The pharmaceutical and biotechnology industries rely on clinical research to develop new drugs and treatments that can change lives. However, the integrity and ethical conduct of these trials are non-negotiable. Good Clinical Practice (GCP) is the international standard that sets the foundation for all clinical research, ensuring that the rights, safety, and well-being of trial participants are protected above all else. This comprehensive training course provides the essential knowledge and skills needed to navigate the complexities of clinical trials in a compliant and ethical manner, fostering a culture of scientific excellence and patient-centric care.

This program goes beyond the textbook, offering a practical and in-depth look at the entire clinical research lifecycle. Participants will learn how to apply GCP principles to real-world scenarios, from meticulous protocol adherence and data management to effective site monitoring and regulatory reporting. By mastering these critical skills, you'll be prepared to contribute to clinical trials with the confidence that you are upholding the highest standards of scientific integrity and protecting the trust of patients who volunteer to advance medical science.

Duration: 10 days

Target Audience:

• Clinical research coordinators and assistants
• Clinical research associates (CRAs)
• Site investigators and sub-investigators
• Data managers and biostatisticians
• Regulatory affairs specialists
• Medical doctors and nurses in a research setting
• Quality assurance and auditing professionals
• Pharmaceutical and biotech professionals
• Clinical trial project managers
• Institutional Review Board (IRB) members

Objectives:

• Master the core principles and standards of ICH GCP.
• Understand the roles and responsibilities of all key players in a clinical trial.
• Apply ethical principles to protect the rights and well-being of trial participants.
• Grasp the essentials of clinical trial design and phases.
• Prepare, obtain, and document a valid informed consent.
• Manage and maintain accurate source documents and case report forms (CRFs).
• Identify, document, and report adverse events and protocol deviations.
• Understand the process of clinical trial monitoring, auditing, and inspection.
• Ensure data integrity and quality assurance throughout a study.
• Comply with key international and local regulatory requirements.

Module 1: Foundations of Clinical Research

• An introduction to the drug development process
• The purpose and benefits of clinical trials
• The different phases of a clinical trial (I, II, III, IV)
• Key stakeholders and their relationships in a study
• Understanding the study protocol and its importance

Module 2: Ethics in Human Research

• The history of ethical scandals in clinical research
• Core ethical principles from the Declaration of Helsinki
• The role and responsibilities of the Institutional Review Board (IRB)
• Protecting vulnerable populations in clinical trials
• Ensuring justice and beneficence in research

Module 3: Introduction to GCP

• The history and purpose of Good Clinical Practice
• The 13 principles of ICH GCP E6 (R2/R3)
• The importance of a risk-based approach to trials
• How GCP ensures patient safety and data credibility
• Applying GCP standards to your daily work

Module 4: Informed Consent Process

• Defining informed consent and its legal basis
• The essential elements of a valid informed consent form
• The roles of the investigator and study staff
• Obtaining and documenting consent from participants
• Special considerations for non-English speakers and minors

Module 5: The Clinical Investigator’s Role

• The investigator's responsibilities to the sponsor and the IRB
• Oversight of the clinical trial site and staff
• Ensuring protocol compliance at all times
• Medical care of trial participants
• Maintaining investigator files and essential documents

Module 6: Sponsor and CRO Responsibilities

• The sponsor's role in trial design and management
• The process of selecting a qualified investigator
• Quality assurance and quality control systems
• The role of the Contract Research Organization (CRO)
• The importance of oversight and communication

Module 7: Clinical Trial Monitoring

• The purpose and types of clinical trial monitoring
• The role and responsibilities of a CRA
• How to conduct a successful monitoring visit
• Source data verification (SDV) and its importance
• Remote and centralized monitoring techniques

Module 8: Data Management and Handling

• The clinical data management (CDM) lifecycle
• Designing and using Case Report Forms (CRFs)
• Data collection, entry, and validation
• Understanding data queries and discrepancy management
• Database lock and data archiving

Module 9: Adverse Event Reporting

• Defining adverse events (AEs) and serious adverse events (SAEs)
• The process of causality assessment
• Timelines for reporting to the sponsor and regulatory bodies
• Reporting protocol deviations and violations
• The role of the Safety Management Plan

Module 10: Clinical Trial Documentation

• The purpose and content of the investigator site file
• Maintaining essential documents for a trial
• The importance of document version control
• Ensuring accuracy and completeness of all records
• The audit trail and electronic signatures

Module 11: Audits and Inspections

• The difference between a sponsor audit and a regulatory inspection
• Preparing for and hosting an inspection (e.g., FDA, EMA)
• The role of the quality assurance (QA) department
• Common inspection findings and how to avoid them
• Responding to audit and inspection reports

Module 12: Drug and Device Accountability

• The importance of investigational product management
• Procedures for receiving, storing, and dispensing products
• Maintaining accurate drug accountability logs
• Handling and destroying unused or expired products
• The role of the site pharmacist

Module 13: Study Close-Out Procedures

• The process of a final close-out visit
• Ensuring all data is captured and forms are signed off
• Finalizing all essential documents
• Archiving trial records for long-term storage
• Preparing the final study report

Module 14: Special Considerations in Research

• Clinical research in pediatric populations
• Clinical trials involving pregnant women
• Research with subjects who have cognitive impairment
• The use of adaptive trial designs
• Multi-site and international clinical trials

Module 15: Introduction to Pharmacovigilance

• The relationship between GCP and pharmacovigilance
• The importance of post-marketing surveillance
• Identifying and reporting safety signals
• Risk management plans and their implementation
• The role of safety data in drug lifecycle management

Module 16: The Future of Clinical Research

• The impact of technology on clinical trials (e-consent, e-source)
• The rise of decentralized clinical trials (DCTs)
• Patient-centricity in trial design
• Real-world evidence and its growing importance
• Career paths and professional development in clinical research

Training Approach

This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.

Tailor-Made Course

This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: info@skillsforafrica.org, training@skillsforafrica.org Tel: +254 702 249 449

Training Venue

The training will be held at our Skills for Africa Training Institute Training Centre. We also offer training for a group at requested location all over the world. The course fee covers the course tuition, training materials, two break refreshments, and buffet lunch.

Visa application, travel expenses, airport transfers, dinners, accommodation, insurance, and other personal expenses are catered by the participant

Certification

Participants will be issued with Skills for Africa Training Institute certificate upon completion of this course.

Airport Pickup and Accommodation

Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: info@skillsforafrica.org, training@skillsforafrica.org Tel: +254 702 249 449

Terms of Payment: Unless otherwise agreed between the two parties’ payment of the course fee should be done 7 working days before commencement of the training.