Standard Operating Procedures Draft
Obtaining and Documenting Informed Consent CR-001
Investigational Product Control and Acountability CR-002
Adverse Event Reporting CR-003
Delegation of Authority & Signature Log CR-005
Obtaining and Maintaining IRB Approval CR-006
General Requirements for HIPAA Compliance CR-007
Regulatory Documents-the Regulatory Binder CR-008
Site Listing on Clinicaltrials.gov CR-009
Reporting of Protocol Violations and Deviations CR-010
Compensation Procedure OCT-002
Investigation Product Storage Procedure OCT-004
Non-Enrolling Trials Procedure OCT-005
Closing Completed Protocols OCT-006
Subject Recruitment and Referral OCT-009
Standard Sponsor Pricing OCT-010
Protocol Budget Development OCT-011
Legal Documents Routing Policy OCT-012
Outpatient Trial Policy - A to Z OCT-013
Inpatient Trial Policy - A to Z OCT-014
Requirements for Document Format QA-001
Document Change Control QA-002