Module 5 Presentations

05/07/2024

CTR : Classification of modifications

Topic

CTR

Substantial modification

• Change that has a substantial impact on the safety or rights of the subjects and/or the reliability and robustness of the data generated • Submission and authorisation required before the change can be implemented • Categorisation of a change as a SM is a responsibility of the sponsor • New concept that does not exist under Directive 2001/20/EC • Any change which is not substantial, but is considered relevant for supervision of the trial by the MSCs • No authorisation or refusal mechanism, immediately implementable but corrective actions by MSCs remain possible • Not the silver bullet to get all your notifications in (not a date stamp process) • Notification of non substantial changes is not required (nor supported). Non substantial modifications should be recorded and contained in the trial documentation and subsequently submitted in the subsequent application of a substantial modification (if any). • Documentation of non substantial modifications should be available on request for inspection purposes as appropriate

Non substantial modification relevant for supervision (art. 81.9)

Non substantial modification

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

35

CTR : Trial and recruitment periods

Topic

CTR

Start of trial

The first act of recruitment of a potential subject for a specific CT

Start / end of recruitment

The first visit of the first subject. Recruitment shall begin within 2 years from trial authorisation. Extension of the recruitment start beyond 2 years is possible via SM.

Restart of trial

The act of restarting the trial after a temporary halt, or after MSC suspension

Restart of recruitment

The act of restarting the recruitment of subjects

Temporary halt

An interruption not provided for in the protocol of the conduct of a trial by the sponsor with the intention to resume it. The temporary halt may be related to subject safety and/or benefit-risk balance, or not, affecting restart process. A halted trial is automatically ended if not restarted within 2 years Extension to restart the halted trial beyond 2 years is possible via SM The last visit of the last subject, or a later point in time as defined in the protocol. Includes also early terminations and whether related to a matter of subject safety and/or benefit-risk balance, or not

End of trial (planned or anticipated)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

36