Professional Resources for Clinical Trial Sites
The Future of Site Documentation:
Leveraging AI Scribes in Clinical Research
A comprehensive guide to implementing AI-assisted documentation that meets ICH GCP E6(R3) and 21 CFR Part 11 standards.
In the world of clinical trials, the mantra has always been: "If it isn't documented, it didn't happen."
As protocol complexity increases and patient enrollment targets tighten, site staff are drowning in "re-entry" work—manually typing notes from patient visits into EHRs and EDCs. AI scribing offers a way out, but only if it can stand up to the scrutiny of a BIMO (Bioresearch Monitoring) inspection.
Why AI Scribing is a Game-Changer for Sites
Traditional documentation is prone to "recall bias" and missing data. AI scribes, like Mozu Health, capture the nuance of a patient encounter in real-time, ensuring that every protocol-required discussion point is recorded accurately.
Eliminate "Note Bloat"
Move from disorganized scribbles to structured, protocol-aligned notes instantly.
Contemporaneous Reporting
Ensure notes are completed at the time of the visit, satisfying a core ALCOA+ requirement.
PI Oversight
Shift the Principal Investigator's role from "data entry clerk" to "data validator."
Making AI Documentation "Audit-Proof"
To use an AI scribe in a regulated clinical trial, the site must ensure the technology meets ICH GCP E6(R3) and 21 CFR Part 11 standards. Here is the framework for a compliant implementation:
1The "Human-in-the-Loop" Requirement
AI should never be the final author. For a record to be attributable and accurate, the Principal Investigator or delegated sub-investigator must:
- Review the AI-generated draft.
- Edit for medical accuracy.
- Sign and date the final version, explicitly noting: "Generated via AI assistance and verified for accuracy by [Name]."
2Guarding Data Integrity (ALCOA+)
An audit-proof AI tool must provide a Traceable Audit Trail. If a value is changed during the review process, the system must log:
- What the AI originally captured.
- What the human changed it to.
- Who made the change and why.
3Patient Privacy & Consent
Under HIPAA and GDPR, patients must be informed.
- Informed Consent (ICF):Ensure your study's ICF explicitly mentions the use of AI recording tools for documentation.
- Data Security:Use platforms that utilize SOC 2 Type II security and provide a Business Associate Agreement (BAA) to ensure data is encrypted and handled according to federal law.
Checklist for Implementation
Before deploying an AI scribe at your site, ensure you have the following in your Regulatory Binder:
| Requirement | Action Item |
|---|---|
| SOP Update | Create a Standard Operating Procedure (SOP) for "Use of AI in Clinical Documentation." |
| Validation | Perform a "test run" with a mock patient to verify the AI's accuracy and file the results. |
| Part 11 Statement | Obtain a letter from the software vendor (e.g., Mozu Health) confirming their 21 CFR Part 11 compliance capabilities. |
| Training Log | Document that all staff using the tool have been trained on its specific privacy and editing features. |
The Bottom Line
AI scribing isn't just about saving time; it's about improving data quality. By capturing the full context of a patient visit, sites can reduce "queries" from sponsors and ensure that their documentation is robust enough to pass any regulatory inspection.
Sample SOP Section: Use of AI-Assisted Scribe Software
To make an AI scribe "official" in the eyes of an auditor, it needs to be integrated into the site's Standard Operating Procedures (SOPs). Here is a sample SOP paragraph that sites can adapt. It is written to satisfy 21 CFR Part 11 and ICH GCP requirements by emphasizing human control and the audit trail.
Section X.X: Generation of Clinical Trial Source Documentation via AI Scribing
1. Purpose and Scope:
This procedure outlines the authorized use of AI-assisted scribing software (e.g., Mozu Health) to facilitate the capture of contemporaneous clinical notes during study-related patient encounters. This process ensures that digital transcriptions meet the ALCOA+ standards for data integrity.
2. Procedural Requirements:
- Patient Consent:
Before activating any AI recording device, the delegated staff member must confirm that the participant has signed an Informed Consent Form (ICF) that explicitly permits the use of digital recording for documentation purposes.
- Human-in-the-Loop Validation:
AI-generated drafts are considered "preliminary" and do not constitute source data until verified. The Principal Investigator (PI) or a delegated Sub-Investigator must review the draft against their own clinical observations for accuracy, completeness, and protocol compliance.
- Attribution & Electronic Signature:
Once reviewed, the investigator shall finalize the note within the EHR or site documentation system. Every note must include the following attestation:
"This clinical note was captured with the assistance of an AI-transcription tool. The output has been reviewed, edited for accuracy, and verified by the undersigned investigator as a true reflection of the patient encounter."
- Audit Trail Maintenance:
The site shall only utilize AI platforms that maintain a 21 CFR Part 11 compliant audit trail. This trail must document the original AI output and any subsequent human edits, including timestamps and user credentials.
- Data Minimization:
To protect participant privacy, raw audio files must be deleted by the software vendor immediately following the generation of the transcript/note, unless otherwise specified by the Study Protocol or Source Data Agreement.
3. Quality Control:
On a quarterly basis, the Lead Clinical Research Coordinator (CRC) will perform a "Source Data Verification" (SDV) spot-check on 5% of AI-generated notes to ensure that the AI is not introducing systematic errors or hallucinations into the trial record.
How to use this:
- Direct Share: You can send this directly to a Site Manager or Principal Investigator.
- Regulatory Binder: Advise the site to print this SOP and place it in their Investigator Site File (ISF) under "Site Procedures."
- Sponsor Approval: Remit this language to the Study Monitor (CRA) during the Site Initiation Visit (SIV) to ensure the sponsor is comfortable with the site's tech stack.
Need Additional Support?
Contact our clinical trials support team for customized SOPs and vendor compliance documentation.