SOP’s Include:
–Standard Operating Procedure For SOP’s
–Testing Personnel Supervision, Oversight, And Training
–Protocol Handling And Approval
–Pre-Study Requirements & Test Product Handling
–Subject Recruitment Methods
–Informed Consent
–Collection, Recording And Storage Of Research Data
–Data Preparation And Reporting Procedures And Review
–Adverse Event Reporting Procedures
–Study Monitoring
–Source Documentation (Study File Content)
–Privacy And Confidentiality
–Sponsor Responsibilities
–Disaster Recovery Planning