This document provides guidance for a general process for collecting the standard 12-lead clinical trial ECG data, to support any trial-specific instructions. It does not include ambulatory (e.g. Holter) ECGs. The document, which is not prescriptive, may be adapted by sites as required.
This procedure describes the process for taking pharmacokinetic (PK) samples from the phlebotomist to processing in an interim processing (e.g. ward) laboratory and onto an analytical laboratory in clinical trials.