq: differential expression analysis with DESeq2 and edgeR
-
09 Genomics
- Genome assembly: de novo and reference-guided approaches
- Genome annotation: gene prediction and functional annotation
- Comparative genomics and synteny analysis
- Epigenomics: ChIP-seq and ATAC-seq overview
- Genome-wide association studies (GWAS) principles
-
10 Proteomics
- Mass spectrometry principles for proteomics
- Protein identification and quantification workflows
- Label-free and label-based quantitative proteomics
- Post-translational modifications (PTMs) analysis
- Proteomics data analysis tools: MaxQuant and Perseus
- Integration of proteomics with genomics for systems biology
3 months · hybrid · ₹40K
Certificate in Medical Writing — syllabus
-
01 Introduction to Medical Writing
- Medical writing landscape: regulatory, scientific, promotional, educational
- Career pathways: regulatory writer, scientific writer, publication specialist
- Indian and global medical writing market in 2026
- ICMJE authorship guidelines and GPP3 publication ethics
- Writing quality frameworks and self-review techniques
-
02 Regulatory Writing (Protocols, CSRs, IB)
- Clinical Study Report (CSR) — ICH E3 structure and hands-on writing
- Clinical Trial Protocol writing — SPIRIT guidance
- Investigator's Brochure (IB) — ICH E6 structure
- Common Technical Document (CTD) module summaries
- Plain-language summaries for trial transparency
-
03 Clinical & Scientific Writing
- IMRaD structure for scientific manuscripts
- Active voice, sentence-level clarity, and plain language principles
- Statistical reporting standards and data presentation
- Tables, figures, and visual abstract design
- EQUATOR Network standards: CONSORT, STROBE, PRISMA
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04 Manuscripts & Publication Writing
- Targeting journals: impact, scope, and audience
- Cover letters and submission strategy
- Peer review response letters and revision management
- Conference abstracts and poster design
- Plagiarism and AI-content detection and disclosure
-
05 Safety Narratives & PV Documents
- Patient narratives for SAEs: structure and content requirements
- DSUR (Development Safety Update Report) structure
- PSUR / PBRER writing and review
- Risk Management Plans: writing and content standards
- MedDRA terminology usage in narrative writing
-
06 Patient-facing / Lay Documents
- Lay summaries for clinical trials: EU and US requirements
- Patient information sheets and consent language
- Plain language principles for non-specialist audiences
- Patient education materials and disease guides
- Readability scoring and lay document testing
-
07 Style Guides, Tools & Quality Review
- AMA Manual of Style, APA, and sponsor style guide application
- MS Word advanced: styles, cross-references, tables of contents
- Reference managers: EndNote, Mendeley, Zotero
- PleaseReview and Veeva Vault Quality Docs overview
- AI-assisted writing — appropriate use and disclosure
- Version control, comment management, and timeline adherence
6 months · hybrid · ₹65K
PG Diploma in Clinical Research — syllabus
-
01 Introduction to Clinical Research
- Definition and history — the basics
- The clinical research industry and how it is structured
- Clinical research versus clinical trials
- Clinical research terminology
- General medical terminology
-
02 General Pharmacology & Mechanism of Drug Action
- Basics of pharmacology; branches of pharmacy
- History of pharmacy
- The Indian pharmaceutical industry
- Pharmacodynamics and pharmacokinetics
- Routes of drug administration
- Dosage forms
-
03 Drug Discovery & Drug Development
- History of drug discovery
- The drug discovery process
- Target identification
- Lead identification and lead optimisation
- Discovery genomics
- Preclinical studies
-
04 Historical Perspectives & Evolution of the Ethical and Regulatory Framework
- The Nuremberg Code, 1947
- The Declaration of Helsinki
- The thalidomide tragedy
- The Belmont Report
- Schedule Y
- Drugs and Cosmetics Act, 1940 & Rules, 1945
- History of the ICH
-
05 Ethical Issues in Clinical Research
- ICH guidelines: ICH-GCP E6(R2) and E6(R3)
- ICMR ethical guidelines
- Ethics of placebo use in clinical trials
- CDSCO and ICMR — India
- USFDA (USA) and EMA (Europe)
- MHRA (UK) and TGA (Australia)
-
06 Stakeholders & Core Team: Roles and Responsibilities
- Investigator — roles and responsibilities
- Sponsor — roles and responsibilities
- Contract Research Organisation (CRO)
- Ethics committee (IRB / IEC)
- Regulatory agencies: USFDA, EMA, CDSCO
- Clinical Research Coordinator (CRC)
- Clinical Research Associate (CRA)
-
07 Clinical Research Documentation
- Essential documents before, during and after the trial — ICH-GCP
- The protocol
- Informed consent documents
- Investigator's Brochure
- Case Report Form
- Clinical Study Report
-
08 Research Methodology & Applied Biostatistics
- Defining the research problem
- Sampling design
- Hypothesis testing
- Parametric and non-parametric tests
- Scientific writing
-
09 Types and Designs Used in Clinical Research
- Diagnostic and treatment trials
- Interventional and observational studies
- Case-control and cohort studies
- Randomised controlled trials
- Quasi-experiments
-
10 Clinical Trial Data Management
- Introduction to data management
- Electronic data records
- eCRF and Interactive Web Response Systems
- Database locking and unlocking
- Good documentation practices
-
11 Pharmacovigilance & Safety Monitoring
- Adverse drug reactions
- Serious Adverse Events (SAE)
- SAE reporting timelines
- Pharmacovigilance methods
- Signal detection and data mining
- PvPI — Pharmacovigilance Programme of India
- Risk Management Plans
-
12 Quality Assurance & Quality Control in Clinical Trials
- Introduction to Quality Management Systems
- Quality assurance
- Quality control
- Audits and inspections
- Types of audit
- General audit observations
-
13 Pharmacoepidemiology & Pharmacoeconomics
- Pharmacoepidemiology — methods
- Clinical application of pharmacoepidemiology
- Principles of pharmacoeconomic analysis
- Pharmaceutical outcomes evaluation
-
14 Medical Device Clinical Trials (MDCTs)
- Medical Devices Rules, 2017
- Classification of medical devices
- Materiovigilance
- Phases of medical device clinical trials
-
15 Medical Writing for Trials & Regulatory Submission
- Case reports
- Article writing
- Designing the clinical trial protocol
- CRF design
- Informed consent documents
- Clinical Study Reports
-
16 Virtual & Decentralised Clinical Trials
- E-consent, including audio-visual consent
- Electronic patient-reported outcomes (ePRO)
- Interactive Web Response Systems (IWRS)
- Telemedicine in trial conduct
- Patient e-diaries
- Remote patient monitoring
-
17 Clinical Trials — Latest Updates (2019 to date)
- ICH-GCP E6(R3)
- NDCT Rules 2019 and the 2023 amendment
- ICMR — HMSC
- Recent CDSCO notices
- NABH ethics committee standards
-
18 Artificial Intelligence in Clinical Research
- Introduction to AI
- Evolution of AI in healthcare
- Machine learning basics
- Deep learning
- Healthcare data types, databases and software
- Modern clinical trial design
- Applications across clinical research
-
19 Placement Mastery
- Resume building
- Communication skills, aptitude and soft skills
- Corporate etiquette
- Interview preparation
- Four mock interviews
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20 Industry-Based Case Studies
- Real trial scenarios worked end to end
- Protocol deviations and how teams resolved them
- Audit findings and corrective actions
- Safety escalations from the practitioner's seat
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21 Capstone Project
- An individual project across a chosen domain
- Supervised by a practising faculty mentor
- Written deliverable plus presentation
- Becomes your interview portfolio piece
6 months · hybrid · ₹65K
PG Diploma in CDM — syllabus
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01 Foundations of Clinical Research & Drug Development
- The drug development lifecycle, discovery to post-marketing
- Key stakeholders: sponsors, CROs, sites, investigators, IRB/IEC
- Phases of clinical trials (Phase I–IV) and their objectives
- How the Indian and global clinical research industry is structured
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02 ICH-GCP & Ethics
- ICH-GCP E6(R3) principles and the core requirements
- Informed consent process and documentation
- The Declaration of Helsinki and ethical foundations
- Roles of sponsor, investigator and monitor
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03 Regulatory Framework
- CDSCO and the New Drugs and Clinical Trials Rules 2019 (India)
- EMA and the EU Clinical Trials Regulation — overview
- USFDA 21 CFR Parts 11, 50, 56 and 312 — overview
- Regulatory submissions and approval pathways at a glance
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04 Clinical Trial Documents & Data
- Protocol, Investigator's Brochure and the essential document set
- Introduction to EDC and the Trial Master File (TMF)
- Case Report Forms (CRFs) and source documentation
- ALCOA+ data integrity principles
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05 Monitoring & Safety Basics
- Types of monitoring visits and the CRA's role
- Adverse events, serious adverse events and safety reporting
- Source data verification (SDV) fundamentals
- Protocol deviations and quality management
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06 Introduction to Clinical Data Management
- The Clinical Data Management process and its objectives
- CDM team structure: data manager, coordinator, programmer
- Introduction to CDM tools and software
- Role of CDM within the clinical trial lifecycle
- Indian and global CDM landscape and career pathways
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07 Guidelines & Data Standards for CDM
- Documentation scenario for data collection and management
- International studies and data privacy requirements
- Guidance for industry: ISO, ICH, HL7, CDISC and CDASH
- Electronic source data in clinical investigations
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08 Study Setup & CRF Design
- Protocol-to-CRF mapping and design principles
- Edit check specification and validation logic
- User acceptance testing (UAT) and go-live procedures
- Annotated CRF (aCRF) and CRF Completion Guidelines
- EDC study build: Medidata Rave hands-on
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09 Data Entry & Discrepancy Management
- Data entry workflows in EDC systems
- Manual review vs automated edit check resolution
- Data review metrics and site performance tracking
- Discrepancy identification and the query lifecycle
- Site communication for query resolution
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10 Standard Coding & Safety Reporting
- MedDRA coding: hierarchy, conventions and version migration
- CDISC standards: CDASH, SDTM and ADaM overview
- WHO-DD drug coding and dictionary management
- Coding consistency and quality control
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11 Data Review & Data Transfer
- External data reconciliation: lab, ECG, IRT, ePRO
- Listings review and data cleaning sign-off
- Data transfer specifications and integration standards
- CDISC Define-XML and Reviewer's Guide preparation
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12 SAE Reconciliation
- SAE reporting workflow: site to sponsor to safety database
- Discrepancy identification and resolution between databases
- CDM–safety database reconciliation process
- Regulatory reporting timelines and CDM's role
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13 Database Closure & Archiving
- Pre-lock checklist and quality review procedures
- Post-lock unlock procedures and documentation
- Long-term data retention and regulatory requirements
- Database lock protocols and authorisation workflow
- Trial Master File (TMF) archiving requirements
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14 Quality Control (QC) & Quality Assurance (QA)
- QC vs QA: definitions and scope in CDM
- Audit trail review and data integrity checks
- Inspection readiness for CDM systems and processes
- Risk-based data monitoring principles
- GCP compliance in data management operations
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15 Tools: Medidata Rave, Oracle Clinical, CDISC
- Medidata Rave: study build, forms, edit checks and reporting
- CDISC SDTM mapping exercises
- Veeva Vault EDC overview and industry adoption
- Oracle Clinical / InForm: overview and when it is used
- SAS programming basics for CDM: data steps and PROC SQL
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16 AI in Clinical Research
- Introduction to AI, machine learning and deep learning basics
- Modern and adaptive clinical trial design
- Remote patient monitoring and patient e-diaries
- Evolution of AI across healthcare and the drug development lifecycle
- Virtual and decentralised trials: e-consent, ePRO, IWRS, telemedicine
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17 AI in Managing Clinical Data
- Types of healthcare data, databases and AI-enabled platforms
- NLP for automated coding and unstructured clinical narratives
- Governance, validation and 21 CFR Part 11 expectations for AI tools
- ML-assisted CRF design and risk-based data review
- Anomaly detection and central statistical monitoring
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18 Career Readiness & Placement Prep
- Clinical research and CDM resume building for freshers
- Industry roles, entry paths and choosing between the two tracks
- Mock interviews with practising clinical research professionals
- Certification pathways and next steps after the diploma
6 months · hybrid · ₹65K
PG Diploma in PV & RA — syllabus
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01 Pharmacology & Drug Development
- Basics of pharmacology, pharmacodynamics and pharmacokinetics
- Routes of administration and dosage forms
- The drug development pipeline
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02 The Clinical Research Industry & Trial Phases
- Structure of the industry; sponsor and CRO roles
- Phases of clinical trials
- Where safety obligations attach at each stage
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03 Introduction to Pharmacovigilance & Drug Safety
- History and evolution of drug safety surveillance
- The WHO-UMC framework and key terminology
- Stakeholders across the safety ecosystem
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04 Pharmacoepidemiology & Biostatistics for Drug Safety
- Epidemiological and statistical principles used in PV practice and research
- Study designs
- Measures of association and their interpretation
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05 Adverse Drug Reactions & Safety Reports
- AE versus ADR and classification of ADRs
- SAE reporting
- Side effects and medication errors
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06 Seriousness, Expectedness & Causality Assessment
- Expectedness assessment
- Causality methods
- The Naranjo algorithm and Hill's criteria applied to worked cases
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07 ICSR Processing & Case Management
- Full ICSR lifecycle: intake, triage and prioritisation
- Data entry and narrative writing
- Quality review and reconciliation
- E2B(R3) submission
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08 Drug Dictionaries & Coding
- MedDRA hierarchy and coding conventions
- WHO Drug Dictionary and MedWatch
- Version migration scenarios with practical exercises
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09 Argus Safety — Extended Hands-on
- Interface walkthrough and case entry
- Workflow management and case assignment
- Querying
- User roles and access management
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10 ARISg, Veeva Vault Safety & ABcube
- Case processing across mid-market and modern platforms
- Comparative analysis of the four systems
- Database migration projects
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11 Clinical Trial Safety, SAE & SUSAR Reporting
- Safety reporting inside clinical trials
- SAE and SUSAR management
- Blinding and unblinding
- Expedited reporting timelines
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12 Aggregate Safety Reports
- DSUR, PADER, PBRER and PSUR
- Data sources, structure and authoring conventions
- Review cycles and submission obligations
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13 Literature Surveillance & Case Retrieval
- Systematic literature search strategies
- Screening and duplicate detection
- Local literature obligations
- Documentation standards
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14 Signal Detection & Data Mining
- Data sources and tools
- Disproportionality analysis (PRR, ROR, EBGM)
- Data-mining methodologies
- Signal validation workflows
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15 Risk Management Plans & Risk Minimisation
- RMP structure and safety specifications
- Pharmacovigilance plans
- Additional risk minimisation measures
- Effectiveness evaluation
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16 AI & Automation in Pharmacovigilance
- Machine learning for intake and triage
- NLP literature screening and duplicate detection
- AI-assisted coding and narrative drafting
- Validation and GxP expectations governing AI in a regulated safety system
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17 Global Regulatory Framework & Agencies
- CDSCO India, USFDA, EMA Europe, MHRA UK and TGA Australia
- Obligations and timelines
- Medicines risk communication
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18 Regulatory Submissions — CTD, eCTD & Dossiers
- CTD and eCTD architecture
- Module-by-module dossier compilation
- Submission pathways
- Publishing conventions
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19 Labelling, Safety Communication & Lifecycle Maintenance
- Company core data sheets
- SmPC, USPI and patient information
- Safety label changes
- Variations and post-approval commitments
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20 AI in Regulatory Affairs & Regulatory Intelligence
- AI-assisted dossier authoring and document management
- Automated regulatory intelligence and change monitoring
- Structured product data and IDMP
- Evolving agency positions on AI
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21 PvPI, Materiovigilance & Herbal Pharmacovigilance
- Indian Pharmacopoeia Commission services and ADR reporting in India
- The Materiovigilance Programme
- Device vigilance abroad
- PV of herbal medicines
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22 GVP, Audits & Regulatory Inspections
- Good Pharmacovigilance Practices
- PV System Master File
- Inspection coordination and readiness
- Common audit findings
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23 Quality Management, SDEA & PV Project Management
- Deviations and CAPA
- Safety data exchange agreements and vendor oversight
- Metrics and compliance tracking
- PV project management
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24 Industry Case Studies, Capstone & Internship
- Real anonymised scenarios from partner CROs
- Assessed capstone project
- Supervised internship block
- Bonus: PV and RA specific resume, LinkedIn optimisation and mock interviews simulating pharma and CRO hiring rounds
FAQ
Clinical research course syllabus — FAQs
Can’t find your answer? Reach out on WhatsApp—we usually reply within an hour during business days.
Ask on WhatsApp →What is the syllabus of a clinical research course?
A clinical research course syllabus covers the drug development lifecycle, ICH-GCP E6(R3), regulatory frameworks (CDSCO, USFDA, EMA), and then the specialisation itself — for example ICSR processing, MedDRA coding, and Argus/ARISg for pharmacovigilance; EDC (Medidata Rave), CDISC, and SAS for clinical data management; or ICD-10/CPT/HCPCS and AAPC CPC prep for medical coding. Every iLearn CRI syllabus is built around hands-on platform work, not theory alone, and the complete module list for each course is on this page.
How long is a clinical research course?
At iLearn CRI, specialised certificate courses run 3 months (Pharmacovigilance & Regulatory Affairs, Clinical Data Management, Medical Coding, Medical Writing, Clinical SAS, Biostatistics, Bioinformatics), the ICH-GCP certification runs 1 month, and the comprehensive PG Diplomas run 6 months. All are available as live online and Pune classroom batches, weekday evenings and Saturdays.
Is the clinical research course syllabus the same online and in the classroom?
Yes. The online and classroom batches follow an identical syllabus, the same hands-on platform exercises, and the same placement preparation. Online students get independent remote access to the same tools (Argus, Medidata Rave, eCTD), so the module work is equivalent.
Can I download the detailed syllabus as a PDF?
Yes — every course has a downloadable syllabus PDF with the full module-by-module curriculum, fees, eligibility, and career outcomes. The download link is on each course page and in the section for that course below.
Found the syllabus that fits?
Talk to admissions about the next batch, or download the full syllabus PDF for your course above.