Draft Workflow

Incoming Communication

Re: Protocol Clarification Request — Section 4.1 Inclusion Criteria

Received: 16 May 2025 16:00 UTC

Site: 01 — University Hospital Brussels

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

Classification

Protocol Clarification

Confidence: 95%

RULE-BASED vrules-v1.0

Classification Reasoning

Primary keyword match in subject: 'protocol clarification'

Channel: email | Direction: out

Text Block Suggestions

1st — Protocol Clarification

Dear {{CONTACT_NAME}}, Thank you for your query regarding the interpretation of the study protocol for PMCF-2024-CAT-00...

Score: 1.65 | Category match: CAT-PCL; Phase match: any; Language match: en

formality=formal (+0.15); detail_level=thorough (+0.10); opening_style=contextual (+0.05)

2nd — Investigator Meeting Follow-Up

Dear {{CONTACT_NAME}}, Thank you for attending the investigator meeting for study PMCF-2024-CAT-001, held on {{DATE}}. ...

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

detail_level=thorough (+0.10); closing_style=warm (+0.05)

Draft Response

Dear Dr. Elise Van den Berg,

Thank you for your query regarding the interpretation of the study protocol for PMCF-2024-CAT-001 at University Hospital Brussels (Site 01).

Your Question:
{{SITE_QUERY}}

Sponsor Clarification:
{{CLARIFICATION_RESPONSE}}

Applicable Protocol Section: {{PROTOCOL_SECTION}}

This clarification is consistent with the current protocol version and does not constitute a protocol amendment. It is intended to provide guidance on the practical application of the referenced protocol section and should be applied uniformly to all subjects at your site from the date of this communication.

Please file this clarification letter in the correspondence section of your Investigator Site File and ensure that all relevant site personnel are informed of its content. If the clarification affects the conduct of study procedures, please update your site-specific procedures accordingly.

This clarification has been documented in the sponsor's protocol clarification log and will be shared with all participating sites if determined to be broadly applicable.

If you have any further questions, please do not hesitate to contact me.

Kind regards,
Sarah Mitchell
Clinical Research Associate
MedCore Clinical Research

Resolved 5 placeholder(s)

Unresolved: PROTOCOL_SECTION, SITE_QUERY, CLARIFICATION_RESPONSE