ISO 14155 Good Clinical Investigation Practices Compliance Checklist?

[tehuff]

Hi Covers!
Does anyone have a checklist of the various documents that are required by ISO 14155 (eg. protocol, ethics committee approvals, etc)? My Notified Body reviewer asked me if I had one (to make his job easier) - I don't and before I reinvent the wheel I thought I would ask you all!

Thanks!

 

[Stijloor]

Re: ISO 14155 compliance checklist?

I know it's weekend, but can someone help by any chance?

Thank you!!

Stijloor.