ECG File Format conversion

Since 2005, the FDA only accepts submissions of annotated ECG waveform data in electronic format (XML). This stipulation complies with the Health Level Seven (HL7) Annotated ECG Waveform Data Standard (aECG) accredited by the American National Standards Institute.

AMPS provides a service converting digital ECG traces of various formats into digital FDA-compliant format XML files. This services is an ideal solution for Core Labs and Sponsors that need to rapidly and efficiently convert large number of ECGs before the submission to the FDA Warehouse.

How to use the Service

ECG file formats accepted as input include: Mortara XML (E-Scribe & H-Scribe), GE MUSE XML (Transactional XML), Philips XML (Sierra XML), Schiller XML, AMPS binary ECG, ISHNE, SCP, and MIT.

The available output ECG formats include: aECG HL7 FDA XML, AMPS binary ECG, ISHNE, SCP, MIT.

Demographic information

To be compliant with the FDA HL7 xml format the following demographic information must be included in each XML file:

Study Identifier (Protocol ID)
Site ID
Subject ID
Date and Time of the Recording

As an added service AMPS can insert into the HL7 XML files annotations and demographic information if available. To minimize the risk of mistakes, the demographic data must be created in an individual Excel spreadsheet file for each study (or group of images uploaded) by the Sponsor/CRO.

Filename convention

Submitted files with defined file names and definitions must be made available to AMPS. Each study can have a different naming convention, chosen by the Sponsor/CRO. AMPS recommends the following file name: DateTime.StudyIdentifier.SiteID.SubjectID.VisitID

Data Transmission and storage

Digital data shall be delivered to AMPS via upload to the secure AMPS FTP server.

After upload the images are automatically stored in a dedicated folder on the AMPS Customer Data Repository server. The Customer Data Repository is a password protected electronic repository that ensures only authorized personnel have access its content. The use of multiple disks guarantees data redundancy and allows data reconciliation in case of a single disk failure.

Intermediate and final results are saved in Read-Only mode. This ensures the results are not inadvertently altered or deleted. Date & time of file-creation, and the Identification of the AMPS personnel who generated the file will be available.

Processed Data Delivery

Delivery of generated HL7 XML files to the Sponsor/CRO can be made to a dedicated server, or by courier using any digital media such as DVD, solid memory/USB, etc. Alternatively, they can be submitted directly to the FDA ECG Warehouse, depending on the Sponsor/CRO request.

Price list

up to 100 ECGs	$ 10 /ECG
up to 300 ECGs	$ 8 /ECG
up to 600 ECGs	$ 5 /ECG

For quantities over 600 ECGs, further information, or questions please contact: AMPS.Services@amps-llc.com