Spreadsheet: 2d76730a-87b5-4a79-99dd-420f12943fe1
Sheet: Sheet1

CHW Billing Plan Template - Study Events Flowchart for HRRBand Billing Review. | Unnamed: 1 | Unnamed: 2 | Unnamed: 3 | Unnamed: 4 | Unnamed: 5 | Unnamed: 6 | Unnamed: 7 | Unnamed: 8 | Unnamed: 9 | Unnamed: 10 | Unnamed: 11 | Unnamed: 12 | Unnamed: 13 | Unnamed: 14
This is a customizable template, it is understood that individual protocols will require additional events, dates, etc.  Please edit the template to fit your individual study and upload to IRBnet with your application materials.
Protocol Title and Study number (if applicable):
PI:
Study Coordinator(s):
Key
NA = Not applicable
NC = Not Chargeable - event performed by research staff or research subject
SoC = Standard of care, bill insurance
Res = Research Specific Activity, bill study
Item or Service provided | Screening | Enrollment | Week 1 | Week 2 | Week 3 | Week 6 | Week 12 | Week 18 | Week 24 | Who Performs the service? | Where does this take place? | Is there a Provider fee for this event? | Has Provider agreed to waive fee? | Comments
Consent process | NC |  |  |  |  |  |  |  |  | Coord/Investigator | Endo Clinic | No |  | PI/Coord - no charge
History | NC | SoC |  |  |  |  |  |  |  | Investigator | Endo Clinic | Yes | No | Standard for this indication
Vital Signs and Weight |  | Soc | [NAME] | [NAME] | [NAME] | [NAME] | [NAME] | [NAME] | SoC | Investigator | CHW Lab | No |  | Baseline to 24 week visit is a 6 month window, vitals/weight are standard of care at these visits, all others are research directed
Physical Exam |  | SoC | [NAME] |  |  |  | [NAME] |  | Soc | Investigator | CHW Lab | No |  | Baseline to 24 week visit is a 6 month window, PE is standard of care at these visits, all others are research directed
CBC |  | [NAME] |  | [NAME] |  | [NAME] | [NAME] | [NAME] | [NAME] | CHW Lab | CHW Lab | No |  | [NAME]
Chem |  | [NAME] |  | [NAME] |  | [NAME] | [NAME] | [NAME] | [NAME] | CHW Lab | CHW Lab | No |  | [NAME]
Urinalsysis |  | [NAME] |  |  |  |  | [NAME] |  | [NAME] | CHW Lab | CHW Lab | No |  | [NAME]
Quality of Life |  | NC | NC |  | NC | NC | NC | NC | NC | Coord/Investigator | Endo Clinic | No |  | Not billable, performed by PI or Study Coordinator
Blinded Drug Dispensed |  |  | [NAME] | [NAME] | [NAME] | [NAME] | [NAME] | [NAME] |  | Pharmacy | Pharmacy | No |  | [NAME]
Control Drug Dispensed |  |  | SoC | SoC | SoC | Soc | Soc | Soc |  | Pharmacy | Pharmacy | No |  | [NAME] is required by protocol , but is also standard of care support medication for this indication.
Study Drug Administered (Daily, self) |  |  | NC | NC | NC | NC | NC | NC | NC |  |  |  |  | self administered, no charge
Pulmonary Function Test |  | [NAME] |  |  |  |  |  |  | [NAME] | [NAME] | [NAME] | Yes | No | [NAME]
CT with contrast, Chest |  | [NAME] |  |  |  |  |  |  | [NAME] | Radiology Tech | Radiology | Yes | No | [NAME]
ECG |  | [NAME] |  |  |  |  |  |  | [NAME] | ECG tech | Cardiology | Yes | Yes | [NAME]
Performance of Services:
***For all study events not performed directly by the study staff (PI, Coordinator, [NAME]) those providing the service must be consulted and have ample time to review what is expected of them.
***Managers of effected units being asked to provide service can request compensation for lost clinical productivity due to research activities, or deny research activity at that time if it is deemed likely to impact patient safety
When requesting a review of study services, the researcher should provide a description of services or events needed from each unit.  This will facilitate reviews, and should result in faster approval times.