Date request started
Today Y-M-D
For questions on completing this form, please contact EHR staff at < EHRCore@unmc.edu >
Request type:* must provide value
Electronic health data
Nebraska biobank specimen request
COVID+ biospecimen request
Electronic health data
Nebraska biobank specimen request
COVID+ biospecimen request
1. Requester First name * must provide value
2. Requester last Name * must provide value
3. Requester Email * must provide value
4. Requester Phone number (for the purpose of contact )* must provide value
5. Check which best describes you :* must provide value
Faculty Clinical fellow, resident or house officer Graduate student or post-doctoral fellow Health professions student Research coordinator Staff Other
Please describe your position at UNMC:* must provide value
5.1 Please enter your supervisor or advisor Name:* must provide value
5.2. Please enter your supervisor or advisor email:* must provide value
6 With which college or institute are you primarily affiliated?
* must provide value
College of Allied Health College of Dentistry College of Medicine College of Nursing College of Pharmacy College of Public Health Eppley Institute Munroe-Meyer Institute Other
6 Which of the following best represents your primary academic appointment unit. If you have a shared appointment with another institution outside UNMC, please specify your UNMC affiliation, and if shared between two UNMC academic units, specify the unit that represents your majority appointment.
* must provide value
College of Allied Health College of Dentistry College of Medicine College of Nursing College of Pharmacy College of Public Health Eppley Institute Munroe-Meyer Institute Other
Please list your institute here:* must provide value
7. With which department in college of Allied Health Professions are you primarily affiliated to ?* must provide value
Department of Clinical, Diagnostic, & Therapeutic Sciences Department of Health & Rehabilitation Sciences Department of Medical Sciences Department of Allied Health Professions Education, Research, & Practice
7. With which department in College of Dentistry are you primarily affiliated to ?* must provide value
Adult Restorative Dentistry Dental Hygiene Growth & Development Oral Biology Surgical Specialties
7. With which department in college of medicine are you primarily affiliated to ?* must provide value
Anesthesiology Biochemistry and Molecular Biology Cellular/Integrative Physiology Dermatology Emergency Medicine Family Medicine Genetics Cell Biology & Anatomy Internal Medicine Neurological Sciences Neurosurgery Obstetrics/Gynecology Ophthalmology and Visual Sciences Orthopedic Surgery and Rehabilitation Otolaryngology, Head and Neck Surgery Pathology and Microbiology Pediatrics Pharmacology and Experimental Neuroscience Physical Medicine and Rehabilitation Psychiatry Radiation Oncology Radiology Surgery
7. With which campus in college of nursing are you primarily affiliated to ?* must provide value
Omaha Lincoln Kearney Norfolk Scottsbluff
7. With which department in college of pharmacy are you primarily affiliated to ?* must provide value
Pharmacy Practice and Science Pharmaceutical Sciences
7. With which department in college of public health are you primarily affiliated to ?* must provide value
Biostatistics Environmental, Agricultural & Occupational Health Epidemiology Health Promotion Health Services Research & Administration
7. With which department/program in Munroe-Meyer Institute are you primarily affiliated to ?* must provide value
Applied Behavior Analysis Developmental Medicine Education and Child Development Genetic Counseling Genetic Medicine Integrated Center for Autism Spectrum Disorders (iCASD) Medical Sciences Occupational Therapy Pediatric Feeding Disorders Physical Therapy Psychology Recreational Therapy Speech-Language Pathology
7.1 With which division in Internal Medicine are you primarily affiliated to? Allergy and Immunology Cardiovascular Medicine Endocrinology, and Metabolism (DEM) Gastroenterology and Hepatology (GI) General Internal Medicine Gerontology and Palliative Medicine Hospital Medicine Infectious Diseases Nephrology Oncology and Hematology Critical Care and Sleep Medicine Rheumatology and Immunology
8. Research assistant in this project name(s) & email(s), if any:
9. Project title:
if related to an existing IRB or grant, please use same title
* must provide value
10. Project aim(s) / Scientific question(s) (Max 300 letters, you will have a chance to upload supplementary document at the end of this section):* must provide value
11. Are you requesting for :
All dates and Medical Record Number are identified data. Please consider requesting data in a form that is not identified (e.g., age instead of birth date, total days of hospitalization vs admission and discharge dates).
* must provide value
Feasability assessment: potential research subject count
Consented patients who opted-in to be contacted for research
Electronic Health Record Data- NO identified data.
Electronic Health Record Data including identified data
Feasability assessment: potential research subject count
Consented patients who opted-in to be contacted for research
Electronic Health Record Data- NO identified data.
Electronic Health Record Data including identified data
11. Specimen type requested (check all that applied)?* must provide value
Serum (500 uL / sample)
Plasma (500 uL/ sample)
DNA (2ug/sample)
Feasibility counts only
Serum (500 uL / sample)
Plasma (500 uL/ sample)
DNA (2ug/sample)
Feasibility counts only
11.1 This feasibility request is:* must provide value
Multi-center trial
Investigator-initiated trial
Multi-center trial
Investigator-initiated trial
11.1.1 This multi-center trial is linked to which of the following: Pharma-sponsored Federally funded Other national funding from whatever source Local pilot grant (including IDeA-CTR, COBRE) Start-up, NU Foundation, or other internal funds Other
Please list the other resources here:
11.1.1 This investigator-initiated trial is linked to which of the following: Planning application for Pharma funding Planning application for Federal grant Planning application for another national source Planning application for Local/regional pilot grant (including IDeA-CTR, COBRE) Start-up, NU Foundation, or other internal funds Other
Please list the other resources here:
12.Data sets requested for:* must provide value
Opt-in Subject Recruitment
Subject Recruitment, Other
Retrospective Study
Health Outcomes Research
Quality Improvement
Transfer of datasets to a registry
Other
Opt-in Subject Recruitment
Subject Recruitment, Other
Retrospective Study
Health Outcomes Research
Quality Improvement
Transfer of datasets to a registry
Other
12.1. Please describe your requested data type here:* must provide value
13. Do you have IRB approval ?* must provide value
Yes
No
13.1. IRB#:* must provide value
13.1.Please tell us why there is no IRB approval or your plan of IRB application submission:
Please note: The investigator must have ethical access to the identified clinical information about the patient;
This may occur in one of three ways: o The investigator has an existing clinical relationship with the patient; that is the information has been shared with the clinician for the primary purpose of care of the individual. o The investigator works with a provider who has an existing clinical relationship with the patient, and the relationship between the investigator and the provider is such that the investigator could reasonably be called upon to care for the patient in a clinical setting. o The investigator's professional responsibilities (independent of her role as a researcher) require that she has this information.
* must provide value
13.2. Please check all the identified variables requested in the study:* must provide value
Name
Medical Record numbers (MRN)
All elements of dates related to an individual (e.g. birth, admission, discharge)
Postal address information: street address, city, county, precinct, ZIP code
Telephone numbers
Fax numbers
Electronic mail addresses
Social Security numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Any other unique identifying number/characteristic/code
Name
Medical Record numbers (MRN)
All elements of dates related to an individual (e.g. birth, admission, discharge)
Postal address information: street address, city, county, precinct, ZIP code
Telephone numbers
Fax numbers
Electronic mail addresses
Social Security numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Any other unique identifying number/characteristic/code
13.3 List all the other identified data requested:* must provide value
11 Type of Specimen Requested ?
Whole blood
Plasma
Serum
Virus from Nasopharyngeal swab in viral media
Tissue (please specify)
PBMCs
Stool
Other
Whole blood
Plasma
Serum
Virus from Nasopharyngeal swab in viral media
Tissue (please specify)
PBMCs
Stool
Other
11.1 Tissue Type (please specify):
11.1 Other (please specify):
12. Number of patients samples needed (Enter 0 if only control samples needed)* must provide value
12 Ideal number of COVID+ samples requested (assuming samples are available) :
12 Minimum number of COVID+ samples needed (if quantity is limited) :
12.1. Specific diagnosis/procedures ICD10 codes to include (ICD10 lookup ):
Email < EHRCore@unmc.edu > for help on this entering
* must provide value
12.2. Specific diagnosis/procedures ICD10 codes to exclude (ICD10 lookup ):
* must provide value
13. Number of control samples needed (Enter 0 if no control sample needed):* must provide value
13.1. Specific diagnosis/procedures ICD10 codes to include (ICD10 lookup ):
Please note if you are requesting healthy control, define 'healthy' using including/excluding criteria (i.e. include normal BMI, exclude diagnosis requested in patient samples, diabetes, etc.)
* must provide value
13.2. Specific diagnosis/procedures ICD10 codes to exclude (ICD10 lookup ):
Please note if you are requesting healthy control, define 'healthy' using including/excluding criteria (i.e. include normal BMI, exclude diagnosis requested in patient samples, diabetes, etc.)
* must provide value
14. Are you also requesting clinical information associated with the samples ?
Only limited non-PHI data available in biobank database !
* must provide value
Yes
No
14.1. Select clinical data type requested (check all that applied):* must provide value
Demographic data
Encounter diagnosis
Lab results,Procedures
Medications
Ob/gyn data
Social history
Other
Demographic data
Encounter diagnosis
Lab results,Procedures
Medications
Ob/gyn data
Social history
Other
14.2.Please specify your data request here:* must provide value
15.1 Please specify what assay(s) will be performed and who will perform it ?* must provide value
15.2 Will the specimen be transferred outside of NU campus ? Yes
No
15.3 Where will the requested specimens be stored and evaluated ?* must provide value
15.1 Transfer of COVID+ Specimens: Which IBC are you working with?
Note: To receive any samples, you will have to include documentation from an Institutitonal Biosafety Committee (IBC) that you have a submitted and approved protocol that suggests that your institution is aware of where the samples will be used and/or stored and the personnel have the proper environment and have received the training required to handle the samples. Information on UNMC's IBC can be found on their website: unmc.edu/ibc
* must provide value
UNMC's IBC
Other IBC
N/A (For diagnostic or clinical laboratory use, only)
UNMC's IBC
Other IBC
N/A (For diagnostic or clinical laboratory use, only)
15.1.1 Name/details of other IBC (include contact info or website) :
15.2 IBC Protocol Status:
Approved
In Preparation/Applying
Not Applicable
Approved
In Preparation/Applying
Not Applicable
15.3 IBC Protocol Number:
14.1. Describe what clinical data is needed :
* must provide value
14.2. Provide inclusion criteria, including ICD 10 diagnosis code if at all possible: ICD10 lookup
* must provide value
14.3. Provide exclusion criteria, including ICD 10 diagnosis code if at all possible: ICD10 lookup
* must provide value
15.Do you require date range of your request:* must provide value
Yes
No
start date:* must provide value
Today Y-M-D
end date:* must provide value
Today Y-M-D
16. Please provide supplementary document (word/pdf) for study specific aims, inclusion/exclusion, variables etc ( < 2 pages document is preferred ).
17. Current prices for biobank samples and the EHR identification service may be found at: https://www.unmc.edu/cctr/resources/biobank/pricing.html . We will bill the cost object provided below through the RSS Core Management System. You will receive two statements for your project one for the sample costs and one for the EHR sample identification.
17. The fees for your feasibility request, $60.00/hour, are fully subsidized by the IDeA-CTR grant, so there will be no cost to you. Please cite the National Institute of General Medical Sciences, U54 GM115458, which funds the Great Plains IDeA-CTR Network in any publications or presentations that might arise from use of this service. The content used is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. 17.For billing rates of this data request, please find it at the link: https://www.unmc.edu/cctr/resources/ehr/services.html
18. Please designate the funding source for the proposed project: Federal funds State funds Industry contract Other funds No funding at this time
18.1. Describe the funds type here:
18.2. Based on your request type, you MUST identify a funding source in question18 ! If you have reasons for NOT identifying a funding source, please list here:
19. Please enter Cost Center/WBS center #:* must provide value
1. I agree to comply with UNMC Policy 6045, "Privacy, Confidentiality and Information Security" and UNMC Policy 6051, "Computer Use and Electronic Information Security".
2. I certify that use of the PHI/de-identified data described above will be used only for the purpose stated above.
3. I certify that the requested data is the minimum amount of PHI/de-identified data necessary to accomplish the purposes stated above.
4. I agree to destroy the PHI/de-identified data after use.
5. I agree to store the PHI/de-identified data on secure network servers or encrypted AND password protected local computer drives or mobile devices.
If I am requesting PHI for a review preparatory to research, I certify that:
1. Review of the protected health information will be conducted solely to prepare a research protocol or for similar purposes preparatory to research;
2. I will not copy nor remove any protected health information from the University of Nebraska Medical Center campus in the course of review; and
3. The protected health information for which use or access is sought is necessary for research purposes.* must provide value
Agree
Do not agree
20. Please note: submitting this form requires you to upload a signed agreement form : https://www.unmc.edu/vcr/_documents/Signature-Page.pdf Please have this document ready to upload so that you do not need to re-complete this form !
* must provide value
Communication Documentation
1.Date of follow up:
Today Y-M-D
1. Service person:
1. Communication summary:
Adding more communications: Yes
No
2.Date of follow up:
Today Y-M-D
2. Service person:
2. Communication summary:
Adding more communications: Yes
No
3.Date of follow up:
Today Y-M-D
3. Service person:
3. Communication summary:
Request Status: Received Pending for clarification Pending for further information (after review) Pending for approval Approved and In preparation of sample/ data release Completed
Final approval issued by: Matt Lunning Jennifer Larsen Purnima Guda Christopher Kratochvil Other
Who issued the approval:
Communication email documentation
Final sample list (NBB_ID) released to the Requester:
Signed MTA
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