Study Startup 100 Series UCSF 101 Study Startup Process UCSF 102 Coverage Analysis UCSF 103 Faculty Oversight Committee for Research (FOCR) UCSF 104 Patient Care Manager (PCM) Communications DOM 105 Safety Committee Submissions DOM 106 New Products Committee Submission DOM 107 CMS Submissions DOM 108 APeX Study Build Request (Maintenance requests) DOM 109 OnCore Clinical Trial Management Systems Regulatory 200 Series UCSF 201 Regulatory Binder DOM 202 Source Documents DOM 203 FDA 1572 DOM 204 Financial Disclosure DOM 205 Delegation Log Completion DOM 206 Documentation of Training Clinical Research Coordinator Orientation 300 Series DOM 301 CRC Orientation DOM 302 Informed Consent DOM 303 Recruitment Methods DOM 304 Atomic Web DOM 305 Scheduling Research Visits Study Management 400 Series DOM 401 Study Manual of Procedures (MOP) DOM 402 Participant Accrual (APeX, OnCore) DOM 403 Participant Reimbursement DOM 404 Billing Review in APeX DOM 405 Biological Specimen Shipping DOM 406 Investigational Product Accountability DOM 407 Investigational Transfer DOM 408 Protocol Amendments (ICF Revisions, CA/budget amend/ training) DOM 409 Record Retention and Destruction DOM 410 Study Closure Compliance 500 Series DOM 501 CHR Initial Submission DOM 502 Continuing Review (Amendments) DOM 503 Safety Reporting DOM 504 Note-to-File DOM 505 Violations DOM 506 Data Security (HIPAA) DOM 507 Monitoring DOM 508 Audits DOM 509 Equipment Calibration
Study Startup 100 Series UCSF 101 Study Startup Process UCSF 102 Coverage Analysis UCSF 103 Faculty Oversight Committee for Research (FOCR) UCSF 104 Patient Care Manager (PCM) Communications DOM 105 Safety Committee Submissions DOM 106 New Products Committee Submission DOM 107 CMS Submissions DOM 108 APeX Study Build Request (Maintenance requests) DOM 109 OnCore Clinical Trial Management Systems Regulatory 200 Series UCSF 201 Regulatory Binder DOM 202 Source Documents DOM 203 FDA 1572 DOM 204 Financial Disclosure DOM 205 Delegation Log Completion DOM 206 Documentation of Training Clinical Research Coordinator Orientation 300 Series DOM 301 CRC Orientation DOM 302 Informed Consent DOM 303 Recruitment Methods DOM 304 Atomic Web DOM 305 Scheduling Research Visits Study Management 400 Series DOM 401 Study Manual of Procedures (MOP) DOM 402 Participant Accrual (APeX, OnCore) DOM 403 Participant Reimbursement DOM 404 Billing Review in APeX DOM 405 Biological Specimen Shipping DOM 406 Investigational Product Accountability DOM 407 Investigational Transfer DOM 408 Protocol Amendments (ICF Revisions, CA/budget amend/ training) DOM 409 Record Retention and Destruction DOM 410 Study Closure Compliance 500 Series DOM 501 CHR Initial Submission DOM 502 Continuing Review (Amendments) DOM 503 Safety Reporting DOM 504 Note-to-File DOM 505 Violations DOM 506 Data Security (HIPAA) DOM 507 Monitoring DOM 508 Audits DOM 509 Equipment Calibration