Introduction

ProtoAudit is an automated system for multi-regulatory clinical trial protocol compliance auditing. It processes structured clinical data against a machine-readable framework to identify violations and generate a quantitative health score.

Key Capabilities

Multi-Regulatory Audit (ICH-GCP, FDA 21 CFR Part 11, CDSCO).
Batch processing for high-volume datasets.
Secure, local-only processing with end-to-end encryption.

Input Data Structure

ProtoAudit requires a structured .xlsx file containing specific worksheets. The Audit Engine ingests this file to perform deep validation.

Required Worksheets

Sheet Name	Description
Patients	Demographics, visits, lab values, and adverse events.
Investigators	Personnel qualifications (MD, MBBS) and GCP training status.
SiteInfo	System validation status (Part 11 compliance) and site details.

The Compliance Framework

Unlike traditional tools that require hard-coding rules, ProtoAudit uses a flexible JSON file to define the "Digital Rulebook". This file contains both protocol-specific rules and regulatory constants.

Sample Structure


{
  "protocolId": "PA-2025-001",
  "regulatoryChecks": {
    "ichE6R2": { "requiresGcpTraining": true },
    "cfr21Part11": { "systemMustBeValidated": true }
  },
  "inclusionCriteria": {
    "minAge": 18,
    "maxHbA1c": 8.5
  }
}

Scoring Logic

The system calculates a Quantitative Compliance Score (0-100%) based on a weighted analysis of identified violations. Violations are categorized by severity:

Critical

High impact on score. E.g., Unsigned Consent Form, Protocol Ineligibility.

Major

Medium impact. E.g., Missed Visits, Out of Window Labs.

Minor

Low impact. E.g., Data transcription errors, formatting issues.

Audit Trail & Security

To ensure the integrity of the audit process, the system generates a secure, time-stamped audit trail. This log records:

File ingestion events (User, Filename, Time).
Execution of audit batches.
Generation of final reports.

This trail is immutable during the session and is appended to the final exported report.