The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
Phase: NA
Conditions: Breast Biopsy
Sponsor: University of Alabama at Birmingham

The Role of Pre-deployment Retraction in Decreasing Biopsy 
Clip Migration During Stereotactic Breast Biopsies 
 
Study Protocol & Statistical Analysis Plan 
 
NCT04398537 
 
 
Date of Last Protocol Approval- 05-Apr-2023 
 
 
Stefanie Woodard, D.O., Associate Program Director, Diagnostic 
Radiology Residency Program 
Associate Professor, Breast Imaging Section, Principal 
Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 

Evaluating the position of a breast biopsy clip introducer and whether or not retraction 
prior to deployment results in less clip migration  
 
 
Principal Investigator: 
Stefanie Woodard, DO 
Assistant Program Director, Radiology Residency Program 
Assistant Professor 
Breast Imaging Section 
UAB Department of Radiology  
JTN 353, 619 19th Street South 
Birmingham AL 35249-6830 
(205) 801-7735  
Email: swoodard@uabmc.edu 
 
Original Protocol:  
 
4/09/2020 
 
 
1. STUDY DESIGN / SUMMARY:  
 
This will be a single-center prospective randomized control trial that IRB-approved study. We plan to 
enroll 250 female patients presenting to UAB for stereotactic biopsy. This study is a prospective will 
target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on 
spanning approximately six months’ time. Patients will be entered into the study only based on their 
already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be 
offered the opportunity to participate or not participate in the study. Their participation is completely 
voluntary. This study will not involve any intervention that is not already a part of standard care. Patients 
will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 
mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to 
deployment. 
2. BACKGROUND AND RATIONALLE 
 
Clip placement after stereotactic biopsy in breast imaging procedures has been an important part of 
breast imaging for years. There have been numerous studies documenting clip migration, and it is now a 
well-known phenomenon.  Numerous case reports describe varying locations of clips following biopsy, 
some being as much as 5 cm from the biopsy site. This creates a problem in both benign and malignant 
diagnoses. In the setting of a benign biopsy, a clip remains important to provide correlation with a biopsy 
finding and the original suspicious mammographic site. In malignant diagnoses, the implication is more 
significant as the clip provides the localization site for excision. Clip migration has been suspected as the 
cause of up to 60% margin positivity (vs 0% when localizing the biopsy site by using hematoma 
identification) in breast cancer cases.1 Although there have been recommended methods of deployment, 
vacuuming of cavity, release of compression after biopsy, and first post-biopsy mammography 
positioning techniques, there has been no prospective study assessing technique of clip retraction prior 
to deployment. Our hypothesis is that retracting to clip 5 mm before clip deployment will help to decrease 
clip migration. This will help improved accuracy of biopsy site localization and in cases of malignancy, will 
allow for less complicated, better localized, and improved results of tumor targeting for surgical resection.  
3. OBJECTIVES 
 
 
3.1 
Primary Objective 
 

To determine which method decreases clip migration better, retracting the clip deployment 
apparatus 5 mm before deployment or not retracting. 
 
3.2 
Secondary Objectives 
 
3.2.1 Compare different breast densities (entirely fatty, scattered fibroglandular densities, 
heterogeneously dense, extremely dense) and their impact on clip migration in both 
groups (retracted vs nonretracted). 
 
3.2.2 Compare different approaches (lateral, medial, superior) to biopsy and evaluate if they 
have an impact on clip migration in both groups (retracted vs nonretracted). 
 
3.2.3 Evaluate if thinner or thicker breasts result in more or less clip migration in both groups 
(retracted vs nonretracted). 
 
3.2.4 Evaluate if patient’s age correlates with more or less clip migration in both groups 
(retracted vs nonretracted). 
 
4. PARTICIPANT SELECTION 
 
     This will be a single-center randomized control prospective IRB-approved study. We will enroll 250 
female patients presenting to have stereotactic breast biopsy procedures. We will approach all 
stereotactic biopsy patients (less excluded patients), targeting 300 with the goal of 250 by 1 year.  
 
4.1 
Inclusion Criteria 
 
All 18-99 year-old healthy females with recommendation for stereotactic biopsy. 
 
4.2 
Exclusion Criteria 
 
4.2.1 
If there is no clip present on post-clip mammography, the patient will be excluded from the 
trial (even if a clip was replaced).  
4.2.2 
If 2 clips were placed (due to one not being seen initially), the patient will be excluded.  
4.2.3 
Patients who have undergone reduction mammoplasty will also be excluded as this has been 
discussed as a potential reason for clip migration8.  
4.2.4 
No pregnant females will be included. There will be no males included.  
4.2.5 
There will be no mentally impaired patients included. 
4.2.6 
No non-english speaking patients included in the study.  
4.2.7 
There will be no prisoners included in this study.  
4.2.8 
Inability to provide written informed consent 
4.2.9 
Males will not be included. 
4.3 
Inclusion of all races and ethnic groups are eligible for this trial. There is no bias towards age 
or race in this trial.  
 
 
5. RECRUITMENT AND SCREENING 
 
5.1 
Recruitment Process 
 
Patients will be presenting to the The Kirklin Clinic at The University of Alabama at Birmingham, 
Fifth floor Mammography for the purpose of previously recommended stereotactic biopsy. The study 
coordinator, PI, or participating attending radiologist will arrange the interview and provide all data for 
entry in a secure web-based research database. 
 

5.2 
Screening Process 
 
The study coordinator, PI, or participating attending radiologist will screen potentially eligible 
patients.  
 
 
6. PROTOCOL PROCEDURES, METHODS, AND DURATION (LAYMAN’S DESCRIPTION) 
 
After confirmation of patient eligibility, the study coordinator, PI, or participating attending radiologist 
will obtain written informed consent. The informed consent process may take up to 10 minutes. The 
patients will be discharged from the study after data has been recorded.  
 
Standard of Care:  
 
The stereotactic biopsy will proceed as normally scheduled. This procedure involves the patient 
presenting to the fifth floor of The Kirklin Clinic (TKC) at The University of Alabama at Birmingham. 
Once she checks in, she is escorted to a changing room where she changes into a gown. She is then 
has brought back to the biopsy suite by the technologist. The technologist reviews the biopsy 
procedure with the patient. The attending radiologist then is notified and joins the technologist and 
patient in the biopsy suite. The radiologist reviews the biopsy with the patient and obtains informed 
consent.  
 
 
Study protocol:  
 
After informed consent for the procedure, the radiologist will discuss the study with the patient after 
the patient. The patient will have time to ask questions and the radiologist will provide answers. If the 
patient expresses understanding and agrees to participate in the study, consent will be obtained in 
written form on a document separate from her biopsy consent document. This will be placed in a 
secure location and locked in a cabinet in the mammography department on the fifth floor TKC, 
accessible only to the PI. 
 
Standard of Care: 
 
The procedure will take place as normally planned with the patient being positioned in craniocaudal 
(CC), lateral-medial (LM), or medial-lateral (ML) position determined by the radiologist ahead of time. 
The choice of positioning is decided on by the radiologist based on experience and best pathway to 
obtain to target. Images are obtained to verify the target location. The skin is cleaned and skin/breast 
anesthetized. A needle (9 gauge 10 cm Eviva vacuum-assisted needle attached to an ATEC vacuum 
suction machine) is placed to obtain the sample of the biopsy target. The tissue undergoes x-ray 
imaging to ensure adequate sampling of tissue. Once sampling is considered appropriate, standard 
steps are performed in the following manner: 
1. After biopsy, the cavity is flushed with sterile saline. 
2. Tubing is disconnected to allow for suction of fluid from the biopsy cavity. Samples are retrieved 
from the collection chamber. 
3. ATEC machine is placed on biopsy setting until visualization of x-rayed specimens 
4. When samples are determined to be adequately retrieved, the clip will be placed (the same clip 
will be chosen for all procedures to improve standardization unless the attending radiologist 
determines another clip would be needed). 
5. Biopsy clip is then advanced to the site. 
At this point, everything performed will is be routine. 
 
Study protocol: 
 
Arm 1: Advancing the clip to the biopsy site and deploying.  

 
Arm 2: Advancing the clip to the biopsy site and retracting 5 mm and then deploying.  
 
Standard protocol 
 
After imaging is obtained to ensure that the clip is visualized, the introducer and clip are removed 
together. 
 
Patient is then slowly released from mammographic compression maintaining pressure on the breast 
for at least five minutes. Slow release of pressure is performed. 
 
The patient is then informed of post-biopsy changes. Pressure is held until hemostasis is achieved 
and a sterile skin glue is applied to the skin incision at the entrance site of the biopsy needle. 
 
A two-view mammogram is performed with the first image obtained in the same position as the 
biopsy is performed. 
 
Clip migration will be measured on the post-biopsy mammogram compared to the pre-biopsy 
mammography exam. Clip migration will be measured by the location of the clip with respect to the 
biopsy site on the immediate post-clip mammography images. While delayed clip migration has been 
found in case reports, the number of cases of this phenomenon is not felt to warrant additional 
mammography exams for this study.8 The millimeters of clip migration will be measured on the CC 
view and on the true lateral (ML or LM) views. Although migration usually only occurs in one plane, 
both planes will be reviewed and if there is migration in two planes, one component factor 
(Pythagorean Theorem as has been used on prior studies1) will be calculated. 
 
We will consider significant migration is anything greater than 10 mm from the biopsy site. The use of 
10 mm has been documented on prior studies and will be considered as a differentiation point in this 
study between significant and nonsignificant movement. A further reason for the use of the 10 mm 
cut off is that at this institution, Savi Scout devices are commonly used for localization. This device is 
12 mm long and can accurately be placed at a location bridging the biopsy site and biopsy clip. Any 
complications will be reported. 
 
7. RISKS 
 
7.1 
Breach of Confidentiality – There is an unlikely potential risk of a breach of confidentiality.  
 
7.2 
Radiation – Study participants will be exposed to radiation from the mammography imaging. 
There is an extremely low risk that the radiation may cause cancer or other radiation effects 
years after the study. Exposure to the radiation through this study is a part of routine 
healthcare. 
 
7.3 
Risk of an Unexpected Imaging Finding – There is a risk that an unexpected imaging finding 
could be detected. In many cases, these are of benefit to the patient, such as detection of a 
unexpected cancer. In some cases, the unexpected finding may be indeterminate, such as a 
renal mass that is not clearly benign or malignant. Indeterminate findings may need additional 
workup that will not be covered as a part of this study. 
 
 
8. PRECAUTIONS / MINIMIZATION OF RISKS 
 
Participants will be monitored by study personnel for risks—physical, psychological, social, 
economic, and/or legal—that participants may encounter during their participation in this study 
or as a result of DECT imaging and data collection required in this protocol.  

 
8.1 
Breach of Confidentiality – The research team is experienced and will utilize best practices to 
avoid a breach of confidentiality.  The risk of confidentially will be minimized by collecting only 
the data that is required by the study, labeling all data forms and samples with a coded 
identifier, and maintaining all study records in locked files or password-protected computer 
files. 
 
8.2 
Radiation – The radiation used in this study is a part of the patient’s standard of care. No 
additional radiation is being used due to the study. 
 
8.3 
Risk of an Unexpected Imaging Finding – All of the research DECT liver CTs will be 
interpreted by a radiologist, a physician with expertise in CT imaging. A formal report will be 
placed permanently in the electronic medical records. Clinically significant unexpected 
imaging findings will be communicated by phone with the gastroenterologist, per standard of 
care at UAB.   
 
 
9. BENEFITS 
 
If our hypothesis is true that retracting the clip 5 mm before clip deployment will help to decrease clip 
migration, this will help improved accuracy of biopsy site localization and in cases of malignancy, will 
allow for less complicated, better localized, and improved results of tumor targeting for surgical 
resection. If the hypothesis does not hold true, than this method of clip deployment should no longer 
be used as it does nothing to improve clip migration. 
 
10. ALTERNATIVES 
 
This is not a treatment study. The alternative is to not participate in this study. 
 
 
11. DATA AND IMAGE ANALYSIS 
 
11.1 
Image Evaluation and Analysis: Clip migration will be measured on the post-
biopsy mammogram compared to the pre-biopsy mammography exam. Clip migration will be 
measured by the location of the clip with respect to the biopsy site on the immediate post-clip 
mammography images. While delayed clip migration has been found in case reports, the 
number of cases of this phenomenon is not felt to warrant additional mammography exams 
for this study.8 The millimeters of clip migration will be measured on the CC view and on the 
true lateral (ML or LM) views. Although migration usually only occurs in one plane, both 
planes will be reviewed and if there is migration in two planes, one component factor 
(Pythagorean Theorem as has been used on prior studies1) will be calculated. 
 
11.2 
We will consider significant migration is anything greater than 10 mm from the 
biopsy site. The use of 10 mm has been documented on prior studies and will be considered 
as a differentiation point in this study between significant and nonsignificant movement. A 
further reason for the use of the 10 mm cut off is that at this institution, Savi Scout devices are 
commonly used for localization. This device is 12 mm long and can accurately be placed at a 
location bridging the biopsy site and biopsy clip. Any complications will be reported. 
 
 
12. STATISTICAL CONSIDERATION: 
This is a single-center prospective randomized study to assess two techniques of clip 
retraction prior to deployment and to determine which method decreases clip migration better, 

retracting the clip deployment apparatus 5 mm before deployment or not retracting. This will help 
improved accuracy of biopsy site localization and in cases of malignancy, will allow for less 
complicated, better localized, and improved results of tumor targeting for surgical resection.   
 
12.1 Sample size justification 
 
A total of  250 female patients presenting to UAB for stereotactic biopsy will be randomly 
assigned as 1:1 ratio to Arm1 (n=125) with advancing the clip to the biopsy site and deploying, or 
Arm2 (n=125) with advancing the clip to the biopsy site and retracting 5 mm and then deploying.  Our 
hypothesis is that retracting to clip 5 mm before clip deployment will decrease clip migration, e.g. only 
20% or less of breast biopsy patients  who will have significant migration (greater than 10 mm from 
the biopsy site) while advancing the clip to the biopsy site and deploying without  retracting will have 
at least of 50% significant migration. This size of 125 in each arm will have 99.9% power to test 30% 
difference (20% vs 50%) or >90% power to test at least 20% difference in proportion of patients who 
will have significant migration using one-sided Fisher's Exact test at 5% significant level (Table 1).  
 
Table 1 Statistical Power to Test Differences Between Two arms. 
Significant 
migration  
in Arm1 
(%) 
Significant 
migration 
in Arm2 
(%) 
Type I 
error 
(%) 
Power 
(%) 
50 
15 
5 
100 
50 
20 
5 
99.9 
50 
25 
5 
99.1 
50 
30 
5 
93.1 
50 
15 
1 
100 
50 
20 
1 
99.6 
50 
25 
1 
95.4 
50 
30 
1 
78.5 
 
A sample size of 125 will also produce two-sided 95% confidence interval to estimate the mean distance of 
migration with 0.177 standard deviation to the limits for each arm. Patients enrollment is expected to be completed 
within one year. 
 
 
13.2 Statistical analysis plan 
 
The primary objective of the number and percentage of breast biopsy patients whose clip has 
greater than 10 mm from the biopsy site as significant clip migration will be estimated and two-sided 
95% confidence interval will be calculated using the method of Clopper–Pearson interval for each arm 
separately. Fisher exact test will be used to examine if there is significant association between arms in 
proportion of significant clip migration. The average of distance of clip migration will be estimated with 
two-sided 95% CI for each arm separately using normal approximation. Two-group student t-test will 
be used to evaluate the mean difference in the distance of migration from the original biopsy site 
between arms. 
Correlation between migration and breast densities (entirely fatty, scattered fibroglandular densities, 
heterogeneously dense, extremely dense), different approaches (lateral, medial, superior) to biopsy, 
if thinner or thicker breasts and age under procedure of retracted (arm2) vs nonretracted (arm1) will 
be evaluated in two ways for the secondary objectives. First, we will consider significant clip 
migration (yes, no) as binary outcome. Analysis of Variance method (ANOVA) will be used to 
compare age differences with controlling of procedures, and Cochran -Mantel-Haenszel Test will be 

used to compare differences in categorical variables, e.g. breast density stratified by retracted (arm2) 
vs nonretracted (arm1). Logistic regression analysis will be explored to identify significant factors 
associated with clip migration. Odds ratio and two-sided 95% CI will be presented for each factor 
significantly contributed in the model.  Second, we will consider distance of clip migration (mm) as 
continuous outcome. ANOVA will be used to evaluate the strength of association (beta coefficient in 
the regression model) and identify significant of factors associated with the distances of migration.  
All analysis will be carried out with Statistical software SAS v9.4. 
 
 
REFERENCES 
1. 
Kass R, Kumar G, Klimberg S, et al. Clip migration in stereotactic biopsy. Am J Surg 
2002;184:325–31.  
2. 
Margolin FR, Kaufman L, Denny SR, Jacobs RP, Schrumpf JD (2003) Metallic marker placement 
after stereotactic core biopsy of breast calcifications: comparison of two clips and deployment 
techniques. Am J Roentgenol 181(6):1685–1690Rosen EL, Vo TT. Metallic clip deployment during 
stereotactic breast biopsy: retrospective analy- sis. Radiology 2001; 218:510 –516.  
3. 
Birdwell RL, Jackman RJ. Clip or marker migration 5-10 weeks after stereotactic 11-gauge 
vacuum-assisted breast biopsy: Report of two cases. Radiology 2003;229:541–4.  
4. 
Philpotts LE, Lee CH. Clip migration after 11-gauge vacuum-assisted stereotactic biopsy: Case 
report. Radiology 2002;222:794–6.  
5. 
Burbank F, Forcier N. Tissue marking clip for stereotactic breast biopsy: initial placement 
accuracy, long-term stability, and usefulness as a guide for wire localization. Radiology 1997; 
205:407– 415.  
6. 
Liberman L, Dershaw DD, Morris EA, et al. Clip placement after stereotactic vacuum-assisted 
breast biopsy. Radiology 1997;205:417–22.  
7. 
Reynolds HE. Marker clip placement following directional, vacuum-assisted breast biopsy. Am 
Surg 1999;65:59–60.  
8. 
Esserman LE, Cura MA, DaCosta D. Recognizing pitfalls in early and late migration of clip 
markers after imaging-guided directional vacuum-assisted biopsy. Radiographics 2004;24:147–56.  
9. 
Burbank F. Mammographic findings after 14-gauge automated needle and 14-gauge directional 
vacuum-assisted stereotactic breast biopsies. Radiology 1997; 204:153-156. 
10. 
Uematsu T, Kasami M, Takahashi K, et al. Clip placement after an 11-gauge vacuum-assisted 
stereotactic breast biopsy: Correlation between breast thickness and clip movement. Breast 
Cancer 2012;19: 30–6.  
11. 
Burnside ES, Sohlich RE, Sickles EA. Movement of a biopsy-site marker clip after completion of 
stereotactic directional vacuum-assisted breast biopsy: Case report. Radiology 2001;221:504–7.  
12. 
Pinkney DM, Mychajlowycz M, Shah BA. A prospective comparative study to evaluate the 
displacement of four commercially available breast biopsy markers. Br J Radiol. 2016;89(1065). 
13. 
Rosen EL, Baker JA, Soo MS. Accuracy of a collagen-plug biopsy site marking device deployed 
after stereotactic core needle breast biopsy. AJR Am J Roentgenol. 2003 Nov;181(5):1295-9.  
 

Page 1 of 6
Version Date:  2/11/2022
CONSENT FORM
TITLE OF RESEARCH:
The role of pre-deployment retraction in decreasing biopsy 
clip migration during stereotactic breast biopsies
IRB PROTOCOL NO.:
IRB-300005277
INVESTIGATOR:
Stefanie Woodard, DO
SPONSOR:
UAB Department of Radiology
General Information
You are being asked to take part in a research study. This research 
study is voluntary, meaning you do not have to take part in it. The 
procedures, risks, and benefits are fully described further in the 
consent form.
Purpose
The purpose of the study is to see if the technique used to place the 
breast biopsy clip, which is a tiny piece of titanium used to identify the 
site of your biopsy, can reduce the movement of the clip after the 
placement. 
Duration & Visits
You will be in this study for one visit. This visit will last up to two 
hours. 
Overview of 
Procedures
This study will include the standard of care breast biopsy. You will be 
randomized (like a flip of a coin) to one of two groups. In one group, a 
clip deployment device will be inserted and clip placed. In the second 
group, 5 mm of withdrawn of the device will be performed prior to 
clip deployment. Both techniques are currently used by physicians. 
We will not know prior to you consenting to participate which group 
you will be assigned.
Risks
The most common risks include bruising and swelling in the breast, 
infection or bleeding at the biopsy site. The clip may or may not be 
placed correctly at the biopsy site regardless of the technique. 
Benefits
You may or may not benefit from this study, but the information may 
be useful is helping improve breast biopsies in the future.
Alternatives
If you do not want to take part in the study, you will continue your 
treatment and imaging ordered by your doctor without any 
consequence.
Purpose of the Research
We are asking you to take part in a research study. The purpose of this study is to compare two 
techniques used to place a clip during a breast biopsy procedure. We are comparing if the 
technique used to place the breast biopsy clip could reduce the movement of the clip.
This study will recruit 251 patients from the University of Alabama at Birmingham. 
UAB IRB
Approved
21-Feb-2022
until
25-May-2022

Page 2 of 6
Version Date:  2/11/2022
Explanation of Procedures
You have been referred to diagnostic mammography to have a procedure called a breast 
biopsy. You will be seen by a Breast Radiologist as a part of your routine clinical care.
There will be no special test or scans related to this study. You will receive standard of care 
treatment. By deciding to participate in this study, you are giving permission for the Principal 
Investigator and staff to review your medical records.
If you take part in this study, you will be assigned to one of two groups:
the clip is placed by inserting the clip-placing instrument into the site of the biopsy then 
withdrawing it by 5 mm where the clip is placed.the clip is placed by inserting the clip-placing 
instrument into the site of the biopsy where the clip is placed without withdrawing the 
instrument.
You will be randomized (like a flip of a coin) to one of the groups. Both techniques are currently 
used by physicians. We will not know prior to you consenting to participate which group you 
will be assigned.
The breast biopsy procedure you will be undergoing is the standard of care stereotactic 
(mammographic-guided) breast biopsy. It will involve cleaning the skin and making the area 
numb by injecting numbing medicine with a small needle. The area of concern in your breast 
will be identified and a needle will be placed into the breast to obtain a small sample of breast 
tissue. After we complete the biopsy, the clip will be placed using one of the two techniques 
described above. Biopsy clip placement is standard of care for all breast biopsies. There are 
different ways to place the clip and we will be using one of two ways to place the clip in your 
breast. Both methods are used by many different doctors. At the end of the procedure, we 
perform a post-biopsy (two-view) mammogram, which is also standard of care for every biopsy.
Your participation in this study will only be one visit. The visit will be your standard of care 
breast biopsy at The Kirklin Clinic (TKC). When you arrive at the TKC the research staff will be 
available to answer any questions regarding the procedure and consent form. This will take 
approximately 30 minutes. After you have signed the consent the breast biopsy will take up to 
one hour.
Risks and Discomforts
If you decide to participate, you will be assigned to a treatment arm (retracting the clip and not 
retracting) by chance, like the flip of a coin. The treatment you are assigned may prove to be
less effective or have more side effects than the other study group or alternatives; however, 
both treatment arms are routinely used in patient care.  Regardless, the general risks of breast 
biopsies include: bruising and swelling in the breast, infection or bleeding at the biopsy site. The 
clip may or may not be placed correctly at the biopsy site regardless of the technique. As far as 
anyone knows, these risks are equivalent for both techniques.
Benefits
You may or may not benefit directly from taking part in this study. However, this study may 
help us better understand how to improve breast biopsies in the future. This may also 
ultimately improve the outcomes for patients with breast cancer.

Page 3 of 6
Version Date:  2/11/2022
Alternatives
The alternative is to not take part in this study.
Confidentiality and Authorization to Use and Disclose Information for Research Purposes
Federal regulations give you certain rights related to your health information. These include the 
right to know who will be able to get the information and why they may be able to get it. The 
study doctor must get your authorization (permission) to use or give out any health information 
that might identify you.
What protected health information may be used and/or given to others? 
All medical information, including but not limited to information and/or records of any 
diagnosis or treatment of disease or condition, which may include sexually transmitted diseases 
(e.g., HIV, etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal 
identifiers, including but not limited to your name, social security number, medical record 
number, date of birth, dates of service, etc.; any past, present, and future history, 
examinations, laboratory results, imaging studies and reports and treatments of any kind, 
including but not limited to drug/alcohol treatment, psychiatric/psychological treatment; 
financial/billing information, including but not limited to copies of your medical bills; any other 
information related to or collected for use in the research study, regardless of whether the 
information was collected for research or non-research (e.g., treatment) purposes; records 
about any study drug you received or about study devices used; and consent forms from past 
studies that might be in your medical record.
Your consent form will be placed in your medical record at UAB Health System or Children’s of 
Alabama. This may include either a paper medical record or electronic medical record (EMR). 
An EMR is an electronic version of a paper medical record of your care within this health 
system. Your EMR may indicate that you are on a clinical trial and provide the name and 
contact information for the principal investigator.
If you are receiving care or have received care within this health system (outpatient or 
inpatient), results of research tests or procedures (i.e. laboratory tests, imaging studies and 
clinical procedures) may be placed in your existing medical record.
If you have never received care within this health system (outpatient or inpatient), a medical 
record will be created for you to maintain results of research tests or procedures.
All information within your medical record can be viewed by individuals authorized to access 
the record.
Who may use and give out information about you?
Information about your health may be used and given to others by the study doctor and staff. 
They might see the research information during and after the study.
Who might get this information?
All individuals/entities listed in the informed consent document(s), including but not limited to, 
the physicians, nurses and staff and others performing services related to the research 
(whether at UAB or elsewhere). Your information may also be given to the sponsor of this 
research. “Sponsor” includes any persons or companies that are working for or with the 

Page 4 of 6
Version Date:  2/11/2022
sponsor, or are owned by the sponsor, or are providing support to the sponsor (e.g., contract 
research organization).
Information about you and your health which might identify you may be given to:

the Office for Human Research Protections (OHRP)

the U.S. Food and Drug Administration (FDA)

Department of Health and Human Services (DHHS) agencies

Governmental agencies in other countries

Governmental agencies to whom certain diseases (reportable diseases) must be reported

the University of Alabama at Birmingham - the physicians, nurses and staff working on the 
research study (whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, 
UAB Highlands Hospital, University of Alabama Health Services Foundation, Children’s of 
Alabama, Eye Foundation Hospital, and the Jefferson County Department of Health, as 
necessary for their operations; the UAB IRB and its staff

the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama 
and its billing agents
Why will this information be used and/or given to others?
Information about you and your health that might identify you may be given to others to carry 
out the research study. The sponsor will analyze and evaluate the results of the study. In 
addition, people from the sponsor and its consultants will be visiting the research site. They will 
follow how the study is done, and they will be reviewing your information for this purpose.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health 
information listed above for the purposes described above. If you refuse to give permission, 
you will not be able to be in this research.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information. However, if you decide to be in 
this study and sign this permission form, you will not be allowed to look at or copy your 
information until after the research is completed.
May I withdraw or revoke (cancel) my permission?
Yes, but this permission will not stop automatically. The use of your personal health 
information will continue until you cancel your permission.
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the study doctor. If you withdraw your 
permission, you will not be able to continue being in this study.
When you withdraw your permission, no new health information which might identify you will 
be gathered after that date. Information that has already been gathered may still be used and 
given to others. This would be done if it were necessary for the research to be reliable.
Is my health information protected after it has been given to others?

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If you give permission to give your identifiable health information to a person or business, the 
information may no longer be protected. There is a risk that your information will be released 
to others. Including others outside of UAB, without your permission.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you 
decide not to be in the study. If you decide not to be in the study, you will not lose any 
benefits you are otherwise owed. You are free to withdraw from this research study at any 
time. Your choice to leave the study will not affect your relationship with this institution.
You may be removed from the study without your consent if the study doctor decides it is 
not in the best interest of your health, or if the study is terminated early.
Cost of Participation
There will be no cost to you for taking part in this study.
If you are in Medicare Advantage (Medicare managed care plan), you should contact 
someone at your plan before you start a clinical trial. They can provide more information 
about additional costs you could incur from participating in clinical trials.
Payment for Participation in Research
You will not receive payment for participating in this study.  
Payment for Research-Related Injuries
UAB has not provided for any payment if you are harmed as a result of taking part in this 
study. If such harm occurs, treatment will be provided. However, this treatment will not be 
provided free of charge.
Significant New Findings
You will be told by your doctor or the study staff if new information becomes available that 
might affect your choice to stay in the study.
Questions
If you have any questions, concerns, or complaints about the research or a research-related 
injury including available treatments, you may contact Dr. Woodard. She will be glad to 
answer any of your questions. Dr. Woodard’s number is 205-801-7735. Dr. Woodard may 
also be reached after hours by paging at 205-934-3411.
If you have questions about your rights as a research participant, or concerns or complaints 
about the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or 
toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, 
Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.

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Signatures
Your signature below indicates that you have read (or been read) the information provided 
above, have had a chance to have all of your questions answered, and agree to participate in 
this study. You will receive a copy of this signed consent form.
Printed Name of Participant
Signature of Participant
Date
Signature of Person Obtaining Consent
Date