Network Supplement to the Lean Edition

1. How to use this supplement

This supplement applies only when [NETWORK NAME] has adopted Model N (SOP-N1). It lists, for each Lean Edition core SOP and module, only what changes in a network. Everything not listed applies as written in the Lean Edition. Each item starts with the Lean step it changes, for example (SOP-05 5.4.4), or "(new, after SOP-05 5.4.4)" where it adds a step. It then points to the Network SOP step that holds the procedure and, where the network can choose who does the activity, to the Appendix B row (B-NN) that sets the default. Legal rules are stated in the Network SOPs only; this supplement points to them.

Network terms (Network Office, member site, entity type, network agreement) are defined in SOP-N1 section 4. Staff at member sites read the section for each Lean SOP they are trained on. The Network Quality Lead trains each role on the relevant sections before the site's network effective date (SOP-N1 5.5.5; SOP-N2 5.1.2).

Four rules apply to every section and are not repeated below:

• Investigator duties never move to the Network Office. The duties that always stay at the site are listed once, in Appendix B Part 1.
• The Hybrid Rule (section 2) decides which Appendix B column applies to each member site.
• Any flow of participant information between legal entities needs a pathway recorded on F-905-01 (SOP-N6 5.3.4). Any payment between legal entities follows SOP-N3 5.7.
• Anyone, including Network Office and shared staff, who does a protocol-specific task for a site's participants is on that site's F-302-01 for the study first, signed by that site's PI (SOP-N5 5.3). Where another legal entity employs the person, a staffing agreement is also on file (SOP-N5 5.6.2).

2. The Hybrid Rule

The Hybrid Rule is stated in SOP-N1 5.2.2 and applies to every Appendix B row. In short: the N-Integrated column applies only to a member site that is the network entity. Any member site that is a separate legal entity, whether commonly owned (a subsidiary, or a professional corporation under a management services arrangement) or independent, uses the N-Affiliated column for every row unless counsel records a row-specific exception on F-900-02. An affiliated covered entity never brings the Network Office inside the covered entity unless the network entity is itself a covered entity and an ACE member (SOP-N6 5.3.3).

In the sections below, "same entity" means a member site that is the network entity, and "separate entity" means any member site that is a separate legal entity, whatever the network calls itself.

3. Lean core SOPs

SOP-01 SOP Control, Training and Qualification

• (SOP-01 5.3 and 5.7) Network SOPs are controlled by the Network Quality Lead under SOP-N1 5.5 (B-01). A member site does not re-approve content; the Site Director signs the site adoption record. For a separate entity, that signature is the entity's adoption, and its existing procedure stays effective until it is signed (SOP-N1 5.5.4).
• (SOP-01 5.7) A site moves to the Lean Edition and network SOPs on its network effective date, set on F-901-02. Until then it keeps its own approved SOPs (SOP-N1 5.1.2; SOP-N2 5.1).
• (SOP-01 5.1.1) The order of precedence adds two levels: network SOPs, then the site's local addenda (F-900-01), then site work instructions (SOP-N1 5.4). A local addendum may only add to or tighten its network SOP (SOP-N1 5.6).
• (SOP-01 5.3.1) A site-only SOP for an activity the network library does not cover is controlled by the site under SOP-01, and the site sends the list to the Network Quality Lead.
• (SOP-01 5.9.1 and 5.11) The Network Office sets role curricula and may run a central training system; the Site Quality Lead adds local addenda, state items and site systems (B-02). Central training records are retrievable by the site for monitors and inspectors.
• (SOP-01 5.9.6) A network investigator meeting counts as protocol training for each attendee when attendance is recorded per person. The PI still confirms each person is trained before signing the delegation log.
• (SOP-01 5.8) Qualification files, license checks and screening may be central (B-03; SOP-N5 5.3.2). Same entity: one file per person may be kept centrally if the site can produce it promptly. Separate entity: the employer keeps the file and stays responsible for screening unless the network agreement assigns it to the Network Office.
• (SOP-01 5.8.1) Staff who work at more than one member site hold a license valid in each state where they do licensed tasks, recorded on F-904-01 (SOP-N5 5.4).
• (Appendix A) One worksheet per state where any member site operates or sees participants remotely, prepared by the Network Quality Lead with counsel and confirmed by each site in that state (B-04). Corporate practice of medicine and state anti-kickback answers are added for each state (SOP-N1 5.2.3; SOP-N3 5.7.3).

SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest

• (SOP-02 5.1.1) Each site's F-102-01 shows the network role each site role works with and, for a separate entity, which legal entity employs each person (B-05). Network Office roles are recorded on F-900-02 Part 1. A working line from a site employee to a network role does not make the Network Office the employer.
• (SOP-02 5.2) Combined-role and independence limits apply across the network. The Network Quality Lead does not audit work they did at their own site.
• (SOP-02 5.4.1) Allocation of a study by the Network Office does not commit the PI. The PI may decline, and the PI workload check counts every active study on which the PI is an investigator at any member site.
• (SOP-02 5.4.2) Each member site normally has its own PI and its own 1572 or investigator agreement. One PI lists locations of two member sites only where the PI personally conducts or supervises the study at each and the sponsor and IRB accept it (SOP-N5 5.5.3); for a separate entity, use of its location or staff also needs a written agreement (SOP-N5 5.6.2).
• (SOP-02 5.6.5) Central services that perform investigator activities are service providers to the PI, also for a same-entity site (SOP-N5 5.7). The PI signs and dates each central service report (SOP-N5 5.7.4).
• (SOP-02 5.5.1) Only the site's PI signs the site's F-302-01. The Network Office, the Network Clinical Operations Lead and the Network Medical Director never delegate tasks or sign delegation entries. The same study at two member sites is two investigator sites with two delegation logs.
• (SOP-02 5.3) When Network Office or shared staff leave or stop working for a site, the Network Office tells each affected Site Director the same day so access is removed. A move between two member sites is a role change within a same entity, and offboarding plus onboarding between separate entities.
• (SOP-02 5.8.5) Each person who completes F-104-01 also completes F-902-02, the network addendum, which records interests in the network entity, its parent and investors and other member sites, classifies each as site-specific or platform-wide, and records any study-volume pay (SOP-N3 5.4.4, 5.7.6).
• (SOP-02 5.8.6) Recusal from allocation is required only for a site-specific interest (SOP-N3 5.4.4). Conflicts of people who work for the Network Office or at more than one site are reviewed by the Network Quality Lead and a network executive without the interest (B-06). Separate entity: each entity makes the determination and management plan for its own staff.
• (SOP-02 5.8.8) Enrollment-linked pay and finder's fees: SOP-N3 5.7.6. No site decision may permit a finder's fee or per-referral bonus.
• (SOP-02 5.8.9) Institutional interests include those of the network entity, its parent and investors. The Network Quality Lead collects them once on F-902-02 and gives each site the list it needs for IRB submissions. Each separate entity also discloses its own.
• (SOP-02 5.8.1) Sponsor payments to the Network Office that are not study costs (for example preferred-site program payments) are listed for each PI so the investigator can judge whether they count under 21 CFR 54.

SOP-03 IRB Oversight, Essential Records and Study Activation

• (SOP-03 5.1.2) IRB of record and reliance agreements (B-08). Same entity: one institution signs each reliance agreement once. Separate entity: each engaged entity is a separate institution and signs through its own official. The Network Office signs for a site only with written authority the IRB accepts.
• (SOP-03 5.2.2 and 5.2.3) Central submissions (B-09): each PI approves the site's own submission; the Network Office never uses a PI's credentials. Site-specific content (contacts, Appendix A entries, cost and injury language matching the site's CTA, conflict disclosures including network interests) is prepared per site.
• (SOP-03 5.2.5) Approvals that arrive in a central eRegulatory system are still checked by the site Regulatory Coordinator.
• (SOP-03 5.4.3) A lapse in IRB approval at one site is handled at that site and does not stop other member sites unless the IRB says so. The Network Quality Lead trends lapses (SOP-N4).
• (SOP-03 5.6 and 5.8.1) Central eISF (B-10): each site has its own ISF section for each study, with access limited to that site's study staff, the Network Office roles that need it and the site's monitors (SOP-N6 5.7.2).
• (SOP-03 5.6.3) Records not specific to one study (network SOPs, central training records, master agreements) may be held by the Network Office; the ISF record location map points to them.
• (SOP-03 5.9.2 and 5.10) Regulatory packets may be assembled centrally (B-07). F-205-01 is completed for each site and study and signed by that site's PI and Site Director. Sponsor activation of one member site does not activate another.
• (SOP-03 5.10.4) Adding a member site to an active study is a new activation with its own F-205-01, unless the sponsor and IRB treat it as a location of an existing site under the same PI. Moving an open study follows SOP-N2 5.8.
• (SOP-03 5.9.1) A sponsor qualification visit may cover several sites. Each site presents its own facilities, staff and data, and no site shows another site's participant records.

SOP-04 Informed Consent

• (SOP-04 5.1.2 and 5.10) Central or remote consent staff obtain consent for a site's participants only when delegated, trained, and approved by the IRB for remote consent where they are not on site (B-12).
• (SOP-04 5.2.4) Medical questions are answered by an investigator of that site. The Network Medical Director does so only if listed as a Sub-I for the study at that site.
• (SOP-04 5.5) The Network Regulatory Lead may keep a consent template and release site versions centrally (B-11). Each site uses only the version the IRB approved for that site. A version approved for one site is never used at another.
• (SOP-04 5.6 and 5.10.5) LAR authority, age of majority and state consent requirements follow the Appendix A worksheet for the state where the site conducts the research, or the state the IRB designates for remote consent, not the state of the Network Office.
• (SOP-04 5.4.4) A central reviewer may act as the second person for consent QC when given access to the site's records under SOP-N6 (B-13). The one-person fallback in SOP-14 5.4.2 still applies.

SOP-05 Pre-Screening, Screening, Eligibility, Randomization and Blinding

• (SOP-05 5.1.3) Record review for pre-screening depends on who holds the records and who reviews them. Central staff who are not workforce of the covered entity holding the records need an IRB or privacy board waiver or the patient's authorization (SOP-N6 5.5.2). ACE rules: SOP-N6 5.3.3.
• (SOP-05 5.1.5 and 5.1.6) A central call center pre-screens for a site only with the site's IRB-approved script, and records each candidate on the site's F-300-01 or a network log that shows the receiving site (B-14).
• (SOP-05 5.1.9) Referring a candidate from one member site to another is never paid (SOP-N3 5.7.1).
• (SOP-05 5.4.4) The concurrent-participation check includes the network check for screening or enrollment in the same or a conflicting study at another member site (B-15; SOP-N6 5.5.4).
• (SOP-05 5.5.1) A central eligibility reviewer may act as second reviewer (B-13). Sign-off on F-303-02 stays with the site PI or a Sub-I on the site's log.
• (SOP-05 5.2.4) IRT accounts are requested per site number; the Network Regulatory Lead may request them and the site confirms roles.
• (SOP-05 5.9) Central unblinded staff are named as unblinded on each site's F-302-01 (B-16). The cross-site blinding rule is SOP-N5 5.8.6. Unblinded records for a site's participants stay in a restricted file the site can produce.
• (SOP-05 5.10.1) Emergency unblinding is a decision of an investigator at the participant's site. Network Office staff may help reach the site's on-call investigator.

SOP-06 Investigational Product Management

• (SOP-06 5.1.2) IP shipped for a site's investigator is in that site's accountability. Default: the sponsor ships IP directly to each investigator site (SOP-N5 5.8.3).
• (SOP-06 5.1.3) A central pharmacy or IP depot stores, prepares or dispenses IP for a site only under SOP-N5 5.8.3 and B-17.
• (SOP-06 5.9.1) Controlled-substance registrations, Schedule I researcher registration and redistribution limits: SOP-N5 5.8.3.
• (SOP-06 5.11.3) Moving IP between member sites is a transfer between investigator sites for every entity type: sponsor written authorization, IRT update, F-304-01 at both sites, receiving PI accountable from receipt. IP is never lent between sites, studies or sponsors.
• (SOP-06 5.3 and SOP-16 5.3.2) Backup storage at another member site needs prior sponsor approval of the location and chain of custody for each move (B-33). Each site's IP stays accounted to that site.
• (SOP-06 5.2.1) Alarms from a central temperature platform go first to the site where the unit is (SOP-N6 5.2.6).

SOP-07 Source Documentation and EDC

• (SOP-07 5.2.1) Where a network system is source for some data, the Source Data Location List names it. Source stays the site's record even when the system is run centrally (B-19).
• (SOP-07 5.3.3 and 5.3.4) When records move between sites or to the Network Office, the original stays with the site that created it, and the receiving team relies on a certified copy or access to the site's system (SOP-N6 5.7.3).
• (SOP-07 5.8.1 and 5.9.3) A central data entry or query team holds its own EDC account for each site and enters data only from that site's source (B-18). Queries needing medical judgment go to the site's investigators, and only the site's PI or delegated Sub-I signs the eCRF.

SOP-08 Protocol Deviations and CAPA

• (SOP-08 5.4 and 5.5.2) The site PI classifies each deviation and decides IRB reporting. Where the Network Regulatory Lead submits a report, the PI approves the content first. The Network Office may ask the PI to reconsider a classification and records the request.
• (SOP-08 5.10.1) The Network Quality Lead trends deviations and CAPAs across sites and opens network-wide CAPAs (B-20; SOP-N4 5.8.2). Trend reports identify sites and studies, not participants.
• (SOP-08 5.9) Each site keeps its own CAPA on F-703-01 and F-703-02, linked to any network-wide CAPA by number (SOP-N4 5.8.2).
• (SOP-08 5.8.3 and 5.8.5) A CAPA that changes a network SOP goes through SOP-N1. Commitments in a site's response to FDA, a sponsor or an IRB remain that site's and PI's commitments.

SOP-09 Safety Reporting (AEs, SAEs, IRB-Reportable Events, Pregnancy)

• (SOP-09 5.4.1) AE assessment stays with the investigators listed for the study at the participant's site. A Network Medical Director, or an unlisted physician at another site, may advise but does not assess or sign.
• (SOP-09 5.4.5 and 5.5.2) A shared after-hours line routes each call to an investigator listed for the participant's study at the participant's site (SOP-N5 5.9.3).
• (SOP-09 5.5.4) The site submits SAE reports directly to the sponsor; they are not routed through the Network Office. Central timeliness tracking uses dates only (B-21; SOP-N4 5.3.2).
• (SOP-09 5.7.1 and 5.7.2) The Network Regulatory Lead may receive and distribute sponsor safety reports (B-22). Each PI still reviews and acknowledges each report.
• (SOP-09 5.8.5) IRB reportability is decided per study and per site by the site's PI. When an unanticipated problem at one site may affect participants at other sites in the same study, the site informs the sponsor and the Network Office.
• (SOP-09 5.8.7) The PI at each other affected site assesses it and reports to that site's IRB as its policy requires, unless the IRB confirms in writing that one report covers all its network sites. The Network Office passes the information on (participant study IDs only, or under SOP-N6 for separate entities) and does not decide for any PI.
• (new, after SOP-09 5.8.4) A problem that starts at the Network Office (for example a central system failure) is sent the same day to the PI of each affected site and study. The awareness date for each site is the date the information reached that site's research staff.

SOP-10 Participant Retention, Withdrawal and Payments

• (SOP-10 5.3) A participant who moves may continue at another member site only as a transfer between investigator sites (SOP-N2 5.8). Moving records between separate entities needs a pathway on F-905-01.
• (SOP-10 5.1.2) Network Office staff who make retention contacts use only the site's IRB-approved materials.
• (SOP-10 5.8.1 and 5.8.7) A central payment program is described to each site's IRB, the vendor is qualified under SOP-M1, and each payment is recorded on the site's F-310-01 (B-23).
• (SOP-10 5.9.2) The payer for each site's participants holds the 1099 duty (SOP-N3 5.7.7).

SOP-11 Specimens, Equipment and Laboratories

• (SOP-11 5.2.4 and 5.10) A central processing hub handles specimens for sites only where the laboratory manual's windows can still be met and the sponsor approves the routing in writing (B-24). The hub location is recorded in the site's ISF.
• (SOP-11 5.9) CLIA rules for hubs and network laboratories: SOP-N5 5.8.4. The Network Office keeps a register of certificates, types, directors and renewal dates for every location.
• (SOP-11 5.3.1) Shipping training per employing entity: SOP-N5 5.8.5.
• (SOP-11 5.4) Moving specimens between sites, or to a hub, is a shipment whether by courier or carried by staff; F-311-01 applies and the stability window covers the whole route.
• (SOP-11 5.7 and 5.8) The Network Office may run one equipment and calibration program (B-25). F-312-01 still shows each item's location and owning site, and the PI of each site whose participants were measured reviews any impact assessment. Equipment owned by one entity and used at another is covered by a written agreement.

SOP-12 Privacy, Electronic Systems and Record Retention

• (SOP-12 5.1.1) The network's HIPAA structure, including any ACE and whether the network entity is a covered entity, is decided and recorded under SOP-N6 5.3; each site's own privacy record matches it. Organized health care arrangements: SOP-N6 5.3.5.
• (SOP-12 5.1.1) Privacy Officer (B-26): SOP-N6 5.3. Where the Network Office handles a covered entity's PHI to provide a service, it is a business associate and a BAA is signed first (SOP-N6 5.3.4).
• (SOP-12 5.2.3 and 5.3) PHI moves between sites, or between a site and the Network Office, only by a pathway on F-905-01 (SOP-N6 5.3, 5.4).
• (SOP-12 5.5.1 and 5.5.3) A privacy incident is reported to the site Privacy Officer, who tells the Network Privacy Officer the same business day. Breach decisions: SOP-N6 5.8.
• (SOP-12 5.6.1) Shared systems are listed once on the Network Office's F-401-01; each site's F-401-01 points to them (B-27; SOP-N6 5.2). Each site verifies only its own configuration.
• (SOP-12 5.7.5) Each legal entity submits its own 21 CFR 11.100(c) certification (SOP-N6 5.2.7).
• (SOP-12 5.10) The archive may be central (B-28). F-402-01 records the site and PI for every box or file, and records of different sites are never mixed. Destruction is approved for the site that created the records (SOP-N6 5.7.4).
• (SOP-12 5.10.4) Separate entity: custody, access and return at exit follow the network agreement (SOP-N1 5.8.1) and SOP-N2 5.9.3.

SOP-13 Monitoring, Audits and Inspections

• (SOP-13 5.1.3) Monitor accounts in shared systems are restricted to the participants of the monitor's study at the sites the monitor is assigned to (SOP-N6 5.2.5).
• (SOP-13 5.2.1 and 5.3) The Network Office may coordinate visit dates when one monitor covers several sites (B-29). Each visit is to one investigator and logged on that site's F-600-01; follow-up letters go to each site's PI.
• (SOP-13 5.4.1 and 5.5.2) The site tells the Network Office the same business day of each audit request and FDA inspection notice. The PI receives the Form FDA 482 and 483 and signs the response. Separate entity: Network Office staff take part only as the Site Director agrees and the network agreement allows, and counsel engaged by the Network Office does not represent the site or PI unless they engage that counsel.
• (SOP-13 5.6.4) Records held centrally are produced by the Network Office when asked and logged on the site's F-702-01. Records of other sites are produced only when FDA asks for them.
• (SOP-13 5.7.2) After a Form FDA 483, the Network Office identifies every site and study where the same PI or Sub-I is listed so each site can notify its sponsors and IRBs as required (SOP-N4 5.8.1).

SOP-14 Quality Control and Quality Review

• (SOP-14 5.1.2) Each site adds the site-side network checks marked S in the SOP-N1 5.9.1 network calendar to its quality calendar.
• (SOP-14 5.4) Cross-site or central reviewers may perform QC (B-13), and a same-entity network may use one network sampling scheme. No one QCs their own work.
• (SOP-14 5.6.1) The quarterly quality review may be held as part of the quarterly scorecard review where it covers the SOP-14 inputs (SOP-N4 5.4.2).
• (SOP-14 5.7.3) The annual internal audit may be central (B-30; SOP-N4 5.5.1). Separate entity: only as its network agreement allows; otherwise the site commissions the audit and shares a summary.
• (SOP-14 5.8.1) Each site's management review may be combined with the network management review (SOP-N1 5.10.2).

SOP-15 Study Closeout

• (SOP-15 5.7.1) Closing a study at one site closes it only at that site. Where one IRB approval covers several sites, the IRB is asked to close only the site that has finished.
• (SOP-15 5.8) Financial closeout may be central (B-32). Separate entity: amounts owed follow the CTA and network agreement (SOP-N3 5.8.2).
• (SOP-15 5.10.2) A member site leaving the network follows SOP-N2 5.9.

SOP-16 Business Continuity and PI Coverage

• (SOP-16 5.1 and 5.2.2) Each site keeps its own F-705-01. The Network Office keeps a network continuity plan for central systems and services and is on each site's contact tree (B-33). A network-wide event is declared under SOP-N1 5.3.4.
• (SOP-16 5.6.2 and 5.6.7) A backup or covering investigator from another member site covers only after SOP-N5 5.9.2 is met for that study and site. A network on-call physician who is not listed may give urgent care but does not act as investigator.
• (SOP-16 5.7.1) When a PI leaves, the Site Director also tells the Network Clinical Operations Lead. A replacement PI from another site still needs sponsor and IRB approval and a new 1572 or investigator agreement.

4. Optional modules

SOP-M1 Service Providers and Vendors

• (SOP-M1 5.1) In Model N, every member site adopts SOP-M1, because Network Office central services are investigator-engaged service providers to each site's PI (SOP-N5 5.7).
• (SOP-M1 5.4) Same entity: an internal service description replaces a contract. Separate entity: a written services agreement, with a BAA where the Network Office handles the site's PHI (SOP-N5 5.7.2).
• (SOP-M1 5.3.5) The Network Office may qualify outside providers once and keep a network approved provider list (B-34). A site relies on it when the PI reviews the record and approves the provider for the study.
• (SOP-M1 5.4) Separate entity: when the Network Office contracts an outside provider for sites, each site gets the access, record ownership and retention rights SOP-M1 requires, and the provider is a subcontractor of the Network Office as business associate.
• (SOP-M1 5.6) A provider problem at one site that could affect others is reported to the Network Quality Lead, who tells the other sites and tracks it under SOP-N4.
• (SOP-M1 5.9) When the Network Office ends a central service, or a site leaves, it returns every study record it holds for the site or keeps it with continued site access (SOP-N2 5.9.3).

SOP-M2 Feasibility, Contracts, Budgets and Research Billing

• (SOP-M2 5.1) In Model N, every member site adopts SOP-M2. All sponsor and CRO inquiries, CDAs and feasibility questionnaires go to central intake (B-35; SOP-N3 5.2). Each site asked still completes its own F-200-01 and go or no-go.
• (SOP-M2 5.2) Population counts and site estimates: SOP-N3 5.3. The Network Office never raises a site's estimate, and the network response gives each site's estimate by default (SOP-N3 5.3.4). Feasibility queries across entities: SOP-N6 5.5.1.
• (SOP-M2 5.4) CDAs: SOP-N3 5.2.2.
• (SOP-M2 5.5 and 5.7) Negotiation may be central (B-36), and each site's Site Director approves its budget exhibit. Signature follows SOP-N3 5.5.2 (B-37). The terms that protect the site run to the member site entity, its PI and staff.
• (SOP-M2 5.8) Where sponsor payments go to the Network Office and are passed on, SOP-N3 5.8 applies (B-39).
• (SOP-M2 5.9) The Network Office may prepare one coverage analysis per protocol version; the billing entity for each site decides billing and localizes it (B-38; SOP-N3 5.6). Physician self-referral review: SOP-N3 5.7.5.

SOP-M3 Recruitment and Advertising

• (SOP-M3 5.2 and 5.3) Network-wide advertising (B-40): each material is IRB-approved for every site it names, and F-300-02 shows which sites each version is approved for.
• (SOP-M3 5.4) A network volunteer database follows SOP-N6 5.5.3.
• (SOP-M3 5.5 and 5.6) No one receives a payment or credit for referring or enrolling a specific person at another site. Recruitment services between legal entities follow SOP-N3 5.7.2.

SOP-M4 Decentralized Trial Elements

• (SOP-M4 5.2) A network home-health or telehealth service is site-engaged for each site it serves (B-41), and visit records return to that site as source. Separate entity: a written agreement and a pathway on F-905-01.
• (SOP-M4 5.4 and 5.5) Licensure follows the participant's location (SOP-N5 5.4). An investigator from another site sees a participant by telehealth only if licensed in the participant's state and added to the study at the participant's site.
• (SOP-M4 5.6) Direct-to-participant shipment from a network central pharmacy follows SOP-N5 5.8.3, with release authorized by the participant's site PI or a delegated IP Manager. A nonresident pharmacy license for the shipping location is recorded in Appendix A.

SOP-M5 Research Integrity and Misconduct Reporting

• (SOP-M5 5.2) In Model N, every member site adopts SOP-M5. The network reporting channel, including an anonymous route, is open to all staff at every site (B-42), in addition to a separate entity's own route. Concerns about network leadership go to [NETWORK GOVERNING BODY CONTACT] (SOP-N1 5.3.3).
• (SOP-M5 5.5) The Network Quality Lead may lead or support an investigation. Separate entity: only as the network agreement allows, and personnel action and notifications remain the entity's decisions.
• (SOP-M5 5.6) The Site Director decides on direct reporting to FDA with counsel and the PI, with the Network Executive consulted. No one is prevented from reporting to FDA directly.
• (SOP-M5 5.4) Concerns that span sites are coordinated by the Network Office, and identifiers are compared only under a pathway on F-905-01.

SOP-M6 Sponsor-Investigator Studies (IND/IDE Holder)

• (SOP-M6 5.1) Before any IND or IDE submission for a study at more than one member site, the PI, Site Director and Network Executive record who holds it (B-43). If the network entity holds it, the network entity is the sponsor, carries every sponsor duty and is the ClinicalTrials.gov responsible party, and the PIs are investigators only.
• (SOP-M6 5.2) The Network Office may perform sponsor tasks as a service provider, and for drug studies may take on sponsor obligations by written transfer (21 CFR 312.52). It never takes on investigator duties at the PI's site.
• (SOP-M6 5.5) A study at several member sites is cooperative research. Where it is federally funded and subject to the Common Rule, US sites use a single IRB (45 CFR 46.114(b)). For FDA-regulated studies without federal funding, the Network Regulatory Lead should arrange one IRB of record where the IRBs and sites agree.
• (SOP-M6 5.5) Separate entity: a written agreement is signed before the site enrolls, covering the protocol, investigator duties, data and specimen transfer under a pathway on F-905-01, FMV payments, subject injury, insurance, publication and record retention.
• (SOP-M6 5.5) The monitoring plan covers every participating site, including the sponsor-investigator's own, monitored by someone outside the sponsor-investigator's study team. Network QA audits do not replace sponsor monitoring.