SOP-N5
Shared Staff, Cross-Site Coverage and Central Services
- Number
- SOP-N5
- Category
- Network
- Edition
- Network Edition 2.0
- Approx. pages
- 6
- Reference Edition source
- SOP-904
[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] deploys staff who work at more than one member site, provides central services to member sites, and covers key roles across sites. It lists the delegation, licensure, Form FDA 1572, supervision and agreement steps that come before any shared person or central service does trial work for a member site.
2. Scope
This SOP applies only when [NETWORK NAME] has adopted Model N. Network terms are defined in SOP-N1 section 4.
In scope: shared staff (floating CRCs, shared Sub-Is, nurses, phlebotomists and others working at more than one member site); central services (regulatory, recruitment or call center, IP or pharmacy, specimen processing or laboratory, QC); cross-site coverage of key roles.
Out of scope: hiring and training steps for all staff (SOP-01, SOP-02), which this SOP adds to; sponsor-contracted providers (SOP-M1); shared systems and PHI flows (SOP-N6).
Where a protocol, sponsor or IRB requirement is stricter than this SOP, follow the stricter requirement.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Network Clinical Operations Lead | Owns this SOP and F-904-01. Approves deployments, checks capacity and keeps the coverage roster. Where not appointed, the Network Quality Lead does this. |
| Network Quality Lead | Records each central service as a service provider, reports service performance to PIs, and reconciles F-904-01 each quarter. |
| Network Regulatory Lead | Prepares 1572 and investigator agreement updates, IRB submissions and financial disclosure for shared investigators. |
| Network Contracts and Finance Lead | Puts staffing and services agreements in place before work crosses a legal-entity line. |
| Principal Investigator (PI) | Decides whether to delegate to a shared person or use a central service, signs the delegation log, oversees the work whoever employs the person, and acknowledges central service reports. |
| Site Director | Requests shared staff, confirms local orientation and reports problems. |
| Regulatory Coordinator | Checks qualifications before the PI signs, files records or pointers in the ISF, and sends investigator changes to the sponsor and IRB. |
| Shared staff member | Works only at the sites and on the studies listed on F-904-01, within delegated tasks and the license of the state where the work is done. Reports license changes the same day. |
4. Definitions
| Term | Definition |
|---|---|
| Investigator site | The site led by one PI under one Form FDA 1572 or device investigator agreement for a study. It may include several locations. |
| Shared staff | A person who performs trial-related activities at more than one member site or for more than one investigator site. |
| Central service | A trial-related service the Network Office provides to member sites from a central team. |
| Home site | The member site or Network Office unit that employs or contracts the shared person. |
| Workforce | Persons whose conduct in work for a covered entity is under its direct control, paid or not (45 CFR 160.103). |
5. Procedure
5.1 Day-one minimum
5.1.1
The day-one items for this SOP are the "first cross-site work" row in SOP-N1 5.1.1, recorded on F-904-01. F-904-01 reconciliation (5.10) starts in the first full quarter.
5.2 Planning and capacity
5.2.1
The Site Director requests shared staff from the Network Clinical Operations Lead, with studies, tasks, hours and dates. Before assigning, the Network Clinical Operations Lead checks the person's total workload across sites and studies, including travel. The PI of each study confirms the person has enough time for the delegated tasks (ICH E6(R3) Annex 1, 2.2).
5.2.2
A person is assigned to no more than [DEFAULT: 3] member sites at once unless the Network Clinical Operations Lead records the reason and the PIs agree.
5.3 Delegation, training and qualification
5.3.1
A shared person is on the delegation log (F-302-01 or the sponsor's log) of each study they work on, signed by that study's PI before any task (SOP-02). Where one PI's investigator site covers several locations under one 1572, the person is entered once per study. Where member sites are separate investigator sites, the person is entered on each site's log, and each PI signs.
5.3.2
Before the PI signs, the Regulatory Coordinator confirms on F-103-02 and F-904-01: current CV and licenses for each state; GCP, SOP and protocol training; training on the site's local addenda and a local orientation (emergency procedures, IP and specimen storage, source); system access limited to assigned sites and studies; financial disclosure for investigators (SOP-02); and a current debarment, disqualification and exclusion screen. The Network Quality Lead may run the screen centrally and record it on F-904-01; a separate member site entity may rely on it only if the staffing agreement says so.
5.3.3
The qualification file may be held centrally. The site ISF holds the study training record and either a copy of the qualification documents or a written pointer to where an inspector can see them.
5.3.4
When a shared person stops work at a site or on a study, the Regulatory Coordinator enters the end date, the PI initials it, the Network Clinical Operations Lead updates F-904-01, and access to that site's records is removed (SOP-N6). When a person leaves the network, every site on the person's F-904-01 record is told the same day.
5.4 Licensure by state
5.4.1
Clinical tasks are done only by people licensed or certified for them in the state where the participant is physically located at the time. State rules are in Appendix A. Before a person works in a new state, the Network Clinical Operations Lead verifies the license on the issuing board's site and records state, type, number, expiry and verification date on F-904-01.
5.4.2
A Nurse Licensure Compact multistate license covers only compact states. Physicians, nurse practitioners and physician assistants need a license in each state unless the state recognizes another route; supervision rules are those of the state where the work is done. Telehealth across state lines follows SOP-M4.
5.4.3
A person whose license lapses in a state stops dependent tasks there the same day, and each affected PI suspends the delegation until renewal is verified.
5.5 Form FDA 1572 and investigator agreements
5.5.1
Drug and biologic studies: a shared Sub-I who makes a direct and significant contribution to the data at an investigator site is listed in Section 6 of that site's 1572 (21 CFR 312.53(c)(1)(viii)); a Sub-I at two investigator sites in one study is listed for both. A Sub-I added after the 1572 is signed is recorded in the study records and reported to the sponsor; a new 1572 is needed only for a new investigator or protocol, or where the sponsor asks (Form FDA 1572 FAQs, 2010, question 7). Every location where study activities happen is listed in Section 3.
5.5.2
Device studies: the shared investigator signs the investigator agreement the sponsor requires for each investigator site before any study task there (21 CFR 812.43(c)).
5.5.3
Where study locations are not close to each other, an investigator who signed a 1572 must be available at each location to conduct or supervise the study, and this cannot be delegated to a Sub-I (Form FDA 1572 FAQs, 2010, question 21). A PI covering a distant site is added as an investigator under SOP-03.
5.5.4
A temporary substitute for staff with an occasional role need not be listed in Section 6 (Form FDA 1572 FAQs, 2010, question 32), but is delegated and trained under 5.3 first.
5.6 Supervision and staffing agreements
5.6.1
The PI directs and oversees a shared person's trial work, whoever employs them (21 CFR 312.60; 21 CFR 812.100; ICH E6(R3) Annex 1, 2.3). Employment matters stay with the home site. The PI reports concerns to the Site Director, who passes them to the home site, and may remove the person from the log at any time.
5.6.2
Under the Hybrid Rule (SOP-N1 5.2.2): where home site and member site are the same legal entity, F-904-01 and the role description document the assignment and no staffing agreement is needed. Where they are separate legal entities, including commonly owned ones, the Network Contracts and Finance Lead puts a written staffing or services agreement in place before the work starts, covering: the PI's right to direct, oversee and remove the person; confidentiality; HIPAA status (workforce of the member site under its direct control, or business associate under a BAA), decided with the Privacy Officer and counsel; professional and general liability cover; credentialing and screening; access to records for monitors, auditors and inspectors; record ownership (records stay with the member site); and FMV fees reviewed under SOP-N3 5.7.3. The agreement is recorded on F-904-01 and listed on F-105-01. Network Office staff count as workforce of an ACE member only where they are under its direct control and that status is recorded here; otherwise the Network Office is a business associate (SOP-N6 5.3.3).
5.7 Central services as service providers
5.7.1
Each central service is a service provider to each member site that uses it for investigator activities (ICH E6(R3) Annex 1, 2.3), including where the site is the network entity. The Network Quality Lead records it on F-105-01 with its risk level (SOP-M1).
5.7.2
Terms are documented before first use: an internal service description approved by the Network Executive for a site that is the network entity; for a separate member site entity, a written services agreement with a BAA or other HIPAA pathway where PHI is involved (SOP-N6).
5.7.3
The PI confirms, before first use for each study, which central services the study uses, and the Regulatory Coordinator records it in the ISF. Central staff who do a protocol-specific task are on the site delegation log; a service log covers only tasks that are not protocol-specific.
5.7.4
The Network Quality Lead reports each central service's performance and issues to each PI using it at least [DEFAULT: quarterly], and at once for issues affecting safety or data reliability. The PI signs and dates the report, records any action on F-105-01, and files it in the ISF.
5.8 Requirements for specific central services
5.8.1
Central regulatory. The Network Regulatory Lead prepares and submits IRB and sponsor documents as Appendix B assigns. The PI signs investigator documents personally. Each document is filed in the site's ISF or its section of the central eISF.
5.8.2
Central recruitment or call center. Pre-screening follows SOP-05 and SOP-M3 with IRB-approved scripts for each study and site. Staff record pre-screening on F-300-01 with the receiving site. The HIPAA pathway is set before calls begin (SOP-N6 5.5).
5.8.3
Central IP or pharmacy. Default: the sponsor ships IP, including controlled-substance IP, directly to each investigator site. IP moves between sites, or from a central pharmacy to a site, only with the sponsor's written approval, temperature control and accountability on F-304-01 at both ends. A central pharmacy follows the pharmacy law of its state and of the state where IP is dispensed (Appendix A). Controlled substances:
- they are stored and dispensed only at a location covered by its own DEA registration (21 CFR 1301.12) and any state registration; counsel confirms whether a central storage location needs its own registration
- Schedule I IP is handled only at a location with a Schedule I researcher registration for the protocol (21 CFR 1301.13(e)(1)(vi); 21 CFR 1301.18). Each registration activity is independent (21 CFR 1301.13(e)), so a practitioner registration for Schedules II to V does not cover it, and each site that handles the substance needs its own
- a move between locations with different registrations follows DEA record and order rules (21 CFR 1304; 21 CFR 1305, including the order form for Schedule I and II)
- a practitioner registered to dispense may distribute to another practitioner registered to dispense without a distributor registration only while the total dosage units of all controlled substances it distributes this way in a calendar year do not exceed 5 percent of the total dosage units of all controlled substances it distributes and dispenses in that year (21 CFR 1307.11)
- routine redistribution from a central location is the exception: counsel confirms before first use whether a distributor registration is needed
5.8.4
Central specimen processing or laboratory. Handling and shipping follow SOP-11. A location that only collects, processes or ships is not a laboratory under CLIA (42 CFR 493.2). A location whose test results are used for a participant's eligibility, safety or care holds a CLIA certificate for that location and complexity; certificates are issued per location with limited exceptions (42 CFR 493.35(b), 493.55(b)), and the research exception (42 CFR 493.3(b)(2)) applies only where no participant-specific result is reported for those purposes. For IND studies the facility is listed in Section 4 of each relevant 1572.
5.8.5
Shipping training. Each hazmat employer trains its own hazmat employees and keeps the records (49 CFR 172.702(a); 172.704(d)). A central course may be used; each employing entity certifies and files the record.
5.8.6
Unblinded staff. A person unblinded for a study does not take a blinded role in it at any member site. F-904-01 records blinding status by study, and the Network Clinical Operations Lead checks it before any cross-site assignment.
5.8.7
Central QC. Reviewers follow SOP-14 and do not QC their own work.
5.9 Cross-site coverage
5.9.1
Each member site's F-705-01 names a backup for each key role (SOP-16). The Network Clinical Operations Lead keeps a coverage roster by role, study and state license, and sets up backups for each enrolling study in advance.
5.9.2
A cross-site backup covers only after 5.3 to 5.5 are complete for that study and site. A covering investigator is listed for the study at that site, accepted by the IRB where required, delegated by the PI, licensed in the state and trained on the protocol. If no qualified investigator can cover, the PI and Site Director pause procedures that need one and tell the sponsor.
5.9.3
A shared on-call line routes each call to an investigator listed for the participant's study and site. The Network Clinical Operations Lead checks the routing list against each site's on-call roster at least [DEFAULT: monthly].
5.9.4
The Site Director records each coverage period on F-306-01 in the ISF, and the Network Clinical Operations Lead records it on F-904-01.
5.10 F-904-01 reconciliation
5.10.1
The Network Clinical Operations Lead keeps F-904-01 current for every shared person and central service staff member. The Network Quality Lead reconciles it against each site's delegation logs, training records and access lists at least [DEFAULT: quarterly]. Where a person worked without delegation, training or license, the site handles it as a deviation under SOP-08.
6. Related Forms and SOPs
- F-904-01 Shared Staff Assignment and Credentialing Log
- F-103-02 Staff Qualification File Checklist
- F-105-01 Service Provider Qualification and Oversight Record
- F-300-01 Pre-Screening Log
- F-302-01 Delegation of Authority Log
- F-304-01 Investigational Product Accountability Log
- F-306-01 Note to File
- F-705-01 Business Continuity Plan and Emergency Contacts
- Appendix A State Law Worksheet
- SOP-01, SOP-02, SOP-03, SOP-05, SOP-06, SOP-08, SOP-11, SOP-14, SOP-16
- SOP-M1 Service Providers and Vendors
- SOP-M3 Recruitment and Advertising
- SOP-M4 Decentralized Trial Elements
- SOP-N1, SOP-N3, SOP-N6
7. References
| Reference | Title |
|---|---|
| 21 CFR 312.53(c)(1)(viii) | Investigator statement: subinvestigators |
| 21 CFR 312.60 | General responsibilities of investigators |
| 21 CFR 812.43(c) | Investigator agreements (devices) |
| 21 CFR 812.100 | General responsibilities of investigators (devices) |
| 21 CFR 1301.12 | Separate registrations for separate locations |
| 21 CFR 1301.13(e), 1301.18 | Registration activities, including Schedule I research; Schedule I research protocols |
| 21 CFR 1307.11 | Distribution by dispenser to another practitioner |
| 21 CFR 1304 and 1305 | Controlled substance records; order forms |
| 42 CFR 493.2, 493.3(b)(2) | CLIA definitions; research exception |
| 42 CFR 493.35(b), 493.55(b) | CLIA certificate per location and exceptions |
| 49 CFR 172.702, 172.704 | Hazmat employee training and records |
| 45 CFR 160.103 | HIPAA definitions (workforce, business associate) |
| ICH E6(R3) Annex 1, 2.2 and 2.3 | Resources; investigator responsibilities and service providers |
| FDA Guidance (May 2010) | Frequently Asked Questions: Statement of Investigator (Form FDA 1572) |
| Reference Edition SOP-904 | Shared Staff, Cross-Site Coverage and Central Services (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.