SOP-902
Network Study Feasibility, Allocation and Central Contracting
- Number
- SOP-902
- Category
- Network
- Edition
- Reference Edition 1.3
- Approx. pages
- 9
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This SOP describes how [NETWORK NAME] receives sponsor study inquiries centrally, combines member site feasibility into one honest network response, decides which member sites take a study, and negotiates master agreements, clinical trial agreements (CTAs), budgets and coverage analyses centrally. It also sets the rules for paying member sites in N-Affiliated and for central invoicing and reconciliation.
2. Scope
This SOP applies only when the site has adopted Model N (SOP-100 Writing, Approving and Controlling SOPs).
In scope: central intake, network feasibility, allocation (F-902-01), master service agreements, CTAs and budgets negotiated centrally, central coverage analysis, payment flows to member sites, central invoicing and reconciliation.
Out of scope: feasibility steps done at each member site (SOP-200 Study Feasibility and Selection), the review content of a CTA and budget (SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets), the method of coverage analysis (SOP-202 Medicare Coverage Analysis and Research Billing Compliance), IRB submissions (SOP-203 IRB Submissions, Approval and Continuing Oversight) and activation (SOP-205 Site Qualification, Initiation and Study Activation). This SOP adds the network layer to those SOPs.
Where the protocol, sponsor or IRB requirement is stricter than this SOP, the network and the member site follow the stricter requirement.
This SOP describes operating steps. It is not legal advice; [SITE NAME] confirms legal and contracting positions with [LEGAL COUNSEL].
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Network Clinical Operations Lead | Owns central intake, network feasibility and allocation. Prepares F-902-01 and the network feasibility response. |
| Network Contracts and Finance Lead | Negotiates master agreements, CTAs and budgets centrally; prepares the central coverage analysis; sets up payment flows to sites; runs central invoicing and reconciliation. |
| Network Regulatory Lead | Advises on regulatory and IRB route for each allocated site (single IRB, reliance, site IRB). |
| Network Medical Director | Optional. Reviews protocol fit and safety demands across sites. Does not replace each PI's assessment. |
| Network Quality Lead | Provides member site performance and quality history (SOP-903) for allocation; reviews payment flows for compliance with this SOP. |
| Site Director | Runs site feasibility under SOP-200, confirms site capacity, accepts or declines allocation for the site, signs site documents where the site is a contract party. |
| Principal Investigator (PI) | Decides whether to take on the study as investigator, approves the site enrollment estimate, and keeps all investigator duties if allocated. |
| Finance / Contracts Lead (site) | Sets up site billing from the localized coverage analysis and reports invoiceable events (Appendix B, SOP-902 rows). |
4. Definitions
| Term | Definition |
|---|---|
| Central Intake | The single point where the Network Office receives sponsor and CRO inquiries for any member site. |
| Network Feasibility Response | The network's combined answer to a sponsor feasibility request, built from member site assessments. |
| Allocation | The network decision on which member sites, and which PIs, are offered to the sponsor for a study. |
| Catchment Overlap | The share of the eligible patient pool of one member site that is also reachable by another member site (for example, the same referring practices, health system or geographic area). |
| Master Service Agreement (MSA) | A framework agreement between a sponsor or CRO and the network entity that sets terms for future studies, each started by a study-specific work order or CTA. |
| Tri-party CTA | A CTA signed by the sponsor (or CRO), the network entity and the member site entity, and sometimes the PI. |
| Fair Market Value (FMV) | The value of services in an arm's-length transaction, not taking into account the volume or value of referrals. |
| Coverage Analysis | Item-by-item determination of which study items are billable to insurance and which are paid by the sponsor (SOP-202). |
5. Procedure
5.1 Central intake
5.1.1
All sponsor and CRO inquiries, confidentiality agreements and feasibility questionnaires for any member site are routed to central intake at [NETWORK INTAKE ADDRESS]. A member site that receives an inquiry directly forwards it to central intake within [DEFAULT: 2 business days] and does not answer the sponsor on the network's behalf.
5.1.2
The Network Clinical Operations Lead logs each inquiry in [NETWORK STUDY PIPELINE TRACKER] with sponsor, protocol, therapeutic area, phase, requested number of sites and response deadline.
5.1.3
The Network Contracts and Finance Lead executes the CDA. In N-Affiliated, the CDA must allow the network entity to share protocol information with the member sites it consults; otherwise each member site signs its own CDA or a joinder before it receives the protocol (SOP-201 5.2).
5.1.4
The Network Clinical Operations Lead screens the inquiry against network capabilities and sends it to the member sites that could plausibly run it. Sites receive only the information needed to assess feasibility.
5.2 Site feasibility at each member site
5.2.1
Each member site that is asked completes SOP-200 for the study, including patient population data, competing studies, capacity, PI review and an enrollment estimate as a range (low and expected), and returns F-200-01 Study Feasibility Assessment to the Network Clinical Operations Lead by the date set.
5.2.2
Each site's estimate is approved by the site's proposed PI. The Network Office must not change a site's estimate upward. Where the Network Clinical Operations Lead questions an estimate, the question goes back to the site and PI, and any revision is recorded on F-200-01.
5.2.3
Population data that contains PHI stays at the site. Sites send counts and aggregate data to the Network Office (SOP-400 Participant Privacy and HIPAA in Research; SOP-905 Network Data, Systems, Privacy and Records Across Sites).
5.3 Combining feasibility for the network response
5.3.1
The Network Clinical Operations Lead combines site estimates on F-902-01 Study Allocation Decision Record. Combined enrollment is not the simple sum of site estimates. Before adding, the lead checks for catchment overlap:
- sites that share referring physicians, a health system, an EHR population or a geographic area
- sites that would use the same advertising or the same database to recruit
- patients who are already seen at more than one member site
5.3.2
Where catchment overlaps, the lead counts the shared pool once and divides it between the sites in the estimate, records the method, and states the overlap in the response. Where overlap cannot be measured, the lead uses the low estimate for the overlapping sites and says so.
5.3.3
The network feasibility response gives enrollment as a range (low and expected) with the main assumptions (screen-fail rate, enrollment months, competing studies), by site where the sponsor asks for site-level numbers. The expected value reported must not exceed the combined expected value on F-902-01.
5.3.4
Competing studies are checked across the whole network, not only at each site. A study that competes with another network study for the same participants at the same sites is flagged on F-902-01.
5.3.5
The Network Clinical Operations Lead signs the response. Where the sponsor asks for named PIs or site-level commitments, each named PI approves the numbers for the PI's site before the response is sent.
5.4 Allocation decision (F-902-01)
5.4.1
Where more member sites are interested or capable than the sponsor wants, or where the network must choose which sites to propose, the Network Clinical Operations Lead prepares an allocation recommendation on F-902-01. Criteria:
- site capacity: staff, space, equipment, IP storage and visit slots for the study period, net of current studies (SOP-200 5.4)
- PI interest, qualification and experience in the indication and phase, and the PI's current workload
- patient population, from site data under 5.2, adjusted for catchment overlap
- performance and quality history from SOP-903 (F-903-01): start-up time, enrollment against estimate, deviation and query rates, audit and inspection findings, open CAPAs
- conflicts: competing studies at the site, and any PI or site financial interest in the sponsor (SOP-104 Conflict of Interest and Financial Disclosure)
- facility needs: CLIA certificate type, controlled-substance registration, imaging or infusion capability
- sponsor requests (for example geographic spread or a named PI)
5.4.2
A member site at Tier 3 or 4 under SOP-903 5.6.1, or at Tier 2 where its escalation plan (F-903-02) says so, is not allocated new studies unless the plan allows it.
5.4.3
Allocation is not based on any site's or PI's volume or value of referrals to another member site, the network entity or any party with a financial relationship to them.
5.4.3.1
A person with an ownership, equity or compensation interest in a member site does not recommend or decide an allocation affecting that site. The decision maker records any such interest, and who stepped aside, on F-902-01 (SOP-104 Conflict of Interest and Financial Disclosure).
5.4.4
The Network Clinical Operations Lead records the decision, the reasons, the sites considered and not chosen, and the decision maker on F-902-01. The Network Medical Director, where appointed, reviews allocation for studies with high safety demands. Each allocated Site Director and PI confirm acceptance in writing.
5.4.5
Each allocated site has its own PI, its own Form FDA 1572 or investigator agreement, its own IRB approval or reliance determination (SOP-203), its own delegation log (F-302-01) and its own activation checklist (F-205-01). Allocation by the Network Office does not replace any of these. Staff shared across sites are handled under SOP-904 Shared Staff, Cross-Site Coverage and Central Services.
5.4.6
When a study needs to move between member sites after activation (for example to rebalance enrollment), the change follows SOP-901 Member Site Onboarding, Integration and Exit 5.8 or adds a new site through SOP-205. Participants are not moved between sites without sponsor and IRB agreement and the participant's consent.
5.5 Master agreements and CTAs
5.5.1
The Network Contracts and Finance Lead negotiates MSAs and CTAs centrally, using the review steps in SOP-201 and the network contract playbook in [NETWORK CONTRACT PLAYBOOK] (a business document kept outside the SOP system and not shared with sponsors).
5.5.2
Signatory:
- N-Integrated, for member sites that are the same legal entity as the network entity: the network entity signs MSAs, CTAs and budgets through the authorized signatories in [NETWORK SIGNATURE AUTHORITY POLICY]. The PI signs only an investigator acknowledgment where the CTA requires one (SOP-201 5.6.2). N-Integrated defaults apply only where the member site and the network entity are the same legal entity. A separate subsidiary, or a professional corporation under a management services arrangement, follows the N-Affiliated rows for PHI, direction of staff, contract signature, records custody and payments unless counsel confirms otherwise (SOP-900, 5.2.1).
- N-Affiliated: the member site entity signs as the institution, either in a two-party CTA with the sponsor or in a tri-party CTA with the network entity. The network entity signs alone only where the network agreement and the sponsor accept the network entity as the contracting institution, and counsel has confirmed it.
5.5.3
Each allocated site has a site-specific budget exhibit that reflects its own costs, staffing, local fees, pass-through costs and billing setup. A single network budget is allowed only where every site has the same cost basis, and the Network Contracts and Finance Lead records why.
5.5.4
The CTA states, for each site, the investigator, the site address, payee, invoicing route, record retention, publication, confidentiality, subject injury and indemnity terms. Where the network entity collects payment for a member entity's work, the CTA or the network agreement says so.
5.5.5
The Network Contracts and Finance Lead sends executed agreements to each allocated Site Director and PI and to the Network Regulatory Lead for filing in each site's ISF (SOP-201 5.7). Study procedures at a site do not start until that site's agreement is executed (SOP-205).
5.6 Coverage analysis
5.6.1
The Network Contracts and Finance Lead prepares one coverage analysis per protocol version under SOP-202, on F-202-01 Coverage Analysis Worksheet.
5.6.2
For each allocated site that bills insurance, the site Finance / Contracts Lead localizes the analysis: payer mix, billing entity and provider numbers, the Medicare Administrative Contractor (MAC) and its local coverage determinations, state Medicaid rules, and any services the site does not provide. Differences from the central analysis are recorded on the site's copy of F-202-01.
5.6.3
The central analysis, the site budget exhibit, the CTA and the consent form must agree on who pays for each item (SOP-202 5.6). The Network Contracts and Finance Lead checks this before each site's CTA is signed and after each amendment.
5.6.4
The site builds its billing grid and claims process from the localized analysis (SOP-202 5.7 and 5.8). Claims are submitted by the billing entity for the service. In N-Affiliated, that is normally the member entity.
5.7 Payment flows to member sites (N-Affiliated)
5.7.1
Where the network entity receives sponsor payments and pays member entities, or where any member entity pays the network entity or another member entity, the payment terms are written in the network agreement or a site subcontract before work starts.
5.7.2
Payments must be fair market value for services actually performed and documented, set in advance, and must not vary with the volume or value of referrals between the parties. No party pays or receives anything for referring a patient, a participant or a study. Finder's fees and per-referral bonuses are prohibited (SOP-310 Participant Payments and Reimbursement and SOP-300 Participant Recruitment, Pre-Screening and Advertising apply to participant-facing payments).
5.7.2.1
Recruitment and referral services between entities (for example a member site, the Network Office or a central recruitment team that identifies or pre-screens candidates for another entity) are paid only as fees for services actually performed (for example hours of pre-screening work, advertising campaigns run, database queries run), set in advance at fair market value. They are never paid per referral, per randomized participant or per enrollee. Where either party bills or refers patients for items or services paid by a federal health care program, the arrangement is reviewed by counsel against the Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) under 5.7.3 before first use.
5.7.3
Where any party bills, or refers patients for items or services paid by, a federal health care program, the Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) makes it a crime to knowingly and willfully pay or receive remuneration to induce referrals. The Network Contracts and Finance Lead obtains counsel review of the payment structure before first use and at each major change, including whether it fits a safe harbor such as personal services and management contracts (42 CFR 1001.952(d)). That safe harbor requires, among other conditions, a signed written agreement covering all the services, a term of at least one year, a compensation methodology set in advance at fair market value that does not take into account the volume or value of federal health care program referrals or business between the parties, and services no greater than reasonably necessary. The review is kept with the network agreement. Whether or not a federal health care program is involved, counsel also reviews the structure before first use against state all-payer anti-kickback, self-referral and fee-splitting laws, which can apply whoever the payer is, including commercial insurance or self-pay; the answer is recorded in each affected member site's Appendix A State Law Worksheet.
5.7.4
In N-Affiliated, the Network Office fee is set in the network agreement before work starts:
- it pays only for services the Network Office actually provides to the member site (for example central contracting, regulatory submissions, coverage analysis, QA, invoicing), listed in the agreement
- the amount or method is set in advance and is fair market value for those services, supported by a documented FMV basis (for example cost-plus or an independent valuation)
- it does not vary with the number of patients, participants or studies one party refers to another. Because the Network Office also allocates studies to member sites, a fee charged per study, per visit or as a percentage of the site's study revenue can look like payment for the allocation; such a fee is used only where it is FMV for a service actually performed for that study and counsel has approved the structure under 5.7.3
- the Network Contracts and Finance Lead keeps records showing the services were performed
- counsel reviews the fee structure under 5.7.3 before the agreement is signed and when the fee or services change
5.7.5
The Network Office fee is shown on each site statement under 5.8.3.
5.7.5.1
Central participant payment programs (Appendix B, SOP-310 rows) follow SOP-310. Before first use, the Network Contracts and Finance Lead records which legal entity is the payer for each site's participants, because the payer holds the W-9 forms and files Forms 1099-MISC (SOP-310 5.9):
- N-Integrated, for member sites that are the same legal entity as the network entity: those sites are one payer; the network entity totals each participant's payments across all member sites and studies for the calendar year and reports
- N-Affiliated, and any member site that is a separate legal entity (SOP-900 5.2.1): each entity that pays participants from its own account reports what it paid; where the Network Office pays a member site's participants from the Network Office account, the Network Office is the payer for those payments
5.7.5.2
The payer arrangement is written in the network agreement and confirmed with the tax advisor, and the participant data the payer receives is recorded on F-905-01 Cross-Entity Data Flow Register.
5.7.6
In N-Integrated, for member sites that are the same legal entity as the network entity, sponsor payments go to the single entity, and internal allocation of revenue to those sites is an accounting matter. N-Integrated defaults apply only where the member site and the network entity are the same legal entity. A separate subsidiary, or a professional corporation under a management services arrangement, follows the N-Affiliated rows for PHI, direction of staff, contract signature, records custody and payments unless counsel confirms otherwise (SOP-900, 5.2.1). The rules in 5.4.3 and 5.7.2 still apply to any payment to a person or entity outside the network entity, including referring physicians.
5.7.6.1
In both variants, the Network Contracts and Finance Lead obtains counsel review under the physician self-referral law (42 U.S.C. 1395nn) before first use (SOP-202) wherever a physician with an ownership, investment or compensation relationship with the network entity or a member site entity orders or refers for designated health services (for example clinical laboratory or imaging services) that the network or a member entity bills to Medicare or Medicaid, including routine costs in a study. This covers referring physicians outside the network and the platform's own physician owners, investors and PIs who order such services for their participants.
5.8 Central invoicing and reconciliation
5.8.1
Each allocated site reports invoiceable events to the Network Contracts and Finance Lead at least [DEFAULT: monthly], with support (visit logs, F-303-01 Screening and Enrollment Log, F-501-01 SAE Reporting Tracker), as SOP-201 5.8.1 describes. Where the site invoices the sponsor directly, it copies the Network Office.
5.8.2
The Network Contracts and Finance Lead invoices sponsors for each site, tracks payments by site and study in [NETWORK ACCOUNTING SYSTEM], and reconciles at least [DEFAULT: quarterly] as SOP-201 5.8.3 describes, by site.
5.8.3
In N-Affiliated, the Network Contracts and Finance Lead pays each member entity its share within [DEFAULT: 30 calendar days] of receiving the sponsor payment, unless the network agreement sets another term, and gives each site a statement showing sponsor payments received, network fees kept and amounts paid.
5.8.4
Each member Site Director may review the records behind the site's statement. Disputes are escalated to the Network Executive and recorded.
5.8.5
At study closeout the Network Contracts and Finance Lead completes final reconciliation for each site (SOP-601 Study Closeout 5.9).
5.9 Records
5.9.1
The Network Clinical Operations Lead keeps intake logs, network feasibility responses and F-902-01 for each study. The Network Contracts and Finance Lead keeps MSAs, CTAs, budgets, coverage analyses, counsel reviews and reconciliations. Copies of site-specific documents are filed in each site's ISF (SOP-204 Essential Documents and the Investigator Site File). Retention follows SOP-402 Record Retention, Archiving and Destruction.
6. Related Forms and SOPs
- F-902-01 Study Allocation Decision Record
- F-200-01 Study Feasibility Assessment
- F-201-01 Contract and Budget Review Checklist
- F-202-01 Coverage Analysis Worksheet
- F-205-01 Study Activation Checklist
- F-302-01 Delegation of Authority Log
- F-303-01 Screening and Enrollment Log
- F-501-01 SAE Reporting Tracker
- F-903-01 Member Site Performance and Quality Scorecard
- F-903-02 Escalation and Site Support Plan
- Appendix A State Law Worksheet
- Appendix B Central and Site Responsibility Matrix
- SOP-104 Conflict of Interest and Financial Disclosure
- SOP-200 Study Feasibility and Selection
- SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
- SOP-202 Medicare Coverage Analysis and Research Billing Compliance
- SOP-203 IRB Submissions, Approval and Continuing Oversight
- SOP-204 Essential Documents and the Investigator Site File
- SOP-205 Site Qualification, Initiation and Study Activation
- SOP-300 Participant Recruitment, Pre-Screening and Advertising
- SOP-310 Participant Payments and Reimbursement
- SOP-400 Participant Privacy and HIPAA in Research
- SOP-402 Record Retention, Archiving and Destruction
- SOP-601 Study Closeout
- SOP-900 Network Governance, SOP Hierarchy and Local Addenda
- SOP-901 Member Site Onboarding, Integration and Exit
- SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation)
- SOP-904 Shared Staff, Cross-Site Coverage and Central Services
- SOP-905 Network Data, Systems, Privacy and Records Across Sites
7. References
| Reference | Title |
|---|---|
| 21 CFR 312.53(a) | Selecting investigators and monitors: sponsor selects qualified investigators |
| 21 CFR 812.43(a) | Selecting investigators: sponsor selects qualified investigators |
| 21 CFR 312.60 | General responsibilities of investigators |
| ICH E6(R3) Annex 1, 2.2 | Resources |
| ICH E6(R3) Annex 1, 3.7 | Investigator Selection |
| 42 U.S.C. 1320a-7b(b) | Criminal penalties for acts involving Federal health care programs: illegal remunerations (Anti-Kickback Statute) |
| 42 CFR 1001.952(d) | Exceptions: personal services and management contracts |
| 42 U.S.C. 1395nn | Limitation on certain physician referrals (physician self-referral law, Stark) |
| CMS NCD 310.1 | Routine Costs in Clinical Trials |
| 42 CFR 405 Subpart B | Medical Services Coverage Decisions That Relate to Health Care Technology (IDE coverage) |
Independent Site SOP Library. Licensed CC BY-NC 4.0 by the American Institute for Medical Research (AIMR), with added permission for any site's internal use (license terms). Not legal advice: each adopting site confirms state law, IRB and sponsor requirements with its own counsel and owns every step it approves.