Currently a significant change is defined as progression from one fibrosis category to another as shown in the Table above. While Claim 1 has been informed by an extensive review of the literature and expert consensus and phantom studies that have not yet been fully substantiated by studies that strictly conform to the specifications given here. The expectation is that during field test, data on the actual field performance will be collected and any appropriate changes made to the claim or the details of the Profile. At that point, this caveat may be removed or re-stated. 3. Profile Activities The Profile is documented in terms of “Actors” performing “Activities”. Equipment, software, staff or sites may claim conformance to this Profile as one or more of the “Actors” in the following table. Conformant Actors shall support the listed Activities by conforming to all requirements in the referenced Section. Table 1: Actors and Required Activities Actor Activity Section Ultrasound Scanner Pre-delivery 3.1. (Acquisition Device) Subject Handling 3.5. Image Data Acquisition 3.6. Technologist Subject Handling 3.5. Image Data Acquisition 3.6. Image Data Reconstruction 3.7. Radiologist Subject Handling 3.5. Image QA 3.8. Image Analysis 3.10. Reconstruction Software Image Data Reconstruction 3.7. Image Analysis Tool Image Analysis 3.10. The requirements in this Profile do not codify a Standard of Care; they only provide guidance intended to achieve the stated Claim. Failing to conform to a “shall” in this Profile is a protocol deviation. Although deviations invalidate the Profile Claim, such deviations may be reasonable and unavoidable and the radiologist or supervising physician is expected to do so when required by the best interest of the patient or research subject. How study sponsors and others decide to handle deviations for their own purposes is entirely up to them.
Currently a significant change is defined as progression from one fibrosis category to another as shown in the Table above. While Claim 1 has been informed by an extensive review of the literature and expert consensus and phantom studies that have not yet been fully substantiated by studies that strictly conform to the specifications given here. The expectation is that during field test, data on the actual field performance will be collected and any appropriate changes made to the claim or the details of the Profile. At that point, this caveat may be removed or re-stated. 3. Profile Activities The Profile is documented in terms of “Actors” performing “Activities”. Equipment, software, staff or sites may claim conformance to this Profile as one or more of the “Actors” in the following table. Conformant Actors shall support the listed Activities by conforming to all requirements in the referenced Section. Table 1: Actors and Required Activities Actor Activity Section Ultrasound Scanner (Acquisition Device) Pre-delivery 3.1. Subject Handling 3.5. Image Data Acquisition 3.6. Technologist Subject Handling 3.5. Image Data Acquisition 3.6. Image Data Reconstruction 3.7. Radiologist Subject Handling 3.5. Image QA 3.8. Image Analysis 3.10. Reconstruction Software Image Data Reconstruction 3.7. Image Analysis Tool Image Analysis 3.10. The requirements in this Profile do not codify a Standard of Care; they only provide guidance intended to achieve the stated Claim. Failing to conform to a “shall” in this Profile is a protocol deviation. Although deviations invalidate the Profile Claim, such deviations may be reasonable and unavoidable and the radiologist or supervising physician is expected to do so when required by the best interest of the patient or research subject. How study sponsors and others decide to handle deviations for their own purposes is entirely up to them.