Module 5 Presentations

05/07/2024

Lifecycle of a CTA

CTD

CTR

EU CT number (part of CT draft creation)

EudraCT number

Get number

Grounds for non acceptance Response (acceptable) Response (unacceptable)

Electronic / paper (country dependant)

CTIS

CTA submission

EC(s) and RA approvals both required to start trial

Country decision required to start trial Substantial modification (SM) Non SM / NSM under Art.81.9 Routine notifications Unexpected events, USM Temporary halts DSUR notifications

CTA authorization

Substantial amendment Non substantial amdt Urgent safetymeasure Temporary halt 90 days (if expected EoT) 15 days (if early termination) 12 months for adult trials 6 months if pediatric EMA Policy 70 Structured data to be completed in EudraCT DB

Maintenance activities

CTA rejected

End of trial notifications

15 days

12 months

CTA summary report

Art.37.4 (all EU MAs)

Initially pdf upload at go live To evolve to structured data

Results posting

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

33

CTR : Harmonized (but also more) notifications

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

34