Clinical Charging Workbook Resources
Event - LIST IS NOT EXHAUSTIVE: | Common Actions to Take (verify with Department Administrator and/or PI): |
|---|---|
Delayed Start Fee | Put 100% of DIRECTS in CRC column |
FDA/Regulatory/Sponsor/CRO Inspection/Other Audit - Per Day | Put 100% of DIRECTS in CRC column |
IND Safety Reporting - Per Report/ processing fee | Put 100% of DIRECTS in CRC column |
Institutional Administrative Efforts to Process IRB Continuing Reviews / Amendment fee/ Renewal fee | Put 100% of DIRECTS in CRC column |
Institutional Regulatory Efforts to Process Sponsor-generated protocol amendments (e.g., IRB, reg doc updates) Informed Consent Document Amendment, Protocol Amendment | Put 100% of DIRECTS in CRC column |
Ongoing Protocol Activities/ per year / Administrative Fees/ beyond year 1- starting year 2 | Put 100% of DIRECTS in CRC column |
Phone Meeting/Teleconference/Webinar/In-Person or Electronic Training - Study Coordinator/Study Nurse (required by the sponsor) - Per Hour | Put 100% of DIRECTS in CRC column |
Re-Consenting - Per Re-consent | Put 100% of DIRECTS in CRC column |
On-Site Routine/Remote Monitoring Visit Fee - Per Day {Monitor Visit Fee} | Put 100% of DIRECTS in CRC column |
Serious Adverse Event Reporting - Per Report (SAE/SA) | Put 100% of DIRECTS in CRC column |
Study Cancellation Fee | Put 100% of DIRECTS in CRC column |
Pre-Screening/Chart Reviews | Put 100% of DIRECTS in CRC column |
Screen Fail V(n) | Put 100% of DIRECTS in CRC column |
Site Audit - Not for Cause | Put 100% of DIRECTS in CRC column |
One Day Prep for FDA/Sponsor/CRO/Other Regulatory Body Audit Conduct Fee | Put 100% of DIRECTS in CRC column |
Sponsor Audit Readiness Fee | Put 100% of DIRECTS in CRC column |
Site Personnel Effort, Participant Recruitment Activities | Put 100% of DIRECTS in CRC column |
Remote Monitoring Visits - Per Hour Additional Effort | Put 100% of DIRECTS in CRC column |
Death Certificate | Put 100% of DIRECTS in CRC column |
Phone Meeting/Teleconference/Webinar/In-Person or Electronic Training - PI/Sub-I (required by the sponsor) - Per Hour | Put 100% of DIRECTS in PI column |
PI Oversight | Put 100% of DIRECTS in PI column |