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Identify potential subjects that meet study-specific eligibility criteria by reviewing patient logs, Cardiology database or specific medical records.
If a patient meets these eligibility criteria AND was seen by the participant site between January 1, 2005 and now, they should be included in the study and a chart review should be completed.
If a potentially eligible subject comes in for an evaluation, a trained staff member or physician will identify eligibility. If eligible, the patient will be approached for participation and consent will be obtained. A waiver of consent should be obtained for the retrospective review of subject records.
All subjects who meet eligibility criteria and were evaluated at the participant site January 1, 2005 to the present will be enrolled in the study and have data from their medical record abstracted into an electronic data capturing system and any relevant echocardiograms uploaded into XNAT. If the subject is being seen for an evaluation, consent will be obtained prior to chart abstraction.
Clinical and demographic data will be abstracted from the subject’s medical record and entered into OpenClinica, an electronic data capturing system. In OpenClinica, once a subject is added a unique identifying number will be assigned – the OpenClinica subject ID number. This number will be used to match the clinical and demographic data with the fetal image uploaded into XNAT.
Subjects that are consented and enrolled will have data collected prospectively, unless data for an outpatient or inpatient visit is missed. If this occurs, data from these visits will be retrospectively abstracted from the patient’s medical record.
All echocardiograms will be uploaded into XNAT separately from OpenClinica. However, the report associated with each echocardiogram will be uploaded into OpenClinica, along with the date of the echocardiogram, type, and quality.
After all clinical, demographic and echocardiogram report data from the patient’s chart is entered into OpenClinica, the complete fetal echocardiograms will be uploaded into XNAT. Once a subject is entered into OpenClinica and a subject ID number obtained, an entry in XNAT will be populated with the OpenClinica subject ID. Therefore, when accessing XNAT to upload the echocardiogram you simply click on the OpenClinica subject ID and upload the fetal image under the corresponding OpenClinica subject ID.
The DICOM headers on all echocardiograms will be automatically de-identified when the image is uploaded into XNAT. If there are any identifiers on the image themselves, these will need to be removed prior to uploading into XNAT. Once images are received in XNAT they will be reviewed, checked for general quality and image anonymization will be verified.
Once all data is abstracted from the subject’s medical record a link to the information in OpenClinica/XNAT and the medical record should be retained at the participant site. Patient Study Files, which include consent (if obtained), data collection worksheets and any Note to Files, CAPA reports, etc. should be retained at the participant site. The OpenClinica subject ID and the patient’s name, medical record, and other identifying information should be kept at the participant site. This will be considered the master link of patient information and subject ID number.
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