How to use the Service
Whether you have original paper ECGs, or already scanned ECGs images, AMPS uses its patented ECGScan software and converts them into XML files to upload to the FDA ECG Warehouse. The following paragraphs describe the acceptable/usable input formats.
Original Paper ECGs
Paper ECG traces can have different layouts. Most frequently a short segment (up to 5 seconds) of each of the 12 leads is printed (e.g. with a 3 x 4 or 6 x 2 format) with or without one or more "long lead" (10 seconds) optionally printed at the bottom of the printout. Some electrocardiograph devices can also generate a 12 x 1 layout where all the 12 leads are fully printed for the entire acquisition length. These formats can be successfully processed by AMPS, with a few notes:
ECG paper traces must show the paper speed and the voltage gain at which they were printed (typical values are: 12.5, 25, 50 mm/sec and 5, 10, 20 mm/mV). The traces can be processed without this information by guessing the values, but a correct digital conversion cannot be guaranteed.
Both the ECG signal and the underlying grid must be visible.
To ensure accurate results, the signal information must be preserved as presented on the original paper trace. Ideally the images should be generated by directly scanning original ECG paper traces. When this is not possible, it is essential to make copies using a high-resolution copy machine, set to copy in color or greyscale only ("flat" black & white copies are not usable). We do not recommend use of photocopies or faxed copies of the original trace as this is likely to produce less accurate results (from loss of definition, noise addition, tilting, etc.). Copied traces can cause the image to be unsuitable for digital conversion and rendered unusable.
Scanned ECG images
During a scan of the original paper ECG (or the photocopy) it must be placed and aligned on the scanner surface, to minimize the tilt effect.
Images must be acquired with a resolution of 300 or 600 DPI, either in gray-scale or color, and stored in PNG, TIFF, BMP or JPG formats. PDF files may be used in case the originals were scanned at the appropriate resolution but will need an additional conversion step.
Where images are scanned at different densities this information should be provided for each image file to enable the conversion process.
To comply with the FDA HL7 XML format, include the following demographic information in each XML file:
- Study Identifier (Protocol ID)
- Site ID
- Subject ID
- Date and Time of the Recording
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. In addition, the same demographic information must be available on the original ECG traces to allow visual inspection and verification. This information will be ideally printed, however hand-written in clear capital letters is also acceptable.
Submitted images 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 will 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.
Between $20 and $40, depending on the quality of the originals and the volume.
Between $10 and $30, depending on the quality of the originals and the volume.
For quantities over 600 ECGs, further information, or questions please contact: ECGScanService@amps-llc.com