Independent Site SOP Library
Network Edition 2.0
An add-on for site networks: 6 network SOPs, a supplement listing what changes in each Lean SOP, and a table of activities a network may centralize. It does not stand alone; every member site also uses the Lean Edition.
Start here
What this is. An add-on to the Lean Edition for site networks (Model N): a Network Office plus two or more member sites. It contains six Network SOPs (SOP-N1 to SOP-N6), the Network Supplement, which lists only what changes in each Lean core SOP and module in a network, the Appendix B exceptions table of activities a network may centralize, and ten network forms. It does not stand alone: every member site moves to the Lean Edition core SOPs, and in Model N also modules SOP-M1, SOP-M2 and SOP-M5, by its network effective date (SOP-N2). It is written to the regulatory baseline of 23 October 2026 and condensed from the Reference Edition network SOPs (SOP-900 to SOP-905).
How it handles mixed ownership. Defaults are set per member site by its legal entity type, not by what the network calls itself. Under the Hybrid Rule (SOP-N1 5.2.2), the N-Integrated column of Appendix B applies only to a site that is the network entity. A commonly owned subsidiary, a professional corporation under a management services arrangement, or an independent site uses the N-Affiliated column for every row unless counsel records a row-specific exception. A management services organization that is not itself a covered entity is never inside an affiliated covered entity; it acts as a business associate under a BAA (SOP-N6 5.3.3).
Review status. Prepared as a template with automated and simulated review, including two rounds of structured adversarial expert review of the network layer; most findings are addressed and the rest are listed as open items. As of 1 November 2026 it has not been reviewed by counsel, a practicing site QA lead or a network operator, and no network has yet adopted it. Open items for counsel: whether the Network Office may run a feasibility query on another covered entity's data under a business associate agreement; whether the network entity is a covered entity and how an MSO's business associate role and any workforce status are documented; whether a site-assigned study ID meets 45 CFR 164.514(c) in a given network; Anti-Kickback Statute and state all-payer anti-kickback, fee-splitting and self-referral review of every payment between entities; physician self-referral (Stark) exceptions for each billing entity, including the platform's own physician owners and PIs; DEA registration for any central storage location and the 21 CFR 1307.11 limit on redistribution; corporate practice of medicine in each state; the network entity's written authority to sign CTAs as a member entity's agent; and any row-specific exception to the Hybrid Rule. Not yet done: a Network Office staffing and effort estimate.
Who owns it once adopted. Once [NETWORK NAME] and each member site approve these documents they are the network's and each site's own SOPs. Each PI keeps all investigator duties. Change or remove any step the network will not follow before approval.
How to start
- Name the Network Executive, Network Quality Lead and Network Privacy Officer, and record each member site's legal entity and entity type on F-900-02 (SOP-N1 5.2 and 5.3).
- Complete the day-one minimum in SOP-N1 5.1: HIPAA structure and F-905-01, a signed network agreement for each separate entity, the network QA contact, Appendix B adopted, and an F-901-02 integration plan with a network effective date for each member site. Day one is complete when F-900-02 Part 0 is complete. Member sites do not need the Lean Edition in place on day one.
- Each member site keeps operating under its own approved SOPs until its network effective date, then moves to the Lean Edition core SOPs, modules SOP-M1, SOP-M2 and SOP-M5, and the Network SOPs, by [DEFAULT: 90 calendar days] after the network start date or its closing date (SOP-N2 5.1).
- Train each role on the Network SOPs and the Network Supplement sections for the Lean SOPs they use before each site's network effective date. Close the remaining items within 6 months (SOP-N1 5.1.3).
Standard operating procedures
Purpose is the first sentence of each SOP's section 1. Pages are estimated at 450 words per page.
Network SOPs (Model N only) (6)
| Number | Title | Purpose | Approx. pages | Links |
|---|---|---|---|---|
| SOP-N1 | Network Governance and Local Addenda | This SOP sets how [NETWORK NAME] governs one quality system across its member sites: what must be in place on day one, who decides, which document wins when two apply, how each member site's legal entity type decides which defaults apply to it, what the network agreement must state, and how network SOPs and local addenda reach every site. | 10 | Read online Word |
| SOP-N2 | Member Site Onboarding, Integration and Exit | This SOP sets how [NETWORK NAME] assesses a site that is joining, brings it onto network SOPs, systems and agreements on a fixed timeline without interrupting participant care, and handles a member site that leaves or closes. | 6 | Read online Word |
| SOP-N3 | Network Feasibility, Allocation and Central Contracting | 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. | 6 | Read online Word |
| SOP-N4 | Network Oversight, Metrics, Central QA and Escalation | This SOP sets how the Network Office of [NETWORK NAME] oversees the quality and performance of member sites: the metric set and quarterly scorecard, central QA audits, CAPA trending across sites, escalation tiers with site support plans, and sharing of findings. | 6 | Read online Word |
| SOP-N5 | Shared Staff, Cross-Site Coverage and Central Services | This SOP sets how [NETWORK NAME] deploys staff who work at more than one member site, provides central services to member sites, and covers key roles across sites. | 6 | Read online Word |
| SOP-N6 | Network Data, Systems, Privacy and Records | This SOP sets how [NETWORK NAME] runs systems shared by member sites, controls who sees each site's records, applies HIPAA when information moves between legal entities in the network, keeps each investigator in control of the study records, and handles privacy incidents that involve more than one entity. | 7 | Read online Word |
Forms and logs (10)
Forms are Word files only. Each one names the SOP that uses it.
| Code | Title | Owning SOP | Download |
|---|---|---|---|
| F-900-01 | Local Addendum to a Network SOP | SOP-N1 | Word |
| F-900-02 | Network Operating Model and Appendix B Adoption Record | SOP-N1 | Word |
| F-901-01 | Member Site Gap Assessment | SOP-N2 | Word |
| F-901-02 | Member Site Integration Plan and Exit Checklist | SOP-N2 | Word |
| F-902-01 | Study Allocation Decision Record | SOP-N3 | Word |
| F-902-02 | Network Interest and Compensation Disclosure | SOP-N3 | Word |
| F-903-01 | Member Site Performance and Quality Scorecard | SOP-N4 | Word |
| F-903-02 | Escalation and Site Support Plan | SOP-N4 | Word |
| F-904-01 | Shared Staff Assignment and Credentialing Log | SOP-N5 | Word |
| F-905-01 | Cross-Entity Data Flow Register | SOP-N6 | Word |
Guides and appendices
Model N only: the duties that always stay at the site, and the activities a network may centralize, with defaults by entity type.
Model N only: what changes in each Lean core SOP and module when the library runs in a network.
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.