ACT Patient Recruitment Workflows

Two possible workflows An ACT SHRINE query is run by the overall PI. Then: 1. Concierge-based workflow SHRINE query is run locally by concierge/manager Concierge obtains patient identifiers for all patients in the query Concierge obtains additional data using site-specific methods 2. Self-service workflow SHRINE query is run locally by manager Investigator obtains the query and works with the data to screen and select potential subjects Investigator obtains data and patient identifiers directly Both workflows require that the SHRINE query be run locally at the site and that someone downloads a list of identifiers (coded or decrypted) from the local i2b2 ACT site.

ACT Workflows and Regulations SHRINE Query SHRINE Local Site Admin/Concierge finds flagged query and identifies local researcher Concierge workflow One IRB per site (what we currently have) Self-service workflow One IRB per clinical trial 4 possible approaches No regulation Exemption granted per project Exemption granted for all projects at once Full IRB ACT Local Site Local investigators look at Limited Data Sets ACT Local Site Get patient identifiers One IRB per trial

Concierge Workflow 1 SHRINE query is created, run, distributed to local sites and flagged. 2 Local site manager/concierge runs the flagged SHRINE query in local ACT i2b2. 3 Local site concierge extracts identifiers for potential subjects in local ACT i2b2 (and can obtain clinical data using site-specific tools outside of ACT).

Self-Service Workflow 1 SHRINE query is created, run, distributed to local sites and flagged. 2 Local site manager runs the flagged SHRINE distributed query locally and assigns it to a local investigator. 3 Local site investigator refines the query using the local i2b2 query tool. (optional) 4 Local site investigator screens and selects individual patients from the query. 5 Local site investigator extracts identifiers for potential subjects and distributes the list to the local patient recruitment team.

Where do these things happen? WHAT WHERE (Tool) WHO 1 SHRINE query is created, run, distributed to local sites and flagged SHRINE web client Senior investigator 2 Local site manager/concierge runs a flagged SHRINE query locally and identifies a local investigator Local i2b2 web client Local site manager or concierge 3 Local site investigator refines the query using the i2b2 query tool (self service workflow only) Local site investigator 4 Local site investigator selects individual patients from the query using local i2b2 query tool (self service workflow only) 5 Local site investigator or concierge extracts identifiers for potential subjects Local site investigator or concierge

SHRINE query is created, run, flagged and distributed to local sites

SHRINE query created at a network site SHRINE Web Client U Pitt SHRINE ACT SHRINE Hub Partners SHRINE Partners i2b2 SHRINE Web Client I2b2 Web Client

SHRINE query flagged SHRINE Web Client ACT SHRINE Hub U Pitt SHRINE Partners SHRINE Partners i2b2 SHRINE Web Client I2b2 Web Client

SHRINE query distributed to local sites SHRINE Web Client U Pitt SHRINE ACT SHRINE Hub Flag Message Partners SHRINE Partners i2b2 SHRINE Web Client I2b2 Web Client Query is distributed to network

Log on to SHRINE web client to create a network query Senior Investigator

SHRINE query is created, run and flagged Senior Investigator

Concierge Service Workflow

Local site manager/concierge logs on to local ACT i2b2 web client

Local site concierge runs the flagged SHRINE distributed query locally Local Site Manager/Concierge

Local site investigator extracts identifiers for potential subjects and distributes the list to the local patient recruitment team

Local site concierge extracts identifiers for potential subjects Local Site Manager/Concierge