SOP-302

Delegation of Authority

Number: SOP-302
Category: Study Conduct
Edition: Reference Edition 1.3
Approx. pages: 7

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On this page

1. Purpose
2. Scope
3. Responsibilities
4. Definitions
5. Procedure
6. Related Forms and SOPs
7. References

1. Purpose

This SOP describes how the Principal Investigator (PI) at [SITE NAME] delegates trial-related activities to qualified staff and service providers, documents that delegation, keeps it current, and oversees the people performing delegated activities. The PI may delegate tasks but keeps ultimate responsibility for the conduct of the trial at the site.

2. Scope

This SOP applies to every study at [SITE NAME] and to everyone who performs trial-related activities under the PI's oversight: Sub-Investigators (Sub-Is), coordinators, nurses, pharmacists or IP Managers, regulatory and data staff, and staff of service providers working under the PI's direction (for example home health nurses or a local imaging center performing protocol-specific activities).

Selection and contracting of service providers is in SOP-105. Training requirements are in SOP-103. The PI's overall duties are in SOP-101. Where the protocol, sponsor or IRB requirement is stricter than this SOP, the site follows the stricter requirement.

3. Responsibilities

Role	Responsibilities
Principal Investigator (PI)	Decides which tasks to delegate and to whom. Confirms each person is qualified, trained and licensed for the tasks before signing. Signs and dates each delegation before the person starts. Signs off end dates. Oversees delegated activities in proportion to their risk. Signs Form FDA 1572 or the device investigator agreement.
Sub-Investigator (Sub-I)	Performs delegated investigator tasks, including medical judgment tasks within their licensure. Supervises staff as the PI directs. Does not delegate tasks to others; only the PI delegates.
Regulatory Coordinator	Maintains F-302-01 Delegation of Authority Log for each study. Checks training and licensure records before routing entries to the PI. Updates the 1572 information, IRB records and sponsor notifications when investigators change. Files the log and supporting records in the ISF.
Clinical Research Coordinator (CRC)	Performs only tasks delegated on F-302-01. Checks the log before assigning work to others. Tells the Regulatory Coordinator when staffing changes.
Quality Lead	Checks delegation in internal QC (SOP-700): every task performed in source by someone delegated and trained on the date performed. Opens CAPA for recurring gaps (SOP-703).
Site Director	Assigns staff to studies with enough time and qualifications for the work (ICH E6(R3) Annex 1, 2.2.2). Notifies the Regulatory Coordinator of staff starts, departures and leaves.
All Research Staff	Perform trial-related activities only when delegated on F-302-01 for that study, and only within their training and licensure.

4. Definitions

Term	Definition
Delegation	The PI's documented assignment of specific trial-related activities to a qualified person or party. The PI keeps ultimate responsibility.
Delegation of Authority Log	F-302-01, the study-specific record of the persons to whom the PI has delegated trial-related activities, the activities delegated, and the start and end dates. It may be combined with the signature and initials record (ICH E6(R3) Appendix C).
Investigator	The individual responsible for the conduct of the trial at a site. Where a team conducts the trial, the PI is the responsible leader (21 CFR 312.3; 21 CFR 812.3(i)).
Sub-Investigator (Sub-I)	An individual member of the trial team, designated and supervised by the PI, who performs critical trial-related procedures or makes important trial-related decisions. Listed in Section 6 of Form FDA 1572 for drug and biologic studies.
Form FDA 1572	Statement of Investigator. The investigator's commitment to conduct a drug or biologic study under 21 CFR 312, listing the sites, laboratories, IRB and Sub-Is (21 CFR 312.53(c)).
Investigator agreement	The agreement signed by each investigator in a device study under 21 CFR 812.43(c).
Service provider	A person or organization that performs trial-related activities under an agreement (ICH E6(R3)).

5. Procedure

5.1 Principles

5.1.1

The PI may delegate trial-related activities but keeps ultimate responsibility and must maintain oversight proportionate to the importance of the activity, the data collected, and the risks to participant safety and data reliability (ICH E6(R3) Annex 1, 2.3.1).

5.1.2

Only the PI delegates. A Sub-I or Lead CRC may recommend delegation and may supervise, but the PI signs each entry.

5.1.3

A person may perform a trial-related activity only after the PI has signed and dated the delegation of that activity to them and the person has completed the training for it. Delegation is never recorded retroactively.

5.1.4

Delegation must be consistent with the person's education, training, experience and licensure under state law and the sponsor's and IRB's requirements.

5.1.5

Delegation records are kept in proportion to the significance of the activity (ICH E6(R3) Annex 1, 2.3.3). At [SITE NAME], everyone who performs a protocol-specific activity is on F-302-01. Clinicians who only provide routine clinical care that the protocol does not specifically require (for example an emergency department physician treating an intercurrent illness) are not listed. Where a sponsor expects additional people to be listed, the site follows the sponsor.

5.2 Decide the tasks and who performs them

5.2.1

Before the site initiation visit, the PI and Lead CRC review the protocol and list the trial-related activities, using the sponsor's task codes if the sponsor provides a log, or the site's standard task list in F-302-01 if not.

5.2.2

The PI assigns tasks to people according to their role and qualifications. The following tasks require an investigator (the PI or a Sub-I listed for the study). Other licensed staff may support them (for example by collecting information or preparing a draft assessment) but do not make the decision or sign:

trial-related medical care and medical decisions (ICH E6(R3) Annex 1, 2.7.1(a))
final confirmation of eligibility (SOP-303)
assessment of adverse events for seriousness and causality (SOP-500)
physical examinations and protocol-required clinical assessments that need clinical judgment
prescribing or ordering investigational product and concomitant medications
review and sign-off of clinically significant laboratory and test results
emergency unblinding decisions (SOP-305)

5.2.3

Tasks that require licensure or certification are delegated only to people who hold it and whose license is current, for example: phlebotomy or IV access where the state requires certification, IP preparation and administration by a licensed nurse or pharmacist, imaging by a certified technologist, and shipping of dangerous goods by staff with current DOT and IATA training (SOP-311).

5.2.4

Advanced practice providers (nurse practitioners, physician assistants) may serve as Sub-Is and perform medical judgment tasks only within their state scope of practice, any required physician collaboration, and the sponsor's and IRB's requirements.

5.2.5

Tasks that may be delegated to trained non-licensed staff include, for example, obtaining consent where permitted (SOP-301), pre-screening (SOP-300), scheduling, data entry and query resolution (SOP-307), IP accountability (SOP-304), specimen processing (SOP-311) and regulatory document management.

5.3 Train and qualify before delegation

5.3.1

Before the PI signs a delegation, the Regulatory Coordinator confirms, using F-103-02 and F-103-01, that the person has:

a current CV (signed and dated if the sponsor requires) and, where applicable, current license and certifications
GCP training per SOP-103
training on the SOPs that apply to their tasks
study-specific training on the protocol, the current amendment, and the systems they will use (for example EDC, IRT, eConsent), with the training recorded on F-103-01 or the sponsor's training log
for investigators, financial disclosure completed per SOP-104
a documented exclusion and debarment check per SOP-103 (site practice; many sponsors require it by contract)

5.3.2

Training covers what the person needs to perform the delegated tasks beyond their usual training and experience (ICH E6(R3) Annex 1, 2.3.2).

5.3.3

System access (EDC, IRT, eConsent, eReg) is requested only after the delegation is signed, per SOP-401.

5.4 Complete and sign F-302-01

5.4.1

The Regulatory Coordinator enters for each person on F-302-01:

printed name and study role
signature and initials (unless the site and sponsor use only electronic signatures)
the delegated task codes
start date
end date when delegation ends
PI initials and date for the start and for the end

5.4.2

The PI reviews each entry against the training and licensure records and signs and dates the start before the person performs any delegated task. The start date on the log is not earlier than the PI's signature date.

5.4.3

When a person's tasks change, the PI signs a new line on F-302-01 for the changed tasks, and the old line is given an end date. The new entry is signed before the new task is performed. Tasks are not added by the person themselves or by the Regulatory Coordinator without the PI's signature.

5.4.4

If the sponsor provides a delegation log, the site uses it in place of F-302-01 as long as it contains the content in section 5.4.1.

5.4.5

Electronic delegation logs in an eRegulatory system are used only if the system meets 21 CFR Part 11 for electronic signatures and is qualified per SOP-401.

5.4.6

The original log is filed in the ISF (SOP-204). Superseded pages are kept, not discarded.

5.5.1

Drug and biologic studies: the PI signs Form FDA 1572 before participating and lists in Section 6 the Sub-Is who make a direct and significant contribution to the data. Staff who perform only support tasks are recorded on F-302-01 and do not need to be on the 1572.

5.5.2

The PI signs a new 1572 when a new protocol is added to the IND for the site, or when the PI changes. When other 1572 information changes (for example a new Sub-I, a new laboratory or a new site address), the Regulatory Coordinator records the change in the study file and informs the sponsor so the sponsor can update the IND. A new signed 1572 is not required by FDA for these changes, but many sponsors require one; the site follows the sponsor.

5.5.3

Device studies: each investigator signs the investigator agreement required by 21 CFR 812.43(c). When investigators are added, the Regulatory Coordinator obtains the sponsor's required agreement and sends it before the new investigator performs any task.

5.5.4

The Regulatory Coordinator submits investigator changes to the IRB as [CENTRAL IRB NAME] requires (SOP-203). A change of PI always requires IRB approval and sponsor agreement before it takes effect.

5.5.5

New investigators complete financial disclosure before participating (SOP-104).

5.6 Ending delegation

5.6.1

Delegation ends when the person leaves the site, moves off the study, goes on extended leave, loses a required license or certification, or the study closes.

5.6.2

The Site Director tells the Regulatory Coordinator of a departure or leave before the last working day where possible, and no later than [DEFAULT: 1 business day after it is known].

5.6.3

The Regulatory Coordinator enters the end date, and the PI initials and dates it. The end date is the last date the person performed or was authorized to perform tasks.

5.6.4

The Regulatory Coordinator arranges removal of system access per SOP-401 by the end date, and notifies the sponsor and IRB of investigator departures as required.

5.6.5

At study closeout, end dates are entered for all remaining staff and the PI signs the log (SOP-601).

5.7 PI oversight

5.7.1

The PI oversees delegated work in proportion to its risk. The minimum oversight duties, including review times for results and the documented oversight review of each study at least [DEFAULT: quarterly] and at each monitoring visit, are in SOP-101, sections 5.4.4 and 5.4.5. This SOP does not restate them. Ad-hoc study team meetings do not need minutes.

5.7.2

The PI is reachable by staff during study visits, or names a Sub-I who is. Coverage arrangements for PI absence are recorded in the study file.

5.7.3

When the PI will be unavailable, the coverage note, sponsor and IRB notice thresholds and covering-investigator rules in SOP-101, section 5.13 apply. The PI cannot transfer ultimate responsibility to a Sub-I without a formal PI change (section 5.5.4).

5.7.4

For studies at more than one site location, the PI oversees work at each location listed on the 1572 or in the device study records, either directly or through a Sub-I who works there, and records how in the study file. Within one investigator site, each staff member appears on the study's delegation log once, not once per location; the entry covers every location where that person works on the study.

5.7.5

Oversight of service providers performing trial-related activities follows SOP-105. Service provider staff performing protocol-specific activities under the PI's direction (for example home health nurses) are listed on F-302-01 or on a sponsor-approved log for that provider, per SOP-105.

5.8 Checking and correcting delegation

5.8.1

The Regulatory Coordinator reviews each log for completeness at least [DEFAULT: quarterly, and before each monitoring visit].

5.8.2

The Quality Lead checks in QC (SOP-700) that each task recorded in source and EDC was performed by a person delegated and trained for it on that date.

5.8.3

A task performed by a person who was not delegated or not trained at the time is a protocol deviation (SOP-308) and is reported to the PI. The PI assesses the effect on participant safety and data reliability. The log is then updated with the current date and the PI's current signature. The original gap is not hidden by backdating; it is explained in F-306-01 Note to File where needed.

F-302-01 Delegation of Authority Log
F-103-01 Staff Training Log
F-103-02 Staff Qualification File Checklist
F-104-01 Conflict of Interest and Financial Interest Disclosure
F-306-01 Note to File
F-308-01 Protocol Deviation Log
F-904-01 Shared Staff Assignment and Credentialing Log (Model N only)
SOP-101 Roles and Responsibilities of the Principal Investigator
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-301 Informed Consent Process and Documentation
SOP-303 Screening, Eligibility Verification and Enrollment
SOP-308 Protocol Deviations and Noncompliance
SOP-401 Computerized Systems and Electronic Records
SOP-600 Sponsor Monitoring Visits
SOP-601 Study Closeout
SOP-700 Internal Quality Control and Quality Assurance Audits
SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
Appendix B Central and Site Responsibility Matrix (Model N only)

7. References

Reference	Title
21 CFR 312.53(c)	Selecting investigators: Form FDA 1572 content
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 11	Electronic Records; Electronic Signatures
ICH E6(R3) Annex 1, 2.2	Resources
ICH E6(R3) Annex 1, 2.3	Responsibilities (delegation and oversight)
ICH E6(R3) Annex 1, 2.7.1	Medical Care of Trial Participants
ICH E6(R3) Appendix C	Essential Records (documentation of delegation; signature sheet)
ISO 14155 (current edition)	Clinical investigation of medical devices for human subjects: Good clinical practice
FDA Guidance (2009)	Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects
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)

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