CARe Submission Form

All research projects that access the UPMC electronic medical record (EMR) must be submitted to the Center for Assistance in Research using eRecord (CARe) per UPMC policy with the exception of clinical trials that are routed through the UPMC Office of Sponsored Programs and Research Support (OSPARS).

 Please complete all fields below and a CARe representative will contact you. Send all general inquiries and questions about completing this form to CARe@upmc.edu, or call 412-864-3491 for assistance.

Project Information

Project Title:  *  
Deadline:   ex. 01/01/2013  *    
Brief Project Description:  *  
IRB Submission Status:  *  
IRB#:

Principal Investigator's Information

PI Honorific:  *  
PI First Name:  *  
PI Last Name:  *  
PI Degree:  *  
PI Title:  *  
PI Affiliation:  *  
   If PI possesses both UPMC and University affiliations, please select University of Pittsburgh.
PI School:  *  
PI Hospital:  *  
PI Department:  *  
PI Address:
PI Phone:   ex. 111-222-3333  *    
PI Email:  *    

Requestor's Information

Requestor Honorific:
Requestor First Name:
Requestor Last Name:
Requestor Title:
Requestor Address:
Requestor Phone:   ex. 111-222-3333  
Requestor Email:  

EMR Access

Select all individuals and/or groups that will be accessing and/or extracting from the UPMC electronic medical record (EMR) for this research project. Select all that apply. If you need any assistance from CARe (e.g., provision of a cohort list, data extraction from EMR, etc.) you must check the CARe box below.


CARe can facilitate your data request by working with the eRecord teams to obtain UPMC EMR data or to program an alert or flag in the UPMC EMR. If you would like CARe assistance, please check this box and select the Request Type that best suits your needs. Complete the rest of the form and a CARe representative will contact you. If assistance from CARe is needed for more than one Request Type, please complete a separate submission form for each type.

Request Type:


If you are using the services of a certified Honest Broker for this research project, please check this box and provide the name and number of the certified Honest Broker below. If you would like CARe to act as your certified Honest Broker, please note that in this section.

Honest Broker Name:
Honest Broker Number:

If the PI is accessing and/or extracting data from the UPMC EMR for this research project, please check this box and answer the questions below.Select this box if the PI needs no assistance from CARe in obtaining a cohort list or extracting data from the EMR.

Does this individual have access to the EMR through their job responsibilites?

Has this individual completed the HIPAA for Researchers module (formerly Module 6)?
* Completion of the HIPAA Researchers Privacy Requirements module is a requirement for University of Pittsburgh faculty, staff, students, collaborators and others who participate in human subjects research at the University of Pittsburgh and/or UPMC that involves protected health information. Click on the link to access this module via your HS Connect account.

If someone other than the PI is accessing the UPMC EMR for this research project, please check this box and answer the questions below. List all persons accessing the UPMC EMR for this research project.

Name:
Role/title:
Does this individual have access to the EMR through their job responsibilites?

Has this individual completed the HIPAA for Researchers module (formerly Module 6)?
* Completion of the HIPAA Researchers Privacy Requirements module is a requirement for University of Pittsburgh faculty, staff, students, collaborators and others who participate in human subjects research at the University of Pittsburgh and/or UPMC that involves protected health information. Click on the link to access this module via your HS Connect account. PI is also responsible for overseeing all data extractions and management

Scope

Provide the following information about the research project.

List all data fields to be accessed and/or extracted from the UPMC EMR for this research project (i.e., as described in section 2.14 of OSIRIS: Describe the medical record information that will be collected from the UPMC/Pitt HIPAA covered entity):

Approximate number of individual patient medical records accessed for this study (i.e., estimated cohort size):
Date range of records to be extracted:
Start date of records:  
No specified record start date
End date of records:  
No specified record end date
Patient visit type:
Gender:
Will any racial or ethnic subgroups be
explicitly excluded from the participation?
specify the subgroups to be excluded:
Age Range: Minimum Age:  
Maximum Age:  

Report / Data Extraction Criteria

Complete this section to request assistance from CARe analysts with data extraction from the electronic medical record. Specify inclusion/exclusion criteria in the fields below and please be as specific as possible. If a field is not applicable, type N/A.

Preferred Output Format(s) – e.g., Excel, etc.:

Domain – List specific hospitals, clinics, departments, providers, etc.:

Disease – List specific disease(s) and/or condition(s) and corresponding ICD-9 diagnosis codes:

Procedures – List specific procedure(s) and corresponding ICD-9 procedure codes (for inpatient) and/or CPT procedure codes (for outpatient):

Pharmaceuticals – List specific medication(s), including generic names and dosages:

Other – Describe any other variables not listed above (Labs, Radiology, Progress notes, etc.):

Research Recruitment Alert

Complete this section to request an alert in the EpicCare to indicate when a patient meets criteria for participation in a specific research study. Please be as specific as possible. If a field is not applicable, type N/A.

EpicCare Departments for which the alert should be configured:
Include department name, number, and who the alert should be viewed by (e.g., provider, nurse, etc.).
NOTE: You must obtain documentation of approval from each department and provide it to CARe.


Alert Message / Display Text:
Example: “Your patient may be eligible for a cardiovascular disease research study. May a research team member contact your patient about this? If YES, please click ACCEPT”


Inclusion Criteria:
List all specific diagnosis codes (specify if “encounter” or “problem list”) and/or procedure codes, and additional demographics, medications, etc. meeting criteria for alert not already specified. Example: Hypertension, benign (ICD-9 code 401.1), problem list; BMI >25; prescribed diuretics, ACE inhibitors, and/or beta blockers


Exclusion Criteria:
List all demographics, medications, etc. that would restrict the alert. Example: Prescribed statins


If a patient declines, if and when should they be asked again?



 

When a patient agrees, an order will be sent to the inbasket. Please specify the following:

Order Name:


Inbasket / Pool Name:


Pool Members: If a pool member does not have access to EpicCare, a view-only access request must be submitted to IMS at https://ims.upmc.com.


Other: If there are other orders and parameters to include, please define them below.


Data Source(s)

Select all electronic data sources that will be accessed for this research project. If you are unsure of the system in which data will be accessed and/or extracted, please check “Unknown.”










De-identification of Data

Select one of the following to indicate the regulatory permissions for accessing and/or extracting UPMC EMR data for this research project.




Required Storage Data





*Reminder: Data must be stored in a secured environment at all times. This includes ensuring that the computer and any media (such as CD-ROMs, thumb drives, removable drives) are encrypted and password protected. Data should not be sent through e-mail, unless it is encrypted (with the key being sent separately). Data are not permitted to be stored in or transferred via personal, unprotected, unencrypted files or devices.

* Your research project may be subject to monitoring and auditing to ensure compliance with policy.

UPMC Policy HS-RS0005 Access, Acquisition and Disposition of Electronic Protected Health Information for Research Purposes
University of Pittsburgh Policy 07-02-06 Security of Electronic Medical Records – Compliance with HIPAA
University of Pittsburgh Policy 10-02-04 Computer Data Administration
University of Pittsburgh Policy 10-02-05 Computer Access and Use
University of Pittsburgh Policy 10-02-08 Use and Management of Social Security Numbers and Use of Primary ID (“UPI”) Numbers
University Policies related to Technology