1. ACT Patient Recruitment Workflows

2. 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.

3. 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

4. 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).

5. Self-Service Workflow1
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.

6. 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

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

8. 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

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

10. 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

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

12. SHRINE query is created, run and flagged
Senior
Investigator

13. Concierge Service Workflow

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

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

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

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