Standard Operating Procedures for Good Clinical Research Practice
SOP-01: Writing, Training and Maintenance of SOPs
Attachment A: SOP Template
Attachment B: RPA Template
Attachment C: SOP Training & Compliance Form
Attachment D: SOP Revision History Log
SOP-2: Delegation of Responsibilities
Attachment A: Delegation of Authority Log
Attachment B: Study Team Training Log
SOP-3: New Employee Onboarding
Attachment A: New Employee Onboarding Checklist
SOP-4: Feasibility
Attachment A: Protocol Feasibility Tool
Attachment B: Protocol Feasibility Score Card
SOP-5: Site Qualification Visit
Attachment A: Site Qualification Visit Agenda
Attachment B: Checklist for a Site Qualification Visit
Attachment C: Site Qualification Visit Summary
SOP-6: Document Management and Retention
Attachment A: Essential Document Checklist
Attachment B: Regulatory Documents Checklist
Attachment C: IRB Submission Checklist
Attachment D: Study Termination Checklist
SOP:8: Site Initiation Visit
Attachment A: Site Initiation Visit Checklist
SOP-9: Protocol Implementation
Attachment A: Protocol Implementation Checklist
SOP-10: Subject Screening and Recruitment
Attachment A: Screening Log
Attachment B: Screening Checklist
Attachment C: Subject Eligibility Criteria Checklist
Attachment D: Enrollment Log
SOP-11: Obtaining Informed Consent
Attachment A: Consent Documentation Note
Attachment B: Consent Process Checklist
SOP-12: Protocol Compliance
Attachment A: Baseline Checklist
Attachment B: Post Visit Checklist
Attachment C: Note to File
Attachment D: Protocol Deviation Tracking Log
SOP-13: Adverse Event Reporting
Attachment A: Adverse Event Log
Attachment B: IND Safety Report Sample Cover Letter
Attachment C: IND Note to File
SOP-14: Research Specimen Management
Attachment A: Research Specimen Shipping Log
Attachment B: Research Specimen Destruction Log
SOP-15: Investigational Product Management
Attachment A: Master Drug Accountability Log
Attachment B: Subject Drug Accountability Log
Attachment C: Subject Drug Diary
Attachment D: Study Drug Transport and Chain of Custody Form
Attachment E:
Device Accountability Log
SOP-16: Data Management
SOP-17: Monitoring Visits
SOP-18: Clinical Research Audits
Attachment A: Audit Preparation Checklist
Attachment B: FDA Inspection Notification Form
