This three-day GCP training course is designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements. The course consists of lecture and exercises designed to focus on the practical implementation of the GCP requirements. Participants will also be placed in several real life situations such as reviewing pre-study documents and informed consent form for completeness and compliance; conducting drug accountability; reviewing case report form for accuracy and adherence to protocol and performing source document verification.
The GCP training course will also provide the attendee with thorough knowledge of the following topics:
- How drugs are discovered and developed for marketing approval
- The four different study phases of clinical research
- What constitutes Good Clinical Practices (GCP)
- Regulatory updates
- How the requirements differ in the US, EU, India, China & Japan
- The principles of ICH GCP
- The IRB/IEC’s composition and role/responsibilities
- The IRB study review & approval process
- The role and responsibilities of the investigator & study site staff
- The role and responsibility of the sponsor
- The history of the FDA & EMA and their role & responsibilities
- Which sections of 21 CFR and ICH Guidelines govern conduct of clinical studies
- The purpose for an IND / CTA and its composition
- How INDs & CTAs are filed, reviewed, approved & amended
- The IND/CTA reporting requirements
- The requirements for Informed Consent
- How to review an Informed Consent form for compliance
- The process for Informed Consent review & approval
- The administration of subjects Informed Consent
- The different types of study Monitoring visits & tasks for each
- Adverse Events - the types and reporting requirements
- How to perform Drug Accountability & compliance
- How to manage study supplies
- How to detect and deal with Fraud
- The purpose and composition of the NDA/MAA
- How NDAs/MAAs are filed, reviewed and approved
- Sponsor responsibilities after approval
- How to review study documents & determine compliance
- How to review Case Report Forms and determine adherence to protocol
1. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
2. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
Who Should Attend
This three-day GCP training course is specifically designed for Clinical Operations Staff (Study Managers, Medical and Study Monitors) as well as GCP Auditors and others involved in conducting clinical studies of new medications who require a working knowledge of the regulatory requirements (US and EU) and ICH Regulations for Good Clinical Practices (GCPs). This three-day program will provide attendees with the training needed to improve clinical trials and ensure compliance with Good Clinical Practice, FDA Regulations, EU Directives and ICH Guidelines. The differences in study initiation and conduct between the US, EU, India, China and Japan will also be discussed.
Clinical Research Managers who oversee and instruct CRMs and CRAs will gain insight in how to best train these employees and how this information can help provide more consistent compliance the GCP requirements. Other research professionals, (i.e., clinical investigators, research coordinators, regulatory and medical communications personnel) will also benefit from this GCP training program.
Upon completion of this course, each participant will have a thorough understanding of the latest updated GCP requirements dictated by FDA, European Regulators and ICH Requirements for Sponsors, Monitors, and Investigators. In addition, the significance of these regulations will be correlated to protocol and case report form development for all phases of clinical research. Information regarding in-field and in-house auditing (i.e., Quality Assurance (QA) procedures compared to FDAs Bio-monitoring system) will be presented. Investigational Review Boards (IRBs) and Informed Consent (IC) as required by the FDA and ICH regulations are discussed in detail and compared with GCP and ICH regulations.
Frequently Asked Questions
Does this course focus on only the GCP requirements of the US or Europe?
This course provides a comprehensive understanding of the GCP requirements for conducting clinical trials in the US, EU, India, China & Japan and other ICH regions. The similarities and differences in regulatory requirements are discussed.
Does this course discuss Risk Based Monitoring?
Yes, both Traditional and Risk Based Monitoring are discussed and compared. The development and implementation of a study specific Monitoring Plan to support Risk Based Monitoring are also addressed.
Many if not all medical institutions are converting to electronic medical records. Does this course address the impact on monitoring and auditing?
The advent of electronic medical records presents many challenges for monitors and auditors. The impact on the auditing and monitoring process as well as related topics such as eCRF and 21CFR Part 11 are discussed.