Automated Breast Ultrasound Case Collection Registry
Conditions: Breast Cancer
Sponsor: GE Healthcare



Study Title: Automated Breast Ultrasound Case Collection Registry
Study No: 110.01-2016-GES-0001
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The Sponsor and Investigator have approved this protocol version, and I confirm hereby to 
conduct the study according to the protocol and in accordance with applicable principles of the 
World Medical Association Declaration of Helsinki and Good Clinical Practice (GCP) guidelines 
as per ISO 14155:2011, any conditions of approval imposed by the reviewing EC or governing 
regulatory body, and applicable laws and regulations. The investigator should not deviate from 
this protocol except for emergency use. I have read and understood and agree to abide by all 
the conditions and instructions contained in this protocol.
Local Principal Investigator at study site:
Investigator Signature
Date
Print Name
Site Name, Department, Address
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Table of Contents
Document and Version Control.................................................................................................................5
List of Abbreviations and Terms...............................................................................................................6
Study Synopsis...............................................................................................................................................7
Administrative Structure of Investigation..............................................................................................9
1. Background and Justification...........................................................................................................10
2. Device Description................................................................................................................................10
Identity, Mechanism, and Function......................................................................................................................................10
2.1
Intended Use.......................................................................................................................................................................................11
2.2
Concomitant/Ancillary Administrations..............................................................................................................................12
2.3
Accountability.....................................................................................................................................................................................12
2.4
Anticipated Risks and Benefits...............................................................................................................................................12
2.5
3. Study Objectives and Endpoints......................................................................................................13
Purpose of the Study.....................................................................................................................................................................13
3.1
Study Endpoints................................................................................................................................................................................14
3.2
Summary of Study Design.........................................................................................................................................................14
3.3
4. Study Design...........................................................................................................................................14
Study Population..............................................................................................................................................................................14
4.1
Number of Subjects........................................................................................................................................................................14
4.2
Protection of Vulnerable Subjects.........................................................................................................................................14
4.3
Eligibility Criteria...............................................................................................................................................................................15
4.4
Recruiting and Screening...........................................................................................................................................................15
4.5
Criteria for Withdrawal/Discontinuation.............................................................................................................................16
4.6
5. Study Procedures..................................................................................................................................16
Subject Preparation........................................................................................................................................................................16
5.1
Description of Study Procedures...........................................................................................................................................16
5.2
6. Study Data Collection and Assessments......................................................................................17
Data Collection for Subject Information and Breast Exams................................................................................17
6.1
Data Collection for Follow-up...................................................................................................................................................18
6.2
Image Data Collection..................................................................................................................................................................18
6.3
Safety Assessments......................................................................................................................................................................18
6.4
7. Qualification and Training Plan........................................................................................................18
Study Staff and Reader Qualifications...............................................................................................................................18
7.1
Training Plan for the Protocol..................................................................................................................................................19
7.2
8. Safety.........................................................................................................................................................19
Anticipated Adverse Events......................................................................................................................................................19
8.1
Adverse Event Definitions..........................................................................................................................................................20
8.2
Documentation of Safety Events...........................................................................................................................................21
8.3
Reporting of Safety Events and Device Complaints.................................................................................................22
8.4
Device Complaints..........................................................................................................................................................................22
8.5
9. Ethical Conduct of the Study.............................................................................................................22
Ethics Committee.............................................................................................................................................................................22
9.1
Regulatory Agencies and Competent Authority(ies)................................................................................................23
9.2
Management of Protocol Modifications and Amendments...................................................................................23
9.3
Participant Information and Informed Consent ............................................................................................................23
9.4
Early Termination of the Study................................................................................................................................................24
9.5
10. Statistical Methods ...............................................................................................................................24
Statistical Hypothesis....................................................................................................................................................................24
10.1
Sample Size Determination ......................................................................................................................................................24
10.2
Statistical Analysis..........................................................................................................................................................................24
10.3
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Handling of Missing Data............................................................................................................................................................24
10.4
11. Quality Assurance and Control ........................................................................................................25
Data Management...........................................................................................................................................................................25
11.1
12. Monitoring Plan......................................................................................................................................26
Confidentiality and Data Protection.....................................................................................................................................26
12.1
Publication Policy.............................................................................................................................................................................26
12.2
References......................................................................................................................................................27
Appendix A – Study Site and Investigator List ..................................................................................29
Appendix B - Amendments (Protocol Version 1.0 to 2.0)...............................................................30
List of Abbreviations and Terms.............................................................................................................30
Administrative Structure of Investigation............................................................................................31
Appendix C - Amendments (Protocol Version 2.0 to 3.0)...............................................................37
Data Collection for Site Image Reads................................................................................................................................38
12.3
6.4
Image Data Collection..................................................................................................................................................................39
All device complaints should be collected, fully investigated, and documented in the source document 
and appropriate case report form (CRF) during the study reporting period.............................................39
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LIST OF ABBREVIATIONS AND TERMS
2DS
2D Synthetic Digital breast tomosynthesis
ABUS
Automated breast ultrasound
ACS
American Cancer Society
ADE
Adverse Device Effect
AE
Adverse Event
ALARP As Low as Reasonably Possible
AMA
American Medical Association 
CA
Competent Authority
CAD
Computer-aided detection
CAPM GE Clinical Affairs Project Manager
CCG
Case Report Form Completion Guidelines
CESM Contrast enhanced spectral mammography
CFR
Code of Federal Regulations
CRF
Case Report Form
DBT
Digital breast tomosynthesis
DCF
Data Clarification Form
EC
Ethics Committee
EU
European Union
FDA
United States Food and Drug Administration
FFDM Full-field digital mammography
GCP
Good Clinical Practice (see ISO 14155:2011) 1
GE
General Electric
GEHC General Electric Healthcare
HHUS Hand-held ultrasound
ICF
Informed Consent Form
ISO
International Standards Organization
MRI
Magnetic resonance imaging
SADE
Serious Adverse Device Effect
SAE
Serious Adverse Event
SoC
Standard of care
SPR
System Problem Report
US
United States
USADEUnexpected Serious Adverse Device Effect
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Eligibility criteria:
Inclusion criteria:
Subjects who meet all the following 
inclusion criteria may be included:
1.
Are asymptomatic adult women 
(aged 18 years or older); 
2.
Are eligible to complete or have 
completed (within 30 days)
screening ABUS and DBT exams 
per the site standard of care;1
3.
Have heterogeneously dense and 
extremely dense breasts (BI-RADS 
C or D, respectively) or are 
determined to have dense breasts 
prior to the study on initial 
screening mammography;
4.
Are able and willing to participate.
Exclusion criteria:
Subjects who meet any of the following 
exclusion criteria will not be included 
that:
1.
Have a breast cancer diagnosis 
(with or without metastasis) or are 
being treated for breast cancer 
within the year prior to the study.
Sample size and 
Sites:
Up to 10,000 (ten thousand) women may participate in the registry at up to 10 
participating sites. 
 
Per-site 
enrollment will be based on actual throughput of qualifying patients.
Study duration:
The study is expected to last approximately 6 years, which includes approximately 
5 years of enrollment and additional follow-up of the last patient in.
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Study Endpoints 
3.2
Performance Endpoints
3.2.1
The type of exams performed per patient (ABUS, DBT, and, if applicable, other exams, such as
FFDM, HHUS, 2D Synthetic (2DS), or MRI)
Efficacy Endpoints
3.2.2
Breast cancer (cancer/non-cancer) status following initial diagnostic exams and at follow-up 
(breast cancer status and, if applicable, breast diagnosis and treatments; see 5.2.4. Follow-up).
Safety Endpoints
3.2.3
Type and number of AEs, SAEs, and device issues will be recorded. Adverse events and 
devices issues not reflected on the product label will be reported to the manufacturer and, for 
GE products, will be dispositioned according to the Sponsor’s complaint handling procedures for 
post-market products.  
Summary of Study Design
3.3
This is a prospective multi-site study of the GE automated breast ultrasound (ABUS) system 
and comparable modalities already used in clinical practice. The study aims to create a registry 
of breast exam patients. No blinding, therapeutic interventions, or masking are employed.
4. STUDY DESIGN
Study Population
4.1
This study will enroll adult women with dense breasts clinically referred for breast cancer 
screening. As this study is expected to span multiple years, during which time these 
recommendations may be revised or updated, the most current applicable guidelines for 
mammographic screening should be employed in this study, at the discretion of the site. 
Number of Subjects
4.2
Up to 10,000 women may participate in the registry at up to 10 participating sites. Enrollment is 
based on a minimum population estimated to be necessary to draw population-based inferences 
in future analysis. Per-site enrollment will be based on actual throughput of qualifying patients. 
The study is expected to last approximately 6 years, which includes approximately 5 years of 
enrollment and approximately 1 additional year to complete follow-up of the last patient in.
Protection of Vulnerable Subjects
4.3
Vulnerable subjects are individuals whose willingness to volunteer in a clinical investigation 
could be unduly influenced by the expectation, whether justified or not, of benefits associated 
with participation or of retaliatory response from senior members of a hierarchy in case of 
refusal to participate. 
This study does not target any groups of subjects considered to be vulnerable subjects in the 
United States. However, as the study is expected to pose minimal risks to subjects, vulnerable 
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subjects that incidentally present at the site and qualify for participation (such as pregnant 
women, employees or faculty of the site, and students) will not be prohibited from participating 
in the registry where acceptable per governing IRB policy. No participants will be under undue 
influence to participate.
The Sponsor and all investigators shall avoid improper influence on, or inducement of, the 
subject, monitor, any investigator(s), or other parties participating in, or contributing to, the 
clinical investigation.
Eligibility Criteria
4.4
Inclusion Criteria 
4.4.1
Subjects who meet all the following inclusion criteria may be included:
1.
Are asymptomatic adult women (aged 18 years or older); 
2.
Are eligible to complete or have completed screening ABUS, DBT, as determined by the 
site;
3.
Have heterogeneously dense and extremely dense breasts (BI-RADS C or D, 
respectively), or are determined to have dense breasts prior to the study on initial 
screening mammography;
4.
Are able and willing to participate.
Exclusion Criteria 
4.4.2
Subjects who meet any of the following exclusion criteria will not be included that:
1. Have a breast cancer diagnosis (with or without metastasis) or are being treated for 
breast cancer within the year prior to the study.
Recruiting and Screening 
4.5
Subjects will be identified for inclusion in this registry study according to the standard 
procedures of the investigational site and in accordance with governing IRB policy. Participation 
in this study is voluntary and will not impact how the subject’s clinical exams are performed. 
Subjects may be included in the registry that are part of any of the following subpopulations 
studied:
1. ABUS/DBT Cohort – Subjects enrolled to the study where no imaging exams are 
required in the study period, as all required imaging exams, ABUS, and DBT, were 
completed within 30 days of enrolling in the study.
2. ABUS-only Cohort – Subjects recruited to the study that have already completed DBT 
before enrolling in the study and will undergo an ABUS exam during the study period. All 
exams should be completed in a 30-day window.
3. DBT-only Cohort – Subjects recruited to the study that have already completed ABUS
before enrolling in the study and will undergo a DBT exam during the study period.  All 
exams should be completed in a 30-day window.
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Following recruitment, a subject will be considered enrolled (the point of enrollment) once 
he/she signs and dates the informed consent form (ICF), except in cases where consent is 
waived in accordance with IRB determination (in which case enrollment is considered to start 
when the subject’s information is recorded and monitored by the Sponsor). Once enrolled, the 
subject will be assigned a unique subject number, which will not contain information that could 
identify the subject (such as subject name or date of birth). The unique subject number will be 
used to label study data throughout the study.
Criteria for Withdrawal/Discontinuation
4.6
A subject may withdraw from study participation and/or request that her data not be included in 
the registry at any time, for any reason. The investigator may withdraw a subject at any time, for 
any reason. The reasons for withdrawal and discontinuation for any subject shall be recorded. 
These will be reported to the Sponsor. The EC should be notified per their notification of subject 
withdrawal policy. Any data and images collected for the subject up until the time of withdrawal 
or discontinuation, may still be included in the study registry and provided to the Sponsor, 
unless the subject requests that their data not be used. The site shall document all requests by 
subjects regarding their data use.
5. STUDY PROCEDURES 
Subject Preparation
5.1
No preparation beyond that required by the site standard of care is required.
Description of Study Procedures
5.2
Patient Procedures
5.2.1
Data will be collected from exams performed on eligible women that have completed or will 
complete (within a 30 day window) DBT and ABUS exams for breast screening. If a subject has 
completed one or more of these exams, but not both, she will be asked to have the remaining 
exam(s) as during the study period. 
If a subject has already been prescribed exam(s) for her regular medical care, the exam will be 
performed as prescribed. All exams are performed on post-market devices according to the site 
standard of care at the site and may be used for medical management. 
The study does not require any therapeutic intervention or change in medical care. 
Site Image Reads
5.2.2
A clinician reader at the site will review DBT ABUS, and any additional imaging completed and 
the reader’s findings will be reported on a case report form (CRF) provided by the Sponsor and 
stored in the study registry. If a biopsy was performed and resulted in negative or benign 
cytology or histopathology, the reader will review the subject’s imaging and histopathology 
findings for concordance. If the imaging and histopathology findings are discordant, re-biopsy 
and resulting histopathology may be required per the site’s standard of care.
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Breast Cancer Status
5.2.3
The site determined breast cancer status (cancer/non-cancer) for each subject based on all 
available clinical information will be collected. Results of any additional exams prescribed for the 
subject’s regular medical care for breast cancer, including biopsy, MRI, HHUS, other imaging 
exams, and/or laboratory tests may be recorded and disclosed to the Sponsor and used in the 
study registry.
Follow-up
5.2.4
No in-office follow-up is required, except as necessary for the patient’s regular medical care. 
Medical records and subject contact (emails/phone calls) may be used to confirm follow-up 
results, or subjects may be contacted to follow-up during their regular clinical visits. To help 
increase follow up responses from patients and decrease dropout from the study, the following 
are options for follow up that can occur 12 months to 30 months after ABUS scanning for this 
study (for non-cancer patients)
!
Mammogram (FFDM or DBT)
!
MRI
!
Ultrasound (ABUS or HHUS)
!
Histology (surgery and/or biopsy)
!
If follow up imaging is unable to be collected within 18 months, clinical state assessment 
via chart review and/or follow up contact with the subject at 18 to 30 months. 
Positive cancer subject’s follow-up will be completed within 12-18 months after ABUS scanning 
for this study. Follow-up may be done by chart review and/or follow up contact with the subject.
6. STUDY DATA COLLECTION AND ASSESSMENTS
Data Collection for Subject Information and Breast Exams
6.1
A subject case report form (Subject CRF) will be provided by the Sponsor that includes the 
following:
!
Subject ID and demographics (including age, gender, ethnicity, and race)
!
Relevant medical history (at minimum pregnancy history, history of breast surgeries and 
interventions, history of breast cancer, history of hormone therapy, breast implants, 
radiation therapy involving chest wall, known gene mutations.)
!
DBT Exam Information (i.e. dates, breast density score, findings, etc.)
Note: To be included in the registry, an ABUS exam must be performed on a GE device.  When 
other automated and/or conventional ultrasound images are obtained incidentally outside of this 
study, those images and the make and model of the acquisition device may be collected and 
disclosed as part of study data. Data may be collected electronically, based on agreement 
between the Sponsor and investigator.
!
ABUS exam information (i.e. dates, views, findings, etc.)
!
Additional exam information (FFDM, HHUS, 2D Synthetic (2DS), CESM, and/or MRI)
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!
Histology information (i.e. procedures, results, etc.)
Data Collection for Follow-up
6.2
A follow-up case report form (Follow-up CRF) will be provided by the Sponsor. For subjects 
diagnosed with breast cancer prior to follow-up, this could include treatment/outcomes and 
follow up dates.  For subjects diagnosed non-cancer prior to follow-up, this could include type(s)
of follow-up (mammography, MRI, ultrasound, histology w/ concordance, chart review, and/or 
subject contact), information on any imaging, information on histology, etc.
Image Data Collection
6.3
The image data from the ABUS and DBT exams completed within 30 days of each other and 
within 30 days of enrollment will be collected after the subject enrolls in the research study.
If applicable and available, other exams, such as additional ABUS and DBT, FFDM, HHUS, 2D 
Synthetic (2DS), CESM, or MRI exams completed up to 30 days prior to enrollment until subject 
completion of study will be collected after the subject enrolls in the research study.
Sites will use a standard anonymization process to de-identify all image data collected for this 
study.
Safety Assessments
6.4
The description, severity, and device relatedness of any AE or SAE occurring during the study 
will be recorded. AE/SAEs will be recorded that occur during the study period, whether the 
exam is prescribed outside of the study or performed as part of the study (after the subject is 
enrolled). Data and images may be collected observationally from ABUS and DBT or other
imaging exams performed prior to the date that a subject enrolls in the study (within a 30-day
window), but safety events occurring before the enrollment in the study may not be tracked (this 
data may, however, be collected to supplement the registry data, when available). Subjects will, 
if necessary, be provided with emergency care. In the event of any device issues, the event will 
be recorded. Safety reporting will be conducted as described in this protocol.
7. QUALIFICATION AND TRAINING PLAN
Study Staff and Reader Qualifications
7.1
All members of the study staff participating in the conduct of the investigation shall be qualified 
by education, training, and/or experience to perform their tasks, and this shall be documented 
appropriately, as per applicable regulatory requirements for the conduct of observational trials.
All image readers will be qualified to practice according the local requirements of the site. The 
Sponsor may request copies of the medical license, curriculum vitae, years in practice, and 
other information about the study readers to confirm qualification to assess images.
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reddening, and hair loss. There are no known additional risks or side-effects specific to 
tomosynthesis aside from the radiation risk associated with all imaging tests involving ionizing 
radiation. Risks associated with FFDM and DBT exams include:
!
Discomfort
!
Skin irritation
!
Bruising
!
Abrasions or tears in the skin
Participating in this study does not change the type or dose of x-ray radiation any subject will 
receive. Thus, the chance of these risks occurring will not be changed or increased by 
participating in this study.
Reporting Unexpected Risks
8.1.3
Because this study spans a multi-year period, it is expected that many subjects will have 
unrelated medical care during the study period. All adverse events that occur while the subject 
is having ABUS, DBT exams under study should be reported, whether or not related to the 
study devices. Adverse events that may be related to study exams or devices should be 
reported throughout the study period. It is not required to report incidental illness or medical 
events between follow-up visits that are not considered related to breast health.
There is always a chance of unexpected risks. Throughout the study, the Sponsor will evaluate 
and update safety information in study documents. 
Adverse Event Definitions
8.2
Adverse Event (AE): any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device [ISO 14155:2011 3.2]. This 
includes events related to the investigational device or the comparator and to the procedures 
involved. For users or other persons, this is restricted to events related to the investigational 
medical device.
Serious Adverse Event (SAE): an adverse event that led to death; led to a serious 
deterioration in the health of the subject, that either resulted in a life-threatening illness or injury, 
a permanent impairment of a body structure or a body function, or in-patient or prolonged 
hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function; or led to fetal distress, fetal death or 
a congenital abnormality or birth defect. Planned hospitalization for a pre-existing condition, or a 
procedure required by the protocol without serious deterioration in health, is not considered a 
SAE [ISO 14155:2011 3.37].
Adverse Device Effect (ADE): an adverse event related to the use of an investigational 
medical device [ISO 14155:2011 3.1]. This includes any adverse events resulting from 
insufficient or inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. This includes any event that 
is a result of a user error or intentional misuse of the investigational device [ISO 14155:2011 
3.43].
Serious Adverse Device Effect (SADE): an adverse device effect that has resulted in any of 
the consequences characteristic of a serious adverse event [ISO 14155:2011 3.36].
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Device deficiency: an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance, such as malfunctions, use errors, and inadequate 
labelling [ISO 14155:2011 3.15].
Unanticipated serious adverse device effect (USADE): a serious adverse device effect,
which by its nature, incidence, severity, or outcome has not been identified in the current 
version of the risk analysis report [ISO 14155:2011 3.42]. In the United States, any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the study documents, will be reported in accordance with 21 
CFR §812.3 and applicable laws and regulations.
Documentation of Safety Events
8.3
All adverse events (AE), including all serious adverse events (SAE), are required to be 
collected, investigated, and documented during the study reporting period, as defined in the 
study procedure set forth in this protocol. Documentation will include:
!
Description of Event
!
Date of onset and resolution 
!
Severity (mild, moderate, or severe) 

Mild: Symptom(s) barely noticeable to the subject or does not make the subject 
uncomfortable. The AE does not influence performance or functioning. 
Prescription drugs are not ordinarily needed for relief of symptom(s).

Moderate: Symptom(s) of a sufficient severity to make the subject uncomfortable. 
Performance of daily activities is influenced. Treatment of symptom(s) may be 
needed.

Severe: Symptom(s) of a sufficient severity to cause the subject severe 
discomfort. Treatment for symptom(s) may be given.
!
Serious (yes/no) 
!
Causal relationship to investigational medical device? (not related, possibly related, or 
related)

Not related: The adverse event is reasonably expected to be related to (or 
caused by) a concurrent illness, effect of another device/drug or other cause, and 
is unlikely related to the investigational product.

Possibly related: The adverse event is reasonably expected to be related to the 
investigational product, and an alternative etiology is equally or less likely 
compared to the potential relationship to investigational product.

Related: There is a strong relationship to investigational product or recurs on re-
challenge, and another etiology is unlikely or there is no other reasonable 
medical explanation for the event.
!
Treatment given and/or action taken (procedure stopped, withdrawn from study, or no 
action)
!
Anticipated (yes/no)
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Reporting of Safety Events and Device Complaints
8.4
The following events are to be reported to the Sponsor within 72 hours of the event occurrence 
and to the EC per their policy:
!
All SAEs and USADEs
!
All device issues that could possible lead to an SAE
Additional follow-up information may be requested by the Sponsor. In addition, safety 
information may be shared with regulatory agencies and other participating sites, as required by
applicable law and regulation.
Device Complaints
8.5
This is a post-market study of commercially available devices that are manufactured by GE and 
other manufactures. Issues with post-market devices should be reported to the manufacturer of 
the device. For device issues reported for the GE ABUS device or other GE devices observed in 
the study, issues should be reported to the Sponsor and will be handled according to the 
Sponsor’s procedures for handling post-market complaints regarding commercial products. 
Device complaints should be reported to the study Sponsor contact identified on the cover page 
of this protocol. 
All device complaints should be collected, fully investigated, and documented in the source 
document. The Principal Investigator is responsible for notifying the Sponsor in the event that 
there is any device issue that could potentially lead to a SAE or otherwise pose a safety risk to 
subjects or operators.
9. ETHICAL CONDUCT OF THE STUDY
The study will be carried out in accordance with the protocol and with principles enunciated in 
the current version of the Declaration of Helsinki; the guidelines of Good Clinical Practice (GCP)
for medical devices, as set forth by ISO 14155:2011 and ISO 14971:2010; applicable sections 
of US FDA 21 CFR; and applicable regulatory authority’s requirements in the United States.
The study will be conducted and reported in accordance with applicable policies of the site’s 
governing Ethics Committee (EC) and governing regulatory authorities.
Ethics Committee
9.1
The responsible Principal Investigator at each site will ensure that approval from an 
appropriately constituted EC is attained for the clinical study prior to enrolling subjects, and 
Principal Investigator will ensure that documentation of approval is maintained for the duration 
of the study. 
The Principal Investigator will ensure that the Sponsor is notified of any withdrawal of EC 
approval within 5 working days of such occurrence. If approval is terminated or suspended, the 
Principal Investigator will promptly notify the Sponsor and provide written explanation.
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Regulatory Agencies and Competent Authority(ies)
9.2
No prospective regulatory approval is required for post-market studies conducted in the United States. 
Any additional requirements imposed by the EC or regulatory authority shall be followed, where
applicable.
Management of Protocol Modifications and Amendments 
9.3
Substantial amendments will only be implemented after approval of the EC. 
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the 
requirements of the protocol. Under emergency circumstances, deviations from the protocol to 
protect the rights, safety, and wellbeing of human subjects may proceed without prior approval 
of the Sponsor and the EC/competent authority (CA). Such deviations shall be documented and 
reported to the Sponsor and the EC as soon as possible. Deviations will be reported as:
!
Critical Deviations: Deviations that significantly affect the safety, efficacy, integrity, or 
conduct of the study. These deviations must be reported to the Sponsor no later than 5 
working days from awareness of occurrence and reported to the EC per the deviation 
reporting policy. 
!
Non-Critical Deviations: Protocol deviations that do not significantly affect the safety, 
efficacy, integrity, or conduct of the trial. These deviations must be documented on the 
CRF Protocol Deviation page and will be reviewed by the study monitor.
Non-substantial modifications may be made during the normal course of device optimization, 
maintenance, and feasibility testing. Non-substantial modifications will be communicated to the 
CA as soon as possible, if applicable, and to the EC per their policy. 
Participant Information and Informed Consent
9.4
Where required by the governing IRB, evidence of written informed consent will be attained. 
During the process of consenting, the investigators will explain to each participant the nature of 
the study, its purpose, the procedures involved, the expected duration of exposure to the 
investigational device, the potential risks and benefits, and any potential discomforts. Consent 
will include informing the patient that participation in the study is voluntary, that she may 
withdraw from the study at any time, that withdrawal of consent will not affect her subsequent 
medical assistance and treatment, and that her medical records may be examined by 
authorized individuals other than her treating physician. The informed consent form will describe 
the study and providing sufficient information to allow the participant to make an informed 
decision about her participation in the study. 
Informed consent documents will be subject to approval by the IRB prior to enrolling subjects in 
the study. Informed consent may not be required for some populations under study, at the 
discretion of the governing IRB at each participating site. In the event that any population/site
qualifies for waiver of consenting requirements in accordance with local IRB requirements, a 
copy of the IRB determination will be stored in site regulatory binders and in the Sponsor’s 
Clinical History File (CHF).
Where evidence of written informed consent is required by the governing IRB, the participant 
shall be provided time to read and consider study information and will then sign and date the 
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11. QUALITY ASSURANCE AND CONTROL
Data Management
11.1
Data management processes for handling study data will be maintained by the Sponsor.
Completion of Case Report Forms (CRFs)
11.1.1
The data reported on the CRFs shall be derived from source documents and be consistent with 
these source documents. Paper CRFs and/or electronic CRFs (eCRFs) will be used to collect 
data. The Sponsor will provide CRFs and train study staff on completion of CRFs using Good 
Documentation Practices (GDP). CRF Completion Guidelines (CCG) may be provided by the 
Sponsor to help facilitate training.
CRFs are to be completed as information becomes available at the site. CRFs should be signed 
by indicated parties, in indicated area(s), to certify the contents of the form. The Principal 
Investigator is ultimately responsible for ensuring completion of CRFs.
If discrepancies are discovered on CRFs during monitoring, the Sponsor’s representative will 
ensure that the study staff makes necessary corrections directly to the CRF(s) prior to 
collection. 
Following CRF collection, the Sponsor will review the data. A Data Clarification Form (DCF) 
may be provided to the site to correct or clarify discrepancies.
If a site discovers discrepancies after CRF collection, the site may notify the Sponsor and 
request data modification.
Data Handling and Record Keeping 
11.1.2
All documents and data shall be produced and maintained in a manner that assures control and 
traceability.
Source Data and Documents
11.1.3
Source data includes information in original records, certified copies of original records of 
clinical findings, observations, or other activities for the study. Source documents for each 
subject must be retained throughout the investigation, including printed or electronic documents 
containing source data. Elements should include:
!
Source data and documentation relevant to data recorded for subject screening and 
CRF corroboration.
!
Subject records containing the completed ICFs and CRFs 
!
Regulatory binder containing the protocol and any subsequent amendments, EC 
submissions and approvals, blank ICF(s), and site logs
!
Reference manuals containing investigator responsibilities, Sponsor, AE/SAE and 
informed consent guidelines, applicable study aids, and training materials
The Principal Investigator or institution shall provide direct access to source data during and 
after the clinical investigation for monitoring, audits, EC review, and regulatory authority 
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inspections. The source data available to the Sponsor will include the original ABUS images, 
any screen-based images, and associated acquisition protocols.
Archiving
11.1.4
All study data must be archived for a minimum of 2 years after study termination or premature 
termination of the clinical trial, in accordance with applicable laws and regulations. No source 
documents or study records will be destroyed without Sponsor notification and approval.
12. MONITORING PLAN
In collaboration with the site, the Sponsor will ensure proper monitoring of the study to confirm 
that all the research requirements are met. Monitoring visits will oversee the progress of a 
clinical investigation and ensure that it is conducted, recorded, and reported in accordance with 
the protocol, written procedures, Good Clinical Practice (GCP) ISO 14155:2011, and the 
applicable regulatory requirements.
Confidentiality and Data Protection
12.1
The investigator agrees to affirm and uphold the principle of the participant's right to privacy,
and the investigator shall comply with applicable privacy laws. Especially, anonymity of the 
participants shall be guaranteed when presenting the data at scientific meetings or publishing 
data in scientific journals. Individual subject medical information obtained as a result of this 
study will be considered confidential, and disclosure to third parties will be prohibited. Subject 
confidentiality will be further ensured by utilizing subject identification code numbers. For data 
verification purposes, authorized representatives of the Sponsor, a competent authority (CA), or 
an ethics committee (EC) may require direct access to parts of the medical records relevant to 
the study, including subject medical history.
Storage of Images and Associated Health Data
12.1.1
Electronic images and associated data will be collected and disclosed to the Sponsor as part of 
this study. Fully de-identified data, which has had all personal identifying information removed, 
may be stored, used, and disclosed by the Sponsor indefinitely. The PI as well as the Sponsor 
and/or its authorized representatives may use any de-identified data collected in this study for 
future technology and engineering development, marketing purposes, education, regulatory 
submissions, publications, or other possible uses.
Publication Policy
12.2
The results of this study may be used in future publications, with agreement from the PI and the 
Sponsor. The conditions of publication are described in a separate contractual agreement.
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REFERENCES
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breast symptoms. American Cancer Society. 2016. Available at: 
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http://www.cancer.org/cancer/breastcancer/moreinformation/breastcancerearlydetection/breast-
cancer-early-detection-acs-recs. Accessed Oct 2016, 18.
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