SOP-N1
Network Governance and Local Addenda
- Number
- SOP-N1
- Category
- Network
- Edition
- Network Edition 2.0
- Approx. pages
- 10
- Reference Edition source
- SOP-900
[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] 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.
2. Scope
This SOP applies only when [NETWORK NAME] has adopted Model N. A single site (Model S) using the Lean Edition ignores the Network Edition.
In scope: the day-one minimum for the whole Network Edition; Network Office roles and the Network Quality Committee; the operating model record (F-900-02), including each member site's entity type and the Hybrid Rule; adoption of Appendix B (Central and Site Responsibilities, Exceptions Table); order of precedence; approval, adoption, training and effective dates of network SOPs; local addenda (F-900-01); network agreement terms; the network calendar; network management review.
Out of scope: onboarding and exit (SOP-N2), feasibility, allocation and contracting (SOP-N3), oversight and escalation (SOP-N4), shared staff and central services (SOP-N5), data, systems and records (SOP-N6). The control of a single SOP stays in SOP-01; this SOP adds the network layer.
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 Governing Body | Board of the network entity, or the joint governance board under the network agreement. Appoints the Network Executive, names [NETWORK GOVERNING BODY CONTACT] and receives the management review summary. |
| Network Executive | Required role. Accountable for the network. Approves F-900-02 with the Network Quality Committee, charters the committee, confirms network agreements, provides resources and chairs management review. |
| Network Quality Lead | Required role. Owns the network SOP system, F-900-02, the day-one record, the network calendar, local addendum review, training assignments and management review records. Secretary to the Network Quality Committee. |
| Network Privacy Officer | Required role. Confirms the HIPAA structure across sites (SOP-N6). May be the Network Quality Lead. |
| Network Quality Committee | Approves network SOPs and major revisions, F-900-02, metric thresholds, the network audit plan and addendum disputes; runs management review. |
| Network Regulatory Lead, Network Contracts and Finance Lead, Network Clinical Operations Lead, Network Training Lead, Network Security Officer | Optional roles. Carry out central activities F-900-02 assigns them. One person may hold several. |
| Network Medical Director | Optional. Reviews network SOPs that affect safety, consent, IP or investigator duties and advises PIs. Never replaces a PI. |
| Site Director | Signs the site's acceptance of F-900-02, the site adoption record and each local addendum. Accountable for adoption and training at the site. |
| Site Quality Lead | Drafts local addenda, keeps site work instructions and site training records, and reports SOP deviations to the Network Quality Lead. Where F-900-02 makes the role central, the Network Quality Lead does these tasks. |
| Principal Investigator (PI) | Keeps all investigator duties. Approves addenda that affect investigator duties, safety, consent, IP or data integrity. Raises any network rule that would stop the PI meeting those duties. |
4. Definitions
These definitions apply to every Network Edition document.
| Term | Definition |
|---|---|
| Model N | The operating model in which a Network Office and two or more member sites use the library together. |
| Network Office | The central organization of the network, collectively. |
| Network entity | The legal entity that runs the Network Office (for example the parent company or a management services organization). |
| Member site | A research site (one or more locations under one site leadership) that operates under the network SOPs. A founding site is a member site on the network start date; a joining site joins later. |
| Entity type | For each member site, one of: (a) the network entity itself; (b) a separate legal entity under common ownership or control with the network entity (for example a subsidiary, or a professional corporation under a management services arrangement); (c) an independent legal entity bound by a network agreement. A platform that controls its professional corporations through a management services organization records every professional corporation as type (b), whatever the network calls itself. Recorded on F-900-02. |
| N-Integrated and N-Affiliated columns | The two default columns of Appendix B. The N-Integrated column applies only to type (a) sites; the N-Affiliated column applies to type (b) and (c) sites (Hybrid Rule). |
| Network variant | A descriptive label only: integrated (all sites type a), affiliated (all sites type b or c) or mixed. It does not decide any default. |
| Hybrid Rule | The rule in 5.2.2 that applies the N-Affiliated column to every Appendix B row for a separate member site entity. |
| Network start date | The date the network starts operating under this edition, after the network-level day-one items in 5.1 are complete. |
| Network effective date (site) | The date a member site's former SOPs are retired and the network SOPs take effect at that site, set on its F-901-02. |
| Network agreement | The written agreement that binds a separate member site entity to the network: an affiliation or membership agreement for type (c); a management services agreement, subsidiary resolution or intercompany agreement for type (b). |
| Network SOP | A Lean Edition core SOP or adopted module, or a Network Edition SOP, approved for use at all member sites. |
| Network minimum | A requirement in a network SOP that no member site may lower. |
| Local addendum | A controlled document (F-900-01) that adds site-specific content to one network SOP for one member site. |
5. Procedure
5.1 Day-one minimum and transition
5.1.1
This table is the only day-one list in the Network Edition; the other Network SOPs point to it. The Network Quality Lead records each network-level and event-triggered item on F-900-02 Part 0, and each per-site item on that site's F-901-02 Part 0. Day one is complete when F-900-02 Part 0 is complete for the network-level items.
| Item | Owner | When | Detail |
|---|---|---|---|
| Network level | Before the network start date | ||
| Network Executive, Network Quality Lead and Network Privacy Officer named; network QA contact and [NETWORK GOVERNING BODY CONTACT] published to every member site | Network Executive | Before start | 5.3 |
| F-900-02 approved: each member site's legal entity, entity type and locations; Appendix B adopted with any row exceptions | Network Quality Lead | Before start | 5.2 |
| HIPAA structure recorded, including whether the network entity is a covered entity and an ACE member; F-905-01 opened with every existing cross-entity flow, and any flow without a pathway stopped | Network Privacy Officer | Before start | SOP-N6 5.3, 5.4 |
| Signed network agreement for each separate member site entity, covering the terms in 5.8.1; corporate authority recorded for each type (a) site | Network Executive | Before start | 5.8 |
| F-901-02 integration plan for each member site, with its network effective date | Network Quality Lead | Before start (founding sites); before closing (joining sites) | SOP-N2 5.3 |
| Metric definitions with interim thresholds, escalation tiers, a same-day route for immediate safety concerns, and the rule that Site Directors report FDA, sponsor and IRB findings within [DEFAULT: 2 business days] | Network Quality Lead | Before start | SOP-N4 5.3, 5.6, 5.8.1 |
| Same-day privacy incident route from each site Privacy Officer to the Network Privacy Officer | Network Privacy Officer | Before start | SOP-N6 5.8 |
| Per member site | Network start date (founding) or closing date (joining) | ||
| Each in-flight study has a named PI, a PI-approved participant care plan, an unchanged or confirmed safety reporting route to the sponsor, and named PI coverage | Network Quality Lead with the PI | Start or closing | SOP-N2 5.4.3; SOP-16 |
| Every sponsor, IRB or CTA notice or consent that must precede the change sent or obtained; otherwise the existing arrangement stays | Network Regulatory Lead; Network Contracts and Finance Lead | Before closing | SOP-N2 5.4.2 |
| Controlled-substance IP held only where a DEA registration covers the location; Schedule I IP only under a Schedule I researcher registration | Site Director | Start or closing | SOP-N5 5.8.3 |
| Insurance in force, with tail coverage where a claims-made policy ends | Network Contracts and Finance Lead | Start or closing | SOP-N2 5.6.1 |
| Site operating under its own approved SOPs, with any transition rule recorded, until its network effective date | Site Director | Start or closing | 5.1.2 |
| Event-triggered | Before the first event, at any site | ||
| Before the first sponsor response or agreement for a member site: intake address published, signatory per site recorded, counsel review of every existing payment between entities, enrollment-pay default adopted, F-902-01 in use | Network Contracts and Finance Lead | First inquiry or agreement | SOP-N3 5.2, 5.5.2, 5.7 |
| Before any person works at a second member site or a central service does trial work for a site: delegation by each PI, licensure, staffing or services agreement and HIPAA status, F-105-01 entry, blinding status | Network Clinical Operations Lead | First cross-site work | SOP-N5 5.3 to 5.8 |
| Before PHI moves between legal entities or a shared system holds more than one site's records: pathway on F-905-01, BAA wherever the Network Office handles another covered entity's PHI, site partitions tested | Network Privacy Officer; Network Quality Lead | First flow or shared system | SOP-N6 5.2, 5.3 |
5.1.2
Network day one does not require any member site to have the Lean Edition in place. Each member site, founding or joining, keeps operating under its own approved SOPs until its network effective date, so there is no gap. On that date it moves to the Lean Edition core SOPs, modules SOP-M1, SOP-M2 and SOP-M5, and the Network SOPs, as its F-901-02 sets out, by [DEFAULT: 90 calendar days] after the network start date (founding site) or closing date (joining site) (SOP-N2 5.1). The event-triggered items in 5.1.1 apply at every site from day one, whatever SOPs it follows.
5.1.3
The rest of the Network Edition is in place within [DEFAULT: 6 months] of the network start date. The Network Quality Lead keeps a dated open-items list and reports it at each Network Quality Committee meeting.
5.1.4
In a network of fewer than [DEFAULT: 5] member sites, the Network Quality Committee may be the Network Executive, the Network Quality Lead and one member site PI, and required role holders may hold the optional roles.
5.2 Operating model, entity types and the Hybrid Rule
5.2.1
Before any member site adopts network SOPs, the Network Executive and Network Quality Lead record on F-900-02:
- the network entity and, for each member site, its legal entity, entity type, locations and state(s)
- the HIPAA structure, including whether the network entity is itself a covered entity and an ACE member, confirmed by the Network Privacy Officer under SOP-N6
- the Appendix B defaults adopted and each row exception, with the reason
5.2.2
Hybrid Rule. The N-Integrated column of Appendix B applies only to a member site that is the network entity (type a). For a member site that is a separate legal entity, whether commonly owned (type b) or independent (type c), the N-Affiliated column applies to every Appendix B row. The only exception is a row-specific exception that [LEGAL COUNSEL] confirms in writing for that site and row, recorded by the Network Quality Lead on F-900-02 Part 4. A general grant of authority in the network agreement is not an exception. No exception moves a duty in Appendix B Part 1, or removes the staffing or services agreement (SOP-N5 5.6.2) or the HIPAA pathway (SOP-N6 5.3.4) needed when work or PHI crosses a legal-entity line. An affiliated covered entity (ACE) makes flows between its member covered entities a use (SOP-N6 5.3.3); it never brings the Network Office inside the covered entity unless the network entity is itself a covered entity and an ACE member.
5.2.3
Before F-900-02 is approved, [LEGAL COUNSEL] confirms the corporate practice of medicine rules for each state where a member site operates and records the answer in that state's Appendix A worksheet. The Network Quality Lead records the date of confirmation on F-900-02.
5.2.4
The Network Quality Lead starts from the column that 5.2.2 sets for each site. A change that gives the Network Office more of a separate entity's activity than the N-Affiliated column allows is a row exception under 5.2.2. Any other change records the reason and evidence that the party taking the activity has the authority and resources to do it.
5.2.5
The Network Quality Committee approves F-900-02, and each Site Director signs to accept the site's assignments. Re-approval:
- a joining site that adopts the defaults for its entity type, or a change to one row that is not a row exception, is approved by the Network Quality Lead and ratified at the next committee meeting
- a change of entity type or a row exception needs committee approval before it takes effect
The Network Quality Lead tells affected staff of each change and assigns training under 5.5.
5.3 Network Office roles and the Network Quality Committee
5.3.1
The Network Executive appoints the Network Office roles and records them on F-900-02 Part 1. Combined roles follow the independence limits in SOP-02; no one audits or QCs their own work.
5.3.2
The Network Executive charters the Network Quality Committee in writing: voting members (at least the Network Quality Lead, the Network Executive or delegate, the Network Medical Director if appointed, and [DEFAULT: one PI and one Site Director] from member sites), quorum, how decisions are recorded, meetings at least [DEFAULT: quarterly], and the decisions it owns. The Network Quality Lead keeps the charter, minutes and decision log in [NETWORK QUALITY SYSTEM LOCATION].
5.3.3
The Network Governing Body names [NETWORK GOVERNING BODY CONTACT] for integrity concerns about network leadership. The contact is not the Network Executive, the Network Quality Lead or anyone reporting to them. Concerns are handled under SOP-M5; where network leadership is implicated, the Network Governing Body appoints an independent investigator.
5.3.4
The Network Executive, or the Network Quality Lead when the Network Executive cannot be reached, declares a network-wide continuity event (for example a shared system outage). Each Site Director then acts under SOP-16.
5.3.5
A Network Medical Director does not sign a Form FDA 1572 or investigator agreement unless named on it, and does not make eligibility, causality or care decisions for another PI's participants.
5.4 Order of precedence
5.4.1
Staff at member sites apply overlapping requirements in this order: law and regulation, including the law of the site's state (Appendix A); determinations of the study's IRB; the protocol and sponsor written instructions; network SOPs; the site's local addenda (F-900-01); site work instructions and job aids. Nothing overrides an action needed to remove an immediate hazard to a participant.
5.4.2
A local addendum applies only at the member site and to the network SOP named on it.
5.5 Network SOPs: approval, adoption, training and effective dates
5.5.1
Network SOPs are the Lean Edition core SOPs, adopted modules, and SOP-N1 to SOP-N6, one version of each effective network-wide. The Network Quality Lead holds the only editable master in [NETWORK SOP REPOSITORY], publishes effective versions read-only to every site, and keeps the network's SOP Master Index on F-100-03.
5.5.2
The Network Quality Lead resolves network placeholders and records on F-900-02 Part 5 whether each Site decision box is resolved once for the network or per site in an addendum. The Network Quality Committee marks network minimums; every regulatory requirement is one. The Network Quality Lead lists them on F-900-02 Part 5.
5.5.3
Major revision: the Network Quality Lead circulates the draft to all member sites for at least [DEFAULT: 14 calendar days] and records how each comment was resolved. The Network Quality Committee approves by recorded vote in its minutes, and the Network Quality Lead records the approval on F-100-01. A minor revision (no change to a requirement, responsibility, timeline or network minimum) is approved by the Network Quality Lead alone and reported at the next committee meeting.
5.5.4
Site adoption: the Site Director signs the site adoption record (F-100-01). The site does not re-approve content. For a separate member site entity, this signature is the entity's adoption under the network agreement, and the site's existing procedure stays effective until it is signed.
5.5.5
The Network Quality Lead sets one network effective date for each revision, at least [DEFAULT: 30 calendar days] after approval of a major revision. The Network Quality Lead or Network Training Lead assigns training by role; staff complete F-100-02 before the effective date. Each Site Director confirms in writing that training is complete and addenda are current, or asks for a later site date of up to [DEFAULT: 30 calendar days], which the Network Quality Lead records on F-100-03. Until then the site keeps the previous version.
5.5.6
The Network Quality Committee may approve an urgent release for a new regulation, an inspection finding or a safety issue. The Network Quality Lead records the reason and interim training method.
5.6 Local addenda
5.6.1
A local addendum may add stricter steps; add steps required by state or local law, the IRB or the site's institution; name local contacts, locations, systems and vendors; or resolve a Site decision box F-900-02 assigns to the site.
5.6.2
A local addendum must not lower or remove any requirement of law, the IRB, the protocol or a network SOP (including a network minimum or timeline), change an assignment F-900-02 gives the Network Office, move an investigator duty away from the PI, or create a new form code.
5.6.3
The Site Quality Lead drafts the addendum on F-900-01. The Network Quality Lead checks it against 5.6.2 before site approval; disagreements go to the Network Quality Committee. Site approval follows SOP-01, with the PI signing where the addendum affects investigator duties, safety, consent, IP or data integrity.
5.6.4
When a network SOP is revised, the Site Quality Lead revises, re-confirms or retires each linked addendum before the network effective date and records it on F-900-01. If that is not done:
- an addendum that implements law, an IRB determination or an Appendix A answer stays in force until reviewed
- an addendum for local practice or systems is suspended, and the network SOP alone applies until it is reviewed
5.7 Investigator duties stay with each PI
5.7.1
Each PI keeps the general responsibilities of an investigator (21 CFR 312.60; 21 CFR 812.100; ICH E6(R3) Annex 1, 2.3). Network governance, assignments and central services do not transfer them. A central activity done for a PI's study is a service the PI oversees in proportion to its risk, and the PI may ask for its records at any time.
5.7.2
A PI who believes a network rule would stop the PI protecting participants or meeting investigator duties raises it with the Site Director and Network Quality Lead. The PI's decision on participant safety stands while the Network Quality Committee reviews it. The outcome is recorded in the committee minutes and, where study-specific, on F-306-01 in the ISF.
5.7.3
The Network Office must not pressure a PI on medical judgment, eligibility, causality, safety reporting or consent. Staff report such pressure to [NETWORK GOVERNING BODY CONTACT] or under SOP-M5.
5.8 What the network agreement must state
5.8.1
This is the single list of required network agreement terms; other Network SOPs point to it. Before a separate member site entity adopts network SOPs, the Network Executive confirms that its network agreement, reviewed by counsel, states each term below, and the Network Quality Lead records the clause for each on F-900-02 Part 7.
| Term | Set by |
|---|---|
| Which network SOPs, minimums and Appendix B assignments bind the entity, and how changes become binding | 5.5 |
| On conflict, the entity's legal duties and the investigator's duties prevail; the entity notifies the Network Office in writing within [DEFAULT: 10 business days]; the parties resolve it by addendum, a change to F-900-02, or exit | 5.4 |
| The Network Office directs the entity's employees only as the agreement allows; staffing and services agreements for shared staff and central services | SOP-N5 5.6.2, 5.7.2 |
| Audit and access rights (records, systems, staff) and the entity's duty to cooperate | SOP-N4 5.5.6 |
| Metric set and data timelines, network-wide CAPA participation, tiers and the consequences of Tier 3 and 4, confidentiality of scorecards and reports | SOP-N4 5.3, 5.6, 5.8 |
| Data rights, the HIPAA basis for each PHI flow, a BAA wherever the Network Office handles the entity's PHI, and record ownership, custody, access and return at exit | SOP-N6 5.3, 5.7 |
| Shared system terms the vendor agreement must back: separation, full export, access for the retention period | SOP-N6 5.2.2 |
| Whether the entity may take studies outside the network and must tell central intake | SOP-N3 5.2.1 |
| CTA structure and signatory, including any written authority for the network entity to sign as the entity's agent | SOP-N3 5.5.2 |
| Every payment between entities in writing before work starts, at FMV, with counsel review | SOP-N3 5.7.1 to 5.7.3 |
| Network Office fee: listed services and FMV basis | SOP-N3 5.7.4 |
| Payee, pass-through of sponsor payments within [DEFAULT: 30 calendar days], statements and record review | SOP-N3 5.8.2 |
| Payer of participant payments for the entity's participants | SOP-N3 5.7.7 |
| Insurance, indemnity, confidentiality, termination and the exit steps | SOP-N2 5.9 |
5.8.2
The Network Quality Lead files a summary of each agreement with F-900-02.
5.9 Network calendar
5.9.1
The Network Quality Lead keeps the network's recurring checks in this table and the year's schedule in [NETWORK QUALITY SYSTEM LOCATION]. Each Site Quality Lead adds the site-side rows (marked S) to the site's SOP-14 5.1 register.
| Check | Cadence | Owner | Record | Home step |
|---|---|---|---|---|
| Network Quality Committee meeting | At least [DEFAULT: quarterly] | Network Quality Lead | Minutes | 5.3.2 |
| Network management review | At least [DEFAULT: annually] | Network Quality Committee | Signed minutes | 5.10 |
| Integration progress review, per integrating site | [DEFAULT: Every 2 weeks] until complete | Network Quality Lead | F-901-02 | SOP-N2 5.3.3 |
| Scorecard data submission (S) | By [DEFAULT: the 10th business day after quarter end] | Site Director | F-903-01 Part 6 | SOP-N4 5.3.5 |
| Scorecard review with site and PIs (S) | Quarterly, within [DEFAULT: 30 calendar days] of quarter end | Network Quality Lead; PIs | F-903-01 | SOP-N4 5.4.2 |
| Scorecards to the committee | At least [DEFAULT: twice a year] | Network Quality Lead | Minutes | SOP-N4 5.4.4 |
| Site CAPA extract (S) | Quarterly | Site Quality Lead | Extract | SOP-N4 5.8.2 |
| Central audit plan; central audit per site | Plan annually; each site at least every [DEFAULT: 2 years] | Network Quality Lead | F-700-02 | SOP-N4 5.5.1 |
| Tier 2 and above progress review | At least [DEFAULT: monthly] | Network Quality Lead | F-903-02 | SOP-N4 5.6.3 |
| Central service report signed by PI (S) | At least [DEFAULT: quarterly] | Network Quality Lead; PI | F-105-01 | SOP-N5 5.7.4 |
| On-call routing list check | At least [DEFAULT: monthly] | Network Clinical Operations Lead | F-904-01 | SOP-N5 5.9.3 |
| F-904-01 reconciliation | At least [DEFAULT: quarterly] | Network Quality Lead | F-904-01 Part 6 | SOP-N5 5.10.1 |
| Shared system access review, site list confirmed (S) | At least [DEFAULT: every 6 months] | Network Quality Lead; Site Director | F-401-01 | SOP-N6 5.2.4 |
| F-905-01 review | At least [DEFAULT: annually] and at each join or exit | Network Privacy Officer; site Privacy Officers | F-905-01 Part 3 | SOP-N6 5.4.2 |
| Network agreement and F-900-02 fit | At management review | Network Quality Lead | F-900-02 Part 8 | 5.10.1 |
5.10 Network management review
5.10.1
The Network Quality Committee holds a network management review at least [DEFAULT: annually], and after any Form FDA 483 at a member site, critical audit finding or finding of possible misconduct. Inputs: scorecards and escalations, SOP deviations and addenda, cross-site CAPA trends, onboarding and exit, contracting, central services, privacy incidents, and whether F-900-02 still fits.
5.10.2
The Network Quality Lead records decisions and actions with owners and dates in minutes signed by the Network Executive, sends a summary to the Network Governing Body, and sends each Site Director the actions for the site. A site's SOP-14 management review may be combined with it.
6. Related Forms and SOPs
- F-900-01 Local Addendum to a Network SOP
- F-900-02 Network Operating Model and Appendix B Adoption Record
- F-100-01 SOP Review and Approval Record
- F-100-02 SOP Training Acknowledgment
- F-100-03 SOP Master Index and Review Schedule
- F-306-01 Note to File
- F-901-02 Member Site Integration Plan and Exit Checklist
- F-904-01 Shared Staff Assignment and Credentialing Log
- F-905-01 Cross-Entity Data Flow Register
- Appendix A State Law Worksheet
- Appendix B Central and Site Responsibilities (Exceptions Table)
- Network Supplement to the Lean Edition
- SOP-01 SOP Control, Training and Qualification
- SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest
- SOP-14 Quality Control and Quality Review
- SOP-16 Business Continuity and PI Coverage
- SOP-M5 Research Integrity and Misconduct Reporting
- SOP-N2 to SOP-N6
7. References
| Reference | Title |
|---|---|
| 21 CFR 312.60 | General responsibilities of investigators |
| 21 CFR 812.100 | General responsibilities of investigators (devices) |
| ICH E6(R3) Principle 10 | Roles and responsibilities should be clear and documented |
| ICH E6(R3) Annex 1, 2.3 | Investigator responsibilities (delegation and oversight) |
| 45 CFR 164.105(b) | Affiliated covered entities |
| FDA Guidance (2009) | Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects |
| Reference Edition SOP-900 | Network Governance, SOP Hierarchy and Local Addenda (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.