Regulatory Open Forum

Hi,

Apologies if this is a a repeat, I did search but did not find a thread.

The question of which labs should be included on the 1572 seems to come up a lot.  I have heard different answers so just wondering if some of you would put in your 2 cents?  Include local labs?  Only the central lab?  etc.

Thoughts?

Thanks in advance!

I am not sure I have ever seen a definitive answer to your question. My approach as always been to include labs that are used to collect data defined in the protocol as endpoints for efficacy and safety. I would not list a local lab if it was not the primary source for protocol defined results. Local labs may be used in some studies to follow up on laboratory abnormalities or other adverse events, but if the protocol has not defined them as an endpoint I would not include the lab on the 1572.

Hi,

Apologies if this is a a repeat, I did search but did not find a thread.

The question of which labs should be included on the 1572 seems to come up a lot.  I have heard different answers so just wondering if some of you would put in your 2 cents?  Include local labs?  Only the central lab?  etc.

Thoughts?

Thanks in advance!

Hi,

Apologies if this is a a repeat, I did search but did not find a thread.

The question of which labs should be included on the 1572 seems to come up a lot.  I have heard different answers so just wondering if some of you would put in your 2 cents?  Include local labs?  Only the central lab?  etc.

Thoughts?

Thanks in advance!