Member Site Onboarding, Integration and Exit

1. Purpose

This SOP describes how [NETWORK NAME] assesses a research site that is joining the network, brings it onto the network SOPs, systems and agreements without interrupting participant care or open studies, and handles a member site that leaves the network or closes. It covers both acquisitions (N-Integrated) and affiliations (N-Affiliated).

2. Scope

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

In scope:

• due diligence and gap assessment of a joining site (F-901-01)
• the integration plan and its milestones (F-901-02)
• notices to sponsors, IRBs and regulators for studies open at the time of joining or exit
• change of ownership steps for acquired sites
• exit: study transfer or closeout, records custody, system access and data return

Out of scope: the business terms of a purchase or affiliation, which are set by the network's executives and counsel. Network governance and adoption of Appendix B are in SOP-900 Network Governance, SOP Hierarchy and Local Addenda. Ongoing oversight of a member site after integration is in SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation).

Where the protocol, sponsor or IRB requirement is stricter than this SOP, the network and the member site follow the stricter requirement. The notice requirements in this SOP are the usual ones; counsel confirms the specific notice requirements for each transaction, because they depend on contract terms, state law and the type of registration or certificate.

3. Responsibilities

4. Definitions

5. Procedure

5.1 Starting the assessment

5.2 Due diligence and gap assessment (F-901-01)

• Staff qualifications: CVs, licenses, GCP and human subjects training, delegation logs, debarment, disqualification and exclusion screens (SOP-103 Staff Qualification, Training and Training Records; SOP-704 Research Misconduct and Fraud Reporting)
• Open studies: list of in-flight studies with sponsor, phase, IND or IDE, IRB of record, PI, enrollment status, participants on treatment or in follow-up, and next key dates
• ISF quality: a sample review of ISFs against F-204-01 Investigator Site File Index, including consent versions used and delegation
• Inspection and audit history: prior FDA inspections and their classification, any Form FDA 483 and the response, warning letters, sponsor audit findings, IRB suspensions or terminations, and open CAPAs
• IRB status: IRBs of record, reliance agreements, any FWA, and IRB accounts
• IP storage: storage areas, temperature monitoring and excursion history, controlled-substance storage and DEA registration (SOP-304 Investigational Product Management)
• Laboratory: CLIA certificate type, holder, location, director and expiry (SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements)
• Systems: eReg, CTMS, eSource, EHR, temperature monitoring and e-signature systems, their validation or fitness-for-purpose evidence, and who owns the data (SOP-401 Computerized Systems and Electronic Records)
• HIPAA status: covered entity or not, Notice of Privacy Practices, authorization templates in use, Part 2 records, and privacy incident history (SOP-400)
• Insurance: professional liability, general liability and clinical trial coverage, limits and whether coverage is claims-made (tail coverage needed at a change)
• Contracts: open CTAs, budgets, service provider agreements, and their assignment and change-of-control clauses
• Records: archived study records, their location and custodian, and retention end dates (SOP-402 Record Retention, Archiving and Destruction)
• State law: the state(s) where the site operates and whether Appendix A covers them

5.3 Integration plan (F-901-02)

• the variant and Appendix B assignments for the site, added to F-900-02 (SOP-900 5.2.4)
• closure of each critical and major gap, with CAPA references (SOP-703 Corrective and Preventive Action (CAPA))
• SOP adoption: the network SOP effective date for the site, local addenda needed, and training of all site staff before that date (SOP-900 5.7)
• completion of Appendix A for the site's state(s) and any state-specific addenda
• systems migration with data integrity checks (5.5)
• study-by-study plan for in-flight studies (5.4)
• contract, insurance, registration and certificate steps (5.6)
• the date from which network SOPs replace the site's own SOPs
• each open FDA, sponsor or IRB commitment of the site (for example a Form FDA 483 response commitment or an open CAPA), as a milestone

5.4 In-flight studies: notices and continuity of care

• Sponsor: written notice of any change in site name, legal entity, address, PI, Sub-I, laboratory or contract party; sponsor agreement before a change of PI or site location takes effect
• Form FDA 1572 or investigator agreement: a new 1572 when the PI changes; changes to other 1572 information (for example research facility address, laboratory, IRB) reported to the sponsor, with a revised 1572 where the sponsor requires one (21 CFR 312.53(c); SOP-302 Delegation of Authority 5.5); device investigator agreements under 21 CFR 812.43(c)
• IRB: notice or approval of a change in PI, site name, location, ownership or institution as the IRB's policy requires; any change of IRB of record is approved by the sponsor and both IRBs before it takes effect, with no lapse in approval (SOP-203 IRB Submissions, Approval and Continuing Oversight)
• Consent: whether the change requires a revised consent form (for example, new site name, contact details or study doctor) and how current participants are told, as the IRB decides (SOP-301 Informed Consent Process and Documentation)
• Delegation: updated F-302-01 for any staff change, with training first

• scheduled visits, dosing and safety follow-up continue on schedule
• IP stays in qualified storage with continuous temperature records and accountability; any IP move between locations is approved by the sponsor first (SOP-304)
• the PI or a Sub-I stays available, and safety reporting continues without a gap (SOP-501 Serious Adverse Event and Expedited Safety Reporting)
• participants know who to call, with updated contact details given as the IRB approves

5.5 Systems migration

5.6 Acquisitions (N-Integrated): change of ownership steps

• CTAs and budgets: review each for assignment and change-of-control clauses; obtain sponsor consent to assignment, a novation, or an amendment naming the new contracting entity, as each agreement requires; confirm payee and tax details change only after the amendment is signed
• Sponsor and IRB notices: under 5.4, including any change of legal entity or institution name
• DEA registration: a DEA registration is specific to the registrant and to the location (a separate registration is required for each principal place of business where controlled substances are dispensed, 21 CFR 1301.12). A registration cannot be assigned or transferred 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 the transfer unless DEA waives it (21 CFR 1301.52(d)). Counsel confirms whether the acquired site needs new registrations, and the state controlled-substance registration (Appendix A), before controlled-substance IP or drugs are handled under the new owner
• CLIA certificate: the laboratory notifies CMS or its state agency of a change in ownership within 30 days of the change (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, including PPM and accreditation)
• Other licenses: state facility, pharmacy or radiation licenses where held, and payer enrollment if the site bills insurance (SOP-202 Medicare Coverage Analysis and Research Billing Compliance)
• Insurance: new coverage in force from the closing date, and tail coverage for claims-made policies of the prior owner
• Records custody: who holds archived study records after closing (SOP-402 5.6; 21 CFR 812.140(e) where IDE custody changes)

5.7 Affiliations (N-Affiliated)

5.8 Transfer of an open study

• sponsor written agreement and any new CTA or amendment
• IRB approval for the receiving PI and site, and closure or modification at the transferring site
• new 1572 or investigator agreement for the receiving PI
• participant notification and re-consent where the IRB requires it, and transfer of participant records with authorization or another HIPAA basis (SOP-400)
• IP transfer or return, with sponsor approval, chain of custody and temperature records
• the last date of responsibility for the transferring PI and the first date for the receiving PI, with no gap in safety follow-up

5.9 Site exit

• the Regulatory Coordinator notifies the sponsor and IRB of any change that leaving the network causes (for example contract party, IRB reliance, systems, monitoring contacts), under 5.4.1
• central services the study depended on (for example central regulatory, eReg, CTMS or invoicing) are handed back to the site or replaced before they stop, with a dated handover on F-901-02
• tri-party or network-signed CTAs are amended or assigned to the member entity (SOP-902)

• N-Affiliated: study records belong to the member site entity and its investigators. Records the Network Office holds for the site, including source documents and eSource held in network systems (for example central eReg, eSource, CTMS or document systems), are returned to the site, or exported as complete certified copies with audit trails, by the exit date or the date the network agreement sets. The Network Office must not withhold the site's records (including over a payment dispute), and must not destroy its own copies before the retention end date unless the site has confirmed in writing that it holds a complete set. Any copy the Network Office keeps is held only under the network agreement and F-905-01
• N-Integrated sale or closure: a written custody agreement with the buyer or an archiving vendor (SOP-402 5.6.3); each sponsor is told the new custodian
• IDE studies: if the investigator transfers custody of records to another person who accepts responsibility, FDA is notified within 10 working days after the transfer (21 CFR 812.140(e)); the Regulatory Coordinator coordinates the notice with the sponsor. For IND studies the sponsor is told in writing of the new custodian (SOP-402 5.6.2)

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-204-01 Investigator Site File Index
• F-302-01 Delegation of Authority Log
• F-401-01 Computerized System Inventory and Access Log
• F-402-01 Record Archiving and Retrieval Log
• 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 Responsibility Matrix
• SOP-100 Writing, Approving and Controlling SOPs
• SOP-102 Site Organization, Roles and Staff Responsibilities
• SOP-103 Staff Qualification, Training and Training Records
• SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
• SOP-204 Essential Documents and the Investigator Site File
• SOP-202 Medicare Coverage Analysis and Research Billing Compliance
• SOP-203 IRB Submissions, Approval and Continuing Oversight
• SOP-301 Informed Consent Process and Documentation
• SOP-302 Delegation of Authority
• SOP-304 Investigational Product Management
• SOP-309 Participant Retention, Withdrawal and Lost to Follow-Up
• SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
• SOP-400 Participant Privacy and HIPAA in Research
• SOP-401 Computerized Systems and Electronic Records
• SOP-402 Record Retention, Archiving and Destruction
• SOP-501 Serious Adverse Event and Expedited Safety Reporting
• SOP-601 Study Closeout
• SOP-700 Internal Quality Control and Quality Assurance Audits
• SOP-703 Corrective and Preventive Action (CAPA)
• SOP-704 Research Misconduct and Fraud Reporting
• SOP-900 Network Governance, SOP Hierarchy and Local Addenda
• 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