Central and Site Responsibilities (Exceptions Table)

1. How to use this appendix

This appendix applies only in Model N. It does two things. Part 1 lists, once, the duties that always stay at the member site. Part 2 lists the activities a network may centralize, with a default for each. Any activity not listed in Part 2 is done by the member site as its Lean Edition SOP says.

Steps:

• The Hybrid Rule (SOP-N1 5.2.2) applies to every row. The N-Integrated column applies only to a member site that is the network entity (type a). For every other member site, including a commonly owned subsidiary or a professional corporation under a management services arrangement (type b) and an independent entity (type c), the N-Affiliated column applies to every row.
• A separate entity uses a different cell only under a row-specific exception that counsel confirms in writing for that site and row, recorded on F-900-02 Part 4 with the counsel reference and, where work or PHI crosses a legal-entity line, the staffing agreement and F-905-01 flow that cover it (SOP-N1 5.2.4). A general grant of authority in the network agreement is not an exception. Approval follows SOP-N1 5.2.5.
• An affiliated covered entity (ACE) never makes a Network Office activity a use unless the network entity is itself a covered entity and an ACE member. Otherwise the Network Office acts for the ACE members as a business associate under a BAA (SOP-N6 5.3.3).
• Never use a row to move a Part 1 duty away from the site. The Network Office may support a Part 1 duty (for example by preparing a form for the PI to sign), but the site person named in the Lean SOP still performs and signs it.
• Where a separate entity's network agreement is silent on a row, the site performs the activity (S) until the agreement is amended.

Codes: C means the Network Office performs the activity and keeps the record; S means the member site does; C/S means shared, with the split stated in the cell. The procedure for each row is in the Network SOP or Supplement section cited; this table says only who.

Part 1. Duties that always stay at the site

Investigator duties. The PI and the investigators listed for the study at the site keep the duties in 21 CFR 312.60 to 312.69, 21 CFR 812.100 to 812.150 and ICH E6(R3) Annex 1, section 2. In particular:

• signing the Form FDA 1572 or investigator agreement, submissions to the IRB, the eCRF and reports
• delegating tasks and signing the site's delegation log (F-302-01), and supervising everyone who does delegated work, whoever employs them
• informed consent, done by staff on the site's delegation log with the site's IRB-approved form
• eligibility decisions and sign-off on F-303-02
• medical care, AE assessment (seriousness, severity, causality, expectedness) and SAE reports sent by the site directly to the sponsor
• classifying protocol deviations and deciding what is reported to the IRB
• emergency unblinding decisions
• control of and accountability for IP received for the site
• accurate source and records, and control of the site's essential records for the full retention period
• permitting monitoring, audit and inspection, receiving the Form FDA 482 and 483, and signing the response
• deciding whether to take an allocated study, and any pause of enrollment

Legal-entity and location duties. These attach to the legal entity or the licensed location:

• HIPAA covered entity duties of each covered entity, (45 CFR 164.530), including breach decisions (45 CFR 164.400 to 164.414); for separate entities, each entity's own Privacy Officer and Security Officer
• CLIA certificate for each testing location (42 CFR 493.35(b), 493.55(b))
• DEA registration for each registrant and location where controlled substances are stored or dispensed (21 CFR 1301.12), and state controlled-substance registration
• state facility, pharmacy and other licenses for each location
• employer duties, including DOT hazmat training records for its own employees (49 CFR 172.702(a)) and tax reporting as payer
• submitting claims under the entity's own billing numbers and the overpayment duty
• for a separate entity: signing its own contracts unless it has given written authority; deciding conflicts of interest and management plans for its own staff; custody of its own study records

Site-run activities. Conducting study visits and procedures; eliciting AEs; completing F-205-01 for each study, signed by the site PI and Site Director; keeping the site's business continuity plan (F-705-01) and first response to temperature alarms; hosting audits and inspections.

Part 2. Activities a network may centralize