r FVIIa for Acute Hemorrhagic Stroke Administered at

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r. FVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

r. FVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Webinar Agenda 12: 30 pm – 1: 10 pm FASTEST: EFIC “How-To” 1: 10

Webinar Agenda 12: 30 pm – 1: 10 pm FASTEST: EFIC “How-To” 1: 10 pm – 1: 30 pm Q&A Pooja Khanolkar, MPH All August 18, 2020

Outline for the Webinar • Discuss the step-by-step process for Exception from Informed Consent

Outline for the Webinar • Discuss the step-by-step process for Exception from Informed Consent (EFIC) for the FASTEST Trial through c. IRB approval • Plan Phase • Implementation Phase • Report Phase

Outline for the Webinar • Discuss the step-by-step process for Exception from Informed Consent

Outline for the Webinar • Discuss the step-by-step process for Exception from Informed Consent (EFIC) for the FASTEST Trial through c. IRB approval • Plan Phase • Implementation Phase • Report Phase • What will not be covered -- the process for EFIC after c. IRB approval (i. e. , when enrolling an eligible subject) • To be covered in a future webinar

PLAN Site e-mails Site-Specific EFIC Plan to NCC Site develops Site-Specific EFIC Plan Sites

PLAN Site e-mails Site-Specific EFIC Plan to NCC Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. NCC e-mails signed Site. Specific EFIC Plan to site NCC signs Site -Specific EFIC Plan Changes can be requested. IMPLEMENTATION Site implements Site-Specific EFIC Plan NCC reviews Site-Specific EFIC Plan Advarra provides feedback to site on Site-Specific EFIC Plan via CIRBI It is strongly recommended that Advarra’s feedback is incorporated into the plan before it is implemented. A response to Advarra’s feedback in CIRBI is required after the plan is implemented. Site notifies NCC when all CC and PD is complete and data is submitted NCC works with NDMC to generate a Site EFIC Report from the sitesubmitted data REPORT For each community consultation (CC) and public disclosure (PD) event or activity, a corresponding CC Form or PD Form is to be completed in Web. DCUTM. A Local Context Form is also to be completed in Web. DCUTM. Clarifications, etc. can be requested to data submitted. Advarra reviews Site. Specific EFIC Plan Site submits Investigator Application, including signed Site-Specific EFIC Plan, in CIRBI Site uploads signed Site. Specific EFIC Plan to CIRBI Sites receive first site start-up payment upon submission of Site-Specific EFIC Plan to Advarra. NCC e-mails signed Site EFIC Report to site Site uploads signed Site EFIC Report and responds to Advarra’s feedback in CIRBI Site action Advarra reviews entire Investigator Application (including signed Site EFIC Report), and decides on site c. IRB approval NCC action Advarra action v 1. 0

Plan Phase Goals: • To have a developed site-specific EFIC plan that has been

Plan Phase Goals: • To have a developed site-specific EFIC plan that has been reviewed by Advarra in place prior to implementation • To allow for the incorporation of Advarra’s feedback into the plan prior to implementation, resulting in a higher likelihood of c. IRB approval during the first review after implementation

Plan Phase People: Trial Resources: • Site personnel • NCC Regulatory Specialists • Advarra

Plan Phase People: Trial Resources: • Site personnel • NCC Regulatory Specialists • Advarra • Site-Specific EFIC Plan Template • Model EFIC Proposal • Memorandum and Guidance on EFIC Activities (COVID-19 specific) • June 2020 Webinar/Slides • U. S. Site List • FAQs for EFIC Review by Advarra • Process for IRB Approval

Plan Phase People: Trial Resources: • Site personnel • NCC Regulatory Specialists • Advarra

Plan Phase People: Trial Resources: • Site personnel • NCC Regulatory Specialists • Advarra • Site-Specific EFIC Plan Template • Model EFIC Proposal • Memorandum and Guidance on EFIC Activities (COVID-19 specific) • June 2020 Webinar/Slides • U. S. Site List • FAQs for EFIC Review by Advarra • Process for IRB Approval

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 1: Define your community -- who

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 1: Define your community -- who are you trying to reach? Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. 1) The community in which research will take place • Geographic area (i. e. , hospital’s catchment area) 2) The community from which participants will be drawn • People likely to suffer from spontaneous intracerebral hemorrhage (ICH) (i. e. , those “at-risk”) Site-Specific EFIC Plan Template: • Section 1, Q. 2. a. : Community demographics (e. g. , percentages by age, gender, race, ethnicity, education, etc. ) • Section 1, Q. 2. d. : Unique community or hospital characteristics, community subgroups historically vulnerable or underrepresented in clinical research

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 1: Define your community -- who

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 1: Define your community -- who are you trying to reach? Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. Ideas for obtaining the information: • Hospital administration • Hospital community relations department • Local IRB • Other departments which have EFIC experience Post additional ideas in the chat! 1) The community in which research will take place • Geographic area (i. e. , hospital’s catchment area) 2) The community from which participants will be drawn • People likely to suffer from spontaneous intracerebral hemorrhage (ICH) (i. e. , those “at-risk”) Site-Specific EFIC Plan Template: • Section 1, Q. 2. a. : Community demographics (e. g. , percentages by age, gender, race, ethnicity, education, etc. ) • Section 1, Q. 2. d. : Unique community or hospital characteristics, community subgroups historically vulnerable or underrepresented in clinical research

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 2: How are you going to

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 2: How are you going to reach your community? Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. • Demographic representativeness (i. e. , strive to reach subgroups in your hospital’s catchment area in rough proportion to their prevalence, including vulnerable and underrepresented subgroups) • Seek diverse input • Required mix of community consultation (CC) events and public disclosure (PD) activities Site-Specific EFIC Plan Template: • Section 1, Q. 3. : CC events • Section 2, Q. 4. : PD activities

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 2: How are you going to

Plan Phase: Site-Specific EFIC Plan Template PLAN Step 2: How are you going to reach your community? Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. Ideas for obtaining local guidance: • Hospital community relations department • Hospital research institute • Local IRB • Hospital diversity office • Patient education teams • Social work teams • Other departments which have EFIC experience Post additional ideas in the chat! • Demographic representativeness (i. e. , strive to reach subgroups in your hospital’s catchment area in rough proportion to their prevalence, including vulnerable and underrepresented subgroups) • Seek diverse input • Required mix of community consultation (CC) events and public disclosure (PD) activities Site-Specific EFIC Plan Template: • Section 1, Q. 3. : CC events • Section 2, Q. 4. : PD activities

Plan Phase: Site-Specific EFIC Plan Template • It may be helpful to answer Q.

Plan Phase: Site-Specific EFIC Plan Template • It may be helpful to answer Q. 1. in Sections 1 and 2 after completing Section 1, Qs. 2. &3. and Section 2, Qs. 2. -4. • Sites that share a community are highly encouraged to work together during the Plan and Implementation Phases Site-Specific EFIC Plan Template: • Section 1, Q. 2. f. : Shared CC events • Section 1, Q. 3. a. : Shared CC events • Section 2, Q. 4. a. : Shared PD activities • Site-Specific EFIC Plans are requested to be submitted to the NCC Regulatory Specialists by September 1 st

PLAN Plan Phase: Site-Specific EFIC Plan Template Site develops Site-Specific EFIC Plan Sites can

PLAN Plan Phase: Site-Specific EFIC Plan Template Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. Site e-mails Site-Specific EFIC Plan to NCC Changes can be requested. NCC reviews Site-Specific EFIC Plan Goal: To make sure your Site-Specific EFIC Plan is ready for Advarra review

PLAN Plan Phase: Site-Specific EFIC Plan Template Site develops Site-Specific EFIC Plan Sites can

PLAN Plan Phase: Site-Specific EFIC Plan Template Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. Site e-mails Site-Specific EFIC Plan to NCC reviews Site-Specific EFIC Plan Goal: To make sure your Site-Specific EFIC Plan is ready for Advarra review Changes can be requested. What will the NCC Regulatory Specialists be looking for? • • • Use your own words; do not simply copy and paste the model EFIC proposal Answer all questions thoroughly, being as locally specific as possible; avoid vague/generic answers Spell out acronyms the first time used Provide a brief description of local organizations, etc. (e. g. , what it is, community/demographic reached) Present information clearly CC events and PD activities correspond to community demographics

PLAN Plan Phase: Site-Specific EFIC Plan Template Site e-mails Site-Specific EFIC Plan to NCC

PLAN Plan Phase: Site-Specific EFIC Plan Template Site e-mails Site-Specific EFIC Plan to NCC Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. NCC reviews Site-Specific EFIC Plan NCC signs Site -Specific EFIC Plan NCC e-mails signed Site. Specific EFIC Plan to site Changes can be requested. IMPLEMENTATION Advarra provides feedback to site on Site-Specific EFIC Plan via CIRBI It is strongly recommended that Advarra’s feedback is incorporated into the plan before it is implemented. A response to Advarra’s feedback in CIRBI is required after the plan is implemented. Advarra reviews Site. Specific EFIC Plan Site submits Investigator Application, including signed Site-Specific EFIC Plan, in CIRBI Sites receive first site start-up payment upon submission of Site-Specific EFIC Plan to Advarra. Site uploads signed Site. Specific EFIC Plan to CIRBI

PLAN Plan Phase: Site-Specific EFIC Plan Template Site e-mails Site-Specific EFIC Plan to NCC

PLAN Plan Phase: Site-Specific EFIC Plan Template Site e-mails Site-Specific EFIC Plan to NCC Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. NCC reviews Site-Specific EFIC Plan NCC signs Site -Specific EFIC Plan NCC e-mails signed Site. Specific EFIC Plan to site Changes can be requested. IMPLEMENTATION Advarra provides feedback to site on Site-Specific EFIC Plan via CIRBI It is strongly recommended that Advarra’s feedback is incorporated into the plan before it is implemented. A response to Advarra’s feedback in CIRBI is required after the plan is implemented. Advarra reviews Site. Specific EFIC Plan Site submits Investigator Application, including signed Site-Specific EFIC Plan, in CIRBI Sites receive first site start-up payment upon submission of Site-Specific EFIC Plan to Advarra. First start-up payment = $8, 492. 50 Site uploads signed Site. Specific EFIC Plan to CIRBI

PLAN Plan Phase: Site-Specific EFIC Plan Template Site e-mails Site-Specific EFIC Plan to NCC

PLAN Plan Phase: Site-Specific EFIC Plan Template Site e-mails Site-Specific EFIC Plan to NCC Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. IMPLEMENTATION It is strongly recommended that Advarra’s feedback is incorporated into the plan before it is implemented. NCC reviews Site-Specific EFIC Plan NCC signs Site -Specific EFIC Plan NCC e-mails signed Site. Specific EFIC Plan to site Changes can be requested. Advarra provides feedback to site on Site-Specific EFIC Plan via CIRBI It is strongly recommended that Advarra’s feedback is incorporated into the plan before it is implemented. A response to Advarra’s feedback in CIRBI is required after the plan is implemented. Advarra reviews Site. Specific EFIC Plan Site submits Investigator Application, including signed Site-Specific EFIC Plan, in CIRBI Sites receive first site start-up payment upon submission of Site-Specific EFIC Plan to Advarra. First start-up payment = $8, 492. 50 Site uploads signed Site. Specific EFIC Plan to CIRBI

Implementation Phase Goal: • To implement the Site-Specific EFIC Plan, and to collect and

Implementation Phase Goal: • To implement the Site-Specific EFIC Plan, and to collect and document the data necessary to generate the Site EFIC Report

Implementation Phase Goal: • To implement the Site-Specific EFIC Plan, and to collect and

Implementation Phase Goal: • To implement the Site-Specific EFIC Plan, and to collect and document the data necessary to generate the Site EFIC Report

Implementation Phase People: • Site personnel Trial Resources: (in addition to those listed in

Implementation Phase People: • Site personnel Trial Resources: (in addition to those listed in the Plan Phase) • Web. DCUTM EFIC Forms Resource Guide

Implementation Phase People: • Site personnel Trial Resources: (in addition to those listed in

Implementation Phase People: • Site personnel Trial Resources: (in addition to those listed in the Plan Phase) • Web. DCUTM EFIC Forms Resource Guide (w/ narrative guidance) • Community-facing materials: • Online survey -- REDCap • Online focus group platform -customized Adobe Connect through an external vendor • Focus group Power. Point presentation and facilitator guide • Opt-out form and card • Additional templated content and template materials

Implementation Phase: Tips IMPLEMENTATION Site implements Site-Specific EFIC Plan • Keep the goals of

Implementation Phase: Tips IMPLEMENTATION Site implements Site-Specific EFIC Plan • Keep the goals of EFIC in mind, and document, document! • Documented written responses are preferred over recording oral responses/impressions For each community consultation (CC) and public disclosure (PD) event or activity, a corresponding CC Form or PD Form is to be completed in Web. DCUTM. A Local Context Form is also to be completed in Web. DCUTM. REPORT Site notifies NCC when all CC and PD is complete and data is submitted • Document any concerns from the community and the followup action taken/needed to address the concerns • Always provide accurate site-specific contact information in PD activities; a PD activity could lead to a CC event! • Complete the CC Form or PD Form in Web. DCUTM in realtime; a separate form needs to be completed for each CC event and PD activity

Implementation Phase: Tips IMPLEMENTATION Site implements Site-Specific EFIC Plan • Keep the goals of

Implementation Phase: Tips IMPLEMENTATION Site implements Site-Specific EFIC Plan • Keep the goals of EFIC in mind, and document, document! • Documented written responses are preferred over recording oral responses/impressions For each community consultation (CC) and public disclosure (PD) event or activity, a corresponding CC Form or PD Form is to be completed in Web. DCUTM. A Local Context Form is also to be completed in Web. DCUTM. REPORT Site notifies NCC when all CC and PD is complete and data is submitted • Document any concerns from the community and the followup action taken/needed to address the concerns • Always provide accurate site-specific contact information in PD activities; a PD activity could lead to a CC event! • Complete the CC Form or PD Form in Web. DCUTM in realtime; a separate form needs to be completed for each CC event and PD activity

Report Phase Goal: • To demonstrate to Advarra that the goals of EFIC were

Report Phase Goal: • To demonstrate to Advarra that the goals of EFIC were met (via the Site EFIC Report)

Report Phase People: • • Site personnel NCC NDMC Advarra Trial Resources: • Site

Report Phase People: • • Site personnel NCC NDMC Advarra Trial Resources: • Site EFIC Report

Site notifies NCC when all CC and PD is complete and data is submitted

Site notifies NCC when all CC and PD is complete and data is submitted REPORT Report Phase: Tips NCC works with NDMC to generate a Site EFIC Report from the sitesubmitted data NCC e-mails signed Site EFIC Report to site Site uploads signed Site EFIC Report and responds to Advarra’s feedback in CIRBI Advarra reviews entire Investigator Application (including signed Site EFIC Report), and decides on site c. IRB approval Clarifications, etc. can be requested to data submitted. • The Site EFIC Report will only be as good as the data submitted in Web. DCUTM

Site notifies NCC when all CC and PD is complete and data is submitted

Site notifies NCC when all CC and PD is complete and data is submitted REPORT Report Phase: Tips NCC works with NDMC to generate a Site EFIC Report from the sitesubmitted data NCC e-mails signed Site EFIC Report to site Site uploads signed Site EFIC Report and responds to Advarra’s feedback in CIRBI Advarra reviews entire Investigator Application (including signed Site EFIC Report), and decides on site c. IRB approval Clarifications, etc. can be requested to data submitted. • The Site EFIC Report will only be as good as the data submitted in Web. DCUTM

PLAN Site e-mails Site-Specific EFIC Plan to NCC Site develops Site-Specific EFIC Plan Sites

PLAN Site e-mails Site-Specific EFIC Plan to NCC Site develops Site-Specific EFIC Plan Sites can complete the CIRBI Investigator Application in parallel. NCC e-mails signed Site. Specific EFIC Plan to site NCC signs Site -Specific EFIC Plan Changes can be requested. IMPLEMENTATION Site implements Site-Specific EFIC Plan NCC reviews Site-Specific EFIC Plan Advarra provides feedback to site on Site-Specific EFIC Plan via CIRBI It is strongly recommended that Advarra’s feedback is incorporated into the plan before it is implemented. A response to Advarra’s feedback in CIRBI is required after the plan is implemented. Site notifies NCC when all CC and PD is complete and data is submitted NCC works with NDMC to generate a Site EFIC Report from the sitesubmitted data REPORT For each community consultation (CC) and public disclosure (PD) event or activity, a corresponding CC Form or PD Form is to be completed in Web. DCUTM. A Local Context Form is also to be completed in Web. DCUTM. Clarifications, etc. can be requested to data submitted. Advarra reviews Site. Specific EFIC Plan Site submits Investigator Application, including signed Site-Specific EFIC Plan, in CIRBI Site uploads signed Site. Specific EFIC Plan to CIRBI Sites receive first site start-up payment upon submission of Site-Specific EFIC Plan to Advarra. NCC e-mails signed Site EFIC Report to site Site uploads signed Site EFIC Report and responds to Advarra’s feedback in CIRBI Site action Advarra reviews entire Investigator Application (including signed Site EFIC Report), and decides on site c. IRB approval NCC action Advarra action v 1. 0

Questions?

Questions?