Clinical Research Standard Operating Procedures
List of Standard Operating Procedures
- SOP #101- Writing SOPs
- SOP #102 - Training Personnel
- SOP #103 - Responsibilities of Research Team
- SOP #104 - Conduct of Clinical Study
- SOP #105 - Document Control
- SOP #201 - Regulatory Documentation (regulatory binder)
- SOP #202 - Privacy and Confidentiality
- SOP #203 - IRB Submission
- SOP #204 - Adverse Event Reporting
- SOP #205 - Conflicts of Interest
- SOP #301 - Study Feasibility
- SOP #302 - Site Qualification visit
- SOP #303 - Site Initiation visit
- SOP #304 - Communication Practices
- SOP #305 - Investigational Product Accountability
- SOP #306 - Randomization and Blinding
- SOP #307 - Venipuncture
- SOP #308 - Specimens Collection and Management
- SOP #309 - Preparing Injectable Medications
- SOP #310 - Site Monitoring Visit
- SOP #311 - Site Closeout Visit
- SOP #312 - Protocol Compliance
- SOP # 401 - Subject Recruitment
- SOP #402 - Informed Consent
- SOP #403 - Eligibility and Enrollment
- SOP #404 - Protecting Confidentiality of Study Subjects
- SOP #405 - Study Visits
- SOP #406 - Payments to Subjects
- SOP #501 - Case Report Forms
- SOP #502 - Source Documentation
- SOP #503 - Electronic Records
- SOP #504 - Archiving Study Records
- SOP #505 - Printing and Certifying Medical Records
- SOP #601 - Quality Control
- SOP #602 - FDA Audits
- SOP #603 - Corrective and Preventative Action Plan
- SOP #604 - Equipment Maintenance and Calibration
- SOP #605 - Temperature Monitoring
- Source Documentation Checklist