Standard Operating Procedures (SOPs)

Obtaining and Documenting Informed Consent CR-001

Investigational Product Control and Acountability CR-002

Adverse Event Reporting CR-003

Financial Disclosure CR-004

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 CR-009

Reporting of Protocol Violations and Deviations CR-010

Accounting Procedure OCT-001

Compensation Procedure OCT-002

F&A Capture Procedure OCT-003

Investigation Product Storage Procedure OCT-004

Non-Enrolling Trials Procedure OCT-005

Closing Completed Protocols OCT-006

Policy Conflicts OCT-007

Advertising OCT-008

Subject Recruitment and Referral OCT-009

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

Training Requirements QA-003

Quality Audits QA-004

Record Retention QA-005


This page was last modified on January 21, 2015