SOP-904

Shared Staff, Cross-Site Coverage and Central Services

Number
SOP-904
Category
Network
Edition
Reference Edition 1.3
Approx. pages
10
Download WordAll Reference Edition documents

[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.

On this page

1. Purpose

This SOP describes 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 when people are absent. It sets the delegation, licensure, Form FDA 1572, supervision and agreement steps that must be complete before a shared person or central service performs any trial-related activity for a member site.

2. Scope

This SOP applies only when [NETWORK NAME] has adopted operating Model N under SOP-100 Writing, Approving and Controlling SOPs. A Model S site ignores it.

In scope:

  • shared staff: floating CRCs, shared Sub-Is, shared nurses and phlebotomists, and other staff who perform trial-related activities at more than one member site
  • central services run by the Network Office for member sites: central regulatory, central recruitment or call center, central IP or pharmacy services, central specimen processing or laboratory services, and central QC
  • cross-site coverage of key roles during absence or vacancy

Out of scope:

  • hiring, onboarding and offboarding steps that apply to all staff (SOP-102 Site Organization, Roles and Staff Responsibilities; SOP-103 Staff Qualification, Training and Training Records), which this SOP adds to
  • sponsor-contracted service providers (SOP-105 Oversight of Service Providers and Vendors, sections 5.7 and 5.8)
  • shared computerized systems, access control and PHI flows between entities (SOP-905 Network Data, Systems, Privacy and Records Across Sites)

Who performs each activity at the Network Office or the member site follows Appendix B, Central and Site Responsibility Matrix (Appendix B, SOP-904 rows). Where a protocol, sponsor or IRB requirement is stricter than this SOP, follow the stricter requirement.

3. Responsibilities

RoleResponsibilities
Network Clinical Operations LeadOwns this SOP and F-904-01. Approves shared staff deployments, checks capacity before assigning a person to more sites or studies, and maintains the cross-site coverage roster.
Network Quality LeadQualifies and oversees each central service as a service provider under SOP-105. Checks F-904-01 against delegation logs and training records.
Network Regulatory LeadPrepares Form FDA 1572 and investigator agreement updates, IRB submissions and financial disclosure for shared investigators. Runs central regulatory services where Appendix B assigns them centrally.
Network Contracts and Finance LeadN-Affiliated: puts staffing and services agreements in place between the Network Office (or the employing entity) and each member site before work starts.
Network Training Lead (or Network Quality Lead)Confirms shared staff are trained on network SOPs, each member site's local addenda (F-900-01) and each study before assignment.
Principal Investigator (PI)Decides whether to delegate to a shared person, signs the delegation log for their study, and oversees that person's work on the study whoever employs them. Accepts or declines each central service used for investigator activities.
Site Director (each member site)Requests shared staff or central services, confirms local orientation, and reports problems with shared staff or central services to the Network Clinical Operations Lead.
Regulatory Coordinator (each member site)Enters shared staff on the site's delegation log once the PI signs, files their qualification records or a pointer to them in the ISF, and sends investigator changes to the sponsor and IRB.
Network Medical Director (where the network has one)Advises PIs and shared investigators on clinical questions. Advisory only: never assesses adverse events, confirms eligibility, or signs any record for a PI, unless separately added to that study as an investigator under 5.5.
Shared staff memberWorks only at sites and on studies listed for them on F-904-01, within their delegated tasks and their license in the state where the work is done. Reports license changes the same day.

4. Definitions

TermDefinition
Network OfficeThe central organization of [NETWORK NAME], acting collectively.
Member siteA site location or legal entity that conducts studies as part of [NETWORK NAME] under its own PI or PIs.
Investigator siteThe research site led by one PI under one Form FDA 1572 or device investigator agreement for a study, usually with its own sponsor site number. One investigator site may include several locations.
Shared staffA person who performs trial-related activities at more than one member site or for more than one investigator site.
Floating CRCA CRC assigned to cover studies at more than one member site, on a planned or as-needed basis.
Shared Sub-IA Sub-Investigator who contributes to studies at more than one investigator site.
Central serviceA trial-related service the Network Office provides to member sites from a central team, for example regulatory submissions, recruitment and pre-screening, IP or pharmacy services, specimen processing or central QC.
Home siteThe member site or Network Office unit that employs or contracts the shared staff member.
Local addendumA member site's documented local variation to a network SOP, recorded on F-900-01 (SOP-900 Network Governance, SOP Hierarchy and Local Addenda).
WorkforceEmployees, volunteers, trainees and other persons whose conduct, in the performance of work for a covered entity or business associate, is under the direct control of that entity, whether or not they are paid by it (45 CFR 160.103).
N-IntegratedModel N in which one legal entity owns all member sites. N-Integrated defaults apply only where the member site and the network entity are the same legal entity. A separate subsidiary, or a professional corporation under a management services arrangement, follows the N-Affiliated rows for PHI, direction of staff, contract signature, records custody and payments unless counsel confirms otherwise (SOP-900, 5.2.1).
N-AffiliatedModel N in which member sites are separate legal entities bound by a network or affiliation agreement.

5. Procedure

5.1 Principles

5.1.1
Each PI keeps full responsibility for their study at their investigator site, including oversight of every person and party performing delegated activities, whoever employs or pays them (21 CFR 312.60; 21 CFR 812.100; ICH E6(R3) Annex 1, 2.3.1).
5.1.2
Shared staff and central services do not change who the investigator is. The Network Office supplies people and services. The PI decides what to delegate to them.
5.1.3
A shared person works for a member site only after every step in 5.3 to 5.5 is complete for that site and study and recorded on F-904-01 Shared Staff Assignment and Credentialing Log.

5.2 Planning shared staff and capacity

5.2.1
The Site Director requests shared staff from the Network Clinical Operations Lead, stating the studies, tasks, expected hours and dates.
5.2.2
Before assigning a person, the Network Clinical Operations Lead checks that the person's total workload across sites and studies leaves enough time to do each assignment properly, including travel time between locations. The PI of each study confirms the person has sufficient time for the delegated tasks (ICH E6(R3) Annex 1, 2.2.2).
5.2.3
A shared 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 and training at each investigator site

5.3.1
A shared person appears on the delegation log (F-302-01 Delegation of Authority Log or the sponsor's log) of each study they work on, signed by that study's PI before any task is performed, as set out in SOP-302 Delegation of Authority.
5.3.2
Where one PI's investigator site covers several member site locations under one 1572, the person is entered once per study, and the entry covers every location where they work on that study (SOP-302, section 5.7.4). Where member sites are separate investigator sites with their own PI and 1572, the person is entered on each investigator site's log for that study, and each PI signs their own entry.
5.3.3
Before the PI signs, the member site Regulatory Coordinator confirms on F-103-02 Staff Qualification File Checklist and F-904-01 that the person has:
  • current CV, licenses and certifications for each state where they will work (5.4)
  • GCP, SOP and protocol training (SOP-103)
  • training on the member site's local addenda (F-900-01) and a local orientation covering the location's emergency procedures, IP and specimen storage, and source documents (SOP-102, section 5.5)
  • system access requested under SOP-905 and SOP-401 Computerized Systems and Electronic Records, limited to the sites and studies assigned
  • for investigators, financial disclosure for each study and investigator site (SOP-104 Conflict of Interest and Financial Disclosure)
  • a current debarment, disqualification and exclusion screen (SOP-103, section 5.2.3). The Network Quality Lead may run this screen centrally for all shared staff and records the date and result on F-904-01; N-Affiliated: each member site may rely on the central screen only if the staffing agreement says so
5.3.4
The qualification file may be held centrally. The member site ISF holds the study-specific training record and either a copy of the qualification documents or a written pointer to where an inspector can see them at the time of an inspection (SOP-204 Essential Documents and the Investigator Site File).
5.3.5
When a shared person stops working at a member site or on a study, the Regulatory Coordinator at that site enters the end date and the PI initials it (SOP-302, section 5.6). The Network Clinical Operations Lead updates F-904-01 and triggers removal of access to that site's records (SOP-905).

5.4 Licensure for clinical tasks in each state

5.4.1
Clinical tasks are performed only by people licensed or certified for that task in the state where the participant is physically located when the task is done. This applies to physicians, nurse practitioners, physician assistants, nurses, pharmacists and, in states that license or certify them, phlebotomists and other technicians. State requirements are recorded in Appendix A, State Law Worksheet.
5.4.2
Before a shared person works in a new state, the Network Clinical Operations Lead checks the license or certification on the issuing board's verification site, records the state, license type, number and expiry date on F-904-01, and files the verification.
5.4.3
A multistate nurse license under the Nurse Licensure Compact covers practice only in compact states. Nurse practitioners, physician assistants and physicians need a license in each state unless the state recognizes another route. Physician collaboration or supervision rules for advanced practice providers are those of the state where the work is done (SOP-302, section 5.2.4).
5.4.4
Telehealth visits across state lines follow SOP-313 Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP), section 5.4. A telehealth or home health clinician from another member site who sees a participant enrolled at a different investigator site is first added to that study at the participant's site (5.3 and 5.5).
5.4.5
A shared person whose license or certification lapses in any state stops tasks that depend on it in that state the same day. The PI of each affected study suspends the delegation until renewal is verified (SOP-103, section 5.2.4).

5.5 Form FDA 1572 and investigator agreements for shared Sub-Is

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 investigator site's 1572 (21 CFR 312.53(c)(1)(viii); Form FDA 1572 FAQs). A Sub-I working at two investigator sites in the same study is listed for both PIs. A Sub-I added after a 1572 is signed is recorded in the study records and reported to the sponsor; a new signed 1572 is needed only for a new investigator or a new protocol, or where the sponsor asks for one (SOP-302, section 5.5.2; Form FDA 1572 FAQs, question 7). Every location where study activities happen is listed in Section 3 of the relevant 1572.
5.5.2
Device studies: the shared investigator signs the investigator agreement the sponsor requires for each investigator site (21 CFR 812.43(c)), before performing any study task there.
5.5.3
The Network Regulatory Lead sends 1572 and investigator changes to the sponsor and submits investigator changes to the IRB as the IRB requires (SOP-203 IRB Submissions, Approval and Continuing Oversight; SOP-302, section 5.5).
5.5.4
A shared Sub-I does not replace the PI's presence. 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 that responsibility cannot be delegated to a Sub-I (Form FDA 1572 FAQs, question 21). A PI covering a distant member site is added as an investigator under SOP-203, not as a Sub-I.

5.6 Supervision of staff the PI does not employ

5.6.1
When a shared person works on a study, the PI of that study directs and oversees their trial-related work (SOP-302, section 5.7), even if the person is employed by the Network Office or another member site. The person follows the PI's instructions on study matters and reports AEs, deviations and problems to that PI and study team.
5.6.2
Employment matters (hiring, pay, performance management, discipline) stay with the home site. The PI reports performance or conduct concerns to the Site Director, who passes them to the home site and the Network Clinical Operations Lead. A PI may remove a shared person from their delegation log at any time.
5.6.3
N-Integrated, where the home site and the member site are the same legal entity: all staff are employees of that entity. The Network Office documents shared assignments on F-904-01 and in each person's role description. No separate staffing agreement is needed. Separate legal entities under common ownership (for example a subsidiary, or a professional corporation under a management services arrangement) follow 5.6.4 unless counsel confirms otherwise (SOP-900 5.2.1).
5.6.4
N-Affiliated: before a person employed by one legal entity performs trial-related work for another, the Network Contracts and Finance Lead puts a written staffing or services agreement in place between the employing entity and the member site. The agreement covers:
  • the PI's right to direct and oversee study work, and to remove the person from a study
  • confidentiality of participant, sponsor and site information
  • HIPAA status: whether the person works as part of the member site's workforce (under its direct control) or as a business associate under a BAA (SOP-400 Participant Privacy and HIPAA in Research; SOP-905), decided with the Privacy Officer and counsel
  • professional liability and general liability insurance, and who covers the person for work at the member site
  • credentialing, background checks and debarment and exclusion screening (SOP-103, section 5.2.3)
  • access to training and qualification records for monitors, auditors and inspectors
  • cooperation with audits and inspections, and record ownership (records created stay with the member site)
  • fees, which are set at fair market value for the services actually provided and reviewed by counsel (SOP-104; SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets)
5.6.5
The agreement reference is recorded on F-904-01 and the agreement is listed on F-105-01 Service Provider Qualification and Oversight Record.

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 the investigator activities it performs (ICH E6(R3) Annex 1, 2.3.1 and 2.3.4). This applies in N-Integrated networks too, because the PI remains responsible for the delegated activity. The Network Quality Lead records each central service on F-105-01 as an investigator-engaged service provider, with its risk level under SOP-105, section 5.2.
5.7.2
The terms of each central service are documented before first use:
  • N-Integrated, for member sites that are the same legal entity as the network entity: an internal service description approved by the Network Executive and filed with F-105-01, stating scope, responsibilities, service levels, records created and where they are kept, and how problems are reported to the PI
  • N-Affiliated, and any member site that is a separate legal entity (SOP-900 5.2.1): a written services agreement meeting SOP-105, section 5.4, with a BAA or other HIPAA pathway where PHI is involved (SOP-905)
5.7.3
The PI of each study confirms, before first use for that study, which central services the study uses. The Regulatory Coordinator records this in the ISF. Central service staff who perform any protocol-specific task are on the site delegation log, F-302-01 (5.3). A service log approved under SOP-105 is used only for tasks that are not protocol-specific.
5.7.4
Oversight follows SOP-105, section 5.6. The Network Quality Lead reports service performance and issues to each PI using the service at least [DEFAULT: quarterly], and immediately for issues affecting participant safety or data reliability.

5.8 Requirements for specific central services

5.8.1
Central regulatory. The Network Regulatory Lead prepares and submits IRB and sponsor documents for member sites as Appendix B assigns. The PI signs investigator documents personally. The original or certified copy of each document is filed in the member site's ISF or its section of the central eISF (SOP-204; SOP-905).
5.8.2
Central recruitment or call center. Pre-screening follows SOP-300 Participant Recruitment, Pre-Screening and Advertising, using IRB-approved scripts for each study and member site. Call center staff record pre-screening on F-300-01 Pre-Screening Log or the shared database, with the member site the candidate is referred to. The HIPAA pathway for use of patient records and for passing candidate details to a member site is set before calls begin (SOP-905, section 5.4).
5.8.3
Central IP or pharmacy services. IP is received, stored, prepared and dispensed as SOP-304 Investigational Product Management sets out. Moving IP between member sites or from a central pharmacy to a member site is done only when the sponsor approves it in writing (SOP-102, section 5.4.3), with temperature control and accountability on F-304-01 at both ends. A central pharmacy that prepares or dispenses IP complies with the pharmacy law of its state and of the state where IP is dispensed, as recorded in Appendix A. Controlled substances are stored and dispensed only at a location covered by a DEA registration (21 CFR 1301.12) and any state registration, and counsel confirms whether a central storage location needs its own registration. Moving controlled-substance IP between locations with different registrations is a distribution between registrants that follows DEA record and order rules (21 CFR 1304; 21 CFR 1305 for Schedule I and II) (SOP-304). A practitioner registered only to dispense may distribute controlled substances to another registered practitioner without a distributor registration only while the total dosage units it distributes in a calendar year stay within 5 percent of all controlled-substance dosage units it distributes and dispenses (21 CFR 1307.11). Where a central pharmacy or storage location would routinely supply member sites, counsel confirms before first use whether a distributor registration is needed.
5.8.4
Central specimen processing or laboratory. Specimen handling and shipping follow SOP-311 Biological Specimen Collection, Processing and Shipping, with IATA and DOT training for staff who package or ship. A central location that performs testing whose results are used for a participant's eligibility, safety or care holds a CLIA certificate covering that location and testing complexity; certificates are issued per location, with limited exceptions (42 CFR 493.35(b), 493.55(b); SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements). For IND studies, a central laboratory facility used for study testing is listed in Section 4 of each relevant 1572.
5.8.5
DOT and IATA shipping training. Each hazmat employer trains its own hazmat employees and keeps the training records (49 CFR 172.702(a); 49 CFR 172.704(d)). N-Affiliated: each legal entity whose staff package or ship specimens or dry ice keeps its own DOT training records; a central training course may be used, but the employing entity certifies and files the record.
5.8.6
Unblinded central staff. A person in an unblinded role for a study (for example a central pharmacist preparing blinded IP) does not take a blinded role in the same study at any member site. F-904-01 records each person's blinding status by study, and the Network Clinical Operations Lead checks it before any cross-site assignment (SOP-305 Randomization, Blinding and Emergency Unblinding).
5.8.7
Central QC. Central QC reviewers follow SOP-700 Internal Quality Control and Quality Assurance Audits and do not QC work they performed themselves.

5.9 Cross-site coverage of key roles

5.9.1
Each member site's F-705-01 Business Continuity Plan and Emergency Contacts names a backup for each key role (SOP-705 Business Continuity and Emergency Preparedness, section 5.7). The Network Clinical Operations Lead keeps a network coverage roster of shared staff who can cover key roles at other member sites, by role, study and state license.
5.9.2
A cross-site backup can cover only after the steps in 5.3 to 5.5 are complete for that study and investigator site. The Network Clinical Operations Lead identifies backups for each enrolling study in advance so that delegation, training and licensure are in place before they are needed.
5.9.3
PI coverage: a covering investigator must be a Sub-I listed for the study at that investigator site (SOP-705, section 5.7.2). An investigator from another member site may cover only after being listed for the study at that site (5.5.1 and 5.5.2), accepted by the IRB where its policy requires (SOP-203), delegated by the PI on F-302-01, licensed in the state, and trained on the protocol. If no qualified investigator can cover, the PI and Site Director pause procedures that need investigator involvement and tell the sponsor.
5.9.4
A shared after-hours or on-call phone line that participants at several member sites may call routes each call to an investigator listed for the participant's investigator site and study. The Network Clinical Operations Lead keeps the routing list current with each site's on-call roster and checks it at least [DEFAULT: monthly].
5.9.5
A temporary substitute for research staff with an occasional role does not need to be listed in Section 6 of the 1572 (Form FDA 1572 FAQs, question 32), but is still delegated and trained under 5.3 before performing any study task.
5.9.6
The Site Director records each cross-site coverage period (who, role, studies, dates) on F-306-01 Note to File in the ISF, and the Network Clinical Operations Lead records it on F-904-01.

5.10 F-904-01 and periodic review

5.10.1
The Network Clinical Operations Lead keeps F-904-01 current for every shared person and central service staff member, with:
  • name, role and home site (employing entity)
  • member sites and studies assigned, with start and end dates
  • delegation log entries by study and investigator site, with PI signature date
  • 1572 or investigator agreement listing, where applicable
  • licenses and certifications by state, with expiry dates and verification date (the licensure-by-state register)
  • debarment, disqualification and exclusion screen date and result
  • blinded or unblinded status by study
  • local addendum and site orientation training dates
  • staffing or services agreement reference (N-Affiliated)
  • system access by site and study (SOP-905)
5.10.2
The Network Quality Lead reconciles F-904-01 against each member site's delegation logs, training logs and system access lists at least [DEFAULT: quarterly], and records the reconciliation. Gaps are corrected and, where a person worked without delegation, training or license, handled as a deviation under SOP-308 Protocol Deviations and Noncompliance and assessed for CAPA under SOP-703 Corrective and Preventive Action (CAPA).
5.10.3
When a shared person leaves the network, the Network Clinical Operations Lead notifies every member site on their F-904-01 record the same day, and each site ends delegation and access (SOP-102, section 5.7; SOP-302, section 5.6).
  • F-904-01 Shared Staff Assignment and Credentialing Log
  • F-302-01 Delegation of Authority Log
  • F-103-01 Staff Training Log
  • F-103-02 Staff Qualification File Checklist
  • F-105-01 Service Provider Qualification and Oversight Record
  • F-300-01 Pre-Screening Log
  • F-304-01 Investigational Product Accountability Log
  • F-306-01 Note to File
  • F-705-01 Business Continuity Plan and Emergency Contacts
  • F-900-01 Local Addendum to a Network SOP
  • Appendix A State Law Worksheet
  • Appendix B Central and Site Responsibility Matrix (SOP-904 rows)
  • SOP-102 Site Organization, Roles and Staff Responsibilities
  • SOP-103 Staff Qualification, Training and Training Records
  • SOP-104 Conflict of Interest and Financial Disclosure
  • SOP-105 Oversight of Service Providers and Vendors
  • SOP-203 IRB Submissions, Approval and Continuing Oversight
  • SOP-204 Essential Documents and the Investigator Site File
  • SOP-300 Participant Recruitment, Pre-Screening and Advertising
  • SOP-302 Delegation of Authority
  • SOP-304 Investigational Product Management
  • SOP-305 Randomization, Blinding and Emergency Unblinding
  • SOP-311 Biological Specimen Collection, Processing and Shipping
  • SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
  • SOP-313 Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP)
  • SOP-400 Participant Privacy and HIPAA in Research
  • SOP-705 Business Continuity and Emergency Preparedness
  • SOP-900 Network Governance, SOP Hierarchy and Local Addenda
  • SOP-905 Network Data, Systems, Privacy and Records Across Sites

7. References

ReferenceTitle
21 CFR 312.53(c)(1)(viii)Investigator statement: names of subinvestigators
21 CFR 312.60General responsibilities of investigators
21 CFR 812.43(c)Investigator agreements (devices)
21 CFR 812.100General responsibilities of investigators (devices)
21 CFR 1301.12Separate registrations for separate locations (controlled substances)
21 CFR 1307.11Distribution by dispenser to another practitioner
21 CFR 1304 and 1305Controlled substance records; order forms for Schedule I and II
49 CFR 172.702 and 172.704Hazmat employee training and training records
42 CFR 493.35(b), 493.55(b)CLIA: separate certificate application for each location, and exceptions
45 CFR 160.103HIPAA definitions (workforce, business associate)
ICH E6(R3) Annex 1, 2.2Resources
ICH E6(R3) Annex 1, 2.3Responsibilities (delegation, oversight, service provider agreements)
FDA Guidance (May 2010; Revision 1 draft, May 2021)Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions, Statement of Investigator (Form FDA 1572)
FDA Guidance (2009)Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects

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.