SOP-N2
Member Site Onboarding, Integration and Exit
- Number
- SOP-N2
- Category
- Network
- Edition
- Network Edition 2.0
- Approx. pages
- 6
- Reference Edition source
- SOP-901
[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] 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.
2. Scope
This SOP applies only when [NETWORK NAME] has adopted Model N. It covers founding sites (member sites on the network start date), acquisitions (the site becomes part of the network entity, or a commonly owned separate entity) and affiliations (the site stays an independent entity under a network agreement).
Out of scope: the business terms of a purchase or affiliation, which the Network Executive and counsel set. Network terms are defined in SOP-N1 section 4. Counsel confirms the notice and transfer requirements for each transaction; this SOP lists what to check.
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 Executive | Approves joining and exit decisions, engages counsel, and decides on missed integration gates. |
| Network Quality Lead | Leads the gap assessment (F-901-01), writes and tracks the integration plan (F-901-02), and confirms readiness before network SOPs take effect at the site. |
| Network Regulatory Lead | Plans sponsor, IRB and 1572 changes for in-flight studies and study transfers. Where the role is not appointed, the Network Quality Lead does this with the site Regulatory Coordinator. |
| Network Contracts and Finance Lead | Plans CTA assignment, novation or amendment, change of ownership items, and financial closeout. |
| Network Privacy Officer and site Privacy Officer | Confirm the HIPAA basis for any PHI or records moving between entities and record it on F-905-01. |
| Site Director (joining or exiting site) | Gives access for due diligence, names an Integration Lead, and carries out site tasks. |
| Principal Investigator (PI) | Remains responsible for the PI's studies throughout. Approves the participant care plan for each in-flight study and agrees any transfer of the PI's studies. |
| Regulatory Coordinator | Sends site notices and files them in each ISF; records records custody on F-402-01. |
4. Definitions
| Term | Definition |
|---|---|
| Joining site | A site being assessed for, or in the process of, joining the network. |
| In-flight study | A study at the joining or exiting site with an approved protocol that is not closed with the IRB. |
| Change of ownership (CHOW) | A change in the legal owner of a site's business or of the entity that holds its licenses, registrations, certificates or contracts. |
| Novation | Replacement of a contract party by a new party with all parties' agreement. |
| Integration Lead | The person the Site Director names to coordinate site tasks in the integration plan. |
| Closing date | The date an acquisition completes or an affiliation agreement takes effect. For a founding site, the network start date (SOP-N1 section 4). |
5. Procedure
5.1 Day-one minimum and integration gates
5.1.1
The day-one items for each member site are the per member site rows in SOP-N1 5.1.1. The Network Quality Lead confirms them on F-901-02 Part 0 on the closing date. From the closing date until its network effective date the site keeps operating under its own approved SOPs, with any transition rule recorded on F-901-02, so there is no gap.
5.1.2
Integration gates. The Network Quality Lead sets target dates on F-901-02 from the closing date:
- by [DEFAULT: day 30]: entity type and Appendix B assignments added to F-900-02; Appendix A completed for the site's states; remaining sponsor and IRB notices (those that do not need prior approval) sent for each in-flight study; critical gaps closed or under CAPA
- by [DEFAULT: day 90], the site's network effective date: staff trained; the Lean Edition core SOPs, modules SOP-M1, SOP-M2 and SOP-M5, and the Network SOPs effective at the site; former site SOPs retired and mapped to their network replacements; local addenda approved; contract, registration and certificate items closed or on a counsel-confirmed timeline; systems migration plan approved
- by [DEFAULT: day 180]: all milestones closed, readiness check done, site in routine oversight under SOP-N4
5.1.3
A founding site follows 5.1 to 5.3 with dates counted from the network start date, and its F-901-01 is completed before that date.
5.1.4
When a gate is missed, the Network Quality Lead records the reason and a new date on F-901-02 within [DEFAULT: 5 business days] and tells the Network Executive. An item outside the network's control (for example a pending sponsor novation or CLIA change) may move with a recorded interim arrangement. A second missed gate goes to the Network Executive, who records a decision on F-901-02.
5.2 Assessment (F-901-01)
5.2.1
The Network Executive tells the Network Quality Lead when a site is under consideration and whether it is an acquisition or an affiliation. The Network Quality Lead opens F-901-01.
5.2.2
Before the network receives any document containing PHI, the joining site's Privacy Officer confirms the basis and the Network Privacy Officer records it on F-905-01. Due diligence uses de-identified or summary data where possible; where PHI must be reviewed, it is reviewed on site under the joining site's control or under a written agreement counsel approves.
5.2.3
The Network Contracts and Finance Lead checks whether open CTAs or CDAs restrict sharing sponsor information with a prospective owner or partner, and restricted information is reviewed only as allowed or after sponsor consent.
5.2.4
The Network Quality Lead assesses the site against network SOPs, covering at least: staff qualifications, training, delegation and exclusion screens; in-flight studies (sponsor, phase, IND or IDE, IRB, PI, participants on treatment or follow-up); a sample ISF review; inspection, audit and CAPA history; IRBs of record and reliance; IP storage, temperature history and DEA and state registration; CLIA certificate type, holder, location and director; systems and data ownership; HIPAA status; insurance; contract assignment and change-of-control clauses; archived records and custodian; and the states where it operates.
5.2.5
The Network Quality Lead grades each gap critical, major or minor (SOP-14 grades) and records the evidence. A critical gap in an in-flight study is reported at once to the joining site's PI and Site Director, who act under their own SOPs; until the site is under network SOPs, the joining site decides any report to its sponsor or IRB.
5.2.6
The Network Executive records the decision (proceed, proceed with conditions, decline) on F-901-01.
5.3 Integration plan (F-901-02)
5.3.1
The Network Quality Lead and the Integration Lead write F-901-02 with an owner and target date for each 5.1.2 gate item, each item in 5.4 to 5.6, each critical and major gap with its CAPA reference (SOP-08), and each open FDA, sponsor or IRB commitment of the site.
5.3.2
On the site's network effective date its former SOPs are retired and mapped to their network replacements. The site does not run old and new SOPs for the same process without a transition rule written in F-901-02.
5.3.3
The Network Quality Lead reviews progress at least [DEFAULT: every 2 weeks] until all milestones close, and records each review on F-901-02.
5.3.4
Integration is complete when every milestone is closed and the Network Quality Lead has done a readiness check. The Network Quality Lead assigns a starting tier under SOP-N4, counting inspection and audit findings from the last [DEFAULT: 2 years], and schedules a first central QA audit within [DEFAULT: 6 months].
5.4 In-flight studies: notices and continuity of care
5.4.1
For each in-flight study, the Regulatory Coordinator lists what changes (legal entity, site name, address, PI, laboratory, IRB of record, contract party, payee, systems) and what each requires:
- sponsor: written notice of each change; sponsor agreement before a change of PI or location takes effect; consent to assignment or change of control where the CTA requires it (5.6.1)
- Form FDA 1572: a new 1572 when the PI changes; other changes reported to the sponsor, with a revised 1572 where the sponsor requires one (21 CFR 312.53(c)); device investigator agreements under 21 CFR 812.43(c)
- IRB: notice or approval as its policy requires; a change of IRB of record is approved by the sponsor and both IRBs before it takes effect, with no lapse (SOP-03)
- consent: whether a revised form or participant notice is needed, as the IRB decides (SOP-04)
- delegation: updated F-302-01 for any staff change, with training first
5.4.2
Before the closing date, the Regulatory Coordinator (or Network Regulatory Lead) and the Network Contracts and Finance Lead send every notice, and obtain every approval or CTA consent, that must precede the change, and record each on F-901-02 Part 3. Where one is not obtained by closing, the existing contracting entity, PI, location and payee stay in place for that study until it is (5.4.4). Notices that do not need prior approval are sent after closing, within the time the sponsor or IRB sets and by the day-30 gate. Each notice and acknowledgment is filed in the ISF.
5.4.3
For each in-flight study with participants on treatment or in follow-up, the PI approves a participant care plan on F-901-02 confirming that visits, dosing and safety follow-up continue on schedule; IP stays in qualified storage with temperature records and accountability, and any move is sponsor-approved first (SOP-06); a PI or Sub-I stays available and safety reporting has no gap (SOP-09); and participants know whom to call.
5.4.4
Integration never interrupts visits, dosing or safety follow-up. Where a change is not approved in time, the existing arrangement stays in place.
5.5 Systems migration
5.5.1
The System Owner for each system documents, before migration, the data to move, the mapping, the checks for complete and accurate transfer, and how audit trails and certified copies of the old system's records are kept (SOP-12). Records stay complete, readable and attributable for their full retention period. PHI moving between entities has a basis on F-905-01.
5.6 Acquisitions: change of ownership
5.6.1
The Network Contracts and Finance Lead, with counsel, plans these items before the closing date and records each on F-901-02:
- CTAs and budgets: sponsor consent to assignment or change of control, a novation or an amendment, as each agreement requires, obtained before closing where the agreement requires consent first (5.4.2); payee details change only after signature
- DEA: a registration is specific to the registrant and to each location where controlled substances are stored or dispensed (21 CFR 1301.12). It cannot be assigned without DEA written consent (21 CFR 1301.52(b)), and a transfer of business needs written notice to the DEA Special Agent in Charge at least 14 days before, unless waived (21 CFR 1301.52(d)). Counsel confirms whether new DEA and state registrations, including any Schedule I researcher registration (SOP-N5 5.8.3), are needed before controlled substances are handled under the new owner
- CLIA: the laboratory notifies CMS or its state agency of a change in ownership within 30 days (42 CFR 493.39 for a certificate of waiver; 42 CFR 493.51 for a certificate of compliance; check the rule for the site's certificate type)
- other licenses (facility, pharmacy, radiation) and payer enrollment where the site bills insurance
- insurance from the closing date and tail coverage for the prior owner's claims-made policies
- records custody for archived study records (SOP-12; 21 CFR 812.140(e) where IDE custody changes)
- a 21 CFR 11.100(c) certification from the new entity where staff sign electronically (SOP-N6)
5.6.2
A site acquired as a separate legal entity (type b) keeps its own registrations, certificates and contracts unless they are moved, and follows the Hybrid Rule (SOP-N1 5.2.2). Employees of an acquired type (a) site complete network onboarding by the site's network effective date, and their training records move to the network training system.
5.7 Affiliations
5.7.1
The network agreement is signed before any network SOP binds the member entity (SOP-N1 5.8). The entity keeps its own CTAs, DEA registration, CLIA certificate, licenses, insurance and employees unless the agreement provides otherwise. Notices under 5.4 are needed only for items that change.
5.8 Transfer of an open study
5.8.1
A study moves to another PI or site only with the agreement of the sponsor, the IRB and the current PI. The Regulatory Coordinator (or Network Regulatory Lead) prepares a transfer plan on F-901-02 covering: sponsor agreement and CTA; IRB approval for the receiving site and closure at the transferring site; a new 1572 or investigator agreement; participant notice and re-consent as the IRB requires, with records moved under authorization or another HIPAA basis on F-905-01; IP transfer or return with sponsor approval and chain of custody; and the last and first dates of responsibility, with no gap in safety follow-up.
5.8.2
A participant who will not move is handled under SOP-10.
5.9 Exit
5.9.1
A member site exits when its network agreement ends, when the network sells or closes it, or when the Network Executive decides under SOP-N4 that membership ends. The Network Quality Lead opens the exit section of F-901-02.
5.9.2
For each in-flight study, the PI and Site Director decide with the sponsor whether it transfers (5.8), continues at the exiting entity outside the network, or closes (SOP-15); the Network Office is consulted where it is a CTA party. Care continues under 5.4.3 until that is done. The exit date is not set before every in-flight study has a confirmed disposition. For a continuing study, central services it depends on are handed back or replaced with a dated handover, network-signed or tri-party CTAs are amended or assigned, and the sponsor and IRB are told of each change.
5.9.3
Records custody: the site Regulatory Coordinator records on F-402-01, for every study done at the site, who holds the records for the full retention period, and tells each sponsor. Records held in network systems are exported as certified copies with audit trails, or kept with continued site access under a written agreement, before network access is removed (SOP-N6 5.7). The Network Office does not withhold a site's records, including over a payment dispute. IDE studies: FDA is told within 10 working days of a custody transfer (21 CFR 812.140(e)).
5.9.4
Before the exit date: the PI ends delegation for shared staff and central investigators unless a staffing agreement continues it, and the sponsor is told (SOP-N5); System Owners remove access both ways except under a continued-access agreement; the Privacy Officers record on F-905-01 what data each party keeps, returns or destroys (nothing within its retention period is destroyed); the Network Contracts and Finance Lead completes financial reconciliation; and the Site Director records which SOPs apply from the exit date and has staff trained on any change. A sale of a type (a) site also completes the 5.6.1 items for the buyer.
5.9.5
The Network Quality Lead removes the site from F-900-02, closes F-901-02 with the Network Executive's signature, and reports the exit at network management review.
6. Related Forms and SOPs
- F-901-01 Member Site Gap Assessment
- F-901-02 Member Site Integration Plan and Exit Checklist
- F-900-02 Network Operating Model and Appendix B Adoption Record
- F-302-01 Delegation of Authority Log
- F-402-01 Record Archiving and Retrieval Log
- F-905-01 Cross-Entity Data Flow Register
- Appendix A State Law Worksheet
- SOP-03 IRB Oversight, Essential Records and Study Activation
- SOP-04 Informed Consent
- SOP-06 Investigational Product Management
- SOP-08 Protocol Deviations and CAPA
- SOP-09 Safety Reporting (AEs, SAEs, IRB-Reportable Events, Pregnancy)
- SOP-10 Participant Retention, Withdrawal and Payments
- SOP-12 Privacy, Electronic Systems and Record Retention
- SOP-14 Quality Control and Quality Review
- SOP-15 Study Closeout
- SOP-16 Business Continuity and PI Coverage
- SOP-N1, SOP-N3 to SOP-N6
7. References
| Reference | Title |
|---|---|
| 21 CFR 11.100(c) | Electronic signatures: certification to FDA |
| 21 CFR 312.53(c) | Information to obtain from the investigator (Form FDA 1572) |
| 21 CFR 812.43(c) | Investigator agreements (devices) |
| 21 CFR 812.140(e) | Records custody (devices) |
| 21 CFR 1301.12 | Separate registrations for separate locations |
| 21 CFR 1301.52 | Transfer of registration; transfer of business |
| 42 CFR 493.39, 493.51 | CLIA notification requirements (change of ownership) |
| 45 CFR 164.508 | Uses and disclosures requiring an authorization |
| ICH E6(R3) Annex 1, 2.12 | Records |
| Reference Edition SOP-901 | Member Site Onboarding, Integration and Exit (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.