Enhancing Skin Cancer Early Detection and Treatment in Primary Care
Phase: NA
Conditions: Cutaneous Melanoma
Sponsor: OHSU Knight Cancer Institute

 
 
Enhancing Skin Cancer Early Detection and Treatment in Primary Care 
 
NCT05675709 
 
 

 
 
 
Study Title: 
Enhancing Skin Cancer Early Detection and Treatment in Primary Care 
Protocol Number:   eIRB #24809 
Version Number:   7 
Version Date: 
October 23, 2023 
Replaces: 
 
Principal Investigator: 
Sue Flocke, Ph.D. 
 
Department of Family Medicine 
Oregon Health & Science University 
3181 SW Sam Jackson Park Road 
Portland, OR 97239  
Phone: (503) 494-4404 
Email: flocke@ohsu.edu  
 
 
Participating 
Investigator(s): 
Elizabeth Berry, M.D. 
Department of Dermatology 
Oregon Health & Science University 
3303 S. Bond Avenue 
Portland, OR 97239  
Phone: (503) 418-3376 
Email: berryel@ohsu.edu 
 
Alex Verdieck Devlaeminck M.D. 
Department of Family Medicine 
Oregon Health & Science University 
3181 SW Sam Jackson Park Road, FM 
Portland, OR 97239  
Phone: (503) 494-5187 
Email: verdieck@ohsu.edu 
 
Sancy Leachman, M.D., Ph.D.  
Department of Dermatology 
Oregon Health & Science University 
3303 S. Bond Avenue 
Portland, OR 97239  
Phone: (503) 418-3376 
Email: leachmas@ohsu.edu 
 
 
 
Statistician: 
Shuling Liu, PhD 
Department of Family Medicine 
Oregon Health & Science University 
3181 SW Sam Jackson Park Road, FM  
Portland, OR 97239  
Phone:  503-494-4991 
Email:  liushu@ohsu.edu   

 
 
Minimal Risk Protocol Template 
 
1) 
Protocol Title 
Enhancing Skin Cancer Early Detection and Treatment in Primary Care 
 
2) 
Objectives 
This mixed method study will evaluate whether a multicomponent education strategy 
improves the ability of Primary Care Providers (PCPs) to identify and triage skin cancer. 
This study will be deployed in two OHSU family medicine clinics: one OHSU Family 
medicine rural-based clinic and one urban underserved Federally Qualified Health 
Center (FQHC) clinic. Baseline data and those not participating in the training will serve 
as controls.   
3) 
Background 
Cutaneous melanoma (CM) is a potentially life-threatening form of skin cancer that is 
increasing in incidence. In the last three decades, incidence rates have more than 
tripled, and CM currently stands as the fifth most common invasive cancer in the United 
States.1,2 According to estimates by the American Cancer Society (ACS), there will be 
nearly 100,000 new cases of CM and about 7,650 deaths due to melanoma in 2022 
alone. The ACS expects that 1,640 of these new cases will occur in Oregon, which 
consistently ranks among the top ten states in the nation for CM incidence.2 Unlike 
other common malignancies, melanoma is most often evident directly on the skin’s 
surface, which lends the opportunity to improve early recognition with the goal of 
decreasing mortality.  
If diagnosed early, both CM and other types of skin cancers are often curable. For 
distant metastatic disease, however, the prognosis is substantially worse. Stage I CM 
disease carries a five-year survival rate of 99%. For stage IV CM, however, the five-year 
survival rate drops to 30%.3 In addition to higher mortality rates, late-stage disease is 
also associated with increased morbidity and increased health care costs. For example, 
late-stage tumors require wider excision margins, sentinel lymph node sampling, 
increased imaging surveillance, and may necessitate the use of expensive and 
potentially toxic therapies in the treatment or adjuvant setting.4  
The early detection of melanoma through simple, noninvasive screening practices has a 
considerable potential to reduce the burden of this disease. In Oregon, there are few 
dermatologists in the areas of highest incidence, so PCPs are in a unique position to 
recognize and treat or triage skin cancers.5,6 However, PCPs have identified barriers to 
their ability to diagnose skin cancer, including knowledge gaps, paucity of time and lack 
of clinical workflows for routine screening and electronic health record (EHR) support 
tools to facilitate screening.7-9 Dermoscopy (using a device with polarized light and 
magnification to visualize underlying skin structures) and EHR tools designed to facilitate 
skin screenings can help overcome these barriers but are rarely used in PCP settings.10-12 
We hypothesize that providing PCPs with the appropriate training and tools to screen 
for and recognize melanoma will facilitate diagnosis of more skin cancers at earlier 

stages. Our team has already developed and demonstrated the efficacy of a PCP 
education intervention (Melanoma Toolkit for Early Detection, MTED)13 and is poised to 
deploy this toolkit in the pilot study outlined in this protocol. 
 
4) 
Study Design  
This study is a mixed method pilot study to determine whether multicomponent  
education module improves the ability of Primary Care Providers (PCPs) to identify and 
triage skin cancer. The main independent variable is the multicomponent education for 
clinicians. This is primarily a feasibility study to evaluate the engagement and uptake of 
the training and change in skin cancer screening behavior on the part of clinical teams. 
We hypothesize that exposure to the intervention will increase clinician knowledge, 
increase the use of a SKLIP dermoscopy device to facilitate capture of high-resolution 
dermoscopy images, and increase screening for skin cancer.  
Outcomes:  
• 
Uptake of the training and performance of skin cancer screening processes 
measured by proportion of clinicians invited to participate in the educational 
intervention that complete the training modules; use of the Epic smart tool and 
dotphrases.  
• 
Clinicial knowledge measured through pre- and post-tests implemented during 
live (in-person or virtual) training. 
• 
Use of the risk assessment tool measured through EHR data. 
• 
Identification of suspicious lesions measured through EHR data. 
We hypothesize that the multicomponent education strategy will result in the diagnosis of more 
skin cancers at earlier stages. Primary endpoints of the study include the pre- and post-
intervention: number of melanomas biopsied, mean and median Breslow depth of melanomas 
biopsied, number of other malignant skin tumors biopsied, total number of referrals to 
dermatology, number of referrals to dermatology for concerning moles, and number of OHSU 
PCPs who access the Melanoma Toolkit for Early Detection (MTED), an online Continuing Medical 
Education training. There will be two comparison groups: OHSU PCPs receiving the intervention, 
OHSU PCPs not exposed to the intervention. 
 
 
 
5) 
Study Population 
a) Number of Subjects 
This study will be conducted at two primary care clinics. Within these two clinics, there are 
approximately 80 clinicians (e.g. MD, NP, PA, DO, APP).  
 
We will invite all advanced practice providers (MD, NP, PA, DO) at these two clinic sites to 
participate in the multicomponent educational intervention, up to 40 clinicians per site. These 
clinicians will take part in the surveys imbedded in the Toolkit, surveys pre-and post-training, 
and live (in-person/virtual) trainings. Thus, we will recruit approximately 40 clinicians within the 
2 clinics for the active intervention. 
 

We will observe the in-person trainings and take detailed fieldnotes. We expect approximately 
40 clinicians will participate in each training.  
 
We will interview approximately 5-10 members per site within the clinic.  
 
We will extract EHR data collected from patients from within these two clinics for the year prior 
and for 1-year post training implementation (2/1/2022-9/30/2024). We estimate up to 200 
individuals with biopsies per year, per clinic. For a subset of patients, we will conduct a chart 
review to affirm use of specific devices to photograph lesions and biopsy results that are not 
readily ascertainable from EHR data alone. 
   
 
b) Inclusion and Exclusion Criteria 
Two OHSU primary care clinics will be assigned to receive exposure to the melanoma early 
detection intervention. Baseline data and clinicians at the two clinics who do not receive the 
intervention will serve as study comparators. 
 
We will be using secondary EHR data from the study clinics. Biopsy and referral data will be 
extracted from EHR from patients within these two primary care clinics who were screened, 
referred, biopsied for potential skin cancer and/or diagnosed with melanoma. Data from all 
other patients seen in these clinics during the time period will be included for comparison. 
These data will be electronic health record (EHR) data from patients between the ages of 18 and 
110 with an encounter in one of the study clinics. A subset of this data will undergo a chart 
review to affirm use of specific devices to photograph lesions and free text biopsy results and/or 
interpretation.  
 
We may observe all in-person trainings. There are no inclusion/exclusion criteria for training 
observation. All training participants will be 18 years or older and are required to speak English 
during the training and in their occupations.  
 
Qualitative interviews will be conducted with clinicians who receive the intervention. These 
individuals are all aged 18 years or older and all practice members speak English. No patients 
will be interviewed for this research.  
 
Exclusion criteria: No one will be intentionally excluded. 
 
c) Vulnerable Populations 
This study will not target vulnerable populations, but they may be included in the EHR 
data. EHR data may include patients under 18, those who may be pregnant or 
decisionally impaired.   
 
d) Setting 
This study will be conducted at OHSU and deployed at two clinics: one OHSU Family medicine 
rural based clinic and one urban underserved FQHC clinic. Study information will be collected 
using EPIC data fields to assess biopsy rates, uptake of risk assessment and health maintenance 
(HM) reminders and use of e consult and formal consultation. Qualitative data will be collected 

using semi-structured qualitative interviews via in-person, phone or video calls. We will also 
conduct and observe in-person trainings.  
   
The population health team at OHSU will pull EHR data from OHSU primary care clinics. They will 
provide a de-identified dataset to OHSU researchers for analysis. No OHSU data will leave OHSU. 
 
e) Recruitment Methods 
Study staff will submit an inquiry for research engagement per the Department of Family 
Medicine’s current Standard Operating Procedure. DFM research leadership and clinic 
leadership will confirm the participation of each clinical site. Then, with clinic leadership 
support, advanced providers from each site will be invited to participate in the multicomponent 
educational intervention.  
 
We will email leaders at each of the sites and ask for permission to observe the trainings and 
take fieldnotes. A reminder invite to the in-person training will be shared with clinic leadership, 
and will be emailed to the participating clinic members (see recruitment materials). This email 
will remind participating clinic members of the upcoming training and include and a copy of the 
information sheet. During the live training, we will ask participants for their email addresses so 
that we may remind them to complete the training post-test and to invite them to complete the 
online portion of the trainings. (See supplemental materials). 
 
Patients are not being directly recruited to this study however, patient level EHR data will be 
used to evaluate the impact of the intervention as outlined in the primary endpoints above. 
 
We will invite and potentially interview all clinicians but will stop once saturation14 is reached 
and no new information is being gleaned. In exchange for participation in the one hour 
interview, clinician member participants will receive a $100 Amazon gift card. 
 
 
f) Consent Process 
As the risks to the clinic staff are minimal, we will request IRB approval to provide study 
information sheets.  Clinicians who participate in the intervention will receive a study 
information sheet describing their participation in the in-person training, online learning 
modules (MTED), the possibility of participating in qualitative interviews, and how data 
will be used to answer study questions. 
 
For the qualitative training observations, we will ask for permission to join the trainings 
and take field notes. This study poses a minimal risk to participants, and as such, a 
formal consent process is not required for observation.  
 
For the qualitative interviews, we request a waiver of written consent. This request is justified, 
since if signed, the signature would be the only thing that would identify the interviewee in 
study records. We will avoid using names during the interviews. If names are used, they will be 
scrubbed from the transcript during the transcribing process. The research team will make clear 
that the interviewee does not need to participate in the interview and there are no 
repercussions for saying no. Prior to an interview, practice members will receive an Information 
Sheet stating the purpose of the study and explaining their rights as a participant in the study. 
The study team will answer any questions about the study, obtain verbal consent, and ask 

permission to record the interview. If a participant agrees to be interviewed but not audio-
recorded the interviewer will take notes during the interview and write them up shortly 
afterwards. Participants will also be instructed that they can request the audio recording to be 
stopped at any point during the interview.  
 
We are requesting a waiver of authorization and consent for secondary analysis of EHR data in 
this research, as patients are not actively recruited. We believe this study meets the necessary 
requirement for a waiver of authorization and consent as: 1) the research involves no more than 
minimal risk to the subjects; 2) the waiver or alteration will not adversely affect the rights and 
welfare of the subjects as it involves no more than a minimal risk of loss of confidentiality; and, 
3) the research could not practicably be carried out without the waiver or alteration because it 
would not be possible to consent the number of patients whose EHR records are needed to 
answer the study question. 
 
6) 
 Study Procedures & Schedule of Events 
The multi-component educational intervention includes the following: 
 
Training:  
Group Training:  
Group training sessions will consist of an initial training and an one hour  follow up refresher 
training on how to use the SKILP device and identifying Melanoma. The in-person trainings are 
designed as lunch and learn sessions. The initial training will include how to use the MTED, how 
to use a SKLIP dermoscopy device, how to use the Epic health maintenance reminder tool to 
document a high-risk patient, and how to triage. We will support workflow restructure to 
involve use of Epic tools, SKLIP devices, etc. but are unable to assess changes to workflow itself. 
PCPs will receive education on how to use a collection of skin cancer-specific SmartPhrases in 
Epic. These SmartPhrases contain resources such as a melanoma risk stratification tool, skin 
cancer after visit summary, and templates for biopsies and skin exams. An accompanying 
PowerPoint document explains how to access and use the SmartPhrases, as well as provides 
instructions on how to satisfy billing codes and health maintenance reminders. The training is 
tailored to PCPs but may be delivered to the entire healthcare team (nursing staff and medical 
assistants) to facilitate implementation.  
 
The follow up refresher training will follow the same format as the initial training and will 
contain similar content as the initial training (See Dermoscopic Red Flags of Melanoma 
Powerpoint in Supplemental Materials).  
 
Live trainings may be in-person or virtual, but will not be recorded. We will use a sign-in sheet to 
collect names and email addresses of those who attended the in-person trainings so that we 
may follow up with them and provide a link to the online portion of the trainings and to 
measure expose of the training. 
 
Lunches will be provided at all group training sessions, along with SKLIP devices at the intial 
training and educational materials. Pre- and post-training tests will be given during the initial in-
person training session to measure uptake of the training. These tests will be distributed 
through an email about the upcoming training (see supplemental materials) and a QR code that 

partctipants can access through their phones or laptops during the training. A pre-recorded 
version of the trainings will also be available to accommodate busy schedules. 
 
Refresher trainings: 
For those that complete the initial training we will offer short refresher trainings via a series of 5 
emails that contain refresher material from the initial training and will be designed to increase 
practice and repetition of identification of skin-related pathologies. Emails will include a link to a 
short Qualtrics survey to measure uptake of training information.  
 
We will email all partcipants of the intial training and offer the refresher materials and the 
option to opt out of the short trainings. Surveys are under development and will be uploaded 
for IRB review prior to sending out to participants.  
 
Training observation:  
A study team member will sit quietly during the in person trainings, and will listen and 
observe what happens, and take jottings or notes. The study team will not collect PHI 
and no identifiers will be recorded. The observers’ field notes will focus on training 
content, questions, and discussion. Following the training, the researcher will type and 
prepare detailed fieldnotes. The original jottings will be destroyed after the final typed 
fieldnotes are prepared.  
 
Online Training/Education: 
The Melanoma Toolkit for Early Detection (MTED) is a Continuing Medical Education 
training that PCPs from the intervention arm of the study will be encouraged to 
complete as part of the intervention.  Participants will be provided with a link by email 
to complete the training within the online platform. The Toolkit contains various Epic 
tools (SmartPhrases, the melanoma risk stratification framework, a skin cancer-specific 
after visit summary) and a self-paced online curriculum  (see IRB #19372 – “Educational 
Program for the Early Detection of Melanoma in Oregon”). A separate copy of the online 
curriculum and surveys has been made specifically for this study to avoid cross-
contamination of data. Knowledge will be assessed among the intervention participants 
as pre-post intervention evaluations. Knowledge and confidence assessments are 
embedded in the online learning MTED modules (as pre- and post-test surveys) and 
have demonstrated improvement in PCP melanoma knowledge and confidence in a 
prior study (Orfaly 2021). This information will allow us to measure the level of uptake 
of the curriculum and track any changes in overall referral and biopsy numbers of 
Toolkit-trained PCPs. The data will always be assessed as an aggregate and never on an 
individual provider basis. Individual PCPs will be de-identified and will create a unique 
ID. Those who complete the MTED training can request CME upon completion.  
 
 
 
 

Interviews:  
The study team will conduct interviews from the two study sites. We will invite everyone who 
participated in the first training to the interviews. Interview will last up to one hour and will take 
place outside of regular work hours.  
 
Using a semi-structured interview guide, the interviewer will ask participants questions designed 
to increase our understanding of approaches to screening for melanoma, current systems in 
place, barriers to implementation, perceptions around skin cancer training and education, 
uptake of training and how it influenced delivery of care. No personal health information (PHI) 
will be collected. Interviews will take place in-person, over the telephone or video all using an 
OHSU-approved platform. If Webex or GoToMeeting (videoconferencing) is used to record the 
conversation, the recording meeting file (MP4 video file format) will be converted to an audio-
file (MP3), and the original file will be immediately destroyed. Audio-recording from interviews 
will be professionally transcribed.  If video is recorded, we will convert the video file to be audio-
only, share that audio with the transcriptionist, and destroy the original video file.  
 
Subsequent interview guides will be informed by the participation in the multi-educational 
training opportunities and will be submitted for IRB approval before they are conducted.  
 
EHR Data: The majority of data for this study will be drawn from the EHR to document 
clinician screening for skin cancer during routine primary care outpatient visits.  
Data collection will include three main time periods: 12 months of baseline data; 2-3 
months of active intervention; and 12 months of post intervention data.  
For a subset of patients, we will obtain patients’ MRN to conduct a chart review. De-
identified data are insufficient to identify medical photography, which requires opening 
charts to review the photographs. Biopsy interpretation are also embedded in the 
patient's chart, which we will review. Any new EHR data will be linked through a 
separate crosswalk and scrubbed for analysis. 
Table 1 includes the indicators from the EHR that will be collected to evaluate the 
impact of the intervention and other co-variates of interest and their data source. 
Quantitative analytic data will include a study ID for clinicians so that we can determine 
exposure of the clinician to the intervention. No patient level identifiers will be used in 
this study. 
Table 1 
Data Class 
Examples include, but are 
not limited to: 
Data 
source 
 
Clinician 
characteristics  
sex, age, degree (MD, DO, 
NP, PA, resident), years of 
practice  
Public 
faculty 
data 

Encounter 
information   
Encounter date, 
encounter type, clinician 
ID, reason for visit, level of 
service, clinic ID, 
Department ID, encounter 
ICD9/10 problems, 
encounter CPT codes, 
encounter payor(s), skin 
cancer screening 
performed, use of skin 
cancer screening tool, use 
of SKLIP, biopsy 
performed, referral to 
dermatology, econsult to 
dermatology. Use of skin 
cancer dot phrase, 
Established vs. new 
patient.  
Patient characteristics 
age, sex, race, ethnicity. 
EHR, chart 
review 
biopsy info/ 
pathology 
Biopsy result, number of 
biopsies performed, 
number of skin lesions 
biopsies, Breslow 
thickness 
EHR, chart 
review 
Clinician 
knowledge and 
confidence 
MTED pre- and post- 
evaluations, 
From IRB 
approved 
Surveys 
(IRB 
#19372 – 
“Education
al Program 
for the 
Early 
Detection 
of 
Melanoma 
in 
Oregon”).  
practice pattern, 
referral practice 
qualitative Interviews 
Coded 
qualitative 
interview 
transcripts 

 
 
 
 
 
 
 
Schedule of Events 
  
 
Pre- Intervention 
 
Intervention 
(~3 months) 
 
Post-Intervention 
(~12 months) 
Procedures 
Present 
 
Apr 2023 
 
Apr&May 
2023 
Aug – Oct 
2023 
 
Oct - Dec 
2023 
 
Jan - Sep 2024  
Pre-intervention EHR Data 
pull 
 
x  
 
 
 
 
 
 
 
 
 
Develop training materials 
x 
 
 
 
 
Recruitment 
 
x 
 
 
 
 
 
 
 
 
Initial Training 
 
 
 
x 
 
 
 
 
 
 
Online Training 
 
 
 
x 
 
x 
 
x 
 
 
Refresher trainings 
 
 
 
 
 
 
 
x 
 
 
Intervention EHR Data pull 
 
 
 
x 
 
 
 
 
Interview guide finalized 
 
 
 
 
 
x 
 
x 
 
 
Qualitative interviews 
 
 
 
 
 
x 
 
x 
 
 
Online survey (MTED) data 
pull 
 
 
 
 
 
x 
 
x 
 
 
Post- Intervention EHR 
Data pull 
 
 
 
 
 
 
 
x 
 
x 
Data analysis 
 
 
 
 
 
 
 
x 
 
 
Dissemination 
(manuscripts, results in 
clinicaltrials.gov, etc.) 
 
 
 
 
 
 
 
x 
 
x 
 
7) 
Data and Specimens 
    
a. Handling of Data and Specimens 
The online surveys containing the knowledge assessments will be administered using Qualtrics, 
an OHSU approved survey application. The research faculty and staff who have access to the 
application for data management and analytic purposes are all trained in and comply with 
research ethics and policies related to research data confidentiality, privacy and security as part 
of their employment at OHSU. PCPs invited to complete the online training and knowledge 
assessments will generate a unique ID that will be requested each time a test is completed.  
Participants who request CME will need to provide names and email address but this data will 
not be linked to data collected in pre- and post-tests or unique ids.  

 
Interviews will be transcribed and will not include interviewees’ names during the interview and 
will be scrubbed during transcription process. If a third-party transcription service is used, we 
will go through OHSU approved vendor Landmark, for which we already have a contract in 
place. The audio files from interviews will be destroyed after the transcript is checked for 
accuracy.  
 
All qualitative data (interviews and fieldnotes) will be stored in a password protected computer 
file on a secure workstation at OHSU and access is restricted to study personnel. Notes will not 
include identifying information about the clinic, health care providers, or patients. Access to 
data will be restricted and require OHSU ID/password authentication. Their study ID number will 
be used to be able to link the interview information with the EHR and clinician performance 
data. 
 
No patients will be individually identifiable for analyses. Each patient will be assigned a unique 
identification number that is not based on any personal identifiers by the OHSU population 
health analysts (not part of the research team). OHSU data population health analysts will retain 
the crosswalk between identifiers and patient data, but not share it with the research team 
 
For a subset of patients, we will obtain patients’ medical records number (MRN) to conduct a 
chart review. The MRN will be linked to a patient’s unique ID number in a separate document 
not for analysis. MRNs will not be recorded in any datasets used for analysis. 
 
We will ensure proper protections are in place to securely transfer and store these data within 
OHSU to prevent disclosure. The limited data set will be analyzed by biostatisticians employed 
by the OHSU department of family medicine. All data will be stored on secure servers and 
password protected computers at OHSU. We have previous experience conducting these types 
of studies. 
 
b. Sharing of Results with Subjects 
Results of the study will not be shared with subjects. All findings will be reported in aggregate.  
 
Meta data including codebook/data dictionary and a document describing data 
used in publications will be added to a repository for 10 years.  
 
 
8) 
Data Analysis 
Quantitative Data: Univariate descriptive statistics will be examined for all variables from the 
MTED pre- and post- evaluation survey. Comparison between data collection timepoints will be 
completed using Chi-square test (categorical), ANOVA (continuous), or Kruskal-Wallis one-way 
ANOVA test (continuous variables that are not normally distributed). Standard qualitative 
analysis techniques will be used for coding open-ended questions. 
 
Descriptive statistics will be used to report screening, biopsy and referral characteristics at each 
data collection time points. Means, standard deviations will be reported for normally distributed 
continuous variables and medians and interquartile ranges (IQR) will be reported for non-

normally distributed ones. Frequencies and percentages will be calculated for categorical 
variables. The main comparison is between clinicians in the multicomponent educational 
intervention arm vs. clinicians at the same sites that do not have exposure to the 
multicomponent educational intervention. These two groups of clinicians are examined using a 
pre-post study design to evaluate outcomes including change in risk assessment, biopsy referral 
and identification of skin cancers. Linear mixed-effects regression models adjusting for 
clustering effects within study sites and other potential confounders will be used to compare 
the intervention and control arms in screening, biopsy and referral characteristics outcomes 
from baseline to post-intervention. A p-value < .05 will be considered statistically significant.  
 
Qualitative data analysis: The study team will meet regularly to review fieldnotes and 
transcribed data and listen to and discuss key segments of the recorded interviews. Analyzing 
qualitative data as it is collected is crucial to monitoring data quality, refining interview guides, 
and monitoring theme saturation. This ongoing process will be used to track emerging themes 
and create a coding template to be used for more in-depth analysis. We will follow the 5-phase 
analysis strategy described by Miller and Crabtree (describing, organizing, connecting, 
corroborating/ legitimizing, representing).14,15 We will use an immersion-crystallization 
approach16 in which the team reads and discusses the data for each participant (immersion) to 
identify key findings (crystallization); first to identify key themes within each “case”, and then to 
identify cross-case findings. 
 
9. Monitoring 
9.1  Data Quality  
 
Quality control procedures for this data include routine (i.e., quarterly) monitoring by the Principal 
Investigator of:  
1. the removal of direct identifiers from information contained with the EHR data and Qualtrics 
data; 
2. the documentation of investigator access to the Qualtrics;  
3. any conditions that may negatively impact the confidentiality of information contained within 
the research registry. 
 
 
9.2  OHSU Knight Cancer Institute Data & Safety Monitoring Plan 
 
This study is under the oversight of the Knight Cancer Institute’s Data and Safety Monitoring Committee 
(DSMC) as described in the Knight institutional Data & Safety Monitoring Plan (DSMP).  The Knight DSMP 
outlines the elements required to ensure the safety of clinical study participants, the accuracy and 
integrity of the data and the appropriate modification of cancer-related clinical research for which 
significant benefits or risks have been discovered or when the clinical study cannot be successfully 
concluded. The Knight DSMP also describes the methods and procedures for ensuring adequate 
oversight of cancer-related research at OHSU. 
 
As described in the Knight DSMP, regardless of a study’s risk level and any specific Knight oversight in 
place, the Investigator is singularly responsible for overseeing every aspect of the design, conduct, and 
final analysis of his/her investigation. The DSMC is responsible for conducting Quality Assurance audits 
on CI approved protocols. This low risk investigator-initiated study may be randomly audited by the 

DSMC audit team. 
 
10) Risks and Benefits  
a. Risks to Subjects 
The primary risk to subjects is related to the small possibility of disclosure of legally protected 
personal health information (PHI) via EHR data acquisition or qualitative data collection (i.e., 
interviews). This potential risk will be described in the Information Sheet. Identities of 
interviewees will not be disclosed in study documents. 
b. Potential Benefits to Subjects 
Clinicians exposed to the intervention may gain additional knowledge and expertise for 
diagnosing and managing skin cancers.  Practice members who attend the group training in 
person will receive a lunch and participating clinics may receive at least 1 SKLIP dermoscopy 
device for every 2 clinicians in the intervention clinics. SKLIP devices may be kept by clinics at 
the conclusion of the intervention. 
Participants who are invited and complete a one time inteview will receive $100 dollar Amazon 
gift card.  
  
c. Ethical and Regulatory Requirements 
a. Protocol Review 
The protocol and informed consent form for this study must be reviewed and approved in 
writing  by the OHSU Knight Cancer Institute (Knight) Clinical Research Review Committee 
(CRRC) and appropriate Institutional Review Board (IRB) prior to any patient being registered on 
this study. 
 
b. Changes to Protocol 
Any modification of this protocol must be documented in the form of a protocol revision or 
amendment signed by the principal investigator and approved by the CRRC and IRB, before the 
revision or amendment may be implemented. The only circumstance in which the amendment 
may be initiated without regulatory approval is for a change necessary to eliminate an apparent 
and immediate hazard to the patient. In that event, the investigator must notify the CRRC and 
IRB in writing within 5 working days after the implementation.  
 
c. Privacy, Confidentiality, and Data Security 
Study staff will be trained to handle data securely for this study. Only staff members who have 
completed OHSU’s required CITI and IRB trainings will be allowed to conduct study activities. 
The study PI, Dr. Sue Flocke will be responsible for ensuring that all individuals have satisfied this 
requirement and will monitor completion of any renewals or additional trainings over the 
course of the study.  
 
EHR Data: Our protocol and procedures for using EHR data ensures no patients are individually 
identifiable for analyses. Data will be destroyed three years after completion of all study 
activities. 
 
Training observations: fieldnotes from observations will be de-identified prior to analysis and 
saved at OHSU on secure, password-protected servers, including the X drive, Sharepoint or 
OneDrive. Research staff have training and expertise in high-quality data management and 
project operations.  

 
Interview data: To minimize risks related to qualitative data analysis, any identifying information 
will be removed during transcription and signed informed consent will not be obtained. The 
audio (or video) files from interviews will be destroyed once transcribed. The interviews contain 
no questions about PHI, though prior to the interview participants’ name, email, and phone 
number may be collected. Access to data will be restricted and require OHSU ID/password 
authentication. Transcribed data will be destroyed after three years of completion of all study 
related activities. All files will be stored on the OHSU approved cloud storage software and 
behind a password and OHSU firewall. Data will be destroyed three years after completion of all 
study activities.  
 
d. Maintenance of Records 
If the investigator relocates or for any reason withdraws from the study, the study records must 
be transferred to an agreed upon designee, such as another institution, another investigator, or 
to OHSU Knight Cancer Institute Clinical Research Management. Records must be maintained 
according to sponsor or FDA requirements. State requirements specific to this protocol. 
 
e. Inclusion of Women, Minorities and Children 
No OHSU Knight Cancer Institute study will focus on any particular gender, racial or ethnic 
subset. No subject will be excluded from the study on the basis of gender, racial or ethnic origin. 
Male, female and minority volunteers will be recruited for this study from the general 
population and approximately 50% men and 50% women will be studied.   
 
The projected gender, racial and ethnic composition of the study will represent that of the 
Oregon population of patients seen in one OHSU Family Medicine rural-based clinic and one 
urban underserved Federally Qualified Health Center (FQHC) clinic. 
 
Table 2: Projected Accrual for the Present Study - Estimated using total unique patients seen in an 
Oregon Family Medicine rural-based clinic from 1/1/21-12/31/21 time frame 
Ethnic Category 
Sex/Gender 
Females 
Males 
Unknown 
Total 
Hispanic or Latino 
331 
209 
 
4.9 
Not Hispanic or Latino 
5092 
 
3898 
 
81.8 
Unknown 
828 
630 
 
13.3 
Ethnic Category: Total of all subjects* 
6251 
4737 
 
100.0 
Racial Category 
 
American Indian or Alaskan Native 
75 
57 
 
1.2 
Asian 
90 
35 
 
1.1 
Black or African American 
36 
39 
 
0.7 
Native Hawaiian or other Pacific Islander 
19 
10 
 
0.3 
White 
4994 
3853 
 
80.5 

Ethnic Category 
Sex/Gender 
Females 
Males 
Unknown 
Total 
More than one race 
212 
132 
 
3.1 
Unknown 
825 
611 
 
13.1 
Racial Category: Total of all subjects* 
6251 
4737 
 
100* 
 
 
Table 3: Projected Accrual for the Present Study - Estimated using total unique patients seen in an 
Oregon Family Medicine urban underserved FQHC from 1/1/21-12/31/21 time frame 
Ethnic Category 
Sex/Gender 
Females 
Males 
Unknown 
Total 
Hispanic or Latino 
561 
437 
 
8.5 
Not Hispanic or Latino 
5367 
3678 
 
80.0 
Unknown 
842 
897 
 
11.5 
Ethnic Category: Total of all subjects* 
6670 
5012 
 
100.0 
Racial Category 
 
American Indian or Alaskan Native 
94 
47 
 
1.2 
Asian 
321 
242 
 
4.8 
Black or African American 
417 
302 
 
6.2 
Native Hawaiian or other Pacific Islander 
38 
22 
 
0.5 
White 
4700 
3579 
 
70.9 
More than one race 
340 
229 
 
4.9 
Unknown 
760 
591 
 
11.6 
Racial Category: Total of all subjects* 
6670 
5012 
 
100* 
 
Source:   Adapted from U.S. Census Bureau, 2010    *Totals may not equal 100 due to rounding. 
 

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