Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear PAPs members,

Greetings!!

Actually we are stuck at the sample retention requirement for Phase I Clinical trails at the site.

We are conducting multicenter Phase I CT, however, the sample manipulation is being carried out at single site from, there it would be distributed to the other sites. 
As per Agency's requirement we are retaining the samples, however, do we need to retain sample at each center?

Input in this regards would be helpful.

Thanks in advance.

Regards

Good morning, 

You need only retain samples of each batch distributed to clinical sites (211.170). The typical clinical site has no provision for storage of retention samples.

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States
------------------------------

Original Message:
Sent: 06-Sep-2022 05:38
From: Anonymous Member
Subject: Sample retention for Multicenter Phase 1 Clinical trial

This message was posted by a user wishing to remain anonymous

Dear PAPs members,

Greetings!!

Actually we are stuck at the sample retention requirement for Phase I Clinical trails at the site.

We are conducting multicenter Phase I CT, however, the sample manipulation is being carried out at single site from, there it would be distributed to the other sites.
As per Agency's requirement we are retaining the samples, however, do we need to retain sample at each center?

Input in this regards would be helpful.

Thanks in advance.

Regards

Hello Arvilla,
Thank you for your response on retention samples.
Is there any timeline requirement of PK & Urine samples to be stored after the trial close-out in Phase 1? 

Thanks & Regards,
Venu

------------------------------
Jonnalagadda Venu Gopal
Bangalore
India
------------------------------

Original Message:
Sent: 07-Sep-2022 06:41
From: Arvilla Trag
Subject: Sample retention for Multicenter Phase 1 Clinical trial

Good morning,

You need only retain samples of each batch distributed to clinical sites (211.170). The typical clinical site has no provision for storage of retention samples.

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States

Original Message:
Sent: 06-Sep-2022 05:38
From: Anonymous Member
Subject: Sample retention for Multicenter Phase 1 Clinical trial

This message was posted by a user wishing to remain anonymous

Dear PAPs members,

Greetings!!

Actually we are stuck at the sample retention requirement for Phase I Clinical trails at the site.

We are conducting multicenter Phase I CT, however, the sample manipulation is being carried out at single site from, there it would be distributed to the other sites.
As per Agency's requirement we are retaining the samples, however, do we need to retain sample at each center?

Input in this regards would be helpful.

Thanks in advance.

Regards