SOP-704

Research Misconduct and Fraud Reporting

Number: SOP-704
Category: Quality Assurance
Edition: Reference Edition 1.3
Approx. pages: 8

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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 [SITE NAME] recognizes, reports, assesses and investigates possible research misconduct and fraud, protects people who report concerns, notifies sponsors, IRBs and FDA where required, and screens staff and service providers against federal debarment, disqualification and exclusion lists.

2. Scope

This SOP applies to all research staff, investigators, contractors and service providers working on studies at [SITE NAME], and to all studies and locations.

It covers:

possible fabrication, falsification or plagiarism in research records and data
research-related fraud (for example, billing for visits that did not occur, enrolling fictitious participants, misusing participant payments)
screening against the FDA Debarment List, the FDA Clinical Investigators Disqualification Proceedings list and the HHS Office of Inspector General (OIG) List of Excluded Individuals/Entities (LEIE)

Honest error and differences of opinion are not misconduct. They are handled under SOP-308 Protocol Deviations and Noncompliance and SOP-703 Corrective and Preventive Action (CAPA).

General workplace complaints, HR matters unrelated to research integrity, and privacy incidents (SOP-400 Participant Privacy and HIPAA in Research) are out of scope unless they also involve research data integrity.

Where a sponsor, IRB, CTA or applicable law sets a stricter requirement, follow it.

3. Responsibilities

Role	Responsibilities
All Research Staff	Report suspected misconduct or fraud promptly. Cooperate with assessments and investigations. Keep the matter confidential. Never retaliate against a person who reports in good faith.
Quality Lead	Receives reports, performs the initial assessment, secures evidence, leads or coordinates the investigation (unless conflicted), keeps F-704-01 and runs debarment and exclusion screening.
Site Director	Co-leads investigations, decides on interim personnel measures, engages [LEGAL COUNSEL] and external investigators, approves notifications to outside parties, and enforces non-retaliation.
Principal Investigator (PI)	Protects participant safety, reports to the sponsor and IRB as required, and supports the investigation unless the PI is implicated.
Regulatory Coordinator	Sends notifications to sponsors and IRBs as directed and files correspondence.
[OWNER OR GOVERNING BODY CONTACT]	Receives reports that involve the Site Director or Quality Lead, and appoints an independent investigator. At an owner-operated site, this is the independent reviewer named under SOP-102 5.3 (5.2.1.1).

4. Definitions

Term	Definition
Research misconduct	Fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results. It does not include honest error or differences of opinion (based on 42 CFR 93).
Fabrication	Making up data or results and recording or reporting them.
Falsification	Manipulating research materials, equipment or processes, or changing or omitting data or results, so that the research is not accurately represented in the research record.
Fraud	Intentional deception for gain, including false claims for payment and false statements to a sponsor, IRB or government agency.
Integrity concern	Any report or observation that suggests possible misconduct or fraud, recorded on F-704-01 Integrity Concern Report.
Good faith	Having a reasonable belief in the truth of the report, based on the information known at the time.
Retaliation	Any adverse action against a person because they reported a concern in good faith or cooperated with an investigation.
Debarment	An FDA action under section 306 of the FD&C Act prohibiting a person from providing services in any capacity to a person with an approved or pending drug product application.
Disqualification	An FDA action making a clinical investigator ineligible to receive investigational products (21 CFR 312.70; 21 CFR 812.119).
Exclusion	An HHS OIG action barring an individual or entity from participation in federal health care programs. Items and services they furnish cannot be paid by those programs.

5. Procedure

5.1 Recognizing possible misconduct or fraud

5.1.1

Staff report concerns based on what they observe, not on proof. Warning signs include:

Implausible data: values that are too perfect or identical across visits or participants; vital signs or lab values that never vary; diaries or ePRO entries completed in batches or at implausible times; data that do not match the participant's medical history.
Phantom participants: participants nobody remembers seeing; no EHR record, insurance or identity record outside the study; contact details that are invalid or shared between participants; visits recorded when the participant or staff member was elsewhere.
Duplicate or professional participants: a participant enrolled in more than one study at once at this or another site; inconsistent medical histories across screenings; participants who appear across many studies and sites. Use any participant registry the sponsor requires, and check the participant's history at screening (SOP-303 Screening, Eligibility Verification and Enrollment).
Altered or recreated records: source documents created after the fact and dated as if contemporaneous; correction fluid or overwriting; signatures that look different from the person's usual signature; the same handwriting in fields that should be completed by different people; EDC audit trails showing changes without source support.
Consent problems: consent signatures dated before the form was IRB-approved, or signatures that appear copied.
Specimen and IP problems: specimens that may come from a different person; IP counts that do not reconcile; returned IP that looks untouched while the participant reports dosing.
Financial irregularities: participant payments to people who did not attend visits; invoices to sponsors or insurers for procedures not performed (SOP-202 Medicare Coverage Analysis and Research Billing Compliance; SOP-310 Participant Payments and Reimbursement).
Pressure: any instruction to change data, backdate records or hide information from a monitor, auditor, IRB or FDA.

5.1.2

QC reviewers, monitors and auditors who notice these signs follow section 5.2 and do not discuss the concern with the person involved.

5.2 Reporting a concern

5.2.1

Any staff member with a concern reports it promptly, and within [DEFAULT: 1 business day of becoming aware], through any of these routes:

the Quality Lead
the Site Director
the PI, if the PI is not involved
[OWNER OR GOVERNING BODY CONTACT], if the Site Director or Quality Lead is involved
the anonymous route: [ANONYMOUS REPORTING CHANNEL]

5.2.1.1

Owner-operated sites. Where the owner, PI and Site Director are the same person, a concern that involves that person goes to the independent reviewer named under SOP-102 5.3 (who is not employed by and does not report to that person), or directly to the IRB, the sponsor or FDA (5.2.2). At such a site the independent reviewer acts as [OWNER OR GOVERNING BODY CONTACT] in 5.2.3 and 5.5.2, receives reports from the anonymous route directly, and, where the Site Director is implicated, makes the decision on reporting to FDA in 5.6.3 with [LEGAL COUNSEL]. Section 5.3 protects anyone who uses these routes from retaliation.

5.2.2

Staff may also report directly to the IRB, the sponsor, or FDA at any time. FDA lists contacts for complaints about FDA-regulated clinical trials by product type on its page Reporting Complaints Related to FDA-Regulated Clinical Trials. This SOP does not require staff to report internally first.

5.2.3

The person receiving the report records it on the report section of F-704-01 Integrity Concern Report (date, reporter unless anonymous, description, studies and records involved, people involved) and passes it to the Quality Lead the same business day, or to [OWNER OR GOVERNING BODY CONTACT] if the Quality Lead is involved.

5.2.4

Instructions to falsify or conceal are reported even if the staff member did not comply. Staff must not carry out an instruction to create, alter, backdate or destroy records.

5.3 Non-retaliation and confidentiality

5.3.1

[SITE NAME] does not retaliate against anyone who reports a concern in good faith or cooperates with an investigation, even if the concern is not confirmed. Retaliation is itself a serious violation of this SOP and is handled as an integrity concern.

5.3.2

The identity of the reporter and of the person the concern is about is shared only with people who need it to assess, investigate or report the matter, or as required by law.

5.3.3

Reports known to be false and made in bad faith are handled through HR.

5.3.4

The Site Director confirms with [LEGAL COUNSEL] that the site's employment policies and any applicable state whistleblower law are consistent with this section.

5.4 Initial assessment and evidence protection

5.4.1

Within [DEFAULT: 2 business days of receipt], the Quality Lead (or independent person under section 5.5.2) and the Site Director:

decide whether the concern, if true, would be misconduct or fraud, or is a deviation or quality matter to route to SOP-308 or SOP-703
identify immediate risks to participant safety and inform the PI (or a non-implicated investigator) to act on them
record the assessment and decision in the Quality Lead section of F-704-01

5.4.2

If the concern may be misconduct or fraud, the Quality Lead secures evidence before anyone involved is told, where possible:

takes custody of, or makes certified copies of, paper records involved
asks system owners and sponsors to preserve EDC, eConsent, IxRS and EHR audit trails
preserves email and file access logs
restricts or monitors the system access of the person involved, as approved by the Site Director
records each item secured, with date and custodian, on F-704-01

5.4.3

Original records are never altered or removed from the study file permanently. Certified copies are made when records must be preserved and the study must continue.

5.4.4

The Site Director decides on interim measures, which may include removing the person involved from study tasks (update F-302-01 Delegation of Authority Log under SOP-302) and pausing enrollment in affected studies with the PI's agreement.

5.5 Investigation

5.5.1

The Quality Lead and the Site Director lead the investigation, with [LEGAL COUNSEL] where the Site Director decides. The investigation should be completed within [DEFAULT: 60 calendar days of the initial assessment], with any extension and reason recorded on F-704-01.

5.5.2

No one implicated in a concern, or with a close personal or financial relationship to someone implicated, takes part in the investigation. If the PI, Site Director or Quality Lead is implicated, [OWNER OR GOVERNING BODY CONTACT] appoints an independent internal or external investigator.

Network note: In Model N, the Network Quality Lead may lead or support an investigation at a member site. N-Integrated: the investigation runs as described in this section, and network leadership may act for the employer. 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). The Site Director decides on direct reporting to FDA under 5.6.3 with [LEGAL COUNSEL] and the PI, with the Network Executive consulted; no one is prevented from reporting to FDA directly (5.2.2). N-Affiliated: the Network Office investigates a member site only as the network agreement allows (access to records, systems and staff interviews); personnel action, licensing board reports and the notifications in 5.6 remain the site entity's decisions. Concerns that span sites (for example the same person enrolled at two network sites) are coordinated by the Network Office, and identifiers are compared only under a permitted pathway (SOP-905).

5.5.3

The investigation may include:

comparison of source, EHR, CRF data, audit trails and appointment, billing, payment and facility access records
verification that participants exist and attended visits (for example, EHR records, identity documents at screening, independent contact with participants by a non-implicated staff member using contact details from the EHR rather than the study file)
signature and handwriting comparison with known samples
interviews with the reporter, witnesses and the person involved, who is given the opportunity to respond to the concern
a check of the person's other studies for the same pattern

5.5.4

Interviews are documented and the interviewee is offered a chance to review their statement.

5.5.5

The investigators record their findings, the evidence, the person's response and their conclusion in an investigation record attached to F-704-01, and enter the conclusion in the Quality Lead section. The conclusion is one of:

not substantiated
substantiated: honest error or noncompliance (route to SOP-308 and SOP-703)
substantiated: misconduct or fraud

5.5.6

The Site Director decides personnel action with HR and [LEGAL COUNSEL]. Where a licensed professional is involved, the Site Director considers whether a report to the state licensing board is required by state law.

5.6 Notifications

5.6.1

Sponsor. The PI (or, if implicated, the Site Director) notifies the sponsor of each affected study when an integrity concern passes initial assessment as possible misconduct or fraud, within the CTA timeline or [DEFAULT: 5 business days] if none, and again with the outcome. The sponsor decides how affected data are handled and may report to FDA. The site does not delete or exclude data on its own. Affected data are corrected or annotated only as the sponsor directs and under SOP-306.

5.6.2

IRB. The PI reports to the IRB under the IRB's policy. Substantiated misconduct is usually serious or continuing noncompliance, which the IRB must have procedures to report to FDA (21 CFR 56.108(b)). Report also if participants' rights, safety or welfare may have been affected.

5.6.3

FDA. The Site Director, with [LEGAL COUNSEL] and the PI, decides whether the site will report directly to FDA, using the contact for the relevant FDA center listed on FDA's page Reporting Complaints Related to FDA-Regulated Clinical Trials. Direct reporting should be considered when data submitted or to be submitted to FDA may be false, when participant safety was put at risk, or when a sponsor does not act. The site reports to FDA where any regulation, CTA or FDA request requires it.

5.6.4

Federally funded research. If any affected research was funded by the Public Health Service (for example, NIH), the site follows 42 CFR 93 (revised rule effective January 1, 2026) and the funding institution's research misconduct procedures, and contacts the prime awardee immediately. Most industry-sponsored studies at the site are not subject to 42 CFR 93.

5.6.5

Payers and law enforcement. Where fraud may involve federal health care program billing, the Site Director consults [LEGAL COUNSEL] about repayment and disclosure obligations, including the HHS OIG Self-Disclosure Protocol.

5.6.6

The Regulatory Coordinator files copies of notifications and responses with F-704-01. The Quality Lead reports the number and type of integrity concerns, without identifying reporters, at management review (SOP-700).

5.7 Screening for debarment, disqualification and exclusion

5.7.1

The Quality Lead (or delegate in HR) screens each person against the lists below:

before hire or engagement, for all research staff, investigators and contractors performing study tasks
before a new investigator is added to a study (Form FDA 1572 or device investigator agreement)
at least [DEFAULT: annually] for all current staff and investigators

5.7.2

The lists are:

FDA Debarment List (drug product applications)
FDA Clinical Investigators: Disqualification Proceedings list
HHS OIG List of Excluded Individuals/Entities (LEIE)

5.7.3

The Finance / Contracts Lead screens service providers and their key personnel against the same lists before engagement and at least [DEFAULT: annually], as part of SOP-105 Oversight of Service Providers and Vendors, and records the result on F-105-01 Service Provider Qualification and Oversight Record.

5.7.4

Each screen is recorded with the date, lists searched, name searched, result and the screener's initials. Staff results are filed in the staff qualification file and tracked on F-103-02 Staff Qualification File Checklist. A dated printout or screenshot of each search result is kept.

5.7.5

If a search returns a possible match:

the screener verifies identity using other identifiers (for example, date of birth, address, license number) before concluding
a confirmed match is reported the same day to the Site Director and Quality Lead
the person does not perform study tasks, or any services subject to the action, until resolved
the Site Director, with [LEGAL COUNSEL], decides next steps and notifies affected sponsors and IRBs as required by the CTA and IRB policy

5.7.6

Staff and investigators must tell the Site Director immediately if they become subject to any FDA, OIG, licensing board or other government action, investigation or proposed action relating to research or health care.

F-704-01 Integrity Concern Report
F-103-02 Staff Qualification File Checklist
F-105-01 Service Provider Qualification and Oversight Record
F-302-01 Delegation of Authority Log
SOP-103 Staff Qualification, Training and Training Records
SOP-105 Oversight of Service Providers and Vendors
SOP-202 Medicare Coverage Analysis and Research Billing Compliance
SOP-302 Delegation of Authority
SOP-303 Screening, Eligibility Verification and Enrollment
SOP-306 Source Documentation and Data Integrity (ALCOA+)
SOP-308 Protocol Deviations and Noncompliance
SOP-310 Participant Payments and Reimbursement
SOP-400 Participant Privacy and HIPAA in Research
SOP-700 Internal Quality Control and Quality Assurance Audits
SOP-703 Corrective and Preventive Action (CAPA)
F-904-01 Shared Staff Assignment and Credentialing Log (Model N only)
SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
SOP-905 Network Data, Systems, Privacy and Records Across Sites (Model N only)
Appendix B Central and Site Responsibility Matrix (Model N only)

7. References

Reference	Title
FD&C Act section 306 (21 U.S.C. 335a)	Debarment, temporary denial of approval, and suspension
21 CFR 312.70	Disqualification of a clinical investigator
21 CFR 812.119	Disqualification of a clinical investigator (devices)
21 CFR 56.108(b)	IRB functions and operations: reporting of serious or continuing noncompliance
42 CFR 93	Public Health Service Policies on Research Misconduct (revised rule effective January 1, 2026; applies to PHS-funded research)
Social Security Act section 1128 (42 U.S.C. 1320a-7)	Exclusion of certain individuals and entities from participation in federal health care programs
18 U.S.C. 1001	Statements or entries generally (false statements to the federal government)
FDA webpage	Reporting Complaints Related to FDA-Regulated Clinical Trials
FDA webpage	FDA Debarment List (Drug Product Applications)
FDA webpage	Clinical Investigators: Disqualification Proceedings
HHS OIG	List of Excluded Individuals/Entities (LEIE)
ICH E6(R3) Principle 9	Clinical trials should generate reliable results
ICH E6(R3) Annex 1, 2.12	Records
FDA Compliance Program 7348.811	Bioresearch Monitoring: Clinical Investigators and Sponsor-Investigators

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.