Companies that do not have SOPs in the consulting service area, the following SOPs are available for sponsor audit and implementation on the trial. The SOPs are compliant with ICH GCP and ISO 9000 requirements.
1. Glossary of Definitions and Abbreviations
2. Standards for Standard Operating Procedures
3. Training Procedures
4. Protocol Development
5. Informed Consent Development
6. Case Report Form Development
7. Site Selection Procedures
8. Site Initiation Procedures
9. Monitoring Clinical Trial Procedures
10. Site Close Out Procedures
11. Clinical Trial Master File Organization
12. Investigational Product Release
13. Investigational Product Accountability
14. Vendor Selection and Qualification
15. Contractor and Consultant Qualification
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