SOPs
- 101-S01 Good Documentation Practices SOP
- 101-S02 Document Control SOP
- 101-S04 Change Control SOP
- 101-S05 Providing OSRO Documents to Collaborators SOP
- 101-S06 Reviewing SROS Contractor Documents SOP
- 102-S01 Auditing SOP
- 103-S01 Training Program SOP
- 104-S01 Corrective and Preventive Action (CAPA) System SOP
- 104-S02 Clinical Protocol Non-Adherence System SOP
- 104-S03 OSRO Internal Deviation System SOP
- 104-S04 Managing Clinical Site CAPAs SOP
- 104-S05 Planned Deviations to Clinical Protocols
- 202-S01 Protocol Development and Review SOP
- 202-S03 Evaluation of Protocol Amendments for FDA Notification Prior to Implementation SOP
- 203-S01 Essential Regulatory Documents Required for a Clinical Study SOP
- 205-S01 Clinical Site Monitoring Plans - Development and Maintenance SOP
- 205-S04 Protocol Close-Out SOP
- 205-S05 Processing Notifications on Changes in Study Status SOP
- 301-S01 Evaluating Serious Adverse Events from Clinical Trial Study Interventions SOP
- 301-S02 Serious Adverse Event Reconciliation SOP
- 303-S01 Sponsor Approval of Dose Escalation SOP
- 304-S01 Management of Investigator's Brochures SOP
- 305-S01 Reference Safety Information – Guidance for PIs SOP
- 401-S01 Financial Disclosure by Clinical Investigators SOP
- 402-S01 Preparation and Submission of IND Annual Reports SOP
- 406-S01 Content of Protocols Potentially Exempt From Requiring an IND or IDE SOP
- 407-S01 Management of FDA Requests for Information SOP
- 410-S01 Determination of Final Clinical Study Report Type SOP
- 501-S01 Investigational Product Certificates of Analysis SOP
- 501-S02 Investigational Product and Investigational Device Labels SOP
- 501-S03 Investigational Product and Investigational Device Quality Agreements and Product Agreements SOP
- 501-S04 Investigational Product Unique Ingredient Identifier SOP
- 501-S05 OSRO Guidelines for Investigational Product Management SOP
- 501-S06 Testing and Retesting Procedures for Investigational Products SOP
- 501-S07 CCR-OSRO Sponsor Investigational Product Preparation SOP
- 503-S01 Shipment of Investigational Product SOP
- 504-S01 Investigational Product Temperature Excursions SOP
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