These are detailed instructions to achieve uniformity throughout the SIREN Network. They ensure maximum safety and efficiency of the clinical research operations.
- Ancillary Study/Substudy Approval Process
- Ancillary Trial Protocol Summary Form
- Central IRB Operations
- Collaborative Trial and Ancillary Study Budget Development
- Conflict of Interest
- COVID19 Guidance
- Data Requests Prior to Trial Completion
- Document Version Control
- DSMB CIRB Joint Operating Procedure
- EFIC ER-CIRB Review Process
- Electronic Informed Consent
- Financial Management
- Grant Writing Timeline
- Human Subjects Protection and Good Clinical Practice Training
- Hub Management of Spokes
- Hub Performance Assessment
- Investigational Material Accountabilitiy
- Maintenance of Essential Documents
- NIH Certification for Protection of Human Subjects
- Participant Reimbursement Policy
- Process for Solicitation and Review of Clinical Trials
- Publications Policy
- Responsibilities of the Investigator
- Short Form Non-English Consent
- SOP Implementation Process Updated 1/30/2024
- Training of Personnel
Clinical Monitoring