M-D-Y
Introduction:
All data pull requests, including those submitted to HADSI, will first submit their project using this intake form. The intake form will automatically capture the required acknowledgments/data use attestations. All approved intake forms will be assigned a project number from OR Once the project requester has the project number, the intake form will go to HADSI to determine if this is a project they want to accept: If so, HADSI can proceed with the data pull from Sentara's portal (or other sources) with the assigned project number ; If not, HADSI will reject the project and will be routed back to OR to determine if/when they can make a direct request through the portal. FAILURE TO COMPLETE ALL REQUIRED FIELDS , INCLUDING SIGNATURE FIELDS, WILL PREVENT YOUR REQUEST FROM BEING PROCESSED.
Would you like to start a new request or join an existing one?
If someone else has already submitted information about this project on this site, Select "Join Existing"
* must provide value
New Request Join Existing
Please Select an Existing Project Existing Project Request ID If there are multiple entries for the project you are trying to join, please choose the first one.
Please select an existing request
Investigation of Lung Cancer Vulnerability to Common Cholesterol and Diabetes Medications Patterns of Ballistic Injury Investigation Of Lung Cancer Vulnerability To Common Cholesterol And Diabetes Medication Preeclampsia with severe features and pregnancy outcomes Sterile versus clean gloves effect on intraamniotic and intrauterine infections in labor at term Immediate versus delayed reconstruction of skin defects following malignant tumor resection Preeclampsia Surgical Techniques And Ventilation Strategies For Laryngotracheal Stenosis Preeclampsia With Severe Features And Pregnancy Outcomes Preeclampsia with severe features and pregnancy outcomes Retrospective Chart And Surgical Specimen Review Of Breast Cancer Retrospective Chart and Surgical Specimen Review of Breast Cancer Retrospective Chart and Surgical Specimen Review of Breast Cancer Racial Disparities in Maternal Cardiovascular Disease Stratifying patients, quantifying therapy efficacy, and detecting treatment/racial disparity in pancreatic cancer at Sentara-EVMS-VOA Quality Improvement of Timing Metrics for Definitive Surgical Management in Head and Neck Cancer Care at the Eastern Virginia Medical School (EVMS) Department of Otolaryngology Racial Disparities in Maternal Cardiovascular Disease Racial Disparities in Maternal Cardiovascular Disease Retrospective Chart and Surgical Specimen Review of Breast Cancer Patterns of Ballistic Injury Case Study: Multiple Sclerosis A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual β-cell function at baseline. MEMORY CONSULTATION CLINIC REGISTRY PROJECT Shearwave Elastography And Placental Pathology Shearwave Elastography and Placental Pathology Blood Transfusion at the time of Cesarean Section Effects of the COVID-19 pandemic on the vascular management of patients with incident end stage renal disease. Comparing immediate and short-term outcomes and success in conservative versus surgical treatment of pulmonary embolism (PE). Effect Of Distance To Treatment On Patient Follow Up Adherence And Complications After Open Reduction Internal Fixation Primary arteriovenous fistula failure in diabetic patients: Are certain methods of glycemic control associated with lower rates of primary failure? Retrospective Chart and Surgical Specimen Review of Breast Cancer Preoperative Azithromycin and postoperative oral antibiotics on surgical site infection in obese women A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual β-cell function at baseline. A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual β-cell function at baseline. Prediction Of Postoperative Hemoglobin Following Cesarean Section Understanding, Improving & Tracking of Diabetes Care in the Western Tidewater Region of Virginia Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial Prevalence of Pathergy After Surgical Procedures in Patients with History of Pyoderma Gangrenosum Preoperative Azithromycin and postoperative oral antibiotics on surgical site infection in obese women TBD Racial Disparities in Maternal Cardiovascular Disease Blood Transfusion At The Time Of Cesarean Section Racial Disparities in Maternal Cardiovascular Disease
Existing Project Request ID
View equation
Are you be requesting a Data Pull or Direct Access to EMR?
Data PullSentara or Medical Group staff will extract specific data from EMR and import it to your REDCap project. Direct AccessYou will be granted access to the EMR system and will locate and extract the data manually then enter it into your REDCap project. * must provide value
Data Pull
EMR Access/Chart Review
Both Data Pull and EMR Access/Chart Review
Data Pull
EMR Access/Chart Review
Both Data Pull and EMR Access/Chart Review
We recommend Data Pull projects be coordinated with HADSI.
Should this project be routed through HADSI?
* must provide value
Yes No
Email Address You must use your institutional email address. Using a Gmail or other generic address will delay the approval process.
* must provide value
Status
* must provide value
MD Student
Med Masters Student
Resident
Fellow
Faculty
Staff
Summer Scholar
Other
MD Student
Med Masters Student
Resident
Fellow
Faculty
Staff
Summer Scholar
Other
When do you anticipate leaving EVMS or Ending your participation on this project?
* must provide value
Today M-D-Y
Have you made arrangements to transfer this project to someone else?
Yes
No
Uncertain
Who will take over your responsibilities?
M1 M2 M3 M4
1-Year 2-Year
Year 1 Year 2
Summer Scholar Affiliation
Database I am interested in
* must provide value
Sentara (EPIC)
EVMS Medical Group (AllScripts)
CHKD
Other
Sentara (EPIC)
EVMS Medical Group (AllScripts)
CHKD
Other
Your data request Must be associated with an Active IRB approved study Unless requesting Aggregate Data. (Numbers of Cases to determine the feasibility of a study) (ie. Asking how many XYZ cases are seen in the ED annually or How many African Americans have been treated for stroke?) You may start the process prior to IRB approval but will not be allowed access to any data until the Approval Letter is received. Is your request in support of an approved study?
* must provide value
Yes No
Protocol Number Protocol Title Expiration Date Next Continuing Review Date
Please upload the Approved IRB Protocol PDF Here.
M-D-Y
IRB Continuing Review Deadline
M-D-Y
Are you (the data access requester) the PI of the IRB approved study? (For you to have EPIC access for research, you must either be a team member or PI of the IRB study)
Yes No
Are you (the data access requester) officially named as a member of the IRB approved study? (For you to have EPIC access for research, you must be a team member of the IRB study)
Yes No
Is the IRB-approved study currently on-going?
Yes No
Sentara requires that trainees/students must be supervised by a faculty level researcher or physician on the IRB-approved study.
P.I. Name EVMS Faulty Department Email
Who is the PI of the IRB approved study?
Is the PI an EVMS Faculty member?
Yes No
What is the EMAIL address of the PI
What is the PI's EVMS department affiliation?
Basic Lab Research
Clinical Research
Community or Public Health
Quality Improvement
Educational Research
Chart Review
Other
Basic Lab Research
Clinical Research
Community or Public Health
Quality Improvement
Educational Research
Chart Review
Other
Are you working with other EVMS students on this IRB-approved study
Yes No
Do these students also need clinical data access for research purpose?
Yes No
Did you have EPIC research access in the past but the EPIC access has expired?
Yes
No
This question is not relevant to me because I am not seeking access to Sentara's EPIC database
Yes
No
This question is not relevant to me because I am not seeking access to Sentara's EPIC database
Was the past EPIC access connected to the current IRB approved study for which you are seeking EPIC access?
Yes No
I have already received EPIC data access for the research project entered in this questionnaire.
Yes
No
This question is not relevant to me because I am not seeking the access to Sentara's EPIC database
Yes
No
This question is not relevant to me because I am not seeking the access to Sentara's EPIC database
When was your EPIC access granted?An estimate is fine.
Today M-D-Y
REQUIRED Please use power analysis to estimate the minimum number of samples/patients needed to obtain statistically significant results for your project. Minimum Number of Samples or Patients: Please upload any supporting documents here:
Samples
* must provide value
Please provide any additional information you think is relevant.
For example;
If you wish to review a single patient's records for a case study vs. Analyze 200 Emergency Department admissions, Tell us here.
All Patient Data must be stored in REDCap. The results of all data requests to SENTARA will be delivered in REDCap. Do You have an EVMS REDCap account?
* must provide value
Yes No
Introduction/Background: Personally identifiable Data(“PID”), protected health information (“PHI”), or other sensitive information (“SI”) (collectively, PID, PHI, and SI shall be known as the “Data”) may be used by Centers, Departments, Project Leaders or Principal investigators (PI) to perform services or to conduct research that has been approved by EVMS. In order to provide this use, EVMS may enter into one or more agreements with the Data provider(s) that place responsibility on EVMS to ensure that the Data is kept confidential and accessed only in a manner permitted by the Data Provider. As such, every individual that will have access has a legal and ethical obligation to safeguard the Data as outlined herein.
Accessing and Using Data: You may only access and use Data when it is necessary, appropriate, and lawful to do so in the performance of your duties at EVMS.
This means that:
Data may only be used for the approved purpose (providing specific services requested by the Data provider or, in the case of research projects, for the project approved by the EVMS IRB and the Data Provider). Any deviations from such use must be specifically approved by the Data provider and/or the EVMS IRB (if applicable). Note that an approved IRB protocol does not automatically grant you the ability to search, access, identify, disclose, discuss, release or reuse Data for future projects, even if you have access to that Data for other purposes or you have been granted access to that Data in the past for another project. Data may not be accessed or used for personal reasons (to check on someone you know, at the request of someone else, out of curiosity, etc.). Data and/or access to Data may not be provided to any unauthorized person or entity (unauthorized means that the person or entity is not part of EVMS and/or does not have a need to access the Data or purposes of this project), without the express written permission of the Data provider. This also means that you may not share Data with a non-EVMS coinvestigator, until/unless such use is approved by the Data Provider. Protecting Data: To keep Data from unauthorized access or use, it must be protected at all times by using the following measures.
Security:
Data in hard copy must be stored in locked drawers or cabinets. Computer workstations, laptops, and mobile devices must be locked when not in use and must utilize screen security (alpha-numeric or fingerprint enabled). You must log out of software or other applications that collect or maintain Data when you leave a workstation. CDs, USB flash drives, and other mobile storage should not be used to store any PID, PHI, or SI without explicit permission and, if approved, they must utilize encryption/password protection. All EVMS workstations and laptops must be maintained in accordance with EVMS Network Information Center (NIC) standards, including but not limited to, up-to-date virus protection. EVMS electronic systems may only be accessed with the credentials (User ID and password) assigned specifically to you by the NIC. Credentials may not be shared, disclosed, or publicly posted and you will be held responsible for any unauthorized access that results if your credentials are shared. You may not use any cloud services for Data unless approved by the NIC. EVMS network accounts (ending in “@evms.edu” or “@CONRAD.org”) must be used for all communications. Further, emails with Data may not be manually or automatically forwarded to a non-EVMS personal email service (Gmail, yahoo, AOL, etc.) and you may not use any “pop” protocol to force your EVMS account email into a non-EVMS personal account. You may not use any tool or techniques to break, exploit, or otherwise circumvent established security measures. All Data in electronic form must be removed from your computer, laptop, or other electronic device at the time such device is retired and/or before the device can be transferred to another area or department. Data and/or devices containing Data may never be thrown in standard trash bins. Data in hard copy must be destroyed by shredding or other method that renders the Data unreadable and unable to be reconstructed. Electronic Data must be cleared using software or hardware products that overwrite/delete the data. It is your responsibility to know whether the Data you receive must be destroyed or returned to the Data provider at the end of the services or research project. Protecting Data: Privacy:
Data must be kept in strict confidence regardless of whether it is communicated to you in hard copy, faxed, electronically transmitted, via oral conversations, or in printed or other formats. This confidence must be kept when performing your duties, as well as during breaks, rest periods, and time away from EVMS. You are responsible for ensuring that discussions concerning Data do not occur in hallways, elevators, or other public areas where someone not authorized to receive the Data could inadvertently overhear PID, PHI, or SI. You may not share, release, or broadcast Data in any manner, including posting of PID, PHI, or SI on any list service, or professional or social media site. If the Data provided is de-identified or a limited data set, you may not request PHI, or a link to PHI, from the Data provider or make any attempt to identify the information contained in the Data or contact the individuals whose information may be contained in the Data. Upon termination of your employment, expiration of your contract or other termination of your relationship with EVMS, you will immediately return any confidential information to EVMS. Compliance: You are responsible for notifying the Center Director, Project Leader or PI , as applicable, and the EVMS Privacy Officer (wileyjp@evms.edu, 446-6008) immediately if:
Your credentials used to access Data have, or may have been hacked, disclosed, or otherwise compromised; You know or suspect that the Data has been inappropriately accessed, disclosed, shared, hacked or otherwise compromised; You misplace or otherwise lose possession of any notebook, device (computer, laptop, mobile device, mobile storage) that contains Data; You overhear, discover, or become aware of any Data that is not being protected as set forth herein. EVMS reserves the right to audit your work environment, computers, or other areas and devices that are used to access/use the Data in order to ensure compliance with the requirements outlined herein. Obligations to confidentiality continue indefinitely, even after termination or expiration of your employment, contract, or other relationship with EVMS and even if you no longer have the Data in your possession. Any non-compliance and/or request or instruction to ignore or bypass the requirements set forth in this document must be reported to EVMS OGC/Institutional Compliance at 446- 7250, OGC@ev By signing below I, ______ , acknowledge that I have read and will abide by the Data Use Requirements outlined and that failure to abide by same, will result in disciplinary action up to and including termination.
* must provide value
Please read and acknowledge these requirements (1- 8)(Warning: any deviation will result in significant delays in Sentara’s processing of your requests)
All data requests made by EVMS Faculty, Staff or Students must be submitted using the Sentara Health Research Center’s portal and coordinated by the EVMS Office of Research. Questions regarding the proper method for requesting data from Sentara can be addressed to the EVMS Office of Research at evmsresearch@evms.edu. IRB approval does not confer Sentara approval; all proposals will be reviewed to ensure compliance with Sentara policies and guidelines. An active IRB approval is required for Sentara to allow use or disclosure of data for a formal research analysis. The approved protocol should include each member of the research team and an approved IRB addendum is required if additional research personnel are added or the project is amended. All students and residents must have a faculty supervisor who will have ultimate responsibility for ensuring the proper conduct of the proposed research. The HIPAA Privacy Rule requires that use or disclosure of data will be limited to the amount of data that is “minimally necessary” to answer the study question and accomplish the study aims. Thus, the number of participants in the cohort should be estimated using a statistical power calculation that is included in the study protocol. The participants should then be defined in the data request by the inclusion/exclusion criteria and the date ranges of study. Also, requested study variables should be justified by the study’s methods and aims. A data collection tool in the form of an Excel spreadsheet should be included with each data request. Requests should include clear definitions for each Epic variable. Epic variables must be specific (i.e., all medications of interest must be listed by name, all procedures and/or diagnoses of interest must be specified and codes included, any calculated variables must include how the variable will be calculated and what Epic variables are required to calculate the variable of interest). Where possible, researchers should note how the data are documented in the Epic record. Requests must include a detailed plan for data transfer, data security, and data destruction following HIPAA guidelines. I, ______ , have read, understand, and agree to follow the 8 requirements listed above.
* must provide value
Please Download and complete this Sentara Research Data Attestation Statement prior to accessing the Sentara Portal .
You will need to upload the completed form there. You will receive an email from the REDCap system which includes the Office of Research Request ID Number requested on the form.
Submit
Save & Return Later