Good Clinical Practice (GCP) ICH E6(R3) Corporate Training
Run inspection-ready clinical trials under ICH E6(R3) with guided, instructor-led training.
This instructor-led program takes your team from GCP principles to an inspection-ready trial file. Through guided hands-on labs, your employees draft protocols, run informed consent, report safety events, and build the quality systems that keep a trial compliant under ICH E6(R3).
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a inspection-ready clinical trial team
The Edstellar CLINICAL TRIAL QUALITY Capability Model
Diagnose
Map your team's current trial conduct, site roles, and GCP readiness before day one.
Standardize
Set shared conventions for protocols, consent language, and safety reporting across sites.
Practice
Run guided labs on protocol writing, AE reporting, and TMF documentation with instructor review.
Measure
Validate trial conduct and documentation quality with repeatable checks and assessments.
Scale
Extend trusted GCP practices to new trials and sites with governance and quality controls.
Need more than one program?Get a group quote
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Program Overview: What is Good Clinical Practice (GCP) ICH E6(R3)?
Good Clinical Practice (GCP) ICH E6(R3) is a 24-hour program for clinical research professionals who must master the revised international GCP guideline. It covers ICH E6(R3) essentials, trial design with quality by design, investigator and sponsor responsibilities, informed consent and participant protection, and safety reporting with data integrity. Participants work through sixteen practice sessions until the new guideline's requirements are second nature.
The program is exercise-driven: each module pairs the guideline text with hands-on practice, from protocol reviews and responsibility mapping to consent procedure drills and essential document assembly. Participants rehearse the exact documentation and decision patterns inspectors expect under E6(R3). Instructors with regulatory inspection experience review every exercise, flagging the gaps that draw findings. It closes with a capstone where each team produces an inspection-ready trial file.
The E6(R3) revision changed the rules: quality by design is now explicit, sponsor oversight expectations are sharper, and documentation standards are higher. Teams still operating on the old guideline risk inspection findings, data rejection, and delayed approvals. This program brings clinical teams fully current, so their trials meet the revised standard from day one.
The capstone is an inspection-ready trial file built to the E6(R3) standard: protocol and quality-by-design documentation, responsibility matrices for investigators and sponsors, consent records, safety reporting logs, and the complete essential document set. Instructors review each file the way an inspector would, issuing mock findings the team must resolve on the spot. Participants return with a file template that passes real inspections and the practiced judgment to keep it that way.
Sessions cover the R3 revision highlights, risk-proportionate quality management, essential documents, data integrity principles, monitoring approaches, and regulatory inspection expectations. The instructor-led format keeps clinical operations, quality, and regulatory roles aligned on the documentation and handoffs that make a trial safe and compliant.
What's Included in this Workshop for Your Enterprise Teams
- 1
Protocol and consent labs
Draft protocol sections and consent documents with instructor support.
- 2
Safety reporting drills
Triage and report adverse events within required timelines.
- 3
TMF documentation practice
Build essential documents for an inspection-ready trial master file.
- 4
Inspection readiness planning
Prepare your team for regulatory inspections and audit visits.
- Instructor-led live sessions with guided lab time
- Hybrid delivery across virtual and onsite formats
- 24 hours of structured program time
- Cohort-sized batches for focused instructor support
- Course materials and lab guides for every module
- Post-program support resources for your team
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
Request a Training Quote- Customized Training Delivery
- Scale Your Training: Small to Large Teams
- In-person Onsite, Live Virtual or Hybrid Training Modes
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- Hands-On Labs on Live Infrastructure, Led by Industry Experts
Good Clinical Practice (GCP) ICH E6(R3) Course Topics and Program Outline
Six instructor-led modules move your team from GCP foundations to a finished capstone: ICH E6(R3) principles, trial responsibilities, consent and safety reporting, quality systems, and a complete inspection-ready trial file.
Built by Edstellar with clinical trial quality practitioners
Built by clinical research professionals who run GCP-compliant trials and inspections in production, shaped around your stack and use cases.
We map your team's trial roles, GCP gaps, and inspection readiness before the first session.
Instructor-led sessions build GCP principles, ICH E6(R3) changes, and protocol fundamentals.
Guided labs on consent, safety reporting, and TMF documentation mirror real trial workflows.
Your team closes with a capstone trial file and a quality plan ready for real inspections.
From GCP principles to an inspection-ready trial file in 24 hours of guided clinical practice.
Delivered as
The program runs instructor-led across virtual, onsite, or hybrid formats. Most practice time is hands-on lab work in guided trial scenarios.
Map the R3 principles to trial roles in a guided responsibility chart.
learna)Evolution of GCP and the ICH E6(R3) revision
b)R3 principles for participant protection
c)Roles across sponsor, investigator, and sites
d)Risk-proportionate quality thinking
Draft a protocol synopsis section with instructor review.
learna)Protocol structure under ICH E6(R3)
b)Quality by design in trial planning
c)Eligibility, endpoints, and assessments
d)Risk-based quality management basics
Build a delegation log and supervision plan for a mock site.
practicea)Investigator qualifications and responsibilities
b)Delegation logs and supervision duties
c)Sponsor oversight and monitoring plans
d)IRB/IEC submissions and approvals
e)Managing trial supplies and devices
Run a mock consent conversation and document it correctly.
practicea)Elements of a compliant consent process
b)Consent documentation and re-consent
c)Protecting vulnerable participants
d)Privacy and confidentiality controls
Triage mock safety events and file them into a trial master file.
applya)Adverse event and SAE reporting timelines
b)Data integrity: ALCOA-C in trial records
c)Essential documents and the trial master file
d)Monitoring, deviations, and CAPA
e)Inspection readiness and regulatory visits
Assemble and defend an inspection-ready trial file.
applya)Assemble a complete trial master file
b)Close gaps found in mock inspection
c)Present your trial quality plan
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Practical capabilities your team can apply immediately to GCP-compliant trial work.
Trial protocol design
Design protocols that embed quality by design and ICH E6(R3) expectations.
ICH E6(R3) compliance
Apply the revised GCP principles to everyday trial conduct and decisions.
Informed consent practice
Run compliant consent conversations and document them correctly.
Safety event reporting
Identify, triage, and report adverse events within required timelines.
TMF documentation
Build and maintain an inspection-ready trial master file.
Data integrity controls
Apply ALCOA-C principles to trial records and source documentation.
Inspection readiness
Prepare sites and sponsors for regulatory inspections and audits.
Teams that Benefit from this Good Clinical Practice (GCP) ICH E6(R3) Group Training
This program suits clinical operations, site teams, quality, and regulatory groups running or overseeing clinical trials, plus sponsors preparing for inspections. Content adapts to role and experience so each cohort practices the workflows it owns.
Operations teams run compliant trials
Clinical operations teams learn protocol design, monitoring, and quality controls for ICH E6(R3) trials.
Workflow friction
- Protocol deviation pressure
- Multi-site coordination
- Timeline constraints
How the program helps
- Design inspection-ready protocols
- Monitor trials effectively
- Manage site performance
Practice use cases
- Protocol reviews
- Monitoring visits
- Deviation handling
QA teams keep trials inspection-ready
Quality assurance teams master audits, CAPA, and the documentation standards inspectors expect.
Workflow friction
- Finding documentation gaps
- CAPA follow-through
- Audit scheduling load
How the program helps
- Audit trial processes
- Drive effective CAPA
- Maintain TMF quality
Practice use cases
- GCP audits
- Inspection prep
- CAPA tracking
Regulatory teams navigate R3 expectations
Regulatory teams interpret ICH E6(R3) changes and align submissions with inspector expectations.
Workflow friction
- Evolving guidance
- Cross-region differences
- Evidence expectations
How the program helps
- Interpret R3 updates
- Prepare submissions
- Brief leadership teams
Practice use cases
- Regulatory submissions
- Guidance reviews
- Inspection support
Sites meet investigator duties
Site teams and investigators practice delegation, consent, and safety reporting under R3.
Workflow friction
- Staff turnover
- Consent documentation
- Safety triage speed
How the program helps
- Run compliant consent
- Report safety events
- Supervise delegated tasks
Practice use cases
- Consent clinics
- Delegation logs
- Safety reporting
Cohorts are grouped by role so labs match the workflows each team owns.
Prerequisites: This program benefits clinical operations, site staff, quality, and regulatory teams involved in clinical trials. Basic clinical research familiarity helps but is not required, and no prior ICH E6(R3) knowledge is needed. The instructor adapts labs to your team's trial portfolio and regulatory context.
Clinical Research Associate to Trial Quality Lead
A growth path from basic GCP literacy to leading inspection-ready clinical trials.
One program that grows with clinical research careers, from GCP basics to confident trial quality delivery.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Choose the delivery format that fits your team's schedule and locations.
Hybrid Training
Blend live virtual sessions with onsite lab days so distributed clinical teams stay aligned while practicing together.
- Live instructor across every session
- Shared lab environments for every learner
- Flexible scheduling for shift-based teams
- Consistent cohort experience
Onsite Training
Run the full program at your facility so labs map directly onto your trial workflows and quality systems.
- Training at your trial site
- Labs aligned to your workflows
- Direct instructor access all week
- Team-wide alignment on conventions
Live Virtual Training
Join live from anywhere with the same guided labs, instructor support, and capstone as onsite delivery.
- Live instructor-led sessions online
- Cloud-based lab environments
- Same capstone and assessments
- Scheduling across time zones
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size and preferred dates and we will send a tailored group quote within one business day.
Yes. A short discovery call helps us align the program with your team's trials and inspection goals.
Yes. The program runs live virtual, onsite, or hybrid with the same labs and instructor support.
Yes. Onsite delivery lets labs map directly onto your trial workflows, systems, and quality needs.
The program runs 24 instructor-led hours across six modules, typically delivered over three to four days.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
GCP opens this path because every person involved in a clinical trial must follow ICH E6(R3). With GCP understood, your team runs trial operations, manages trial data and finally writes the clinical documents that report the results.
Why Choose Edstellar as Your Good Clinical Practice (GCP) ICH E6(R3) Training Provider
Edstellar delivers instructor-led corporate training that turns clinical teams into confident GCP practitioners, with labs and an inspection-ready capstone file built around your trials.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Labs and the capstone adapt to your team's trial phases, therapeutic areas, and regulatory context.
Proven Methodology
A structured learn, practice, apply arc moves clinical teams from GCP basics to inspection-ready trial files.
Practice-Based Learning
Guided labs on protocols, consent, safety reporting, and TMF documentation mirror real trial workflows.
Expert Trainers
Instructors are practicing clinical research professionals with production experience in GCP trials and inspections.
Global Scale
Cohort batches run across regions and time zones with consistent curriculum, labs, and instructor support.
Measurable Outcomes
Pre and post assessments track GCP knowledge, documentation accuracy, and readiness for regulatory inspection.
Connect ICH E6(R3) Principles With Practical Trial Documentation and Review
Edstellar develops GCP capability by linking trial roles and quality planning with the records that document their execution. Participants review protocol material, rehearse consent, and work through safety and data-integrity cases. The final trial file is reviewed for clear responsibilities, coherent decisions, and traceable evidence rather than assumed inspection success.
- Step 01
Consult
We review clinical-research familiarity and gaps in protocol work, delegation, consent records, or safety documentation, identifying the trial responsibilities held by participants.
- Step 02
Plan
GCP and E6(R3) foundations lead into quality-focused trial design, sponsor and investigator duties, consent, and essential documents before the complete trial-file exercise.
- Step 03
Align
We align clinical-trial quality expertise with operations, site, and regulatory roles, confirming the portfolio context while establishing shared principles for participants new to E6(R3).
- Step 04
Customize
Mock protocols, delegation records, and safety-event cases reflect relevant trial settings, allowing practical documentation without using identifiable participant information or confidential clinical records.
- Step 05
Execute
Participants draft protocol sections, rehearse consent, and triage mock safety events, receiving feedback on role accountability, participant protection, data integrity, and filing consistency.
- Step 06
Evaluate
We assess the trial file for traceable responsibilities, supported protocol and safety decisions, complete consent documentation, and coherent essential records that participants can explain.
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Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Good Clinical Practice (GCP) ICH E6(R3) Training Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request Good Clinical Practice (GCP) ICH E6(R3) Training for Your Team
Tell us about your team and clinical trial goals, and we will design a cohort plan around them.