Clinical Trial Compliance Course
Register for this course
We are committed to delivering this course in multiple training formats to accommodate your needs. Our state-of-the-art learning facilities ensure a comfortable and engaging experience. With our flexible face-to-face training calendar, you can select any classroom course and have it delivered at a venue of your choice, offering you unparalleled convenience and exceptional value.
Course Overview
Clinical trial compliance is more critical than ever as regulations evolve, trials become more complex, and new technologies emerge. This course equips compliance professionals, clinical operations staff, and trial managers with the tools to ensure trial integrity, ethical conduct, and regulatory alignment. Key areas include risk based oversight, quality by design, new Good Clinical Practice (GCP) guidelines, and digital strategies to maintain compliance across the trial lifecycle.
Course Duration
5 Days
Target Audience
- Clinical Trial Managers and Coordinators
- Clinical Research Associates (CRAs)
- Compliance / Quality Assurance Professionals in Clinical Research
- Regulatory Affairs Specialists
- Clinical Operations / Clinical Oversight Teams
Personal Impact
- Build confidence in navigating and applying the updated ICH GCP E6(R3) guideline.
- Develop the ability to proactively identify, assess, and mitigate compliance risks across the study lifecycle.
- Improve skills in creating and reviewing compliance documentation, training programs, and oversight plans.
- Become a more strategic compliance partner, not just reactive quality control, but proactive quality assurance.
Organizational Impact
- Strengthen trial quality and integrity through a risk based, compliance first culture.
- Reduce regulatory risk by embedding oversight and quality control in trial design and operations.
- Improve efficiency and resource use by focusing monitoring on high risk elements.
- Enhance readiness for inspection and audit through modern, documented compliance systems.
Course Level: Intermediate
Course Objectives
By the end of this course, participants will be able to:
- Understand the latest GCP regulatory framework, including ICH E6(R3), and its implications for trial compliance.
- Implement Risk‑Based Quality Management (RBQM) strategies to focus oversight on critical to quality (CtQ) factors.
- Build a quality by design (QbD) approach into clinical trial protocols and operations.
- Establish effective compliance systems for data integrity, documentation, and audit readiness, including digital and hybrid trials.
- Operationalize oversight of delegated tasks, outsourcing, and third party partner risk.
- Integrate oversight tools and digital compliance mechanisms (e.g., centralized monitoring, data governance) for modern trials.
Course Outline
Module 1: Regulatory Foundations & GCP Updates
- The ICH GCP E6(R3) guideline: key changes, principles, and risks
- Proportionality and risk based approaches in trial conduct
- Sponsor vs investigator responsibilities under R3
- Implications for decentralized and hybrid trial models
- Exercise: Map out how ICH E6(R3) changes affect key roles in your organization (sponsor, CRA, investigator).
Module 2: Risk Based Quality Management (RBQM)
- Defining and identifying Critical to Quality (CtQ) factors
- Risk assessment and risk planning for clinical trials
- Centralized and targeted monitoring strategies vs traditional monitoring
- Risk review committees and cross functional oversight
- Case Study: Design a risk based monitoring plan for a clinical study, detailing which sites/data to prioritize and why.
Module 3: Quality by Design (QbD) & Trial Design
- Embedding quality into trial protocols from the start
- Identifying CtQ parameters in your protocol
- Building monitoring, quality checks, and contingencies around those parameters
- Delegation and oversight of third parties (CROs, vendors) under a QbD framework
- Group Project: Take a study protocol (real or hypothetical) and redesign it integrating QbD and compliance checkpoints.
Module 4: Data Integrity, Documentation & Compliance Systems
- Good documentation practices (GDocP) in modern trials
- Governance for digital records: audit trails, metadata, source data verification
- Ensuring data integrity throughout the data lifecycle (collection, processing, reporting)
- Handling deviations, protocol non compliance and corrective/preventive actions
- Exercise: Develop a data governance plan for a clinical trial, covering roles, documentation standards, and system controls.
Module 5: Digital Compliance & Emerging Oversight Tools
- Centralized and remote monitoring: tools, metrics, and implementation
- Electronic Trial Master File (eTMF) and audit readiness
- Patient centric and decentralized trials: regulatory insights and risk management
- Preparing compliance for AI, machine learning or real world data approaches
- Capstone Project: Build a compliance roadmap for a trial using modern oversight tools and ICH E6(R3) principles from protocol to close out.
Course Administration Details:
METHODOLOGY
The instructor-led trainings are delivered using a blended learning approach and comprise presentations, guided sessions of practical exercise, web-based tutorials, and group work. Our facilitators are seasoned industry experts with years of experience, working as professionals and trainers in these fields. All facilitation and course materials will be offered in English. The participants should be reasonably proficient in English.
ACCREDITATION
Upon successful completion of this training, participants will be issued a Skillstate Institute certificate.
TRAINING VENUE
The training will be held at a Skillstate Institute Training Centre. The course fee covers the course tuition, training materials, two break refreshments, and lunch. All participants will additionally cater to their travel expenses, visa application, insurance, and other personal expenses.
ACCOMMODATION AND AIRPORT PICKUP
Accommodation and airport pickup are arranged upon request. For reservations contact the Training Officer.
Email: info@skillstateinstitute.org
Phone: +254100920301
TAILOR-MADE
This training can also be customized to suit the needs of your institution upon request. You can have it delivered in our Training Centre or at a convenient location. For further inquiries, please contact us on:
Email: info@skillstateinstitute.org
Phone: +254100920301
PAYMENT
Payment should be transferred to our Skillstate Institute account through a bank on or before the start of the course. Send proof of payment to info@skillstateinstitute.org