Reporting Research Payments: Distinguishing Clinical Trials from General Support (42 CFR § 403.904(c))

For small practices, research dollars can flow in many forms, per-patient payments, start-up fees, data abstraction support, or unrestricted “departmental” funds. Under the Physician Payments Sunshine Act (PPSA), manufacturers must publicly report many such transfers, and 42 CFR 403.904(c) dictates the data elements that separate research from general support. Clinical trials, “clinical investigations”, trigger additional data, such as study identifiers, that do not apply to routine general payments.

Getting the classification right matters. True research requires a protocol-anchored relationship and must be reported with the specific research data set. By contrast, general support (for example, an unrestricted educational donation or office equipment not tied to a study) is recorded under non-research categories, if reportable at all. A lean tracking system aligned to 403.904(c) lets small practices show why a payment is (or is not) research, speeds corrections during CMS’s dispute window, and reduces reputational risk.

Patients, payers, and journalists routinely consult CMS Open Payments to understand financial ties between industry and clinicians. For community-based practices that conduct clinical research, the most frequent source of confusion is whether incoming funds constitute research for Open Payments purposes, and if so, whether they are clinical trials or other research. The determinant is not the sponsor’s label on an invoice; it is whether the transfer meets the regulatory definition and data requirements of 42 CFR 403.904(c), supported by terms in 403.902.

This article provides a clinic-ready framework to classify each transfer correctly, collect only the evidence that matters, and guide quick fixes when a manufacturer miscoded a payment. The goal: keep your public profile accurate while minimizing administrative load.

Legal Framework & Scope Under 42 CFR 403.904(c)

What 403.904(c) requires. Section 403.904(c) lists the data elements that manufacturers must include with each payment or other transfer of value. For research payments, those elements go beyond the general fields (e.g., recipient, amount, date, nature) and include research-specific items such as:

• The name of the research study or protocol.

• The context of the research (e.g., clinical investigation vs other research).

• Principal investigator(s) and associated covered recipients.

• Entity paid if different from the covered recipient (for example, your clinic or a research site organization).

• Related product(s) if applicable.

• Clinical trial identifiers when available (e.g., a ClinicalTrials.gov number) for clinical investigations.

Definitions you must know (403.902). The definitions section clarifies terms that drive classification:

• “Payment or other transfer of value”: Any transfer from an applicable manufacturer to a covered recipient, with certain exclusions.

• “Research”: Generally involves a written research agreement or protocol and funding to support a study with scientific objectives, often accompanied by IRB oversight or similar governance.

• “Clinical investigation”: A subset of research involving human subjects to evaluate a product’s safety or effectiveness, commonly the studies that merit a trial identifier.

Clinical trials vs general support. If the payment is tied to a specific research protocol with identifiable PIs and a study design, it should be treated as research and reported with the research data fields in 403.904(c). If a transfer is not tied to a protocol and lacks a written research agreement, it falls outside the research reporting framework and is generally handled as non-research support (if reportable at all) under the separate natures of payment.

Why this matters for clinics. Although manufacturers bear the reporting duty, your practice’s documentation becomes the evidence manufacturers use to classify payments. Mapping your records to the 403.904(c) data set improves accuracy and provides leverage if public data are wrong.

Wrap-up: The legal signal for research is the presence of a protocol and research agreement, plus the ability to populate 403.904(c)’s extra data fields. If you cannot support those fields, the transfer likely belongs in general support categories, not in research.

Program oversight. CMS administers Open Payments and publishes the data. Manufacturers are responsible for accurate submissions, but clinicians and their organizations can review and dispute entries before publication using CMS processes.

Common triggers for clinic involvement:

• A manufacturer reports an unrestricted “educational” grant as research without a protocol in place.

• A true clinical trial payment appears in general categories, omitting required research fields like PI or trial identifier.

• A research payment routed through the clinic’s entity is posted under the wrong physician or misses the PI attribution.

Your leverage point: Evidence that lines up with 403.904(c), the study name, protocol ID, PI list, research site entity, and product identifiers, will usually resolve misclassifications quickly during the review window.

These controls are deliberately lean and tied to the regulation. Each item explains how to implement it, what evidence to retain, a low-cost method, and the relevant authority.

Control 1, classify every incoming dollar with the “protocol test.”

 How to implement: Ask two questions for any vendor-funded payment: (1) Do we have a written research agreement? (2) Do we have a protocol or study plan? If both are “yes,” treat as research; if not, treat as general support.

 Evidence to retain: Executed agreement, protocol synopsis, IRB acknowledgment if available.

 Low-cost method: Add a “research vs support” column to your tracker with a two-checkbox logic.

 Authority: 42 CFR 403.904(c) (research data elements), 42 CFR 403.902 (definitions).

Control 2, Mirror the 403.904(c) research fields in your tracker.

 How to implement: Build columns for: study name; context (clinical investigation vs other research); entity paid; PI(s) and NPI(s); covered recipients linked to the project; related product; payment amount/date; trial identifier (if available); site location.

 Evidence to retain: Contract data sheet, sponsor payment remittances, PI roster.

 Low-cost method: A protected spreadsheet template shared with the research coordinator and compliance lead.

 Authority: 42 CFR 403.904(c).

Control 3, Separate “entity paid” from “covered recipient attribution.”

 How to implement: When the sponsor pays the clinic (entity) for a study, record (a) the entity paid (your practice) and (b) the covered recipients (e.g., PI physicians) who must be linked for reporting. This ensures the manufacturer can attribute the payment properly.

 Evidence to retain: Sponsor remittance to entity, PI designation letter, study team list.

 Low-cost method: A one-page “PI linkage” form signed at study start.

 Authority: 42 CFR 403.904(c) (entity paid vs covered recipient fields).

Control 4, Prepare the NCT (or equivalent) early for clinical investigations.

 How to implement: If the study will have a ClinicalTrials.gov identifier, capture it as soon as available. If pending, note “identifier pending” and calendar a follow-up, so the manufacturer receives the number in time to file.

 Evidence to retain: Trial registry acknowledgment, sponsor email listing the identifier.

 Low-cost method: A “study identifiers” tab in your tracker with reminders.

 Authority: 42 CFR 403.904(c) (study identifiers for clinical investigations).

Control 5, Disaggregate PI and non-PI compensation streams.

 How to implement: Record separate line items for (a) per-patient payments, (b) start-up/regulatory fees, (c) PI consulting if outside the research budget, and (d) pass-through subject stipends. Each has distinct reporting implications.

 Evidence to retain: Budget schedule, subject stipend policy, PI consulting agreement.

 Low-cost method: Use subcategories in your tracker that map to the manufacturer’s reporting categories.

 Authority: 42 CFR 403.904(c) (granularity of research data elements).

Control 6, Guardrails for “general support.”

 How to implement: If funds are unrestricted (e.g., “departmental educational grant”) and there is no protocol, classify as general support. Capture the nature of payment used by the manufacturer (e.g., education, equipment) and confirm whether a covered recipient is identifiable. If yes, expect general-payment reporting; if no, it may be outside reportable scope.

 Evidence to retain: Sponsor letter stating purpose and restrictions (or lack thereof).

 Low-cost method: A simple letter template requesting clarity on restriction and intended use.

 Authority: 42 CFR 403.904(c) (data elements for all payments); 42 CFR 403.902 (definitions).

Control 7, “Who benefited?” reconciliation before year-end.

 How to implement: Each quarter, reconcile whether any general support turned into protocol-tied work (for example, funds initially unrestricted but later assigned to a study). If so, reclassify and furnish research fields to the sponsor.

 Evidence to retain: Journal entries and internal memos showing reallocation.

 Low-cost method: A quarterly 20-minute review with research staff.

 Authority: 42 CFR 403.904(c) (accurate research data at submission).

Control 8, Dispute kit keyed to missing or incorrect 403.904(c) fields.

 How to implement: If a manufacturer files a research payment without required research fields, or mislabels general support as research, submit a dispute citing the exact 403.904(c) element(s) that are incomplete or inapplicable.

 Evidence to retain: Protocol and agreement (for research), or sponsor letter showing no protocol (for general support).

 Low-cost method: A one-page dispute template with checkboxes for each research field.

 Authority: 42 CFR 403.904(c); dispute procedures appear in CMS program materials.

Wrap-up: Aligning your internal records to 403.904(c) transforms classification from guesswork into a structured, evidence-based decision any small clinic can manage.

Case Study

Scenario: A community oncology practice receives $50,000 labeled “data infrastructure support.” No protocol is attached at the time of payment. Six months later, the same sponsor opens a Phase IV outcomes study at the clinic with a detailed budget and assigns $30,000 of the prior support to that protocol. The manufacturer files the full $50,000 as research in Open Payments and lists the medical director as PI.

Analysis under 42 CFR 403.904(c):

• The initial $50,000 lacked a written research agreement and protocol, so at the time of transfer it was general support, not research.

• Once $30,000 was formally assigned to the outcomes study with a protocol and PI, that portion meets the research criteria and must include research data elements (study name, PI, entity paid, related product, and, if applicable, trial identifiers).

• The remaining $20,000 remains general support. Reporting all $50,000 as research overstates the research component and misleads the public profile.

Resolution: The clinic provides (1) the later protocol and budget addendum linking $30,000 to the study and (2) the sponsor’s original unrestricted-support letter for the remaining $20,000. The manufacturer corrects the report: $30,000 properly listed as research with full 403.904(c) fields; $20,000 recorded as general payment (education/other), or removed if not reportable under the applicable categories.

Takeaway: Tie dollars to protocols when they exist, and only then classify as research. Use 403.904(c) fields as your checklist.

Wrap-up: These six tasks keep your files aligned to the letter of 403.904(c), minimizing misclassifications and accelerating dispute resolution.

Risk Traps & Fixes Under 42 CFR 403.904(c)

The traps below arise when clinics do not map their documentation to the rule’s research data elements. Each item includes the error, the authority, and the consequence.

• Calling unrestricted “education” money research without a protocol. Fix: Require a written research agreement and protocol before classifying as research; otherwise record as general support. Authority: 403.904(c), 403.902. Consequence: Overstated research profile and potential public confusion.

• Omitting PI attribution when the entity is paid. Fix: Record entity paid and linked PIs in your tracker, so the manufacturer can attribute correctly. Authority: 403.904(c). Consequence: Mis attribution to the wrong clinician or none at all.

• Missing trial identifier for clinical investigations. Fix: Track the identifier early and update the sponsor when available. Authority: 403.904(c). Consequence: Incomplete research record and avoidable disputes.

• Bundling pass-through stipends with PI compensation. Fix: Separate subject stipends, PI fees, and site costs as distinct lines. Authority: 403.904(c). Consequence: Inaccurate nature/context reporting.

• Reclassifying mid-year funds without updating records. Fix: When unrestricted dollars are allocated to a protocol, update the tracker and notify the sponsor. Authority: 403.904(c). Consequence: Wrong totals in the public file.

• Treating registry participation payments as research absent a protocol. Fix: Verify there is a study plan and data collection protocol; otherwise handle as general support. Authority: 403.904(c), 403.902. Consequence: Misclassification and credibility issues.

Wrap-up: Each fix points straight back to a missing or misapplied 403.904(c) field. Use the fields themselves as your internal guardrails.

Assign a single owner for the research-payments tracker, often the research coordinator or compliance lead, with the authority to request missing details from sponsors. Designate a backup to maintain continuity. Train staff with a 10-minute primer: “protocol + agreement = research; otherwise, general support.” Keep two KPIs visible: (1) % of research lines with all 403.904(c) fields complete, and (2) % of clinical trials with trial identifiers recorded before manufacturer filing deadlines.

Bake the classification into intake: no funds are posted to the research cost center until the two “protocol test” checkboxes are satisfied or the transfer is logged as general support with a sponsor letter. Prior to CMS’s review window, run a 30-minute huddle to confirm that each reported research payment from sponsors is traceable to your tracker with matching fields.

The PPSA’s research reporting is not a matter of labels but of data integrity. If a transfer is truly research, 42 CFR 403.904(c) expects a complete package of fields, study name, context, PIs, entity paid, product link, and trial identifiers where applicable. If those fields cannot be supported, the transfer belongs in general support categories, if reportable at all. A small clinic can manage this with a single spreadsheet and disciplined evidence capture.

Immediate next steps for a small clinic

1. Stand up the 403.904(c) mirrored tracker today and migrate any open studies into it.

2. Implement the protocol test at intake: no protocol + no research agreement = general support.

3. Create a PI linkage form so entity-paid research can be correctly attributed to covered recipients.

4. Add a trial-identifier column and a calendar reminder to update sponsors as soon as numbers are assigned.

5. Prepare a one-page dispute template keyed to missing/incorrect 403.904(c) fields for the next CMS review window.

• 42 CFR 403.904, Reports of payments or other transfers of value

• 42 CFR 403.902, Definitions

• 42 U.S.C. 1320a-7h, Transparency reports and reporting of physician ownership or investment interests

• CMS Open Payments, Research Payments and Clinical Investigations Guidance