In compliance with ICH Good Clinical Practice (GCP) and FDA expectations, research studies should be conducted uniformly, according to Standard Operating Procedures (SOPs). The list below is to be used as guidance; research teams are not required to have each of the SOPs suggested below, but rather should develop a customized set to meet their program specific needs. Research teams may need to develop additional SOPs related to specific research specialties or subject populations (e.g. Phase I dose escalation studies, enrollment of minors or vulnerable populations, evaluation of capacity to consent, significant risk procedures, etc.)
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Suggested SOPs
- SOP on SOPs
- Staff Qualifications SOP
- Study Initiation SOP
- Data Collection Form SOP
- Maintaining a Regulatory File SOP
- Informed Consent Process SOP
- Adverse Events (AEs) /Unanticipated Problems (UPs) SOP
- Protocol Deviations SOP
- Appropriate Storage, Retention and Destruction of Research Records SOP
- Masking Subject Identifiers SOP
- Receipt and Storage of Laboratory Supplies SOP
- Handling of Specimens SOP
- Investigational Product Accountability SOP
- Unblinding Investigational Product Assignment SOP
- Monitoring Visits, External Audits, Regulatory Inspections SOP
- Study Close-Out/Termination Visit SOP
Suggested Guidance Documents
- IRB Submission Guidance
- Subject Research Records Guidance
- Notes to File Guidance
- Study Startup Procedures Guidance
- Subject Screening Guidance
- Delegation of Authority Guidance