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Standard Operating Procedures |
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Can-Meds strives to maintain a complete and current set of standard operating procedures which ensure the quality of our work. Staff are trained on SOPs any in-person group training sessions and training is tracked in individual, detailed records for each employee. A list of our current SOPs is as follows:
- SOPs: Development, Training and Adherence
- Good to Clinical Practice - Application
- Privacy Policy
- Administration of Informed Consent
- Subject Adherence to Study Visit Requirements
- Study Metrics
- Adverse Event Reporting
- Electronic Study Document Management
- Study Archiving
- Study Subject Reimbursement
- Protocol Waivers
- Study Closure
- Regulatory Audits
- Investigational Product Inventory Control
- Data Collection
- Source Documentation
- IND Safety/SAE Reporting
- Equipment Servicing and Maintenance
- Patient Consent to Access Personal Health Information
- Development and Approval of Informed Consent Forms
- Revision of Approved Informed Consent Forms and the Reconsent Process
- Regulatory Document and IRB Submissions - Updates and Maintenance
- Handling Procedures for Injectable IPs
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