This training series for Clinical Investigator and Coordinator 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 Close Out Visits
2. Interim Monitoring Visits
3. Advertising for Study Subjects
4. Completion of Form FDA 1572
5. Corrective and Preventative Actions
6. Documenting Delegation of Authority
7. Investigator On Call or Off Hours Policy
8. Confidentiality of Clinical Trial Information
9. Clinical Research Personnel CVs and Licenses
10. Completing and Maintaining Case Report Forms
11. Introduction to Standard Operating Procedures
12. 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, Coordinator 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, coordinators, 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.

To date, over 250 students have completed this Clinical Operations Program since 2008.

12 Training Modules Covering 8 Hours of Training
$275.00