Good Clinical Practice (ICH GCP E6 R3)
The principles and responsibilities of ICH GCP E6(R3) for investigators, sponsors and site staff in clinical trials.
At a glance
- 2 days
Who it's for
- Clinical research staff
- Investigators and coordinators
- Monitors and QA staff
Learning objectives
- Understand ICH GCP E6(R3) principles
- Know the roles of sponsor, investigator and IRB
- Obtain valid informed consent
- Assure data quality and integrity
Detailed content
- Ethics and participant safety
- Risk-based quality
- What changed in R3
- Sponsor
- Investigator
- Ethics committee
- Consent process
- Vulnerable participants
- Documentation
- Source data
- Monitoring
- Audits and inspections
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- GCP principles
- Roles and responsibilities
- Informed consent
- Data quality
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Patient-flow mapping and waiting-time analysis
- Accreditation tracer exercise
- Incident and near-miss review (RCA)
- Case studies from Egyptian and Gulf organizations
Tools and templates you keep
- Tracer and audit tools
- Healthcare KPI dashboard
- Course workbook and slide handouts
- Templates and checklists used in the exercises
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- JCI Accreditation Standards (8th ed.)
- GAHAR standards (Egypt)
- IHI Model for Improvement
Certificate
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
New in our 2026 portfolio — tell us your dates and we will confirm the trainer and schedule.
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Frequently asked questions
How long is Good Clinical Practice (ICH GCP E6 R3)?
The program runs 2 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
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Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.