Language to Include in IRB Applications

Clinical Research Data Warehouse (CRDW)

In Section 26.2 – Select “Yes” and select “PRO00013874 – Clinical Research Data Warehouse”

In the Recruitment section (17) of the PRO SmartForm, investigators should identify all recruitment pathways including use of CRDW (if applicable). If investigators wish to use CRDW – use this language.

In Section 17.2, Select “Other Strategies” option and insert the following:

"To identify potential participants and obtain their contact, demographic, and/or visit information for recruitment, the investigator will (a) search for eligible participants with the following inclusion and exclusion criteria by querying a de-identified CRDW cohort discovery tool (e.g., i2b2, TriNetX, or Jupyter Hub) or querying an identified CRDW cohort discovery tool (e.g., EMERSE) and then (b) use Honest Broker to extract the following identified information for each potential participant:

a. <Specify participant inclusion/exclusion criteria to be queried>

b. <Specify participant information to be extracted>

c. Using this identified information, the investigator will then <<insert next steps of how Investigators will contact potential participants>>...”

Froedtert Health (FH) Enterprise Analytics (EA)

In the Recruitment section (17) of the PRO SmartForm, investigators should identify all recruitment pathways including use of FH EA (if applicable). If investigators wish to use FH EA – use this language.

In Section 17.2, Select “EPIC Tools:” option and insert the following:

"To identify potential participants and obtain their contact, demographic, and/or visit information for recruitment, the investigator will provide the following inclusion and exclusion criteria for FH EA to build <<insert list of all required EPIC tools>> to extract the following identified information for each potential participant:

a. <Specify participant inclusion/exclusion criteria to be queried>

b. <Specify participant information to be extracted>

Using this identified information, the investigator will them <<insert next steps of how investigators will contact potential participants>>..."

Clinical Research Data Warehouse (CRDW)

In Section 26.2 – Select “Yes” and select “PRO00013874 – Clinical Research Data Warehouse”

Add one of the following options in the procedures section of the PRO SmartForm application depending on the type of project being submitted Reliance (7.1.1), FLEX (19.7) or Research (30.1). Investigators must clearly state whether the CRDW is the ONLY way clinical data will be accessed or the CRDW is one of several clinical data sources (i.e. FH EPIC, CW EPIC, Versiti clinical data, or external data).

To the procedure section, add one of the following options:

"Clinical data for this study will be obtained by... <Add one of the following language options A or B>

(A) ...searching for eligible participants with the following inclusion/exclusion criteria by (a) querying a de-identified CRDW cohort discovery tool (e.g., i2b2, TriNetX, or Jupyter Hub) or querying an identified CRDW cohort discovery tool (e.g., EMERSE) and then (b) using Honest Broker to extract the following identified information for each potential participant :

a. <Specify cohort inclusion/exclusion criteria to be queried>

b. <Specify clinical information to be extracted/accessed>

OR

(B) ...entering a list of medical record numbers for identified participants into the Honest Broker tool and then submitting a request to extract or access the following clinical information for each participant:

a. <Specify clinical information to be extracted/accessed>

Using this identified clinical information, the investigator will then...”

Froedtert Health (FH) Enterprise Analytics (EA)

Add the following language in the procedure section of the PRO SmartForm application depending on the type of project being submitted Reliance (7.1.1), FLEX (19.7) or Research (30.1). The investigator must clearly state whether FH EA is the ONLY way potential participant clinical data will be accessed, or FH EA is one of several clinical data collection strategies.

To the procedure section, add the following:

"Clinical data for this study will be obtained by working with the Froedtert Enterprise Analytics team to create a custom data pull from <<list FH EPIC and/or any specific FH Enterprise Data Warehouse databases needed for the project>>. The custom extract will include the following clinical information for each potential participant:

a. <Specify cohort inclusion/exclusion criteria to be queried>

b. <Specify clinical information to be extracted/accessed>

Using this identified clinical information, the investigator will then…”

Section 52.1.2 – Upload correspondence (email/intake form) with CBMI confirming the custom data pull from FH EPIC by the Froedtert Health Enterprise Analytics team

Add the following language in the procedures section of the PRO SmartForm application depending on the type of project being submitted Reliance (7.1.1), FLEX (19.7) or Research (30.1). The investigator must clearly state whether CAPS is the ONLY way identified participant data will be accessed or CAPS is one of several clinical data collection strategies.

To the procedure section, add the following:

"Clinical data for this study will be obtained by the Center for Advancing Population Science (CAPS) team through a direct data pull from FH EPIC Clarity. The custom extract will include the following clinical information for each participant:

a. <Specify cohort inclusion/exclusion criteria to be queried>

b. <Specify clinical information to be extracted/accessed>

The CAPS team will submit an analysis plan to CBMI which accurately describes the project cohort and extract definitions prior to accessing identified data. CBMI will submit a custom identified Honest Broker request on the project team’s behalf. Once approved, the CAPS team will use Epic Clarity to build an analytic dataset, <specify additional services as appropriate>, and then provide the investigator with aggregated results to inform results dissemination, including...<specify intended output: abstract, manuscript, etc.>”

In addition to the above language in the procedure section, please make sure the following are included in the PRO SmartForm:

• Section 2.1 (Project Team Members) please add members of DOM Biostatistical Support to the project team as appropriate.
• Section 52.1.2 - Email correspondence from CAPS/DOM Biostatistical Support OR a copy Statistical Support Request form

Investigator wants to use a CRDW cohort discovery tool (i2b2 or TriNetX) to identify eligible participants and use Honest Broker to get de-identified data, or use the CRDW Jupyter Hub to get de-identified data, or use a de-identified dataset from one of the external TriNetX networks, for research.

• If the research project is only using de-identified data, the project may qualify for a Not Human Subjects Research (NHSR) Determination.
• If a research project involves accessing data from multiple sources, please consult the IRB Office (irboffice@mcw.edu) before submitting to confirm if the project qualifies for NHSR determination.

If investigators will ONLY be accessing a Clinical Research Data Warehouse tool (i2b2, TriNetX, Honest Broker, Jupyter Hub) for de-identified data, complete the following:

1. In Project Category (3.0) of the PRO SmartForm, select “Not Human Subject Research” (NSHR). This will display the NHSR questions within the PRO SmartForm application.
2. In the Source section (3I - Sources) of the PRO SmartForm, Investigators should select MCW Clinical Research Data Warehouse.

In Section 26.2 – Select “Yes” and select “PRO00013874 – Clinical Research Data Warehouse”

In Section 52.1.2 – The following language should be included in the project’s protocol summary: "Clinical data for this study will be obtained by searching for eligible participants by querying a Clinical Research Data Warehouse tool (<<i2b2, TriNetX, or Jupyter Hub>>) with the following inclusion/exclusion criteria, and then extracting or accessing the following de-identified clinical information from <<Honest Broker, Jupyter Hub, or a TriNetX Dataset>> for each potential participant:

a. <Specify cohort inclusion/exclusion criteria to be queried>

b. <Specify clinical information to be extracted/accessed>

In Section 26.2 – Select “Yes” and select “PRO00013874 – Clinical Research Data Warehouse”

Add the following language in the procedures section of the PRO SmartForm application depending on the type of project being submitted Reliance (7.1.1), FLEX (19.7) or Research (30.1). Investigators must clearly state whether the CBMI custom data pull is the ONLY way potential participant clinical data will be accessed or the CBMI custom data pull is one of several clinical data collection strategies.

To the procedure section, add the following:

"Clinical data for this study will be obtained by working with the Center for Biomedical Informatics (CBMI) team to create a custom data pull from <<list data sources such as EPIC, Press Ganey, or other sources>> The custom extract will include the following clinical information for each participant:

a. <Specify cohort inclusion/exclusion criteria to be queried>

b. <Specify clinical information to be extracted/accessed>

Using this identified clinical information, the investigator will then…”

Section 52.1.2 – Upload correspondence (email/intake form/letter of agreement with statement of work) from CBMI confirming the custom data pull for the research team

Add one of the following options in the procedures section of the PRO SmartForm application depending on the type of project being submitted Reliance (7.1.1), FLEX (19.7) or Research (30.1). Investigators must clearly state whether the ICDR is the ONLY way clinical data will be accessed or one of several clinical data sources (e.g., EPIC, Versiti clinical data, or external data).

To the procedure section, add one of the following options:

“Clinical data for this study will be obtained by... <Add the appropriate language option A and/or B>

(A) ...requesting a custom clinical data extract from the Integrated Cancer Data Resource (ICDR). The ICDR data analyst will submit a custom Honest Broker request on behalf of the requesting team to deliver the following:

a. <Specify cohort inclusion/exclusion criteria to be used by ICDR>

b. <Specify clinical information to be extracted/accessed>

Investigator has IRB approval to access identified F&MCW images for research but wants them de-identified so the images can be sent outside F&MCW in de-identified format.

Investigators should check their protocol, contract, grant, or subaward to confirm how images must be delivered to the designated external party (Sponsor and/or Collaborating Institution) to confirm if de-identification is required or if there is an existing data sharing agreement which outlines data (including a limited data set) may be shared externally.

If de-identification is required per protocol, contract, grant, or subaward, investigators should add the following language in Section 34.4 (Privacy & Data Confidentiality) to describe how images will be de-identified prior to transmission to external parties:

"Subject scan images to be provided to <list all external third parties> will be totally de-identified per study protocol by submitting index images and destinations to the CBMI Image De-Identification Service for image de-identification and Honest Broker delivery." <<insert kinds of images, how many images and to whom the images will be sent to>>

Investigators should provide information to the CBMI team indicating that the investigator already has IRB approval to access or use these specific images, and IRB approval for access to IDENTIFIED images. If there is a question, CBMI team will communicate with the IRB to confirm.

Investigator wants to use a CRDW cohort discovery tool (i2b2 or TriNetX) to identify eligible participants, use Honest Broker to get de-identified image accession IDs and other cohort data as specified, and then have the CBMI IDSC team deliver de-identified images for that cohort for research.

• If the research project is only using de-identified data and images, the project may qualify for a Not Human Subjects Research (NHSR) Determination.
• If a research project involves accessing data or images from multiple sources, please consult the IRB Office (irboffice@mcw.edu) before submitting to confirm if the project qualifies for a NHSR determination.

If investigators will ONLY be accessing a Clinical Research Data Warehouse cohort discovery tool (i2b2 or TriNetX) to identify eligible participants, use Honest Broker to access and receive de-identified data, and then use the Image De-Identification Service (IDSC), complete the following:

1. In Project Category (3.0) of the PRO SmartForm, select “Not Human Subject Research” (NSHR). This will display the NHSR questions within the PRO SmartForm application.
2. In the Source section (3I - Sources) of the PRO SmartForm, Investigators should select MCW Clinical Research Data Warehouse.

In Section 26.2 – Select “Yes” and select “PRO00013874 – Clinical Research Data Warehouse”

In Section 52.1.2 – The following language should be included in the project’s protocol summary: "Clinical data for this study will be obtained by searching for eligible participants by querying a Clinical Research Data Warehouse cohort discovery tool (i2b2 or TriNetX) with the following inclusion/exclusion criteria, then requesting to extract or access the following de-identified clinical information for each potential participant, and then using the IDSC to provide de-identified images:

• <Specify cohort inclusion/exclusion criteria to be queried>
• <Specify all clinical information to be extracted, including encrypted image accession IDs>
• <Specify the type(s), number, and destination(s) of de-identified scan images to be requested>

For research teams who wish to access and use ROSIE supercomputer at MSOE to employ machine learning (ML) techniques on existing de-identified data, add the following language in the procedures section of the PRO SmartForm application depending on the type of project being submitted Reliance (7.1.1) or Research (30.1).

In addition, if investigator requires CRDW, FH EA, or CBMI to help build a dataset, add all appropriate “Use of” scenarios listed in this guide depending on the type of data they wish to receive.

To the procedure section [Reliance (7.1.1) or Research (30.1)], add the following:

• Send de-identified data to Milwaukee School of Engineering to run developed algorithms to build, train, and validate artificial intelligence neural networks.

In Section 26.2 – Select “Yes” and select “PRO00013874 – Clinical Research Data Warehouse”