Training
Site Training . . Regulatory: ICH-GCP and CFR Applications
If you have a urgent or compulsory need to receive training in any aspect of the clinical trial industry, we will guide you to appropriate path for Global and Federal compliance involving all processes and procedures in clinical research.
All aspects of clinical research are well understood and applied to every project. We utilize a variety of presentation media to disseminate necessary information. This augments the success of your team, utilizing prepared slides, discussions, practical examples and videos.
Our training teams are comprehensive, current and immensely practical with a hands on approach, while keeping a steadfast focus to all regulatory and protocol driven requirements.
We have been training both newcomers as well as seasoned individuals to make the best use of time and planning, for not only monitoring visits, but report writing and timely document maintenance.
- 21CFR 11, 50, 54, 56, 312, 314 integrated with The CFR
- ICH-GCP E6 R2 (E6R3 draft version endorsed on 19May2023) pending update for final version.
- ICH Harmonization Efficacy Guidelines: Quality/Safety/Efficacy/Multidisciplinary
- History & Overview of Clinical Research
- Evolution of ICH-GCP:
- Data Collection & CRF Completion: ALCOA + C
- Clinical Trial Design and Endpoints for Success Objective
- Protocol & Amendments [ICH-GCP Guidelines Section 6]
- Investigator's Brochure [ICH-GCP Guidelines Section 7]
- Essential Documents in Clinical Trials: How, What, Where, When, and Why
- Role and responsibilities of Research team (DOA Log)
- Data Manager Responsibilities and Team Expectations
- Time Management: Study Timelines and Deadlines
- Central File: Reconciliation to Investigator Site File per ICHE6, Section 8
- Code of Federal Regulations directly applicable to clinical research site
- Audit Preparation from study planning, through to closure
- Preparation of PSV, SIV, IMV & COV. What NOT to forget !
- Roles & Responsibilities of Sponsor, Investigator & Monitors (21CFR312)
- Roles and Responsibilities of Investigational Review Board
- Roles & Responsibilities of Site Study Team on the Delegation Log
- Inform Consent process and documentation
- Monitoring in Clinical Trials: Monitoring Plan Adherence
- Uniformity and Contemporaneous Data Collections
Once these procedures are well understood and implemented, repeating the plan at every visit, will dramatically decrease the time spent on routine procedure checks as well as regulatory upkeep.
Employing the use of a draft agenda at every visit, provides the framework for the follow up letter as well as the platform for future activities