Module 5 Presentations

05/07/2024

CTIS Correspondence between Sponsor and MS 4 types of RFI correspondence via CTIS

Application RFI

Ad Hoc RFI

Sponsor opinion for intended CM

ASR RFI

Annual safety report(ASR) assessment

Application evaluation

Intended corrective measure (CM)

Trigger

Ad hoc assessment*

≤12 calendar days determined by RMS / MSC Application legally lapsed in system

Response timeline Outcome if no response

Determined by MSC

7 calendar days

Determined by MSC

No immediate legal impact MSC may take / apply corrective measure(s)

*results from any event or notification (e.g. affecting subject safety and/or risk benefit balance) on same trial or other trial

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

25

CTIS information flow

From R.Pankow, DIA EU CTR, Nov2020

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

26