# SiteVault Solution for Financial Disclosure Forms

Source: https://sites.veevavault.help/gr/sitevault/studies/fdf-workflow/

SiteVault’s Digital Financial Disclosure workflow transforms a historically manual, fragmented process into a centralized, digital standard. By moving away from dozens of unique Sponsor templates toward a single, industry-standard Financial Disclosure Form (FDF), research sites reduce administrative burden, eliminate “wet-ink” errors, and accelerate study start-up.

To print the information on this page, see the [FDF Feature Summary](/gr/uploads/sitevault/downloads/SiteVault-Feature-Digital-Financial-Disclosure-Forms.pdf). For the steps to initiate an FDF workflow, see [Financial Disclosure Forms](/gr/sitevault/studies/fdf/).

 [Select here for an interactive demo.](https://app.arcade.software/share/i4AdjEYZ5cbAiElOggTa) 

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## The Problem vs. The SiteVault Solution

| The Status Quo (The Problem) | The SiteVault Standard (The Solution) |
| --- | --- |
| **Variability:** Sites manage 10+ different Sponsor FDF templates, increasing the risk of missing specific clauses. | **Uniformity:** One standard template covers all FDA/AAHRPP requirements across every study. |
| **Manual Tracking:** Paper and PDF forms require generation of individual forms for every PI and sub-I, and manual “chasing” of signatures and physical filing. | **Automation:** Digital workflows automate FDF creation, distribution, tracking, and filing for every investigator in a single click. |
| **Compliance Risk:** Clerical errors, missing signatures, or lost dates lead to audit findings. | **Data Integrity:** 21 CFR Part 11-compliant signatures with a validated, timestamped audit trail. |

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## Built for Regulatory Excellence

SiteVault’s FDF is built to satisfy the most stringent global regulatory requirements. Use these points to satisfy Sponsor Quality Assurance (QA) teams:

- **FDA 21 CFR Part 54:** The template explicitly captures all four categories of disclosable financial interests (Compensation affected by outcome, Proprietary interest, Equity interest in public entities \>$50k, and Significant payments \>$25k).
- **FDA 21 CFR Part 11:** All digital signatures meet the requirements for electronic records, ensuring authenticity, integrity, and non-repudiation.
- **The “One-Year Rule”:** The workflow includes built-in reminders and fields for investigators to report changes for up to one year following study completion.
- **AAHRPP Standards:** Aligns with accredited IRB reporting needs for conflict of interest (COI) transparency.

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## Supporting Language for Site SOPs

Sites can incorporate the following into their Internal SOPs or “Letter of Intent” to Sponsors:

> “[Site Name] leverages the SiteVault Industry-Standard FDF workflow as our primary method of Financial Disclosure collection. This supports a robust, institutional Conflict of Interest (COI) policy. By using a validated, digital system, we ensure that every investigator is screened against the same rigorous criteria, reducing the risk of non-disclosure and ensuring that all reporting to the IRB is accurate and timely”.

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## Sponsor Objection Handling

If a Sponsor insists on using their own forms or manual processes, use the following responses to advocate for the SiteVault standard:

### Scenario 1: The Sponsor insists on their “Legal Branding”.

> **The Response:** “We understand the importance of legal consistency. However, our institution has standardized on the SiteVault FDF to ensure 100% compliance with FDA 21 CFR Part 54 across all investigators. This eliminates the risk of our team missing a disclosure due to template fatigue or clerical error”.

### Scenario 2: The Sponsor requests a “Wet-Ink” signature.

> **The Response:** “Our site has moved to a paperless environment to improve audit readiness. The SiteVault electronic signature is 21 CFR Part 11 compliant and provides a more robust audit trail than a scanned PDF or wet-ink document”.

### Scenario 3: The Sponsor claims their form is “Required by the FDA”.

> **The Response:** “The FDA does not mandate a specific form (like Form 3455) for investigator collection; they mandate the collection of specific data. The SiteVault FDF captures all data points required by the FDA and provides a cleaner, more defensible record for inspection”.

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## Value Realization for the Sponsor

When talking to Sponsors, highlight how this process benefits their timelines and data quality:

- **Faster FPI (First Patient In):** Digital FDFs are completed in minutes, not days, removing a common bottleneck in Study Start-Up.
- **Clean TMF (Trial Master File):** Sponsors receive high-quality, legible, and fully executed digital documents that are “inspection-ready” upon receipt.
- **Reduced Queries:** Standardization means fewer back-and-forth emails regarding missing dates or illegible handwriting.

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For the steps to initiate an FDF workflow, see [Financial Disclosure Forms](/gr/sitevault/studies/fdf/).