Draft Workflow

Incoming Communication

Ethics Committee Approval — Amendment 2 — Site 07 Lyon

Received: 01 Dec 2025 09:00 UTC

Site: 07 — Hospices Civils de Lyon

From: Dr. Isabelle Lefebvre (Principal Investigator)

Classification

Regulatory / Ethics

Confidence: 95%

RULE-BASED vrules-v1.0

Classification Reasoning

Primary keyword match in subject

Channel: email | Direction: in

Text Block Suggestions

1st — Amendment Notification to Site

Dear {{CONTACT_NAME}}, MedCore Clinical Research is pleased to inform you that a protocol amendment for study PMCF-2024...

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

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

2nd — Competent Authority Query Response

Dear Sir or Madam, Re: Response to Information Request — PMCF Study PMCF-2024-CAT-001 Device: VascuPath 3F Intervention...

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

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

3rd — Annual Progress Report Reminder

Dear {{CONTACT_NAME}}, This is a reminder that the annual progress report for study PMCF-2024-CAT-001 is due for submis...

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

formality=formal (+0.15)

Draft Response

Dear Dr. Isabelle Lefebvre,

MedCore Clinical Research is pleased to inform you that a protocol amendment for study PMCF-2024-CAT-001 has been approved and is being distributed to all participating sites.

Amendment Number: {{AMENDMENT_NUMBER}}
Amendment Date: 16 Mar 2026
Effective Date: {{EFFECTIVE_DATE}}

Summary of Changes:
{{AMENDMENT_SUMMARY}}

Rationale for Amendment:
{{AMENDMENT_RATIONALE}}

Required Actions at Your Site:
1. Review the amended protocol and associated documents (enclosed)
2. Submit the amendment to your local Ethics Committee / IRB for review and approval, if not already done centrally
3. Update the Investigator Site File with the new protocol version
4. Ensure all site staff involved in study conduct are trained on the changes and that training is documented on the delegation and training log
5. Begin implementing the amended procedures from the effective date, or from the date of local EC approval, whichever is later
6. Confirm implementation by returning the enclosed Amendment Acknowledgment Form to MedCore Clinical Research by {{DEADLINE_DATE}}

If the amendment affects the informed consent process, re-consent of currently enrolled subjects may be required. Guidance on re-consent procedures is provided in the enclosed cover note.

If you have any questions about the amendment or its implementation, please contact me.

Kind regards,
Sarah Mitchell
Clinical Research Associate
MedCore Clinical Research

Resolved 4 placeholder(s)

Unresolved: AMENDMENT_NUMBER, EFFECTIVE_DATE, AMENDMENT_RATIONALE, AMENDMENT_SUMMARY, DEADLINE_DATE