Draft Workflow

Incoming Communication

Serious Adverse Event Report — Subject 01-005 — Hospitalization After Procedure

Received: 05 Oct 2025 07:30 UTC

Site: 01 — University Hospital Brussels

From: Dr. Elise Van den Berg (Principal Investigator)

Classification

Safety / Vigilance

Confidence: 95%

RULE-BASED vrules-v1.0

Classification Reasoning

Primary keyword match in subject: 'safety event'

Channel: email | Direction: in

Text Block Suggestions

1st — FSCA Site Notification

Dear {{CONTACT_NAME}}, URGENT — Field Safety Corrective Action Notification Study: PMCF-2024-CAT-001 — VascuPath 3F Int...

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

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

2nd — Regulatory Authority Notification Cover Letter

Dear Sir or Madam, Re: Serious Adverse Event Notification — PMCF Study PMCF-2024-CAT-001 Device: VascuPath 3F Intervent...

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

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

3rd — Request for SAE Follow-Up Information

Dear {{CONTACT_NAME}}, We are writing in reference to the serious adverse event reported for Subject {{SUBJECT_ID}} at ...

Score: 1.50 | Category match: CAT-SAF; Phase match: any; Language match: en

formality=formal (+0.15)

Draft Response

Dear Dr. Elise Van den Berg,

URGENT — Field Safety Corrective Action Notification
Study: PMCF-2024-CAT-001 — VascuPath 3F Interventional Catheter
FSCA Reference: {{FSCA_ID}}

MedCore Clinical Research is initiating a Field Safety Corrective Action (FSCA) affecting the VascuPath 3F Interventional Catheter units distributed to your site. This action is being taken in accordance with EU-MDR Article 83 and has been reported to the relevant competent authority.

Nature of the Issue:
{{FSCA_DESCRIPTION}}

Required Actions at Your Site:
{{REQUIRED_ACTIONS}}

Affected Device Lot Numbers: {{LOT_NUMBERS}}
Completion Deadline: {{DEADLINE_DATE}}

Please acknowledge receipt of this notification within 24 hours by returning the enclosed FSCA Acknowledgment Form. All affected devices must be quarantined immediately pending further instruction. Do not use any device from the affected lots in study procedures until cleared by the sponsor.

A member of our clinical monitoring team will contact you within 48 hours to verify implementation of the required corrective actions. If any affected devices have already been used in study procedures since 16 Mar 2026, please notify us immediately so that appropriate subject safety assessments can be conducted.

This communication is confidential and should be shared only with authorised site personnel involved in study conduct.

Kind regards,
Sarah Mitchell
Clinical Research Associate
MedCore Clinical Research

Resolved 4 placeholder(s)

Unresolved: LOT_NUMBERS, REQUIRED_ACTIONS, DEADLINE_DATE, FSCA_ID, FSCA_DESCRIPTION