Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks ....
Transcript of Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks ....
![Page 1: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/1.jpg)
Budgets & Finance
Tracy Mudri Simon Wong
![Page 2: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/2.jpg)
Creating Budgets Tips and Tools
![Page 3: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/3.jpg)
Budgeting
• Start-up • Close-out • Invoiceable • Per-patient
![Page 4: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/4.jpg)
4
Protocol-related tasks Budget-related tasks REB Docs Training Communication w/Departments Communications w/Sponsor
Start Up Close Out Invoicables Per Patient
Pharmacy, CIU, Lab start-up Office supplies
Categories of tasks
FEES
Complete Feasibility Questionnaire from Sponsor
Review protocol & study flow • Logistics; Potential barriers; Recruitment Strategy
Pre-Study Site Selection visit, prepare for & attend
Preparation of Regulatory Documents
• Financial disclosures, 1572, study personnel CV’s….
Preparation of Source Documents
Site Initiation Visit
Investigator meeting attendance
Tasks
Start Up Costs
![Page 5: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/5.jpg)
5
Close Out Costs
Closeout Visit, Prepare for & Attend Complete Queries Box up Study Records (Archiving) Transport Study Records for storage Regulatory close with REB Close out study account w/Extramural (incl.payroll
transfer) Invoicing Producing addt’l information after study close out
Start Up Close Out Invoicables Per Patient Tasks
![Page 6: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/6.jpg)
6
Invoicable Costs
Amendments (minor/major) As needed Monitoring Visits Per Visit Subject Re-consent Per subject/per amend
as needed Screen Failure Up to 4 REB renewal Annual SAE reporting Per report Cancellation fee If applicable * if study cancelled before the start of patient
recruitment – 70% of start up fee
Start Up Close Out Invoicables Per Patient Categories of Tasks Frequency
Invoicables may or may not happen Specify Frequency or Quantity Overhead Equipment or lab supplies
![Page 7: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/7.jpg)
7
Per Patient Costs
Start Up Close Out Invoicables Per Patient
![Page 8: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/8.jpg)
Factors impacting budgets • The type, phase, and complexity of the protocols involved • Screen failure rates • The actual time it takes to perform the work
• Staff time/salaries • Anticipated challenges
• Recruitment • Patient demographics and scheduling challenges • Data management in busy studies • Resources – knowing what’s available and how to access them
![Page 9: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/9.jpg)
Budgeting Templates Resources
![Page 10: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/10.jpg)
NACTRC On-Line Application www.nactrc.ca
PI Resources: • AHS Pricing Information • Budget checklist • Budget templates
![Page 11: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/11.jpg)
Alberta Clinical Research Consortium http://acrc.albertainnovates.ca • ACRC Internal Costing Guide • ACRC Internal Costing
Template
![Page 12: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/12.jpg)
Negotiations Tips and Tools
![Page 13: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/13.jpg)
Budget negotiations… • Sponsor’s initial budget is STARTING POINT for negotiations
(perform a thorough analysis of the specific protocol) • Communicate resources available to conduct trial
• Expertise • Facilities • Access to large patient population
• Remain neutral…establish that you are negotiating the budget on behalf of the study team
• A break-even point and bottom line should be determined
![Page 14: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/14.jpg)
Budget negotiations… • Keep the PI in your corner
• Keep them informed • Ready to intervene • Ready to remind sponsor of the benefits of having you as a site
• Keep momentum going if negotiations are moving quickly • Remain calm and exercise some patience • Reach out to resources within the NACTRC for advice or
assistance
![Page 15: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/15.jpg)
Justification • Sponsors are looking for justification of internal costs
• Break it down for them
Major Amendment: Discussions/correspondence between sponsor and site re changes to protocol and ICF
(SC/PI’s time) Amending ICFs (approval from sponsor – SC time) Ethics Submission Training (site personnel will need to attend 1 hr training session; 3 SC x 112/hr and 1PI/2
Sub-I’s at $350/hr)
![Page 16: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/16.jpg)
When to accept or walk away… • Accept
• Study objective is very important Question needs to be answered
• Grant – no room for negotiating
• Walk away • Discuss with your PI
Potential for a deficit (small or large) Sponsor is being unreasonable
![Page 17: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/17.jpg)
Standardized Site Costs on the horizon?
• Sponsors want a standardized cost list Advantages: • Decrease negotiation time • Other Institutions are providing this; keeps us competitive
Disadvantage: • Sponsors will use this a precedent no matter what the situation
complexity of the protocol other factors that may play into higher costs
![Page 18: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/18.jpg)
Electronic Funds Transfers Requesting and obtaining payment
![Page 19: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/19.jpg)
EFTs For AHS accounts only: 1. Request for Banking Information (RBI) form
• Sponsor requests AHS banking info 2. Account Information Form (AIF)
• AHS sends encrypted email 3. Pay Advice
• When Sponsor makes EFT payment
![Page 20: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/20.jpg)
1. Request for Banking Info
![Page 21: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/21.jpg)
2. Account Information Form
![Page 22: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/22.jpg)
2. Account Information Form (cont.)
Very important!
![Page 23: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/23.jpg)
3. Pay Advice
![Page 24: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/24.jpg)
3. Pay Advice (cont.)
Reference Info
![Page 25: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/25.jpg)
Process Overview
• Complete RBI
Sponsor
• Send AIF
AHS • Send
Payment Advice
Sponsor
• Verify payment
PI/NACTRC
![Page 26: Budgets & Finance - NACTRC · • Invoiceable • Per-patient . 4 Protocol-related tasks . Budget-related tasks . REB Docs . Training . Communication w/Departments . Communications](https://reader030.fdocuments.in/reader030/viewer/2022011905/5f28af875874c432821ae83a/html5/thumbnails/26.jpg)
New! Emailing PI Reports (Exp. Jan 2018)