Technical Know How – RPL’s ECG Core Lab
Richmond Pharmacology’s Core ECG Laboratory was established in 2004 to provide centralized digital and manual ECG data analysis for Richmond Pharmacology’s in house TQT trials, in addition to ECG reading, analysis and reporting for clinical trials conducted at other centres.
System Specification and Configuration
As a standard Richmond Pharmacology use FDA compliant Digital 12-Lead ECG and Digital 12-Lead Holter devices for collection, transmission and processing of digital ECG and Holter recordings for TQT studies.
Each bedside has a GE MAC 1200, 12-lead ECG machine connected to the MUSE® Server allowing for storage of thousands of digital ECG’s. These digitized ECG's are available to our cardiological sciences team as required for subsequent digitized reading, analysis and reporting. The system is FDA 21 CFR Part 11 compliant with secure authorized user access and password protection to allow access to users for their required access levels only. A detailed audit trail is available and includes the username, date and time of access of any individual using the system and what addition or change they made to the database.
Prior to commencement of a study involving Richmond Pharmacology, all digital 12-Lead ECG machines used for the project are configured to ensure that every ECG data file contains the exact and correct information in FDA compliant format (HL7) as per ICH E14. The configuration of each of Richmond Pharmacology’s ECG machines used in our in house or external TQT study undergoes a vigorous validation process, including acquisition and transfer of test ECGs from the machine’s simulator. To further standardise the process, the same machine is always used for the same subject throughout the study. The standard configuration and validation process is fully documented and available to clients upon request.
The digital 12-Lead Holter devices used by Richmond Pharmacology are designed to be used for FDA compliant arrhythmia analysis. The data obtained from these digitised 12-Lead Holter devices ensure Richmond Pharmacology’s core lab can report on ventricular and supraventricular arrhythmias, and ischemia parameters in addition to quantifying heart rates and providing qualitative reporting of cardiac rhythm information.
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