This training series for Clinical Operations provides highly detailed and concentrated instruction on Good Clinical Practices (GCPs) and the International Conference on Harmonisation (ICH) requirements for Investigational Operations. The program seeks to increase your legal and regulatory understanding of GCP and ICH requirements and recommendations. Each module covers methods for controlling a defined area of investigational research by taking the regulations a part for a more detailed understanding by the learner, including the interdependency between each area of research. The specific areas covered include:

1. Study Budget Process
2. Study Close Out Visits
3. Interim Monitoring Visits
4. Writing and Revising SOPs
5. Facilitating FDA Inspections
6. Archival of Research Records
7. Advertising for Study Subjects
8. Transporting Hazardous Goods
9. General Correspondence Policy
10. Completion of Form FDA 1572
11. IRB Regulatory Documentation
12. Corrective and Preventative Actions
13. Protocol Feasibility Assessment Plan
14. Financial Disclosure by Investigators
15. Documenting Delegation of Authority
16. Investigator On Call or Off Hours Policy
17. Responsibilities of Clinical Investigators
18. Confidentiality of Clinical Trial Information
19. Investigator Qualification (Pre-Study) Visits
20. Clinical Research Personnel CVs and Licenses
21. Completing and Maintaining Case Report Forms
22. Community Outreach (Pre-Consent Patient Selection)
23. Preparing and Managing Source Data Documentation
24. Obtaining and Documenting Subject Informed Consent
25. Investigator and Clinical Research Team Member Training

This and all Norton Training Institute programs are developed by regulatory-expert former FDA Investigators and current industry auditors and consultants that bring their real world experience to this training.

For the Clinical Investigator and his/her Study Team, each training module coincides with Standard Operating Procedures available from the Norton Training Institute, thus satisfying your requirement for annual GCP training along with controlling your research through written procedures.

This training series is designed for industry investigators, monitors, auditors, project managers, and other research partners that need to understand how clinical investigators must meet regulatory and legal requirements for receiving investigational products and for testing human research subjects with these investigational test articles.

25 Training Modules Covering 8 Hours of Training
$275.00