Good Clinical Practice — SOPs for Sponsors

General Administration

1. Sponsor Responsibility and Delegation of Responsibility
   • Fulfilling FDA Obligations
   • Delegation of Responsibility
   • Transfer of Responsibility to Contractors
2. Document Development and Change Control
   • Document Initiation and Approval Procedures
   • Document Change Procedures
   • Document Implementation
3. Sponsor Research Team Training
   • Training Plan
   • Documentation of Training
4. Conflict of Interest Disclosure Requirements
   • Financial Disclosure for Sponsors and Investigators
   • FDA Reporting Requirements
5. Vendor Selection and Agreements
   • Institutional Vendor Requirements
   • Regulatory Aspects
   • Vendor Audits

Regulatory Affairs

1. FDA Contacts and Submissions
   • Oral and Written Correspondence with FDA
   • Meetings with FDA
   • IND Development and Submission
   • IDE Development and Submission
2. FDA Reporting Requirements
   • Preparation of Reports
   • Drug Study Reporting
   • Device Study Reporting
3. Gene Transfer Research
   • RAC Review of Research
   • Reporting Requirements

Protocol Development

1. Clinical Protocol Development
   • Writing the Clinical Protocol
   • Protocol Review and Approval
   • Protocol Amendments
   • Case Report Forms
   • Compliance with Protocol
2. Documents for Informing Investigators (Drug Studies)
   • Investigator Brochure
3. Documents for Informing Investigators (Device Studies)
   • Preparing the Investigational Plan
   • Report of Prior Investigations

Study Start-Up

1. Investigator Selection and Qualification
   • Investigator Qualification
   • Investigator Agreements
   • Disqualified Investigators
2. Initiation Visit and Site Training
   • Initiation Visit Preparation
   • Investigative Site Training
   • Documenting the Initiation Visit

Project Management

1. Communications
   • General Communications
   • Communications with IRB
   • Communications with Investigators and Site Staff
   • Communications Records
2. Investigational Product Inventory Management
   • Labeling and Release of Investigational Product
   • Investigational Product Receipt, Storage and Issue
   • Final Product Accountability Verification
3. Documentation and Records Retention
   • Creating the Regulatory Master File
   • Maintenance of the RMF
4. Routine Monitoring Visits
   • Scheduling/Frequency of Visits
   • Preparation for a Monitoring Visit
   • Conducting a Monitoring Visit
5. Study Closeout Visit
   • Site Closeout for Completion of Enrollment
   • Suspension for Inadequate Enrollment
   • Termination for Protocol Violations

Subject Management

1. Human Subject Protection
   • IRB Submissions and Review
   • Informed Consent Process
   • Emergency or Other Unique Research
2. Subject Recruitment Practices
   • Sponsor-Produced Materials
   • Investigator-Produced Materials
3. Subject Eligibility and Enrollment
   • Subject Eligibility Documentation
   • Conduct of Screening Activities at the Site
4. Specimen Management
   • Assessing Site's Specimen Management Capability
   • Specimen Handling and Retention Requirements
5. Adverse Event Recognition and Reporting
   • Identifying Adverse Events at the Clinical Site
   • Clinical Management and Documentation of Adverse Events
   • General Procedures for Adverse Events
   • Drug Adverse Events
   • Device Adverse Events

Data Management

1. Clinical Data Management
   • Data Collection and Transcription
   • Data Management and Retention
2. Use of Electronic Data Management Systems
   • Electronic Systems Set-up
   • Electronic Data Collection and Management

Quality Assurance

1. Quality Assurance Audits
   • Internal Audits
   • Audits by Third Parties
   • Auditing the Investigative Site
2. FDA Inspections
   • Opening the Inspection
   • Conducting the Inspection
   • Concluding the Inspection