OSU COMOR SOP-01
IHIS Research Access Manager Checklist
Attachment A
IHIS Research Access Manager Checklist
This checklist is a tool for managers and is not required to be completed. However, the following information should be available and/or completed prior to submitting a request for access to the electronic medical record for research purposes.
Failure to provide any of the following information may lead to a delay in approving access requests.
Please visit IHIS Access for Researchers for helpful information regarding the IHIS access review and approval process or contact the COM HIPAA Privacy Officer directly.
Employee ID Number: Click here to enter text.
Employee Name: Click here to enter text.
Cost Center Number: Click here to enter text.
Department Name: Click here to enter text.
Employee Job Title: Click here to enter text.
Student (Mark all that apply if applicable):
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OSU COMOR SOP-01
IHIS Research Access Manager Checklist
Attachment A
Graduate
Professional
Undergraduate
Non-OSU
Paid
Unpaid
Receiving Course Credit
Not Receiving Course Credit
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OSU COMOR SOP-01
IHIS Research Access Manager Checklist
Attachment A
FOR OSU STUDENTS PROVIDE COMPLETED DOCUMENTATION OF THE FOLLOWING:
Request for Research Access to Health System Clinical Information form
Statement of Confidentiality
FOR GRADUATE DEGREE STUDENTS (unpaid) IN A HEALTHCARE DISCIPLINE PROVIDE COMPLETED DOCUMENTATION OF THE FOLLOWING:
Please note: unpaid OSU undergraduate students, non health care graduate student volunteers and general adult volunteers (are deemed Adult Volunteers) and will not be given access to IHIS
Request for Research Access to Health System Clinical Information form
Statement of Confidentiality
COM/OHS and OSUMC Adult (18 and Over) Research Volunteer Application
Background Check Completed
Yes
No: COMPLETE OSUWMC BACKGROUND CHECK
Drug Screen Completed
Yes: PROVIDE DATE OF COMPLETION
No: COMPLETE DRUG SCREENING AND PROVIDE DATE OF COMPLETION (Contact Employee Health to schedule SAM 5 drug screen)
Vaccinations Completed: N/A for those not in direct contact with patients or biospecimens
Yes: PROVIDE DATE OF COMPLETION
No: COMPLETE VACCINATIONS AND PROVIDE DATE OF COMPLETION (Contact Employee Health to schedule vaccinations. May include demonstration of Hepatitis B, Rubella, Rubeola and documented history of Chicken Pox, current Tetanus and negative PPD Tuberculosis test.)
NA: INDIVIDUAL DOES NOT HAVE DIRECT CONTACT WITH PATIENTS
CITI Training Completed
Yes: PROVIDE DATE OF COMPLETION
No: COMPLETE TRAINING AND PROVIDE DATE OF COMPLETION
HIPAA CBLs Completed (Note Access will be turned off if HIPAA training is not completed)
Yes: PROVIDE DOCUMENTATION/DATE OF COMPLETION
No: COMPLETE CBLS AND PROVIDE DOCUMENTATION
Provide IRB Approval Number(s) (for example: 2010H0123, 2012C0123): Click here to enter text.
Employee Listed as Key Personnel or Sub-Investigator
Yes
No (SUBMIT EXPEDITED AMENDMENT TO LIST EMPLOYEE AS KEY PERSONNEL)
Signed Protocol Specific HIPAA Authorization Form Obtained Prior to Accessing Individual Patient Information
Yes
No
Partial or Full Waiver of HIPAA Authorization Required
No (individual will only access subject records that have a clinical relationship with the PI or approved sub-investigators for screening purposes prior to obtaining patient written HIPAA Authorization)
Yes (individual will be screening patient information prior to obtaining written HIPAA authorization from patients that do not have a clinical relationship with the PI or approved sub-investigators. Or the study was approved with a Full Waiver of HIPAA Authorization and written authorization will not be obtained)
PROVIDE APPROVED WAIVER OF HIPAA AUTHORIZATION (ORRP FORM APPENDIX N)
IHIS Functionality Needs (check all that apply)
View and/or Print Records
Document in the Record
Associate Patients to Studies for Research Billing
Complete Research Billing Work Queues
Schedule Research Subjects
IHIS CBLs Completed for View only access (guidance can be provided by COM HIPAA Privacy Officer)
Yes
No: COMPLETE CBL IN NetLearning “E-ALL-IHIS-1012-View Only Access 100”
NA
IHIS In-Class Training Completed (guidance can be provided by COM HIPAA Privacy Officer)
Yes
No: ENROLL IN CLASS THROUGH NetLearning
o For full access to document a research encounter, associate patients to a research study and view the full medical record the following class must be completed
§ CLS-RSCH-IHIS-Clinical Foundation 100 (10 hours)
o For access to complete research billing work queues specific to your study the following class must be completed
§ CLS-RSCH-IHIS-Billing Charge Review 100 (2 hours)
o For access to schedule subject appointments and procedures specific to your study the following class must be completed
§ CLS-RC-IHIS-Scheduler 200
NA
Describe Data Storage & Security Plan (Electronic: Network Drive, Encrypted Portable Device; Paper: Locked Cabinet Location, etc...): Click here to enter text.
Request IHIS Research Access
Enter eService Request for IHIS
o IT Services
o Account Request Forms
· Select New Hire Account (for new paid employees of OSUWMC, COM or OSUP including paid students)
· Select Account Modification (for individuals who have any existing computer access at the medical center)
· Select Non-Hospital Employee Account (for new non-COM employees, monitors, contract employees, agency staff, adult volunteers or unpaid students)
o Complete the form
o Check the box that access is for research
o Enter IRB approval number
o Check the box for IHIS
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