Phase 1 QC strategy?

[David Ives]

Good afternoon all!

Looking to hear what standards others have employed for time based or milestone based QC on Phase 1 trials? For example do you only do a closeout QC, do you do a startup, conduct, and closeout but with a limited scope, etc…

I have seen everything from multiple milestones to only a close out QC, the challenge is often times Phase 1 studies start and stop in a matter of months. This is a small window to QC (completeness in particular). How do you handle this?

Thanks in advance!
David

[Darwin Thukkan]

Hi David,

Sorry for the late response. I do not have much experience on Phase-I trial however i can provide my suggestion. The QC can be performed as per each milestone, based on duration of the study. QC must be performed during Maintenance phase since the error can be identified and rectified accordingly.

Thanks,
Darwin

[Marie-Christine Poisson-Carvajal]

Hi David,

Basically agree with Darwin. There is no one size that fits all. In my opinion, the frequency or time points for TMF review should be flexible and adapted to the study. Usually, Phase 1 studies are of short duration and so I would recommend to perform a review at time of site close-out and then one at the end of the study. Again, frequency and/or time points/milestones should be determined by the study team at the beginning of the study and agreement recorded in the TMF management plan.

[John Parker]

Hi David

In my experience it will vary and I would take in to account the risks associated with the study in respect to the TMF and the knowledge and experience that is built up with the Phase I CRO if they have been delegated responsibility for managing the Sponsor TMF. There is no mandated frequency, only that the Sponsor will implement an appropriate level of QC to ensure the right level of quality is achieved.

[Author]

Posts