SOP-N3
Network Feasibility, Allocation and Central Contracting
- Number
- SOP-N3
- Category
- Network
- Edition
- Network Edition 2.0
- Approx. pages
- 6
- Reference Edition source
- SOP-902
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This SOP sets how [NETWORK NAME] receives sponsor inquiries centrally, combines member site feasibility into one network response, decides which member sites are offered for a study, and negotiates agreements, budgets and coverage analyses centrally. It also sets the rules for money that moves between legal entities in the network and for central invoicing.
2. Scope
This SOP applies only when [NETWORK NAME] has adopted Model N. It adds the network layer to SOP-M2 (feasibility, contracts, budgets and research billing at each site), which every member site adopts in Model N. Network terms are defined in SOP-N1 section 4.
In scope: central intake and CDAs; network feasibility and the network response; allocation (F-902-01); master agreements, CTAs and budgets; central coverage analysis; payments between entities and counsel review; staff compensation linked to enrollment; central invoicing and reconciliation.
Where the protocol, sponsor or IRB requirement is stricter than this SOP, the network and the member site follow the stricter requirement.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Network Clinical Operations Lead | Runs central intake, network feasibility and allocation, and prepares F-902-01 and the network response. |
| Network Contracts and Finance Lead | Negotiates agreements and budgets the Appendix B defaults assign centrally, prepares the central coverage analysis, obtains counsel review under 5.7, and runs central invoicing and reconciliation. |
| Network Quality Lead | Supplies each site's tier and quality history (SOP-N4) for allocation and for the sponsor disclosure in 5.3.5. |
| Network Medical Director | Optional. Reviews allocation for studies with high safety demands. Does not replace any PI's judgment. |
| Site Director | Runs site feasibility under SOP-M2, confirms capacity, accepts or declines allocation, and signs for the site entity where it is a contract party. |
| Principal Investigator (PI) | Approves the site enrollment estimate, decides whether to take the study, and keeps all investigator duties. |
| Finance / Contracts Lead (site) | Localizes the coverage analysis, builds the site billing grid and reports invoiceable events. |
4. Definitions
| Term | Definition |
|---|---|
| Central intake | The single point where the Network Office receives sponsor and CRO inquiries for any member site. |
| Catchment overlap | Part of one member site's eligible pool that another member site can also reach (same referrers, health system, database or area). |
| Allocation | The network decision on which member sites and PIs are offered to the sponsor. |
| Site-specific interest | An ownership interest in, or compensation tied to the results of, one particular member site. |
| Platform-wide interest | An interest held equally across all member sites, for example equity or options in the network entity. Nominal ownership of a professional corporation under a stock transfer restriction or similar agreement, with no economic interest beyond fixed compensation, is a platform-wide interest. |
| Fair market value (FMV) | The value of services in an arm's-length transaction, not taking into account the volume or value of referrals or business between the parties. |
| Tri-party CTA | A CTA signed by the sponsor or CRO, the network entity and the member site entity. |
5. Procedure
5.1 Day-one minimum
5.1.1
The day-one items for this SOP are the "first sponsor response or agreement" row in SOP-N1 5.1.1. The Network Contracts and Finance Lead (or Network Executive where the role is not appointed) records them on F-900-02 Part 0.
5.2 Central intake and CDAs
5.2.1
All sponsor and CRO inquiries, CDAs and feasibility questionnaires for any member site go to [NETWORK INTAKE ADDRESS]. A member site that receives one directly forwards it within [DEFAULT: 2 business days] and does not answer for the network. The Network Clinical Operations Lead logs each inquiry in [NETWORK STUDY PIPELINE TRACKER].
5.2.2
A CDA signed by the network entity covers member sites of the same legal entity. For a separate member site entity, the CDA must permit disclosure to the member sites the network consults, or the entity signs its own CDA or a joinder, before it receives the protocol. The Network Office records which sites received the information.
5.2.3
The Network Clinical Operations Lead sends the inquiry only to member sites that could plausibly run it, with only the information needed to assess feasibility.
5.3 Site feasibility and the network response
5.3.1
Each member site asked completes its feasibility under SOP-M2 and returns F-200-01, with an enrollment estimate as a range (low and expected) approved by the proposed PI. The Network Office does not change a site's estimate upward; a question goes back to the site and PI, and any revision is recorded on F-200-01.
5.3.2
Population data that contains PHI stays at the site, and sites send aggregate counts. Feasibility queries the Network Office runs on another covered entity's data follow SOP-N6 5.5.1.
5.3.3
The Network Clinical Operations Lead combines site estimates on F-902-01 after checking for catchment overlap (shared referrers, health system, EHR population, advertising, databases, or patients seen at more than one site). A shared pool is counted once and divided, and the method is recorded. Where overlap cannot be measured, the low estimate is used for the overlapping sites and the response says so. Competing studies are checked across the whole network.
5.3.4
The network response gives each proposed site's PI-approved enrollment estimate (low and expected) with its main assumptions, and the network total as a summary line. A network-only figure is given only where the sponsor asks for one. The network expected value does not exceed the combined expected value on F-902-01. Where the sponsor asks for named PIs or site commitments, each PI approves the site's numbers before the response is sent. The Network Clinical Operations Lead signs the response.
5.3.5
Answers to a sponsor's questions about inspections, audits and findings are complete and accurate. Beyond that, the network discloses a site's internal tier (SOP-N4) to a sponsor only where a CTA or law requires it, or where a Tier 3 or 4 issue affects that sponsor's study; the PI decides how that sponsor is told (SOP-N4 5.6.3). A site at Tier 3 or 4 is proposed only where its F-903-02 plan allows it (5.4.2), and the issue is then disclosed to the sponsor within CTA and CDA confidentiality terms. The decision is recorded on F-902-01.
5.4 Allocation (F-902-01)
5.4.1
Where the network must choose which sites to propose, the Network Clinical Operations Lead prepares a recommendation on F-902-01 using: capacity net of current studies; PI interest, qualification and workload; population adjusted for overlap; tier and quality history from F-903-01; conflicts (competing studies, PI or site financial interest in the sponsor under SOP-02); facility needs (CLIA certificate type, DEA registration, imaging, infusion); and sponsor requests.
5.4.2
A site at Tier 3 or 4, or at Tier 2 where its F-903-02 plan says so, is not allocated new studies unless the plan allows it.
5.4.3
Allocation is never based on the volume or value of referrals by any site or PI to another member site, the network entity or any related party.
5.4.4
Interests: a person with a site-specific interest does not recommend or decide an allocation affecting that site; the decision maker records the interest and who stepped aside on F-902-01. A platform-wide interest does not require recusal. Each holder records each interest once on F-902-02, the network addendum to F-104-01, and the Network Quality Lead keeps the list on it.
5.4.5
The Network Clinical Operations Lead records the decision, reasons, sites considered and not chosen, and the decision maker on F-902-01. Each allocated Site Director and PI accepts or declines in writing. Each allocated site keeps its own PI, 1572 or investigator agreement, IRB approval or reliance, delegation log and activation checklist (SOP-03). Moving a study between sites follows SOP-N2 5.8; participants move only with sponsor and IRB agreement and the participant's consent.
5.5 Master agreements, CTAs and budgets
5.5.1
Who negotiates follows the adopted Appendix B defaults. Central negotiation uses the review steps in SOP-M2 and the [NETWORK CONTRACT PLAYBOOK], an uncontrolled business document not shared with sponsors.
5.5.2
Signatory, under the Hybrid Rule (SOP-N1 5.2.2):
- a member site that is the network entity: the network entity signs through [NETWORK SIGNATURE AUTHORITY POLICY]; the PI signs only an investigator acknowledgment where the CTA requires one
- a separate member site entity: that entity signs as the institution, in a two-party CTA with the sponsor or a tri-party CTA with the network entity
- a separate member site entity that has given the network entity written authority in the network agreement to contract in its name: the member site entity is the contracting institution, and a network entity officer signs as its authorized agent. Counsel confirms that the authority covers CTAs, and a copy of the authority is kept with the CTA
- the network entity signs alone as the contracting institution only where the network agreement and the sponsor accept it and counsel has confirmed it in writing
5.5.3
Each allocated site has a budget exhibit for its own costs, staffing, local fees and billing setup, unless every site has the same cost basis and the Network Contracts and Finance Lead records why. The CTA states, for each site, the investigator, address, payee, invoicing route, retention, subject injury and indemnity terms, and whether the network entity collects payment for the site. The site Site Director approves the site budget.
5.5.4
The Network Contracts and Finance Lead sends executed agreements to each Site Director and PI for the ISF. Study procedures at a site start only after its agreement is executed.
5.6 Coverage analysis and billing
5.6.1
The Network Contracts and Finance Lead prepares one coverage analysis per protocol version on F-202-01 (SOP-M2).
5.6.2
The billing entity for each site decides whether the study bills insurance, and its Finance / Contracts Lead localizes the analysis (payer mix, billing entity and numbers, MAC and local coverage determinations, state Medicaid rules, services not provided) on the site's copy of F-202-01. The site PI reviews the routine-cost determinations for the site. The site builds its billing grid and submits claims under its own billing numbers and is responsible for them.
5.6.3
Before each site's CTA is signed and after each amendment, the Network Contracts and Finance Lead checks that the coverage analysis, budget exhibit, CTA and consent form agree on who pays for each item.
5.7 Payments between entities and counsel review
5.7.1
Every payment between the network entity and a separate member site entity, or between member site entities, is written in the network agreement or a subcontract before work starts. It is FMV for services actually performed and documented, set in advance, and does not vary with the volume or value of referrals. No one pays or receives anything for referring a patient, participant or study; finder's fees and per-referral or per-enrollee payments are prohibited.
5.7.2
Recruitment or pre-screening services between entities are paid only as fees for work done (hours, campaigns run, queries run), never per referral, per randomized participant or per enrollee.
5.7.3
Single counsel review rule. The Network Contracts and Finance Lead obtains counsel review before first use, and at each change, of every payment structure in 5.7.1, 5.7.2, 5.7.4 and 5.7.6, whatever the payer. Counsel reviews against:
- the federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) where any party bills, or refers for items or services paid by, a federal health care program, including fit with a safe harbor such as personal services and management contracts (42 CFR 1001.952(d))
- state anti-kickback, patient-brokering, fee-splitting and self-referral laws, which may apply to all payers, including commercial insurance and self-pay
The review is kept with the network agreement, and the state-law answer is recorded in each affected state's Appendix A worksheet.
5.7.4
The Network Office fee to a separate member site entity is set in the network agreement before work starts, pays only for listed services the Network Office actually provides, rests on a documented FMV basis (for example cost-plus or an independent valuation), and does not vary with participants or studies referred. Because the Network Office also allocates studies, a fee charged per study, per visit or as a percentage of site study revenue is used only where counsel has approved it under 5.7.3. The fee is shown on each site statement.
5.7.5
Physician self-referral (Stark), every entity type. Wherever a physician with an ownership, investment or compensation relationship with the network entity or a member site entity orders or refers designated health services (for example clinical laboratory or imaging) that the network or a member entity bills to Medicare or Medicaid, including routine costs in a study, counsel reviews the arrangement under 42 U.S.C. 1395nn before the entity bills, and records which exception applies for each billing entity. This covers the platform's own physician owners, investors, PIs and Sub-Is who order such services for their participants, as well as outside referring physicians. The law imposes liability without intent, so the review is repeated at each change in ownership or compensation terms.
5.7.6
Compensation linked to enrollment. Default: no investigator or staff compensation is tied to an individual participant's referral, consent, enrollment or randomization. Any study-volume component (for example a team bonus on studies completed) needs counsel review under 5.7.3, a written cap, and a record on F-902-02 for each person it covers. Metrics are never used to pressure enrollment (SOP-N4 5.2).
5.7.7
Central participant payment programs: 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-10). Member sites of the same legal entity are one payer, which totals each participant's payments across those sites for the calendar year. A separate member site entity reports what it pays; where the Network Office pays a member site's participants from its own account, the Network Office is the payer. The arrangement is written in the network agreement, confirmed with the tax advisor, and the participant data the payer receives is recorded on F-905-01.
5.8 Invoicing and reconciliation
5.8.1
The payee named in the CTA invoices the sponsor. Each allocated site reports invoiceable events to the Network Contracts and Finance Lead at least [DEFAULT: monthly] with support (visit logs, F-303-01, F-501-01); where the site invoices directly, it copies the Network Office.
5.8.2
Where the network entity is the payee, the Network Contracts and Finance Lead invoices for each site, tracks payments by site and study in [NETWORK ACCOUNTING SYSTEM], and reconciles at least [DEFAULT: quarterly]. A separate member site entity is paid its share within [DEFAULT: 30 calendar days] of the sponsor payment, unless the network agreement sets another term, with a statement of payments received, network fees kept and amounts paid. The Site Director may review the records behind it; disputes go to the Network Executive and are recorded.
5.8.3
At closeout, the Network Contracts and Finance Lead completes final reconciliation for each site (SOP-15).
5.9 Records
5.9.1
The Network Clinical Operations Lead keeps intake logs, network responses and F-902-01. The Network Contracts and Finance Lead keeps agreements, budgets, coverage analyses, counsel reviews and reconciliations. Site-specific copies are filed in each site's ISF. Retention follows SOP-12.
6. Related Forms and SOPs
- F-902-01 Study Allocation Decision Record
- F-902-02 Network Interest and Compensation Disclosure
- F-104-01 Conflict of Interest and Financial Interest Disclosure
- F-200-01 Study Feasibility Assessment
- F-202-01 Coverage Analysis Worksheet
- 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
- F-905-01 Cross-Entity Data Flow Register
- Appendix A State Law Worksheet
- SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest
- SOP-03 IRB Oversight, Essential Records and Study Activation
- SOP-10 Participant Retention, Withdrawal and Payments
- SOP-12 Privacy, Electronic Systems and Record Retention
- SOP-15 Study Closeout
- SOP-M2 Feasibility, Contracts, Budgets and Research Billing
- SOP-N1, SOP-N2, SOP-N4, SOP-N6
7. References
| Reference | Title |
|---|---|
| 21 CFR 312.53(a) | Sponsor selects qualified investigators |
| 21 CFR 812.43(a) | Sponsor selects qualified investigators (devices) |
| ICH E6(R3) Annex 1, 3.7 | Investigator selection |
| 42 U.S.C. 1320a-7b(b) | Anti-Kickback Statute |
| 42 CFR 1001.952(d) | Safe harbor: personal services and management contracts |
| 42 U.S.C. 1395nn | Physician self-referral law (Stark) |
| CMS NCD 310.1 | Routine Costs in Clinical Trials |
| Reference Edition SOP-902 | Network Study Feasibility, Allocation and Central Contracting (background and full wording) |
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.