Draft Workflow

Incoming Communication

Protocol Deviation Notification — Visit Window Exceeded — Subject 06-011

Received: 14 Mar 2026 08:30 UTC

Site: 06 — Ospedale San Raffaele

From: Giulia Bianchi (Study Coordinator)

Classification

Protocol Deviation

Confidence: 90%

RULE-BASED vrules-v1.0

Classification Reasoning

Primary keyword match in subject: 'Protocol Deviation Notification'

Channel: email | Direction: in

Text Block Suggestions

1st — CAPA Request

Dear {{CONTACT_NAME}}, Following the impact assessment of the protocol deviation reported by {{SITE_NAME}} (Site {{SITE...

Score: 1.60 | Category match: CAT-DEV; Phase match: any; Language match: en

formality=formal (+0.15); detail_level=thorough (+0.10)

2nd — Deviation Acknowledgment

Dear {{CONTACT_NAME}}, MedCore Clinical Research acknowledges receipt of the protocol deviation report submitted by {{S...

Score: 1.60 | Category match: CAT-DEV; Phase match: any; Language match: en

formality=formal (+0.15); detail_level=thorough (+0.10)

3rd — Deviation Assessment Follow-Up

Dear {{CONTACT_NAME}}, This is a follow-up regarding the protocol deviation at {{SITE_NAME}} (Site {{SITE_NUMBER}}), De...

Score: 1.55 | Category match: CAT-DEV; Phase match: any; Language match: en

formality=formal (+0.15); opening_style=contextual (+0.05)

Draft Response

Dear Giulia Bianchi,

Following the impact assessment of the protocol deviation reported by Ospedale San Raffaele (Site 06), Deviation Reference {{DEVIATION_ID}}, we have determined that a Corrective and Preventive Action (CAPA) plan is required.

Assessment Summary:
{{ASSESSMENT_SUMMARY}}

Classification: {{DEVIATION_CLASSIFICATION}}

Your site is requested to develop and submit a CAPA plan that addresses the following:

1. Root cause analysis — identification of the underlying reason(s) the deviation occurred
2. Corrective action — steps to remedy the specific deviation and mitigate any impact on affected subjects or data
3. Preventive action — measures to prevent recurrence, including any retraining, process changes, or additional oversight
4. Implementation timeline — proposed dates for each corrective and preventive measure

Please submit the completed CAPA plan by {{DEADLINE_DATE}} using the CAPA Response Form (Study Form DEV-03). The plan will be reviewed by MedCore Clinical Research and, if acceptable, implementation will be verified during the next monitoring visit.

If you require guidance on the expected scope or format of the CAPA plan, please contact me directly.

Kind regards,
Sarah Mitchell
Clinical Research Associate
MedCore Clinical Research

Resolved 5 placeholder(s)

Unresolved: ASSESSMENT_SUMMARY, DEVIATION_CLASSIFICATION, DEVIATION_ID, DEADLINE_DATE