Certification in Clinical Research & Operations

Area	🔵 E6(R2) — Previous Version	🟢 E6(R3) — Current (2025)
Scope	Focused on traditional interventional clinical trials with investigational products	Expanded to cover diverse clinical studies including non-drug interventions, adaptive, decentralised and platform trials NEW
Structure	Single monolithic document with 8 sections and 1 annex	Restructured into a Core Guideline + Annexes (Annex 1: Clinical Trials; Annex 2: Non-Traditional Trials) NEW
Quality Management	Quality Assurance and Quality Control defined; limited proactive approach	Formal Quality Management System (QMS) approach; risk-based thinking embedded throughout; Critical Process & Data identification required EVOLVED
Risk-Based Monitoring	Introduced in R2 as an option; Annex 1 guidance on RBM added	RBM is now the default standard; centralised monitoring, statistical approaches, and hybrid monitoring explicitly incorporated ELEVATED
Roles & Responsibilities	Sponsor, Investigator, and Monitor defined; limited sub-delegation clarity	More explicit obligations for all parties; sub-investigator, vendor oversight (CRO), and delegated functions more clearly defined EVOLVED
Informed Consent	Paper-based consent standard; eConsent mentioned briefly	Electronic Informed Consent (eIC) formalised; remote consent processes addressed for decentralised settings NEW
Technology & Data	CDMS, EDC mentioned; limited digital guidance	Extensive guidance on digital health technologies (DHTs), wearables, BYOD policies, and electronic source data (eSource) NEW
Decentralised Trials	Not addressed	Decentralised Clinical Trials (DCTs), remote SDV, and local HCP involvement explicitly covered in Annex 2 NEW
Investigator Site File	Essential documents listed; ISF/TMF in Appendix	TMF/ISF principles updated; alignment with TMF Reference Model; fit-for-purpose documentation stressed UPDATED
Participant Protections	Standard protections; Declaration of Helsinki reference	Strengthened participant-centric language; diversity, equity, and inclusion in trial participation now emphasised NEW
Oversight of Vendors/CROs	Sponsor retains ultimate responsibility; delegation noted	Explicit framework for vendor qualification, oversight, and quality agreements; CRO accountability heightened STRENGTHENED
Protocol Deviations	Definitions and reporting requirements covered broadly	Refined categorisation of deviations; emphasis on systemic deviation analysis and CAPA integration REFINED
Terminology	"Subjects" used throughout	"Participants" replaces "subjects" — reflects person-centred, ethical language shift NEW
India / CDSCO Applicability	CDSCO formally adopted E6(R2) via Schedule Y amendments and NDCTR 2019	CDSCO yet to formally adopt R3; however, R3 principles (RBM, eConsent, digital tools) are being piloted and anticipated in upcoming CDSCO updates WATCH

Curriculum Structure

3-Month Course Modules, Lessons & Topics

Click any module header to expand lessons and topics. Each module is a CLINI-MENTOR LMS "Topic" with lessons, and quizzes

MOD 01

Introduction to Clinical Research & Drug Development

4 Lessons 12 hrs

▾

Learning Objective Learners will understand the drug development pipeline, history and evolution of clinical research, the role of regulatory oversight, and the shift from ICH E6(R2) to R3.

🎬

Lesson 1.1 — History & Evolution of Clinical Research

Video + Reading

Origins of clinical trials — thalidomide disaster and the birth of modern regulation
Declaration of Helsinki (1964, 2013 revision) — ethical pillars of human research
Belmont Report — respect for persons, beneficence, and justice
Tuskegee study — ethical lessons and lasting impact on informed consent
Timeline: from unregulated experimentation to ICH harmonisation
India's clinical trial history — Bhopal legacy, CDSCO evolution, and post-2013 reforms

📖

Lesson 1.2 — Drug Development Pipeline & Clinical Trial Phases

Reading + Infographic

Drug discovery to market: target identification → pre-clinical → IND → clinical phases → NDA/MAA
Phase 0 (microdosing) — concept and regulatory basis
Phase I — First-in-Human (FIH), SAD/MAD studies, healthy volunteer considerations
Phase II — Proof of concept, dose-ranging, biomarker studies
Phase III — Pivotal trials, randomisation, blinding, multi-site design
Phase IV — Post-marketing surveillance, pharmacovigilance obligations
Adaptive trial designs — seamless Phase II/III, basket, and umbrella trials
Bioequivalence (BE) / Bioavailability (BA) studies — relevance to India's generics industry

🎬

Lesson 1.3 — ICH E6(R2) vs E6(R3): A Paradigm Shift in GCP

Video + Comparison Activity

What is GCP and why it matters for every clinical trial professional
ICH E6(R2) — key principles, structure, and limitations
ICH E6(R3) (2024 Final) — rationale for revision, scope expansion
New Annex 1 (clinical trials) vs Annex 2 (non-traditional / decentralised trials)
Shift to Quality Management System (QMS) and risk-based thinking
Person-centred language: "participants" vs "subjects"
Digital health technologies (DHTs), eSource, and wearables under R3
Electronic Informed Consent (eIC) formalized in R3
CDSCO's current position on E6(R3) adoption
Practical implications for CRAs, site staff, and sponsors in India

❓

Lesson 1.4 — Regulatory Bodies & Global Clinical Research Landscape

Reading + Quiz

USFDA — structure, NDA/BLA, IND process, 21 CFR Parts overview
EMA — IMPD, CTR (EU Clinical Trials Regulation 536/2014)
CDSCO — DCGI, Schedule Y, NDCTR 2019, SUGAM portal, clinical trial site registration
PMDA (Japan), NMPA (China), TGA (Australia) — brief overview for global context
ICH membership and harmonisation goals
Module 1 End Quiz: 20 MCQs (CLINI-MENTOR LMS Quiz Block)

MOD 02

GCP Principles, Ethics & Participant Rights

4 Lessons 14 hrs

▾

Learning Objective Learners will master the 13 GCP principles under ICH E6(R3), comprehend informed consent frameworks, and apply ethical reasoning to real-world scenarios.

🎬

Lesson 2.1 — The 13 Principles of GCP (ICH E6 R3 Aligned)

Video

All 13 GCP principles with clinical application examples
Principle 1: Ethical conduct in accordance with Declaration of Helsinki
Principle 2: Risk–benefit assessment and ongoing evaluation
Principle 3: Participant rights, safety, and well-being over science
Principle 4: Non-clinical and clinical information supporting trials
Principle 5: Scientific soundness of protocols
Principle 6: Compliance with approved protocol
Principles 7–13: IRB/IEC roles, qualified investigators, accountability, data integrity, confidentiality, GMP, and quality systems
How E6(R3) QMS framework integrates with these principles

📖

Lesson 2.2 — Informed Consent: Process, Documentation & Special Populations

Reading + Activity

Elements of informed consent — all required and additional elements (21 CFR 50.25)
Consent process — steps, timing, re-consent requirements
Vulnerable populations: children, pregnant women, prisoners, cognitively impaired
LAR (Legally Acceptable Representative) — CDSCO and FDA positions
Emergency research and waiver of consent (21 CFR 50.24)
Electronic Informed Consent (eIC) — ICH E6(R3) framework, FDA eIC guidance (2016 + 2023 updates)
Common ICF deficiencies found in FDA Warning Letters and CDSCO inspections
Short form consent and translation requirements
Illiteracy provisions — CDSCO and Indian-context scenarios

📖

Lesson 2.3 — Institutional Review Boards (IRBs) & Independent Ethics Committees (IECs)

Reading

IRB structure and composition requirements — 21 CFR Part 56
IEC in India — CDSCO requirements, accreditation by NABH
Types of IRB review: full board, expedited, exempt
Protocol submission to IRB/IEC — required documents and timelines
Continuing review obligations and frequency
Unanticipated problems and adverse event reporting to IRB/IEC
Central IRBs vs local IRBs — trend in multi-site trials
Waiver of IEC review — scenarios and limitations

✏️

Lesson 2.4 — Ethics Case Studies & Module 2 Assessment

Case Study + Quiz

Case Study A: Consent obtained improperly — what should the CRA do?
Case Study B: Participant wants to withdraw — protocol obligations
Case Study C: IRB was not notified of a protocol deviation — escalation steps
Case Study D: eConsent system failure mid-trial in a DCT setting
H5P Drag-and-Drop: Match GCP principles to real-world scenarios
Module 2 End Quiz: 25 MCQs + 2 scenario-based questions

MOD 03

Roles, Responsibilities & Sponsor–Site Relationships

4 Lessons 14 hrs

▾

Learning Objective Learners will distinguish the roles of sponsors, CROs, investigators, sub-investigators, monitors, and coordinators, and understand how these roles have been refined under ICH E6(R3).

🎬

Lesson 3.1 — Sponsor Obligations (ICH E6 R3 + 21 CFR 312)

Video

Sponsor definition and legal accountability under ICH E6(R3)
Sponsor–CRO relationship and transfer of obligations — written agreements under R3
Investigational New Drug (IND) application — FDA 21 CFR Part 312
Protocol development, amendments, and protocol deviations
Investigational Product (IP) management and accountability
Safety reporting obligations: IND Safety Reports, SUSAR, DSUR
Trial Master File (TMF) management responsibilities
Oversight of vendors and third-party service providers under R3
Financial disclosures — 21 CFR Part 54

🎬

Lesson 3.2 — Investigator & Site Staff Roles

Video + Reading

Principal Investigator (PI) — qualifications, training, and legal obligations
Sub-Investigators — delegation log, supervision, training records
Clinical Research Coordinator (CRC) / Clinical Trial Coordinator (CTC) — role in India
Site Management Organisation (SMO) — role and India landscape
Pharmacist's role in IP dispensing and accountability
Investigator responsibilities for ICF, eligibility, data recording
Site initiation visit (SIV) checklist — what sponsors expect
Investigator qualifications and Form FDA 1572
CDSCO site registration and investigator registration requirements (SUGAM)

📖

Lesson 3.3 — Clinical Research Associate (CRA) / Monitor Role

Reading + Activity

CRA responsibilities — source data verification (SDV), source data review (SDR)
Types of monitoring visits: pre-study, initiation, routine, close-out
Writing monitoring visit reports (MVRs) — structure and content
Risk-Based Monitoring (RBM) framework under ICH E6(R3) — key metrics and signals
Central monitoring vs on-site monitoring
Remote SDV — tools, acceptability under USFDA and EMA
Escalation procedures — when and how to escalate findings
CRA career pathways in India — Entry CRA, CRA I, CRA II, Sr CRA, Lead CRA

❓

Lesson 3.4 — CRO Management, Outsourcing & Module 3 Quiz

Reading + Quiz

Contract Research Organisation (CRO) — types, full-service vs functional CROs
CRO selection criteria — qualification audits, SOPs, capabilities
Quality Agreements and Service Level Agreements (SLAs)
Outsourcing in clinical research — trends in India (Noida, Hyderabad, Bengaluru CRO hubs)
CDSCO's expectations for sponsor oversight of CROs
Module 3 End Quiz: 25 MCQs

MOD 04

Clinical Trial Documentation & Essential Documents

4 Lessons 14 hrs

▾

Learning Objective Learners will understand the Investigator Site File (ISF), Trial Master File (TMF), essential documents under ICH E6(R3), and source data principles including ALCOA+.

📖

Lesson 4.1 — Trial Master File (TMF) & Investigator Site File (ISF)

Reading + Infographic

Purpose and regulatory basis of TMF (ICH E6 R3 Section 8)
TMF Reference Model (DIA) — structure and applicability
TMF vs ISF — sponsor vs site responsibilities
Essential documents: before, during, and after a clinical trial
TMF inspection readiness — FDA, EMA, and CDSCO audit findings
eTMF — electronic TMF platforms (Veeva Vault, Ennov, MasterControl)
TMF completeness metrics and KPIs used in industry
Common TMF deficiencies and how to avoid them

🎬

Lesson 4.2 — Source Data, Source Documents & ALCOA+

Video + Exercise

Definition of source data and source documents
ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available
Source data verification (SDV) and source data review (SDR) — differences
Electronic source (eSource) — acceptability, regulatory guidance, 21 CFR Part 11
Patient-reported outcomes (PROs) and eDiaries as source data
Wearable device data as source — ICH E6(R3) position
Common data entry errors and correction procedures — NEVER use white-out
CDSCO's stance on electronic records and audit trails

📖

Lesson 4.3 — Case Report Forms (CRFs), EDC Systems & Data Queries

Reading + Demo

Paper CRF vs Electronic CRF (eCRF) — evolution and current standard
EDC systems in use: Medidata Rave, Oracle InForm, Veeva EDC, REDCap
CRF completion guidelines — do's and don'ts
Data queries — automated queries, manual queries, site response timelines
Database lock and audit trail review
Data management plan (DMP) — sponsor obligation
Role of site coordinator in EDC data entry

✏️

Lesson 4.4 — Protocol Deviations, Violations & CAPA + Module 4 Assessment

Case Study + Quiz

Protocol deviation vs protocol violation — definitions and regulatory significance
Major vs minor deviations — classification frameworks
Reporting requirements: to IRB, sponsor, and CDSCO/FDA
Root cause analysis (RCA) tools — fishbone, 5-Why method
Corrective Action and Preventive Action (CAPA) process
E6(R3) emphasis on systemic deviation analysis
Module 4 End Quiz: 25 MCQs + deviation classification exercise
Written Assignment 1: TMF gap analysis exercise (submitted via CLINI-MENTOR LMS Assignments)

MOD 05

Pharmacovigilance, Safety Reporting & Adverse Events

4 Lessons 14 hrs

▾

Learning Objective Learners will accurately classify adverse events, understand expedited and periodic safety reporting obligations, and apply CDSCO and FDA pharmacovigilance requirements.

🎬

Lesson 5.1 — Adverse Event Classification & Causality Assessment

Video

AE, SAE, SUSAR, AESI — definitions and key distinctions
Serious criteria: fatal, life-threatening, hospitalisation, disability, congenital anomaly, other
Causality assessment methods: WHO-UMC scale, Naranjo algorithm
Expected vs unexpected adverse reactions — IB reference
AE vs adverse drug reaction (ADR) — regulatory distinction
Severity vs seriousness — common misconception clarified
MedDRA coding basics — introduction to LLT, PT, HLT, SOC hierarchy

📖

Lesson 5.2 — Safety Reporting Timelines: FDA, EMA & CDSCO

Reading + Timeline Infographic

7-day and 15-day expedited SUSAR reporting — FDA 21 CFR 312.32
Annual Safety Report (DSUR) — ICH E2F requirements
CDSCO SAE reporting within clinical trials — NDCTR 2019, Form CTA
MedWatch Form FDA 3500A — use and submission
CIOMS forms for international safety reporting
Pregnancy reporting obligations in clinical trials
Development Safety Update Report (DSUR) — structure and frequency
IND safety reports — what triggers a 7-day vs 15-day report

📖

Lesson 5.3 — Data Safety Monitoring Board (DSMB) & Trial Stopping Rules

Reading

DSMB / IDMC — composition, independence, and charter
Interim analysis and DSMB review schedules
Pre-specified stopping rules — O'Brien–Fleming boundaries, alpha spending
Sponsor vs DSMB communication protocol
Blinded safety reviews vs unblinded interim analyses
India context: CDSCO's expectations for DSMB in pivotal trials

❓

Lesson 5.4 — PV Systems, Pharmacovigilance in India & Module 5 Quiz

Reading + Quiz

WHO Programme for International Drug Monitoring — VigiBase
India Pharmacovigilance Programme (PvPI) — NPPC, AMCs, and HCPs
Suspected Unexpected Serious Adverse Reactions (SUSARs) in India
Compensation for trial-related injury — CDSCO 2013 guidelines
PV in post-marketing setting — PSUR vs DSUR
Module 5 End Quiz: 25 MCQs + AE classification exercise

MOD 06

Regulatory Submissions, IND/CTRI & Study Start-Up

4 Lessons 16 hrs

▾

Learning Objective Learners will navigate the IND application process, CTRI registration, site feasibility, and the study start-up activities from a sponsor, CRO, and site perspective.

🎬

Lesson 6.1 — IND Application & CTA Process (FDA + CDSCO)

Video + Document Walkthrough

IND application structure: covering letter, Form FDA 1571, clinical protocol, IB, CMC, pre-clinical data
Types of INDs: Investigator IND, commercial IND, emergency IND, treatment IND
IND safety hold — triggers and sponsor response obligations
CDSCO IND equivalent — CTA (Clinical Trial Application) under NDCTR 2019
SUGAM Portal navigation — step-by-step for CTA submission
DCGI approval timelines and fee structures
Difference between Phase I, II, III CTA requirements in India
Academic / investigator-initiated trial (IIT) exemptions and simplifications

📖

Lesson 6.2 — CTRI Registration & Clinical Trial Registration Requirements

Reading + Demo

Clinical Trial Registry — India (CTRI): ctri.nic.in — mandatory registration
WHO ICTRP requirements and international trial registries (ClinicalTrials.gov)
Prospective vs retrospective registration — ethical implications
CTRI registration fields — mandatory data elements and WHO Data Set
Results registration and summary results upload obligations
CDSCO requirement for CTRI number before site initiation

📖

Lesson 6.3 — Site Feasibility, Selection & Study Start-Up

Reading + Checklist Activity

Site feasibility questionnaire — sponsor requirements and CRO role
Site qualification visit (SQV) / pre-study visit — objectives and checklist
Investigator and site selection criteria
Clinical Trial Agreement (CTA) / Site Contract — budget, payment milestones
Financial negotiation basics — indirect costs, overhead, per-patient costs
IRB/IEC submission and approval timelines
Site Initiation Visit (SIV) — training agenda, IP receipt, system access
Regulatory package assembly — essential documents pre-enrolment

❓

Lesson 6.4 — Protocol, Amendments & Module 6 Assessment

Reading + Quiz

Protocol structure: background, objectives, endpoints, design, eligibility, procedures, statistics, ethics
Primary, secondary, and exploratory endpoints — types and selection
Protocol amendment types — administrative vs substantial
Protocol amendment submission requirements — FDA, EMA, CDSCO
Blinding and unblinding procedures
Module 6 End Quiz: 25 MCQs

MOD 07

Clinical Data Management, Biostatistics Basics & Decentralised Trials

4 Lessons 16 hrs

▾

Learning Objective Learners will understand CDM processes from data collection to clean file, apply introductory biostatistical concepts, and comprehend decentralised clinical trial models under ICH E6(R3) Annex 2.

🎬

Lesson 7.1 — Clinical Data Management (CDM) Lifecycle

Video

CDM process overview: study setup → data collection → cleaning → database lock
Data Management Plan (DMP) — purpose and contents
Edit checks, validation rules, and discrepancy management
Data review listings and data cleaning milestones
CDISC standards: CDASH (collection), SDTM (submission), ADaM (analysis)
Medical coding: MedDRA for adverse events, WHO Drug Dictionary for medications
Database lock procedure — frozen vs hard lock
21 CFR Part 11 requirements for CDM systems

📖

Lesson 7.2 — Biostatistics Fundamentals for Clinical Trials

Reading + Infographic

Randomisation methods — simple, block, stratified, minimisation
Blinding — single blind, double blind, open-label, assessor blind
Sample size and statistical power — conceptual introduction (no formulas)
Null hypothesis, p-value, confidence interval — plain language explanation
ITT vs per-protocol vs safety populations
Statistical Analysis Plan (SAP) — what it is and who produces it
Multiplicity and alpha correction — why it matters in clinical trials
Reading a clinical trial results table — practical exercise

🎬

Lesson 7.3 — Decentralised & Hybrid Clinical Trials (DCTs)

Video + Interactive

What is a Decentralised Clinical Trial (DCT)? — Definition, drivers, post-COVID acceleration
ICH E6(R3) Annex 2 — specific provisions for non-traditional trial models
FDA Draft Guidance on DCTs (2023) — key recommendations
Types of DCT elements: remote visits, home nursing, local HCP, eConsent, eDiary, telemedicine
Digital Health Technologies (DHTs) in trials — wearables, apps, sensors
Bring Your Own Device (BYOD) policy considerations
Data integrity in DCTs — source data from remote settings
CDSCO's current position on DCTs — draft guidance and anticipated updates
Patient centricity and diversity implications of DCTs

✏️

Lesson 7.4 — Audit, Inspection Readiness & Module 7 Assessment

Case Study + Assignment + Quiz

Difference between audit and inspection
Types of audits: system audit, site audit, data audit, TMF audit
FDA inspection types: routine, for-cause, pre-approval inspection (PAI)
CDSCO site inspection process and Form 44
Common FDA Form 483 observations and Warning Letter findings related to Indian sites
Inspection readiness checklist for site coordinators
Module 7 End Quiz: 25 MCQs
Written Assignment 2: DCT design feasibility brief — 2-page case-based exercise

MOD 08

Career Readiness, SOPs, Industry Tools & Capstone Project

4 Lessons 20 hrs

▾

Learning Objective Learners will understand SOPs, industry tools, and the entry-level career landscape in Indian and global clinical research, and will complete a capstone case project integrating all course learning.

📖

Lesson 8.1 — Standard Operating Procedures (SOPs) & Quality Systems

Reading + SOP Exercise

What is an SOP? — Purpose, structure, and lifecycle
SOP development: drafting, review, approval, and versioning
SOP training and deviation from SOP — documentation requirements
GCP-required SOPs: monitoring, TMF management, AE reporting, IP handling
ICH E6(R3) quality system requirements — CAPA, change control
Exercise: Read and critique a sample monitoring SOP for GCP compliance gaps

🎬

Lesson 8.2 — Industry Tools, Technologies & Digital Literacy for CRPs

Video + Demo

EDC systems: Medidata Rave, Oracle InForm, REDCap — navigation demo
eTMF systems: Veeva Vault Clinical — introduction
CTMS (Clinical Trial Management Systems) — Veeva CTMS, Medidata CTMS
Safety databases: Argus Safety, Oracle Empirica (introduction)
IRT/RTSM systems for randomisation and IP supply
Microsoft Excel for clinical data management basics — pivot tables, data cleaning
e-Signature and 21 CFR Part 11 compliance in eTMF/EDC
AI tools emerging in clinical operations — what fresh CRPs should know

✏️

Lesson 8.3 — Career Pathways, Resume Building & Clinical Research Industry in India

Workshop + Activity

Entry-level roles: CRC, Data Entry Associate, PV Associate, CTA, Regulatory Affairs Associate
CRO landscape in India — top employers (IQVIA, Syneos, Parexel, Fortrea, ICON, Veeda, Clintec)
Pharma clinical operations teams — how they differ from CROs
SMO landscape in India — Noida, Mumbai, Hyderabad, Bengaluru clusters
Resume writing for clinical research freshers — keywords, GCP certification mention
LinkedIn profile optimisation for clinical research visibility
Interview preparation: common fresher interview questions with model answers
CliniMENTOR programme — CLINIASSURE mentorship access for placement support
GCP certification pathways: ACRP CRC Exam, SOCRA CCRC, TATA Clinical Research Certificate

✏️

Lesson 8.4 — Capstone Project: Integrated Clinical Trial Simulation

Capstone Assignment

Capstone Scenario: A Phase II Randomised Controlled Trial (RCT) in Type 2 Diabetes — Sponsor: hypothetical pharma company; Sites: 3 Indian hospitals
Task 1: Draft a 1-page protocol synopsis (objectives, design, eligibility, endpoints)
Task 2: Prepare an informed consent scenario response for a low-literacy participant
Task 3: Classify and report a SAE using CIOMS Form — causality and seriousness assessment
Task 4: Identify 5 protocol deviations from a simulated CRF packet — classify and write a CAPA
Task 5: Create an ISF essential document checklist for pre-study visit
Task 6: Write a 300-word reflection: How does ICH E6(R3) change the way you would handle monitoring at this site vs R2?
Capstone evaluated by CliniMENTOR trainer — feedback within 7 days
Final Module Quiz: 30 MCQs — comprehensive across all 8 modules

Assessment Framework

Evaluation Structure (CLINI-MENTOR LMS Aligned)

📝 Formative Assessments

Per-Module Quizzes (8 × 25 MCQs)30%

Case Study ParticipationNon-graded / reflective

Passing Score per Quiz70%

Attempts Allowed2 per quiz

📋 Summative Assessments

Written Assignment 1 (TMF Gap Analysis)15%

Written Assignment 2 (DCT Design Brief)15%

Capstone Project (6-task simulation)30%

Minimum Capstone Score60%

Overall Pass Threshold65%

🏅 Certification Criteria

All 8 module quizzes passedRequired

Both assignments submittedRequired

Capstone project submitted & passedRequired

Course completion ≥ 80% lessonsRequired

Certificate issued viaCLINI-MENTOR LMS + Digital Badge

🖥️ CLINI-MENTOR LMS Configuration

Course typeSelf-paced + Live QnA

Prerequisite enforcementPhase-locked (1→2→3)

Discussion forumsPer-module BuddyBoss/BBPress

Certificate templateCLINIASSURE ACADEMY branded PDF

Support channelCLINI-BUDDY (WhatsApp / Portal)

Timeline

3-Month Week-by-Week Schedule

Week	Phase	Module	Key Deliverables	Hours	Assessment
W1	Phase 1	MOD 01 — Intro & Drug Development	Lessons 1.1–1.4; ICH R2 vs R3 note	12	Quiz 1
W2	Phase 1	MOD 02 — GCP, Ethics & Consent	Lessons 2.1–2.4; Case studies A–D	14	Quiz 2
W3	Phase 1	MOD 02 continued + Review	IRB/IEC deep dive; Phase 1 review session	8	—
W4	Phase 1→2	MOD 03 — Roles & Responsibilities	Lessons 3.1–3.4; Sponsor–CRO deep dive	14	Quiz 3
W5	Phase 2	MOD 04 — Documentation & ALCOA+	Lessons 4.1–4.3; eTMF intro	10	—
W6	Phase 2	MOD 04 continued + Assignment 1	Lesson 4.4; CAPA; Assignment 1 due	10	Quiz 4 + Assign 1
W7	Phase 2	MOD 05 — Pharmacovigilance	Lessons 5.1–5.4; SAE exercise	14	Quiz 5
W8	Phase 2→3	MOD 06 — IND/CTA & Study Start-Up	Lessons 6.1–6.4; CTRI demo	16	Quiz 6
W9	Phase 3	MOD 07 — CDM & Biostatistics	Lessons 7.1–7.2; CDISC intro	10	—
W10	Phase 3	MOD 07 — DCT + Audits + Assignment 2	Lessons 7.3–7.4; Assignment 2 due	12	Quiz 7 + Assign 2
W11	Phase 3	MOD 08 — SOPs, Tools & Career	Lessons 8.1–8.3; Resume workshop	12	—
W12	Phase 3	MOD 08 — Capstone Project	Lesson 8.4; Capstone submission; Final Quiz	20	Capstone + Final Quiz
TOTAL PROGRAM HOURS				~142 hrs

Certification in Clinical Research
& Operations

About This Certification

Target Learner

Regulatory Alignment

LMS Platform

Structure

Assessment

Exit Credential

Governing Bodies & Applicable Guidelines

ICH

USFDA

CDSCO

ICH E6(R2) vs. ICH E6(R3) — Key Differences

ICH E6(R2) vs ICH E6(R3) — Side-by-Side Comparison

3-Month Course Modules, Lessons & Topics

Foundation Phase — Introduction to Clinical Research

Introduction to Clinical Research & Drug Development

GCP Principles, Ethics & Participant Rights

Core Operations Phase — Trial Execution & Management

Roles, Responsibilities & Sponsor–Site Relationships

Clinical Trial Documentation & Essential Documents

Pharmacovigilance, Safety Reporting & Adverse Events

Advanced Practice Phase — Specialisation & Career Readiness

Regulatory Submissions, IND/CTRI & Study Start-Up

Clinical Data Management, Biostatistics Basics & Decentralised Trials

Career Readiness, SOPs, Industry Tools & Capstone Project

Evaluation Structure (CLINI-MENTOR LMS Aligned)

📝 Formative Assessments

📋 Summative Assessments

🏅 Certification Criteria

🖥️ CLINI-MENTOR LMS Configuration

3-Month Week-by-Week Schedule

Certification in Clinical Research& Operations

About This Certification

Target Learner

Regulatory Alignment

LMS Platform

Structure

Assessment

Exit Credential

Governing Bodies & Applicable Guidelines

ICH

USFDA

CDSCO

ICH E6(R2) vs. ICH E6(R3) — Key Differences

ICH E6(R2) vs ICH E6(R3) — Side-by-Side Comparison

3-Month Course Modules, Lessons & Topics

Foundation Phase — Introduction to Clinical Research

Introduction to Clinical Research & Drug Development

GCP Principles, Ethics & Participant Rights

Core Operations Phase — Trial Execution & Management

Roles, Responsibilities & Sponsor–Site Relationships

Clinical Trial Documentation & Essential Documents

Pharmacovigilance, Safety Reporting & Adverse Events

Advanced Practice Phase — Specialisation & Career Readiness

Regulatory Submissions, IND/CTRI & Study Start-Up

Clinical Data Management, Biostatistics Basics & Decentralised Trials

Career Readiness, SOPs, Industry Tools & Capstone Project

Evaluation Structure (CLINI-MENTOR LMS Aligned)

📝 Formative Assessments

📋 Summative Assessments

🏅 Certification Criteria

🖥️ CLINI-MENTOR LMS Configuration

3-Month Week-by-Week Schedule

Certification in Clinical Research
& Operations