Research Access to Patient Data (RAPiD) Portal

UW Medicine and Fred Hutch recognizes the need for access to clinical data and/or systems to support research studies. To that end, a number of options are available to internal and external researchers.

This multipart form will expedite providing you with the most appropriate access to support your work. Part 1 collects information about you as the requester and the study for which you are seeking access to patient data (identified, de-identified or limited). Part 2 is specific to the request type (i.e. Leaf, Full EHR access, etc.). For some requesters, there may be a third part which is an attestation page.

If you need help with this form or have questions, please email: researchit@uw.edu

Available Research Monitor Tip Sheets:

(Select all that you wish to download - You may unselect to hide the download links)

Attachment:Requesting External Monitor Access.pdf

Attachment:Ellkay Monitor Tip Sheet.pdf

To continue with your External monitor request, please click the link below:

Continue External Monitor Request

Please review our available options below:

Leaf

Leaf is a free self-service tool which provides investigators with a user friendly interface for querying the electronic health system records within UW Medicine and Fred Hutch Cancer Center (FHCC). Leaf is mostly meant for cohort discovery in early stages of any study, but can be used to gather statistics or to do limited chart abstraction

Requirements: AMC account, Completion of the Data Access Policy Training, IRB approval (for identified access - excluding preparatory to research)

For More Information, Please visit:
Leaf information provided by UW ITHS

Research Coordination Support Services

The Research Coordination Center (RCC) is a multidisciplinary team of research coordinators, regulatory specialists, and study monitors who can support the design and conduct of clinical and translational research.

The RCC can function in an honest broker role to manually abstract data from the EMR. RCC coordinators will work with the study team to insure accuracy and quality of data abstraction.

Requirements: IRB approval (for identified data)

Note: The RCC operates on a fee for service model.

For More Information, Please visit:
RCC information provided by UW ITHS

Research IT and UW Finance Data Services

The Research IT Bio-Medical Informatics Data Services team can extract larger datasets from the medical record. These datasets can be delivered as a one time extract, on-going report or in a REDCap project. This service is mostly suited for extracting larger amounts of data instead of manual abstraction.

The UW Physicians and UW Medicine Finance teams can provide financial data through this process. All data pulled by UWP or UW Finance, will be sent through the Research Honest Broker process, so please be aware that additional time for this review may extend timelines.

Requirements: IRB approval (for identified data)

Note: The RIT Data Services team operates on a fee for service model.

For More Information, Please visit:
RIT Data Services information provided by UW ITHS

Affiliated Developer (AD) Research Data Pull

An affiliated developer / departmental data analyst can be granted approval to pull data for research purposes from the Electronic Data Warehouse or through the use of Leaf in order to procure data for a specific investigator and research study. Any agreement for the time and use of departmental resources for research data queries are between the AD and the investigator requesting the data. Affiliated Developers in partnership with the requesting investigator are required to abide by all security and compliance requirements of UW Medicine and Fred Hutch Cancer Center Protected Health Information (PHI), including honest broker reviews and Account of Disclosures (AoD).

Requirements: IRB approval (for identified data - excludes preparatory to research), AMC Account, Completion of the Data Access Policy Training

Research SlicerDicer Export or Report Conversion

The self service tool SlicerDicer is a reporting tool in Epic that allows a user to tap into patient data to investigate clinical conjectures or make new discoveries about patient populations. Aimed primarily at physicians who want to look at trends in their patients, SlicerDicer can also be useful in an inpatient setting or for research.

Current Data Models in Epic:
* Outpatient (Ambulatory) Data

Data available in SlicerDicer is not "real time" and represent data on 1 day delay.

Clinical staff can export patients for which they are a member of the care team. Researchers who wish to export the full data set from a SlicerDicer query must complete the RAPiD request and an Honest Broker will pull and provide the data to the investigator through a secure mechanism.

Requirements include: Study IRB approval (unless part of Prep to Research); DUA if data is shared outside UW Medicine; approval through the ITHS COVID Portal if the query involves COVID-related data; access to the UW Epic instance; and completion of this intake form.

Full EMR Access

UW Medicine can grant direct access to the medical records if all other options are exhausted. To get approved for such an exception, you''lll need to demonstrate why each of the other options are not feasible.

Examples of reason are: To ensure quality or continuity of care during the research process, Complex evaluations that require highly specialized skill, or Real time access requirements.  

Requirements: IRB approval, AMC Account, Completion of the Data Access Policy Training

Note: The CRI Access committee (CRI ARC) will evaluate your reasoning on merit before granting an exception. All access will have an expiration date based on IRB approval.

Access to an Ancillary System

Many users within UW Medicine and partner institutions require access to ancillary systems that may contain PHI. For this reason, users will need to have a UW NetID and AMC account to access them.

Examples: OnCore Clinical Trials Management System (CTMS), Vestigo, Forte EDC, etc.

Requirements: AMC Account, UW NetID

External Monitor Access

A research monitor or sponsor auditor are individuals performing remote or in-person visits with advanced notice, who are employed or contracted by an entity under contract with UW Medicine and/or Fred Hutch Cancer Center (FHCC) to ensure that the data being recorded and submitted to the entity by UW Medicine and/or FHCC research staff is complete and accurate.

Research monitors/sponsor auditors will be granted limited access to the EMR, with access to only the records of patients that signed consent for the specific trial being monitored/audited. Although the research monitors/sponsor auditors are limited to which patient charts they can access, once inside a patient chart they will have access to that patient's entire chart for the purposes of conducting their job duties.

Requirements: Study IRB approval, Contract execution between sponsor and UW Medicine, Completion of this intake form, UW Epic Link Access

Research (Non-Monitor) Access

Research (non-monitor) access is for individuals who need access to the UW Medicine EHR in a view only format. This access is to review patients and data for research purposes only; users are not able to document, run reports. EHR access to the EHR will be requested and processed from the Okta Portal.

Research (non-monitor) users will be granted access to the EMR, with access to all patients, however users should be aware that all activities within the EHR are logged and audited and inappropriate access and use could result in loss of access.

Requirements: Study IRB approval, Data Use Agreement with UW Medicine (If external to a UW Medicine covered entity), and Completion of this intake form, UW Epic Link Access

Select the data services team that best fits your needs:

Research IT Data Services
Research IT Data Services provides a variety of services ranging from data extracts from the electronic medical record or financial systems, REDCap integration or data migration.

Hospital Finance (Coming soon)
Hospital Finance specializes in data extracts from data sources that contain hospital billing data with dollar amounts included. If your data requires more than just financial dollar amount data, it is possible that you will be asked to work with Research IT or an Affiliated Developer to receive your complete data set.

UW Physicians (Coming soon)
UW Physicians provides data sourced from professional (physician) billing activity. If your data requires more than just physician billing data, it is possible that you will be asked to work with Research IT or an Affiliated Developer to receive your complete data set.

UW Radiology (SOMRAD) (Coming soon)
UW Radiology (SOMRAD) can provide radiology studies (MRI, CT, X-ray) for research.
Radiology's integration with the RAPiD portal is coming soon, but still under development after feedback from the larger UW Medicine research community.
If you have a need for services regarding images of image studies at this point in time,
please contact the radiology department directly by emailing them at radrecs@uw.edu

Radiology's integration with the RAPiD portal is coming soon,
but still under development after feedback from the larger UW Medicine research community.

If you have a need for services regarding images of image studies at this point in time,
please contact the radiology department directly by emailing them at

radrecs@uw.edu

Are you a radiologist in the UW Radiology (SOMRAD) department?

* must provide value

Yes

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Please select the ancillary system you are requesting access to:

* must provide value

Forte EDC

OnCore CTMS

Vestigo

Other

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Enter the system to which you are requesting access:

* must provide value

Name:
Email:
Job Title:

Employer:

Many users have logins / NetIDs for more than one organization.

What organizational ID will you use to to log into ______?

Are you a staff member of the CTMS Program or Parallel Office?
Who is your direct manager at ______?
What is your direct manager's email address?

Do you have a UW NetID?

Do you have a UW AMC Account?

Name:
Email:			Date of Birth:
Phone:

If the system is rejecting your Date of Birth (DOB), please ensure that you are formatting it correctly.

Ensure that you are typing the slash ( / ) between the month and day, as well as between the day and the year
Ensure that your month is represented by 2 digits (ex: January = 01)
Ensure that your day is represented by 2 digits (ex: 2nd of the month = 02)
Ensure that your year is the full calendar year that you were born (ex: 1976)

Have you submitted a monitoring visit request through the RAPiD Process before?

Have you submitted a request through the RAPiD Process before?

You must enter your login/username (it should be your email address), or click the "I don't know it" button and complete the subsequent questions.

NOTE: If you do not answer one of these items and leave them both blank, the system will not prevent you from moving forward, however the administration team will not be able to process your request and will have to reject the submission.

In order to look up or add your access to the system, please select and complete one of the three approved unique identifiers:

Unique Identifier

Sponsor you are representing
Full name of primary study team contact at UW or Fred Hutch

To ensure you have access to the correct research study, please provide the RG number for the study
If you are unsure of the RG number, please consult with your research study team contact. This number is required to submit your request



Please enter the dates that you would like to review participants
Start Date:		End Date:
Maximum time for release is 2 calendar weeks

Please be sure to submit your request at least three business days of advanced
notice to ensure we are able to process the request in time and, to ensure that
the study team has adequate time to release the patient records.

Is your primary employer UW Medicine or FHCC?

* must provide value

Yes

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Please enter the FULL NAME of the orginization you are employed through


Primary study team contact within UWM or FHCC

You indicated a primary study team contact email outside of the University of Washington and Fred Hutch Cancer Center. Please check the email entered and make sure that you are inputting the correct primary study team contact within UWM or FHCC.

Is this is a request to access legacy data?

Yes

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Job Function

* must provide value

Thank you for your interest in using Leaf for your project. You have indicated that you are with ______ , which is outside of the UW Medicine HIPAA Coverage and therefore Leaf access is restricted. We are unfortunately unable to move forward with your request at this time.

Please click the submit button below to close out this request. You will receive a follow-up email with information regarding your request and possible next steps.

A UW AMC account is required to access, perform and/or use: ______. Please note that even with approval, until your AMC account has been created, you will not be able to move forward with your use of the tool.

Please complete the additional fields below. This system will email your clinical sponsor/manager with instructions on how to request an AMC account for you. You will be notified by email when your AMC account has been created.

UW Clinical Sponsor/Manager:
UW Clinical Sponsor/Manager's Email:

A UW AMC account is required to access the EDW and other databases to pull and provide data for research purposes. Please note that even with approval, until your AMC account has been created, you will not be able to move forward with your use of the tool.

Please complete the additional fields below. This system will email your clinical sponsor/manager with instructions on how to request an AMC account for you. You will be notified by email when your AMC account has been created.

UW Clinical Sponsor/Manager:
UW Clinical Sponsor/Manager's Email:

Are you involved in any other UW Medicine research projects?

Yes

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Please list all studies you are associated with.
(1 study per line and use format: Short title/PI/RG#)

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Per UW Medicine Compliance Policy: Comp.103-

Activities that are sometimes categorized as "preparatory to research" are considered to be research by the Human Subjects Division, which makes such determinations on behalf of the University. These include but are not limited to: screening activities such as review of PHI to identify possible research subjects, feasibility studies and/or pilot studies. Such activities may involve the use of human subjects directly or indirectly (through individually identifiable health records, the collection or review of other data such as samples, specimens or autopsy materials).

Link to full policy

Preparatory to Research is IDENTIFIED patient data. If you need simple feasibility counts, answer "no" below.The "Preparatory to Research" designation is typically only used for the purpose of preparing a research protocol or planning the research activity.

Is any of the information you plan to access for your project preparatory to research?

Please note that per UW Medicine Compliance, identifiable data for preparatory to research is not allowed. You have indicated that you are with ______ , which is outside of the UW Medicine HIPAA Coverage. We are unfortunately unable to move forward with your request at this time.

Please click the submit button below to close out this request. You will receive a follow-up email with information regarding your request and possible next steps.

Please note that per FHCC Compliance, identifiable data for preparatory to research is not allowed. You have indicated that you are with ______ , therefore are unfortunately unable to move forward with your request at this time.

If you would like more information, please refer to the FHCC Preparatory to Research Policy. You will need to use your FHCC credentials to login and view this policy.

Please click the submit button below to close out this request. You will receive a follow-up email with information regarding your request and possible next steps.

Please note that per UW Medicine Compliance, identifiable data for preparatory to research is not allowed. You have indicated that you are with ______, which is outside of the UW Medicine HIPAA Coverage. We are unfortunately unable to move forward with your request at this time.

Please click the submit button below to close out this request. You will receive a follow-up email with information regarding your request and possible next steps.

I agree to this condition

I do not agree to this condition

Use or disclosure of the PHI is sought solely to review it for the purpose of preparing a research protocol or planning the research activity. (For example, a researcher may review PHI to design a research study or to assess whether a sufficient number or type of records exist to conduct the research)

* must provide value

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No PHI will be removed from the UW Medicine covered entity by the researcher in the course of the review

* must provide value

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The PHI for which use or disclosure is sought is necessary for the research purposes

* must provide value

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You have indicated that you do not agree to one or more of the preparatory to research statements. Please note that per UW Medicine Compliance, identifiable data for preparatory to research is only allowed with agreement the the above statements. We are unfortunately unable to move forward with your request at this time. If you find that you have made a selection in error, please correct it before moving forward.

If you did not make an error and you do not agree with one or more of the preparatory to research statements, please click the submit button below to close out this request. You will receive a follow-up email with information regarding your request and possible next steps.

To complete the preparatory to research attestation, please sign using your mouse or finger. This electronic signature will be considered the same as a inked signature

* must provide value

Add signature

Study Short Title (lay name):

* must provide value

Study Long (IRB approved) Title:

* must provide value

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Study PI

* must provide value

PI Email

* must provide value

Study Sponsor

* must provide value

Current state of IRB approval

* must provide value

Approved

Not Approved

In Progress

Not Required

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We will be unable to process your request before you have IRB Approval

You may continue to fill out this request, however, do not submit the request, instead, please click the "Save and Return" button. Once your study have been approved, please use the link provided by the system to return to you request and complete the process.

If you do submit the request, there will be no way to return and you will have to re-enter all information.

Under which IRB is/was your project submitted?

Please provide explanation as to why IRB approval is not required.

* must provide value

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If you have any supporting documentation, please use this field to upload that file.

Upload file

What is the IRB study number?

* must provide value

Does the study have an IRB expiration date?

* must provide value

Yes

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When will the current IRB approval expire?

M-D-Y

Upload IRB Approval Letter	Upload IRB Approved Study Protocol

Please upload the IRB approval letter.

* must provide value

Upload file

Please upload the IRB approved protocol.

* must provide value

Upload file

For piping purposes in data service process section. Reach out to Research IT Data Services for any related questions.

View equation

For piping purposes in data service process section. Reach out to Research IT Data Services for any related questions.

View equation

Is there is an IRB waiver for the use and disclosure of PHI?

* must provide value

Yes

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For a study involving an IRB-waiver, please identify the date the waiver was approved.

* must provide value

M-D-Y

Please indicate whether individual study participants have authorized the use and disclosure of their protected health information consistent with HIPAA?

* must provide value

Yes

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Please click the "Submit" button below to move on to part 2 of this request. The next section will be specific for you requested access to ______

Please click the "Submit" button below to move on to the agreement of use and attestation page.

Please click the submit button below to close out this request. You will receive a follow-up email with information regarding your request and possible next steps.

As a member of the CTMS Program or Parallel Office, you will need access to items that are protected and require both a UW NetID and a UW AMC Account.

The next form will be to request an AMC account. Your account will be sponsored through The Enterprise Records and Health Information office at UW Medicine. It may take up to 1 business week for your AMC account to be created. You will be notified by email when your account is live.

Once you have completed the AMC Account Form your Manager will receive an email notification with a link to a CTMS specific form. This must be completed to get your account in OnCore Created.

Click the "Submit" button below to take you to the AMC account form.

By clicking the "Submit" button below, your manager will receive an email with a link to authorize your use of the the OnCore CTMS.

In order to grant you access to ______ a sponsored UW AMC account is required.

Click the "Submit" button below to begin the AMC account creation process.

Once your AMC account has been created, we will work with the appropriate team to have your access to ______ provisioned. Please be aware that this full process (AMC account creation and access provisioning) may take up to 14 business days to complete.

Click the "Submit" button below to complete this request and notify the appropriate team to begin the provisioning process to ______.

Thank you for your interest in using the UW Medicine EHR for your research. You have indicated that you are requesting access for a study that is not IRB approved. We are unfortunately unable to move forward with your request at this time. If you feel message is in error, please correct the above field and enter the required IRB information.

If you do not have IRB approval, please click the submit button below to close out this request.

If your IRB application is in the process of being resubmitted, you can click the "Save and Return" button, and once your study is approved, you can return and change the required IRB fields above.

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.