Network Governance, SOP Hierarchy and Local Addenda

1. Purpose

This SOP sets up the governance of [NETWORK NAME] when this SOP library runs as a network. It describes the Network Office and its governance body, how the network chooses its operating variant and adopts Appendix B Central and Site Responsibility Matrix, how network SOPs, local addenda and site work instructions rank against each other, how network SOPs are approved, versioned and trained on across member sites, and how network management review works. It also states how each Principal Investigator keeps the investigator duties the regulations place on them.

2. Scope

This SOP applies only when the site has adopted Model N (SOP-100 Writing, Approving and Controlling SOPs). A Model S site ignores it.

In scope:

• the Network Office, the Network Quality Committee and any Network Medical Director
• the choice between N-Integrated and N-Affiliated and the adoption of Appendix B (F-900-02)
• the order of precedence between network SOPs, local addenda (F-900-01) and site work instructions
• approval, version control, training and effective dates for network SOPs at each member site
• terms the network or affiliation agreement must contain in N-Affiliated
• network management review

Out of scope: onboarding and exit of member sites (SOP-901 Member Site Onboarding, Integration and Exit), study allocation and central contracting (SOP-902 Network Study Feasibility, Allocation and Central Contracting), site metrics, central QA and escalation (SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation)), shared staff (SOP-904 Shared Staff, Cross-Site Coverage and Central Services), and data, systems and records across sites (SOP-905 Network Data, Systems, Privacy and Records Across Sites). The mechanics of writing and controlling a single SOP stay in SOP-100; this SOP adds the network layer on top.

Where the protocol, sponsor or IRB requirement is stricter than this SOP, the network and the member site follow the stricter requirement.

3. Responsibilities

4. Definitions

5. Procedure

5.1 Network Office and governance body

• 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] drawn from member sites)
• quorum and how decisions are recorded
• meeting frequency, at least [DEFAULT: quarterly]
• the decisions it owns under this SOP

• network audit plan: prepared by the Network Quality Lead under SOP-903 and approved by the Network Quality Committee before the start of each audit year
• network-wide business continuity event (for example an outage of a shared system or central service affecting more than one member site): declared by the Network Executive, or by the Network Quality Lead when the Network Executive cannot be reached; each Site Director then acts for their own site under SOP-705 Business Continuity and Emergency Preparedness
• network SOP changes: any staff member sends the request to their Site Quality Lead or directly to the Network Quality Lead, who logs it on F-100-03 (network version); approval follows 5.6

5.2 Choosing the variant and adopting Appendix B

• the variant: N-Integrated or N-Affiliated, with the legal basis (common ownership, or the network agreement and its date)
• the member sites, their legal entities and their locations
• for each member site, its entity type: the network entity itself, a separate subsidiary, or a professional corporation under a management services arrangement; for each member site that is a separate legal entity, the Appendix B rows that follow the N-Affiliated default (at least PHI, direction of staff, contract signature, records custody and payments) unless counsel confirms otherwise
• the HIPAA arrangement that applies across sites (single covered entity, affiliated covered entity, organized health care arrangement, or separate covered entities with business associate or data use agreements), confirmed with the Network Privacy Officer under SOP-905. An organized health care arrangement does not by itself permit sharing PHI for research (SOP-905 5.3.5)
• the Appendix B column adopted for each activity, with each change from the default and the reason

5.3 Order of precedence in Model N

• applicable law and regulation, including the law of the state where the member site operates (Appendix A State Law Worksheet)
• determinations and policies of the reviewing IRB for the study
• the IRB-approved protocol and sponsor written instructions that apply to the study
• network SOPs (this library as adopted network-wide), and site-only SOPs for activities the network library does not cover (SOP-100 5.11.7)
• the member site's local addenda (F-900-01)
• the member site's work instructions and job aids

5.4 Network SOP content

5.5 Local addenda

• add steps that are stricter than the network SOP
• add steps required by state or local law, or by the site's IRB or institution (for example a state consent or LAR rule from Appendix A)
• name local contacts, locations, hours and escalation routes
• name local systems, equipment and vendors and the steps specific to them
• resolve Site decision boxes that F-900-02 assigns to the site

• lower or remove any requirement of law, regulation, the IRB or the protocol
• remove a step, lower a requirement or lengthen a timeline in the network SOP, including a network minimum
• change a responsibility that F-900-02 assigns to the Network Office, unless F-900-02 is changed first under 5.2.4
• move any investigator duty away from the PI
• create a new form code (site forms are attached to the addendum and referenced by title)

5.6 Approval and version control of network SOPs

5.7 Training and effective dates across sites

5.8 Investigator duties stay with each PI

5.9 N-Affiliated: what the network agreement must state

• which network SOPs, network minimums and Appendix B assignments are binding on the member entity, and how changes become binding (for example, by site adoption under 5.6.2, or automatically after a notice period)
• the Network Office's audit and access rights at the member site, including access to source, ISF, systems and staff for QA under SOP-903, and the member's duty to cooperate
• data rights: what data and records each party may access, use and keep, the legal basis for any PHI flow (BAA, DUA or participant authorization), and who owns study records and is custodian (SOP-905, SOP-402 Record Retention, Archiving and Destruction)
• which party signs CTAs and budgets and how funds flow (SOP-902)
• what happens on conflict between a network SOP and the member's own policies or legal duties: the member entity's legal duties and the investigator's regulatory duties prevail; the member notifies the Network Office in writing within [DEFAULT: 10 business days] of finding the conflict; the parties resolve it by a local addendum, a change to F-900-02, or exit
• direction of staff: the Network Office directs member site employees only to the extent the agreement allows
• insurance, indemnity, confidentiality and termination terms, and the exit steps in SOP-901

5.10 Network management review

• member site scorecards and escalations (F-903-01, F-903-02)
• network SOP deviations, local addenda and their trends
• CAPA trends across sites, and CAPAs that should apply network-wide
• status of member site onboarding, integration and exit (SOP-901)
• allocation and contracting performance (SOP-902)
• shared staff and central services (SOP-904)
• data, systems and privacy incidents across sites (SOP-905)
• adequacy of F-900-02 and Appendix B assignments

5.11 Day-one minimum

• F-900-02 Network Operating Model and Appendix B Adoption Record approved, including the entity type of each member site (5.2.1)
• Appendix B adopted, with the column chosen for each activity (5.2)
• the HIPAA arrangement across sites confirmed with the Network Privacy Officer (5.2.1 and SOP-905)
• for each member site, the signed network agreement (N-Affiliated or a separate entity under 5.9.3) or the corporate authority (a site that is the same legal entity as the network entity)
• for each member site, an integration plan on F-901-02 (SOP-901)
• a named network QA contact (the Network Quality Lead or a person that role names) published to every member site

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-102-01 Site Organization Chart and Role Assignment Record
• F-306-01 Note to File
• F-901-02 Member Site Integration Plan and Exit Checklist
• 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-100 Writing, Approving and Controlling SOPs
• SOP-102 Site Organization, Roles and Staff Responsibilities
• SOP-402 Record Retention, Archiving and Destruction
• SOP-700 Internal Quality Control and Quality Assurance Audits
• SOP-704 Research Misconduct and Fraud Reporting
• SOP-705 Business Continuity and Emergency Preparedness
• SOP-901 Member Site Onboarding, Integration and Exit
• SOP-902 Network Study Feasibility, Allocation and Central Contracting
• 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