FAQs: Funding, Financial Agreements and Study Payments
- Who should I contact for general questions about the Funding Memorandum on a SWOG-led study?
The primary contact for federal and non-federal funding on SWOG studies is listed on each of the study-specific funding memoranda currently posted on the CTSU website protocol abstract page under the “Funding Information” tab.
For general questions about SWOG Funding Memoranda, please contact firstname.lastname@example.org.
- Who should I contact for questions pertaining to a National Coverage Analysis?
National Coverage Analysis (NCA) documents can be found on the protocol abstract page of the CTSU website under the “Funding Information” tab. For questions about the posted NCA document, contact the CTSU by phone at: 1-888-823-5923 or E-mail at: email@example.com.
Source: CTSU FAQs (Login with CTEP IAM ID required to access link).
- Who should I contact for assistance with missing payments?
Please contact Kyle Theige (firstname.lastname@example.org) if your site has missing federal payments for activity past 6 months. Please contact Debbie Allen (email@example.com) for missing non-federal payments.
Source: Institutional Membership/SWOG Financial Agreements
- Who should I contact to execute Financial Agreements with SWOG?
The primary contact for federal and non-federal funding on SWOG studies is listed on each of the study funding memos (and also listed below).
When your site is ready to establish these required agreements, please reach out to the appropriate contact and they will work with you to get all of the necessary information completed and the agreement executed. Please be sure to include a copy of your site’s W-9 when reaching out to both SWOG Group Chair’s Office (GCO) and SWOG Clinical Trials Program (SWOG-CTP).
Federal Funding Questions Contact:
Kyle Theige, Grants & Contracts Coordinator, Oregon Health & Science University (SWOG GCO)
Phone: (503) 494-5514 or E-mail: firstname.lastname@example.org
Non-Federal Funding Questions Contact:
Debbie Allen, Director of Finance, SWOG-CTP and The Hope Foundation
Phone: (734) 998-6890 or E-mail: email@example.com
Mariela Pucci, Accounting Specialist, SWOG-CTP and The Hope Foundation
Phone: (734) 998-7174 or E-mail: firstname.lastname@example.org
- Who do I invoice for payment?
Unlike more traditional subawards, for the NCTN- and NCORP- fixed price agreements, there is no invoicing required; Instead, payments are triggered via federal study activity that is listed on the study-specific funding memo (funding memos also clearly state whether a study is NCTN or NCORP).
Some additional funding items may require an invoice; however, such a request is not typical. In the unusual case that an invoice is required, this will be indicated in the “Notes” section of the study-specific funding memorandum along with specific instructions for the invoice.
- Where do I find information on payment amounts and funding for each study?
Payment amounts and instructions are listed on each individual study’s funding memo. The funding memo for each study is available on the protocol abstract page of the CTSU website (www.ctsu.org) under the “Funding Information” tab.
(To access the protocol abstract page: Login to the CTSU website with your CTEP IAM ID and password >> then click on the “Protocols” tab in the top left corner >> then, either search for (type the protocol number (e.g., S1826) into the search box at top left of screen and click “Go”) or select the applicable protocol from the navigation folders in the left navigation pane >> this will open the protocol abstract page for the respective protocol on the right hand side of the CTSU website. Then, click on the “Funding Information” Tab that is located in the top middle of the screen on the protocol abstract page.
The primary contact for questions pertaining to federal and non-federal funding is listed near the end of each study-specific funding memorandum.
For general questions about information included on the study-specific funding memorandum, please contact email@example.com.
- Where do I find information on non-standard payment amounts and funding for each study?
In addition to the standard federal and non-federal amounts, funding memos may also include line-item amounts such as “Federal Other*” or “Federal DCTD Special.” More information on these payments (such as eligibility, physical payment, etc.) can be found in the “Study Specific Notes” section.
- How can I tell if a protocol-related procedure is covered?
Since May 2016, the CTSU has been developing National Coverage Analysis (NCA) documents for new NCTN Phase III treatment trials and select Phase II studies that are cross-network as well as cross network NCORP cancer control and prevention trials. The NCA is intended to serve as a guidance tool for sites to assist with billing compliance and help determine what procedures are covered by trial funding, what may be billable, and to specify procedures that may not be funded and therefore may be the financial obligation of the patient participating in the study. The NCAs developed by the CTSU follow National Coverage Determinations, as defined by Medicare and the National Comprehensive Cancer Network (NCCN) guidelines, as the basis for coverage analysis development. The NCA is intended for nationwide coverage usage, however coverage may vary locally. Institutions that chose to utilize this tool are responsible for the verification and modification of the coverage analysis in compliance with their institutional guidelines and local coverage determinations. NCA documents can be found on the protocol abstract page of the CTSU website under the “Funding Information” tab. For questions about the posted NCA document, contact the CTSU by phone at: 1-888-823-5923 or E-mail at: firstname.lastname@example.org.
Source: CTSU FAQs (Login with CTEP IAM ID required to access link).
- Are the activity payments for submission of biospecimens and other ancillary items such as images also generally intended to cover the cost of the associated collection procedure, test or scan for the patient?
No; Biospecimen and imaging submission payments are usually meant to cover the cost to the site associated with the submission (i.e., site labor, supplies, postage or shipping, etc.).
If a study has a non-standard of care procedure or test, the funding for the study should include a payment to cover the cost of that procedure and test. This information is available on the study’s funding memo, coverage analysis and protocol. SWOG encourages each site to review the funding memo, coverage analysis, protocol, and evaluate their local coverage prior to opening a study.
- Does SWOG provide a FedEx (or similar courier) Account number for biospecimen shipments to the SWOG Biospecimen Bank or processing laboratory?
Shipment cost for biospecimen shipments is usually intended to be offset by the biospecimen submission payment listed on the funding memo. SWOG does not provide a FedEx, UPS or other courier account number. In some cases, a pre-paid shipping label will be provided with a return shipping box as part of a specimen collection kit.
- What types of financial agreements does SWOG utilize for site payments?
SWOG uses two primary types of financial agreements when processing site payments – Purchase Service Agreements (PSA’s) and fixed-price agreements. Per NCI requirements, each site will need to establish a fixed-price agreement for both NCTN and NCORP studies. Additionally, each site will have two PSA’s – one with the Group Chair’s Office and one with SWOG-CTP.
Fixed-Price Agreements are not just vendor agreements; Instead, they are established subawards that last the duration of the respective grant cycle and allow for payments to be made to the site for specific federal study activity.
There are two separate fixed-price agreements that a site must execute:
* NCTN Fixed-Price Agreement: covers federal funding listed on NCTN studies
* NCORP Fixed-Price Agreement: covers federal funding listed on NCORP studies
Because fixed-price agreements are only required for federal funding received via NCTN and NCORP grants, site’s must only complete one set of agreements (NCTN and NCORP) with SWOG Group Chair’s Office (GCO) (meaning they are not required for non-federal funding via SWOG-CTP).
Purchase Service Agreements (PSA): Sites must also establish two PSAs (one for federal payments and one for non-federal payments) between the participating site/institution and SWOG.
* SWOG-CTP (The Hope Foundation): covers non-federal payments
* SWOG Group Chair’s Office (GCO) via OHSU: covers federal payments not covered under SWOG’s main NCTN and NCORP grants (payments such as PCORI, RO1, etc.)
- Do sites need a contract or a scope of work (SOW) with SWOG?
Beginning March 1, 2019, all sites that receive (or could receive) NCTN or NCORP grant-sourced payments directly from SWOG will need separate fixed-price subawards for NCTN and NCORP funded study activity. This is due to NCI-requirements for all NCTN and NCORP grant funded study activity that replaced (effective March 1, 2019) the historical Purchase Services Agreements (PSA) process.
Conversely, non-federal study activity payments continue to flow through SWOG-CTP on the PSA each site has with them.
Additional federal grant funding (such as R01 or PCORI) will continue to be distributed through the current PSA with the SWOG Group Chair’s Office at OHSU. If additional federal grant funding (other than NCTN and NCORP grants) is available, this will be indicated by a separate funding source on the study-specific funding memorandum.
Please see also: “What types of financial agreements does SWOG utilize for site payments.”
- Do sites need to invoice SWOG for study activity?
SWOG does not typically make study activity payments to sites from an invoice. Payment for study activity is automatically triggered as indicated on the study-specific funding memorandum (accessible from the protocol abstract page of the CTSU website).
Some funding items may require an invoice; however, such a request is not typical. The notes section of the funding memorandum for each such item will indicate if an invoice is required.
- What is the payment schedule?
Unlike more traditional subawards, there is no standard payment schedule associated with the NCTN- and NCORP- fixed price awards; Instead, payments are triggered via federal study activity that is listed on a given funding memo (funding memos also clearly state whether a study is NCTN or NCORP).
See also “How are payments triggered?”.
- How are payments triggered?
Payment triggers for each study activity are listed on the study’s funding memorandum.
Generally, federal base intervention payments are triggered by the enrollment of the patient. Federally-funded biospecimen and other ancillary payments from federal funding are usually triggered by entering the submission dates in the ‘Funding’ tab in OPEN on the CTSU website.
Non-federal funding and additional federal funding (non-NCTN or NCORP) payment triggers are listed in the notes section of the funding memorandum for each type of submission or activity. Usual payment triggers include submission of data into the SWOG Specimen Tracking System (SpecTrac) or submission of a particular activity form. SWOG encourages each site to review the funding memo for payment triggers prior to opening a study.
- Are biospecimen and other ancillary submission payments made per submission or per enrollment?
Payments for biospecimen and other ancillary submissions are usually paid as a one-time payment per enrollment for the amount listed of each specific type of submission or activity. The one-time payment will be triggered with the first time point, unless otherwise stated on the funding memo.
Some study activities will have payments at multiple time points and are triggered accordingly. In this case, the activity time points and payment amounts will be listed on the funding memo under the ‘study component description’ column in the table and/or in the notes for that particular funding activity.
- Where do the payment checks come from?
Payments for study activity will be paid to the site from the NCTN Group credited with the enrollment. If SWOG is credited with an enrollment, payments will be distributed as described below:
Main members and affiliates – Federal payments will be distributed by OHSU, the fiscal manager for SWOG’s federal grants. Payments for non-federal funds are distributed by SWOG-CTP.
Components of main members or affiliates – Both federal and non-federal funds will be distributed to the site by the site’s main member or affiliate. Please contact the head CRA for the site’s main member or affiliate for specifics details.
LAPS and NCORP sites – Most federal funding for study activity for LAPS and NCORP sites will be available to the site via their grants with NCI. Please contact your site’s LAPS or NCORP grant coordinator for more information. Federal funds that are not part of the site’s LAPS or NCORP grant, as well as Non-federal funds, will be distributed as indicated above for main members and affiliates.
- How does SWOG determine where payment checks are mailed?
The payee address is determined during the subaward agreement process. If the payee address changes for your site, please notify the funding contacts for both federal and non-federal funding.
- How are payments handled if a site participates in a study from a different NCTN group?
If a site participates in a non-SWOG led study though NCTN and credits SWOG for the enrollment, the federal and non-federal funds are typically distributed by SWOG.
The federal funds, in this case, will be paid through SWOG’s own grant; consequently, federal funds will generally be paid within the same time period as with SWOG led trial participation.
The non-federal funds are passed from the Lead NCTN Group to the credited NCTN Group for distribution. Consequently, non-federal funds will likely take longer to distribute than SWOG trial participation.