Heart Biomarker Evaluation in Apnea Treatment

10.5.2 Certification Recording Requirements

These submissions must be correctly de-identified, re-identified with a standard convention, successfully converted to EDF format and placed on the ftp server. This serves both as part of the tech certification process and as practical experience in using the equipment in the study environment. Certification studies also allow for verification that all sensors and equipment are functioning properly before being used on a study participant, and that post-acquisition treatment and transfer of data is consistent with study protocol. The certifying tech need not actually perform every required task but will be responsible for the acceptable completion of each task.

Once certified, this tech will be responsible for the performance of study-related duties by other sleep laboratory staff and adherence to HeartBEAT protocol.

To be considered acceptable the recordings submitted for certification must:

• Have good quality signal on each channel (i.e.: all electrodes must work) and signals must be relatively free from artifact.
• Reflect HeartBEAT PSG protocol and procedure including placement of electrodes and sensors.

• Have correct study identification as a certification recording using the following format when naming (or re-naming) the recording: [CR] [techID]_[date of study].

  • An example of this format would be CRtechID_102907.

• The electronic recording file must be accompanied with paperwork that matches this naming convention and additionally includes the technician identification and equipment ID.

• Include the following:

  • Signal Evaluation (SE) form.