SOP-02
Roles, PI Oversight, Delegation and Conflicts of Interest
- Number
- SOP-02
- Category
- Core
- Edition
- Lean Edition 2.0
- Approx. pages
- 7
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This SOP describes how [SITE NAME] records its organization and roles, keeps needed independence when one person holds several roles, brings staff on and off the research team, how the Principal Investigator (PI) accepts a study, delegates and oversees trial-related activities, and how investigators and staff disclose and manage financial and other conflicts of interest.
2. Scope
This SOP applies to every PI and Sub-Investigator (Sub-I), all research staff, contractors and service-provider staff working under the PI's direction, and the site's owners and directors, at every [SITE NAME] location, for drug and biologic studies (21 CFR 312), device studies (21 CFR 812) and studies subject only to 21 CFR 50 and 56. Duties of a PI who also holds the IND or IDE are in SOP-M6, if adopted.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Holds overall responsibility for study conduct, participant rights, safety and well-being, and data reliability at the site. Personally conducts or supervises the study. Delegates only to qualified, trained people and oversees them. Signs the Form FDA 1572 or investigator agreement. Provides financial disclosure. |
| Sub-Investigator (Sub-I) | Performs significant trial procedures or makes important trial decisions as delegated. Covers for the PI when named. Does not delegate. |
| Site Director | Owns the organization chart and role assignments. Confirms resources before a study is accepted. Runs onboarding and offboarding. Makes conflict of interest (COI) determinations with the Quality Lead. |
| Quality Lead | Reviews combined roles against 5.2. Runs the site COI disclosure cycle. Checks delegation and offboarding records in QC (SOP-14). |
| Independent Reviewer | Performs the reviews this library assigns when no independent person exists inside the site (5.2.3). |
| Regulatory Coordinator | Maintains F-302-01, the 1572 or investigator agreement records and sponsor financial disclosure. Notifies the sponsor and IRB of staff changes. Requests and confirms removal of sponsor system access. |
| CRC / Lead CRC | Performs only delegated tasks. Brings safety, eligibility, deviation and data issues to an investigator promptly. Hands over open tasks when a team member leaves. |
| All Research Staff | Work within their delegation, training and licensure. Complete F-104-01 when required. Escalate any participant safety concern to an investigator immediately. |
4. Definitions
| Term | Definition |
|---|---|
| Principal Investigator (PI) | The person responsible for the conduct of the trial at the site; where a team conducts the trial, its responsible leader (ICH E6(R3) Glossary; 21 CFR 312.3; 812.3(i)). |
| Sub-Investigator (Sub-I) | A member of the trial team designated and overseen by the investigator to perform significant trial-related procedures or make important trial-related decisions (ICH E6(R3) Glossary). |
| Delegation | The investigator's documented assignment of trial-related activities to other persons or parties; the investigator keeps overall responsibility (ICH E6(R3) Annex 1, 2.3.1). |
| Form FDA 1572 | Statement of Investigator for IND studies (21 CFR 312.53(c)). |
| Investigator Agreement | The agreement each device investigator signs under 21 CFR 812.43(c). |
| Critical Role | PI, Sub-I, IP Manager, Regulatory Coordinator, or CRC on an active study. |
| Combined Role | One person holding two or more standard roles. |
| Clinical Investigator (21 CFR 54) | A listed or identified investigator or subinvestigator directly involved in treating or evaluating participants, including their spouse and each dependent child (21 CFR 54.2(d)). |
| Disclosable Financial Interests (21 CFR 54) | Compensation affected by the outcome; a significant equity interest (any non-public interest, or more than $50,000 in a public sponsor); a proprietary interest in the product; significant payments of other sorts (more than $25,000 beyond study costs), during the study and for 1 year after (21 CFR 54.2(a) to (f)). |
| Conflict of Interest (COI) | An interest or relationship that could affect, or appear to affect, judgment in conducting or reporting research. Institutional COI is such an interest of [SITE NAME] or its owners. |
5. Procedure
5.1 Organization and roles
5.1.1
The Site Director keeps F-102-01 showing the legal entity, locations, the holder of each standard role, reporting lines, each Location Lead, a named trained backup for each critical role, and each combined role with its controls. The Site Director updates and signs it within [DEFAULT: 10 business days] of any change and keeps superseded versions.
5.1.2
Each role has a role description the holder signs at hire and on change. Only F-302-01 authorizes study tasks.
5.1.3
Before study activity at a location, the Regulatory Coordinator confirms it is on the 1572 or device records, approved or notified to the IRB as its policy requires, approved by the sponsor, and covered by a current CLIA certificate for any testing there (SOP-11). The PI or a Sub-I is on site or immediately reachable when investigator procedures take place, and [DEFAULT: on site for all dosing visits].
5.2 Combined roles and the independent reviewer
5.2.1
The Quality Lead reviews each combined role before it starts. At any size:
- no one QCs or audits their own work, or is sole approver of an SOP they wrote (SOP-01)
- unblinded staff do not perform blinded or causality assessments or share treatment information (SOP-05)
- protocol-required independent raters take no task the protocol says compromises their independence
- an impartial witness for consent is not on that study's team (SOP-04)
- the person who approves participant payments does not reconcile them for the same study (SOP-10)
5.2.2
When the PI is also the Site Director or an owner, business decisions on enrollment targets, study selection or staffing never override medical judgment on eligibility, safety or withdrawal.
5.2.3
Where no second person can meet a limit, or the owner, PI and Site Director are one person, that person's COI, any review, approval or CAPA closure of their own work, and the annual internal audit (SOP-14) go to the independent reviewer. When the owner is a PI, that audit includes a clinician's review of a sample of the owner's eligibility and SAE decisions. The reviewer records each review on the record the relevant SOP names; a missed turnaround is recorded on F-306-01 and counted at the quarterly quality review (SOP-14).
5.3 Onboarding, role changes and offboarding
5.3.1
The Site Director starts F-102-02 by the start date. Before any research task, the person signs the role description and a confidentiality agreement and completes license verification, screening and training (SOP-01). Keys, codes and IP or controlled-substance storage access are issued only as the role requires, recorded on F-102-02.
5.3.2
System Owners grant site system access only after role confirmation and system training; the Regulatory Coordinator requests sponsor system access after delegation. Both are recorded on F-401-01. On a role change, F-102-01, training, access and F-302-01 are updated.
5.3.3
When a person gives notice, the Site Director starts F-102-02 offboarding that day and tells the Regulatory Coordinator. Before the last day, the Lead CRC hands open queries, AE and SAE follow-up, pending signatures, scheduled visits and IP reconciliation to a named person, and the leaver completes their own source entries.
5.3.4
Site access is removed by [DEFAULT: the end of the last working day] (at or before notice for an involuntary departure). The Regulatory Coordinator asks sponsors to revoke access [DEFAULT: the same business day] and follows up until confirmed (ICH E6(R3) Annex 1, 2.12.10(b)), recorded on F-401-01. The Site Director collects keys, changes codes and signs F-102-02.
5.3.5
Agency, per diem and contract staff follow the same steps, under a written agreement covering confidentiality, qualification, training and notice of staff changes (SOP-M1, if adopted).
5.4 Accepting a study and investigator commitments
5.4.1
Before the site commits, the PI reviews the protocol and Investigator's Brochure (IB) or device information and confirms with the Site Director, on F-200-01 (SOP-M2, if adopted) or F-306-01: the PI is qualified and licensed in [STATE] and has time for the study within the PI study limit below; recruitment potential is realistic; and staff, facilities, providers and, where the study has no Sub-I, a covering investigator (SOP-16, 5.6.2) are available. Otherwise the PI declines or the Site Director adds resources.
5.4.2
For IND studies, the PI signs Form FDA 1572 after checking that it lists every study location, laboratory or testing facility, the IRB and each Sub-I making a direct and significant contribution to the data, and that the Section 9 commitments are understood. For device studies, the PI signs the investigator agreement with CV, relevant experience, any terminated research and financial disclosure (21 CFR 812.43(c)).
5.4.3
The PI signs protocol and amendment signature pages and reads the IB before the first consent and each update on receipt.
5.4.4
A new signed 1572 is needed only for a new PI or a new protocol under the IND (FDA 1572 FAQs). For other changes (Sub-I, location, laboratory, IRB), the Regulatory Coordinator sends the sponsor a dated change notice within [DEFAULT: 5 business days] and files it, with the sponsor's acknowledgment, beside the current 1572; an updated 1572 is prepared when the sponsor asks.
5.5 Delegation
5.5.1
Only the PI delegates, only to people qualified by education, training, experience and [STATE] licensure. Before the initiation visit, the PI and Lead CRC list study tasks using sponsor codes or the F-302-01 list.
5.5.2
Only an investigator (PI or a listed Sub-I) decides or signs: medical care and decisions; final eligibility; AE seriousness and causality; clinical examinations needing judgment; IP and concomitant medication orders; sign-off of clinically significant results; emergency unblinding. A nurse practitioner or physician assistant acts as a Sub-I only when listed for the study and within [STATE] scope of practice, and assesses AEs only as the SOP-09 Site decision on licensed roles allows.
5.5.3
Before the PI signs, the Regulatory Coordinator confirms on F-103-01 and F-103-02: current CV and license; GCP; SOP, system and protocol training for the tasks, or a recorded proportionality determination (SOP-01); screening; and, for investigators, financial disclosure (5.8).
5.5.4
F-302-01 records name, role, signature and initials, task codes, start and end dates. The PI signs each entry before the person performs the task; the start date is never earlier than the signature. Changed tasks get a new signed line. Everyone performing a protocol-specific activity is listed; clinicians giving only routine care are not. A sponsor log with this content may replace F-302-01; electronic logs meet SOP-12.
5.5.5
Delegation ends when a person leaves, moves off the study, goes on extended leave, loses a required license or the study closes. The Site Director tells the Regulatory Coordinator within [DEFAULT: 1 business day]; the PI enters and initials the end date.
5.5.6
The Regulatory Coordinator checks each log before every monitoring visit. A task done by someone not delegated or trained at the time is a deviation (SOP-08); the PI assesses it, the log is updated with current dates, and the gap is explained on F-306-01, never backdated.
5.6 PI oversight
5.6.1
The PI oversees delegated work in proportion to risk. At minimum the PI or a delegated Sub-I:
- reviews F-303-02, prepared by the CRC, and signs eligibility for every participant before randomization or first dose (SOP-05)
- assesses each AE for seriousness, severity, expectedness where required and causality (SOP-09)
- signs and dates results with clinical significance noted, within the protocol's timeframe or, where silent, critical values the same day, results the laboratory flags abnormal or relevant to a protocol safety parameter within [DEFAULT: 2 business days], and other results within [DEFAULT: 5 business days] or before the next visit, whichever is first
- reviews external data affecting eligibility or safety when the sponsor provides it, deviations (SOP-08) and monitoring findings (SOP-13)
5.6.2
Critical values are the reporting laboratory's critical list plus protocol alert values. The laboratory or CRC phones them to the investigator, or out of hours the covering investigator (SOP-16), and records the call in source.
5.6.3
The PI documents oversight of each study at least [DEFAULT: quarterly] and at each monitoring visit in a dated note (F-306-01) in the ISF covering enrollment, deviations, AEs and open actions. One meeting may cover several studies with a line per study.
5.6.4
When a delegate or provider underperforms, the PI acts (retraining, supervision or removal), records it, and refers systemic problems for CAPA (SOP-08).
5.6.5
The PI approves each service provider used for investigator activities and oversees it under SOP-M1 (if adopted; otherwise the PI files the approval and certificates in the ISF). For a sponsor-arranged provider, the PI reviews the sponsor's information and decides whether it is appropriate and stays responsible.
5.7 Investigator duty map
5.7.1
The PI keeps responsibility for these duties when tasks are delegated:
- IRB approval before consent or enrollment, IRB reporting, no change without approval except for an immediate hazard (SOP-03)
- consent before any study procedure (SOP-04)
- medical care by a qualified investigator, and informing the primary physician with consent (SOP-09)
- SAEs to the sponsor immediately (21 CFR 312.64(b)); progress and final reports (312.64(a), (c)); device reports (SOP-09, 5.8.2)
- IP only to participants under investigator supervision, with accountability (SOP-06)
- source definition before the study, case histories and data endorsement (SOP-07); privacy and retention (SOP-12)
- access for monitoring, audits and inspections (SOP-13); coverage in absence and PI change (SOP-16)
5.7.2
If the PI ends participation without sponsor agreement, the PI informs the sponsor and IRB within [DEFAULT: 5 business days] with reasons, informs participants and arranges follow-up (ICH E6(R3) Annex 1, 2.6).
5.8 Financial disclosure and conflicts of interest
5.8.1
At start-up, the Regulatory Coordinator sends each PI and Sub-I on the 1572 or device records the sponsor's disclosure form (or F-104-01), with the Finance / Contracts Lead's list of the sponsor's non-study payments to [SITE NAME]. Each investigator checks their records and discloses the Section 4 interests for themself, spouse and dependent children; "none" needs the same check. Where an investigator owns part of the site, the Regulatory Coordinator confirms with the sponsor how site payments are counted and records the answer.
5.8.2
The Regulatory Coordinator checks, sends and files each form; no investigator starts before the sponsor has it.
5.8.3
Investigators report changes within [DEFAULT: 30 calendar days], during the study and for 1 year after completion (21 CFR 54.4(b); 312.64(d); 812.110(d)). The Regulatory Coordinator forwards updates within [DEFAULT: 5 business days], records each 1-year end date, then obtains each investigator's confirmation of no unreported change.
5.8.4
An investigator on the reviewing IRB does not take part in its review of a study in which they have a conflicting interest (21 CFR 56.107(e)).
5.8.5
Research staff, owners and directors complete F-104-01 at hire, with the annual screen (SOP-01), within [DEFAULT: 30 calendar days] of a new interest, and before a study whose sponsor or product they have an interest in. The Site Director discloses on F-104-01 any interest of [SITE NAME], its parent or owners in a sponsor, CRO or product.
5.8.6
Within [DEFAULT: 15 business days], the Quality Lead and Site Director record on F-104-01: no conflict; conflict managed under a plan; or not manageable (the person stays off the study or the site declines it). Where a reviewer, the Site Director or an owner holds the interest, the independent reviewer takes their place.
5.8.7
A management plan names the study, interest and controls (for example IRB and consent disclosure; no consent, eligibility, causality or efficacy assessment by the person; review by an unconflicted investigator; divestment). It is approved by the Site Director or independent reviewer, signed by the person and PI, and checked in QC (SOP-14). An undisclosed conflict or unfollowed plan is noncompliance (SOP-08).
5.8.8
A finder's fee is a payment to a person, other than the site's sponsor-funded study budget, for referring or enrolling a specific individual; finder's fees are prohibited, whoever pays. Sponsor per-participant and milestone payments to the site under the clinical trial agreement are site revenue, not compensation to a person. Staff incentives tied to a specific individual's enrollment are [DEFAULT: prohibited]. Other pay linked to enrollment results is approved in writing by the Site Director (Site decision below).
5.8.9
The Regulatory Coordinator answers IRB COI questions using the IRB's definitions, discloses institutional interests when the IRB form asks, and files the correspondence. For PHS-funded studies, the Quality Lead adds 42 CFR 50 Subpart F requirements before award. The Quality Lead keeps COI records confidential for each related study's retention period (SOP-12).
6. Related Forms and SOPs
- F-102-01 Site Organization Chart and Role Assignment Record
- F-102-02 Staff Onboarding and Offboarding Checklist
- F-103-01 Staff Training Log
- F-103-02 Staff Qualification File Checklist
- F-104-01 Conflict of Interest and Financial Interest Disclosure
- F-302-01 Delegation of Authority Log
- F-303-02 Eligibility Verification Checklist
- F-306-01 Note to File
- F-700-02 Annual Audit Plan and Audit Report
- F-703-01 CAPA Record
- F-200-01 Study Feasibility Assessment (SOP-M2, if adopted)
- F-401-01 Computerized System Inventory and Access Log
- SOP-01 SOP Control, Training and Qualification
- SOP-03 IRB Oversight, Essential Records and Study Activation
- SOP-04 Informed Consent
- SOP-05 Pre-Screening, Screening, Eligibility, Randomization and Blinding
- SOP-06 Investigational Product Management
- SOP-07 Source Documentation and EDC
- SOP-08 Protocol Deviations and CAPA
- SOP-09 Safety Reporting (AEs, SAEs, IRB-Reportable Events, Pregnancy)
- SOP-10 Participant Retention, Withdrawal and Payments
- SOP-11 Specimens, Equipment and Laboratories
- SOP-12 Privacy, Electronic Systems and Record Retention
- SOP-13 Monitoring, Audits and Inspections
- SOP-14 Quality Control and Quality Review
- SOP-16 Business Continuity and PI Coverage
- SOP-M1 Service Providers and Vendors (if adopted)
- SOP-M2 Feasibility, Contracts, Budgets and Research Billing (if adopted)
- SOP-M6 Sponsor-Investigator Studies (IND/IDE Holder) (if adopted)
7. References
| Reference | Title |
|---|---|
| 21 CFR 54 | Financial Disclosure by Clinical Investigators |
| 21 CFR 56.107(e) | IRB members with a conflicting interest |
| 21 CFR 312.53(c); 312.60 to 312.69 | Form FDA 1572; investigator responsibilities |
| 21 CFR 812.43(c); 812.100 to 812.150 | Investigator agreements; device investigator responsibilities, records and reports |
| 42 CFR 50 Subpart F | Promoting Objectivity in Research (PHS-funded) |
| 42 CFR 493 | Laboratory Requirements (CLIA) |
| 45 CFR 164.308(a)(3) | HIPAA Security Rule: workforce security |
| ICH E6(R3) Principles 5 and 10 | Qualified individuals; roles and responsibilities |
| ICH E6(R3) Annex 1, 2.2, 2.3, 2.6, 2.7 and 2.12.10 | Resources; delegation and oversight; termination; medical care; system access |
| FDA Guidance (2009) | Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects |
| FDA Guidance (May 2010; Revision 1 draft, May 2021) | Frequently Asked Questions, Statement of Investigator (Form FDA 1572) |
| FDA Guidance (2013) | Financial Disclosure by Clinical Investigators |
| Reference Edition SOP-101, SOP-102, SOP-302 and SOP-104 | Background and full text |
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.