This full-day series of three pre-conference sessions are designed to provide full, comprehensive training on ICH/FDA Good Clinical Practice guidelines, resulting in a GCP certification of training completion for attendees.
This Good Clinical Practice Training session has been accepted by the TransCelerate Mutual Recognition (MR)
Program of the TransCelerate Site Qualification and Training (SQT) initiative and is considered acceptable
GCP training by any sponsor which recognizes the TransCelerate program.
Participants who attend the full training will receive a certificate of training completion.
Janet Holwell - Clinical Research Consultant/Trainer - Holwell Clinical Research Consulting
Patricia Mendoza - Senior Quality Assurance Auditor - Medpace
The overall objectives for the total course are:
- Describe the background, principles, and application of ICH GCP, including the scope and intent of guidelines and U.S. regulations that govern clinical research
- Identify requirements and steps from study start up to study closeout.
- Describe ICH GCP key roles and responsibilities in the conduct of clinical trials including inspection readiness from study start
- Explain the importance of and comply with safety reporting requirements
- Discuss post-study activities, audits, and inspections
The individual modules covered with the their corresponding objectives are:
Module 1 – The Drug Development Process and the Evolution of Regulation
- Describe the steps involved in clinical development
- Explain the scope and intent of guidelines and regulations that govern clinical research, particularly the ICH–GCP
- Differentiate between the investigator’s and the sponsor’s responsibilities in clinical research
Module 2 – Study Start Up to Study Activation
- Describe the study start up to site activation process and requirements and best practices
- Recognize the importance of conducting a study assessment for feasibility and what that means in regard to the various stakeholder obligations
- Explain the role of the role of the Organization, Human Research Protection Program/Institutional Review Board, and Researcher/Research Staff in the research and study approval process
- Ensure that research review process complies with applicable regulations, guidelines and human research standards including ethical standards
- Ensure the informed consent process is conducted in compliance with applicable regulation and GCP requirements.
Module 3 – Ongoing Trial Procedures
- Recognize the importance of planning to operationalize the entire trial before it starts
- Describe the anatomy of a study start-up and QA check
- Manage trial processes with continuous quality by design assessments to run an effective clinical trial program
Module 4 – Safety in Clinical Trials
- Recognize and define essential safety terms
- Describe the processes involved in Adverse Event (AE) reporting
- Identify the roles and responsibilities of all those involved in the AE reporting process
- Explain the importance of and comply with safety reporting requirements
- Specify differences between the drug and device regulatory definitions and reporting requirements
Module 5 – Audits and Inspections
- Recognize the importance of quality in clinical trials
- Describe the anatomy of a regulatory inspection
- Manage audits and inspections effectively