Submitting studies to WIRB as a CHLA researcher Agenda Overview of - - PDF document

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Submitting studies to WIRB as a CHLA researcher

 Overview of WCG and WIRB  Initial Review



Preparing to Submit



How to submit  Connexus and Submission Overview

Agenda

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Overview of WCG and CHLA Agreement

Several Companies, One United Mission: Provide the people who perform clinical trials with the highest quality of services to accelerate the scientific advancement of human health, while ensuring that the risks of progress never outweigh the value of human life.

WIRB-Copernicus Group Overview

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WCG Family of IRBs



Western IRB “WIRB”



Copernicus “CGIRB”



Aspire IRB



Midlands



New England

WIRB-Copernicus Group Overview

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CHLA has entered into a Master service agreement with WIRB-Copernicus Group (WCG)



Western IRB (WIRB) – Partnered with CHLA to create a workflow that follows local requirements – “rules”



CHLA requires the submission be submitted to and processed by WIRB staff to ensure CHLA requirements are followed



Sister IRBs – The reliance agreement is there but there are no processing rules established. Contact the CHLA HSPP

Important Facts

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What type of studies can you submit to WIRB?

 Industry initiated (the clinical trial protocol is authored by the Sponsor)  Industry sponsored (the clinical trial is fully funded by the Sponsor)  Multi-center (the same clinical trial is performed at two or more institutions)

Important Facts

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Initial Review

Preparing to submit to WIRB

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Local IRB vs Central IRB



Local IRB

• WIRB approval of a protocol does not mean we are the central IRB
• WIRB may have reviewed the study for another affiliated client(s)
• Sponsor consent form template(s) may be required for submission
• You are responsible for making all submissions for the study to WIRB
• Sponsor/CRO may submit on your behalf if there is an agreement between

you and the sponsor/CRO



Central IRB

• Sponsors will typically submit on your behalf
• Protocol submissions will be reviewed for CHLA but the sponsor must

request we review for all sites or specify CHLA in their submission

Local or Central?

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Contact WIRB Client Services to ask whether WIRB has reviewed the protocol (provide sponsor protocol # and title)



If yes –

• Request WIRB-approved ICF Templates for the study (if you need them, not

required for CHLA clearance)

• Connexus access
• Ask if WIRB is the central IRB



If no –

• Request from the sponsor all protocol documents that require IRB review for

submission to WIRB via Connexus as a new study after CHLA HSPP clearance

Communicate with the sponsor/CRO as to who will make the submission

Has WIRB reviewed the study?

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CHLA-WIRB Consent Form Checklist and Required Consent Language when relying on WIRB is required



WIRB pre-panel/board staff will create your site specific consent/assent* form(s) only when the checklist is completed and included with your initial review submission

• If the checklist is missing, WIRB staff will hold the submission to request

the checklist



Pre-panel staff will provide the pre-review to both site coordinator(s) and the sponsor/CRO.

• WIRB does not negotiate language on your behalf, that is between CHLA

and sponsor/CRO. Any request to change institutional language needs approval from the CHLA HSPP

* Only when a sponsor’s assent template is available

Preparing your Consent Form Checklist

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Complete the grey fill-in fields where applicable.

Preparing your Consent Form Checklist

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 Check the checkboxes where applicable  Where there is sample language, complete the Similar

alternate language field only if required

Preparing your Consent Form Checklist

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Assent

 All subjects unable to consent are required to assent, unless the

investigator determines that the capability of the subject is so limited that the subject cannot reasonably be consulted.

 Children ages 7 to 13: Subjects must be given an assent

information sheet. CHLA prefers it not have a signature line.

• Complete the CHLA assent template and submit as subject material

OR

• Select to use the sponsor’s assent information sheet

Preparing your Consent Form Checklist

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Assent

 Last question on the checklist

Preparing your Consent Form Checklist

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Assent

 Children ages 14 to 17: If assent is obtained, subjects will sign

the main/parental consent form, unless the investigator determines that the subject is not capable of signing. CHLA prefers that this age group not sign a separate assent form.

• WIRB will add assent signature lines to the main/parental consent
• If sponsor has an adolescent assent template, our staff will not
• process. Communicate the CHLA preference for this age group with

sponsor.

Preparing your Consent Form Checklist

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Ensure that you comply with your local CHLA requirements by doing the following BEFORE submitting to WIRB:



Review and follow the CHLA Instructions for Submission to the Western IRB (WIRB) guidance



Submit request to rely on WIRB to CHLA HSPP in iStar



Ceded review application



Completed CHLA-WIRB Consent Form Checklist and Required Consent Language when relying on WIRB



Completed CHLA Assent Template (ages 7-13) if CHLA template is used



Site-specific recruitment or subject materials, if used



All department/division and ancillary reviews must be completed before a submission may be cleared

Meeting your institutional requirements

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Once the CHLA HSPP has reviewed your reliance request, they will issue:



CHLA HSPP will issue a clearance notice



WIRB staff will refer to this as your “institutional sign-off” 

You are ready to submit to WIRB!

Meeting your institutional requirements

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Initial Review

How to submit to WIRB

How to submit to WIRB

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All Submissions to WIRB Must Include:



WCG Initial Review Submission Form (IRSF)



Attachments as directed during the completion of the IRSF



CHLA HSPP Clearance Notice



CHLA/WIRB Consent Form Checklist



CHLA Assent Template (ages 7-13) if CHLA template is used



Protocol and study level documents (if study not yet reviewed by WIRB)



Site-specific recruitment or subject materials



PI medical license (for PI’s not previously reviewed by WIRB)



PI CV (for PI’s not previously reviewed by WIRB)

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Smart PDF forms are available in two locations:



WIRB.com > Download Forms Page



Via Connexus Quick Access Links > IRB Forms and Guides

How to submit to WIRB

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Select WIRB as Destination IRB

Completing the Submission Form

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Select Submission Type (2 Common Options)

Completing the Submission Form

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CPUS – No / IRB Determinations – No

Completing the Submission Form

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Site Contacts

Completing the Submission Form

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List sponsor, CRO, SMO and CHLA study coordinators that need to receive IRB correspondence

Translated Documents



Confirm with sponsor if translation costs will be covered

• Mark Yes if covered and confirmed – Complete and submit the Translation

Request Form

• Not including this form will delay your initial review if you mark YES
• Mark No – If confirmation from the sponsor/CRO is not received or not

covered

Completing the Submission Form

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Billing Always verify with the sponsor and check the CTA before answering this question.



Mark Yes – If WIRB is the central IRB and sponsor allows WIRB to bill direct.

Completing the Submission Form

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Billing



Mark No if CHLA must be billed

• IMPORTANT: CTA budget must include WIRB review fees



When billing CHLA, must add this department for WIRB billing: (Next page)

Completing the Submission Form

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Billing to CHLA

Tigran Garoian Children’s Hospital Los Angeles 4650 Sunset Boulevard, Mail Stop #97 Los Angeles, CA 90027 Attn: Contracts and Clinical Research Team Chlaclinicalresearch@chla.usc.edu IMPORTANT: CTA budget must include WIRB review fees

Completing the Submission Form

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Institutional Services



Select YES to and Indicate Institution Name/Number:

Completing the Submission Form

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CHLA Institution#: 130163

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Research Locations



List where research activity conducted

Completing the Submission Form

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CHLA studies should NOT list any research locations that are not CHLA. Consent

 Complete the sections for

Consent Setting, LAR, Consent Process

 Consent Documentation

Completing the Submission Form

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Financial Interest Disclosure



Any financial conflict over $5,000 by PI or any research team member or their immediate families must be disclosed to WIRB on this submission form

• If there is a COI for the PI, provide a copy of the conflict of interest management

plan provided by the CHLA COIRC

Completing the Submission Form

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 The form will guide you as to what documents are required for

submission

• There will be signs in the form if supplemental forms are required

 Reference the end of the form

for a list of required documents  The form includes a tool to check for missing entries

• Missing entries will be highlighted

Submission Documents

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Connexus and Submission Processing

Connexus

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https://portal.wcgclinical.com/WCG/Home.aspx http://www.wirb.com

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Connexus

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https://portal.wcgclinical.com/WCG/Home.aspx

Connexus - Dashboard

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Submitting in Connexus

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If study has been approved by WIRB and Connexus access provided



Click the My Studies Tab

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Locate and select the study by IRB Tracking number

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Under “Submissions for this Study” select “Submit New Investigator” at the top right of your screen

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Follow the submission wizard instructions and submit the following:

• Initial Review Submission Form (IRSF)
• Attachments as directed during the completion of the IRSF
• CHLA HSPP Clearance Notice, CHLA-WIRB Consent Form Checklist, CHLA assent

template if using CHLA template

• Site-specific recruitment or subject materials
• PI medical license and CV (for PIs who have not previously submitted to WIRB)

Submitting in Connexus

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Submitting in Connexus

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If study has been NOT been approved by WIRB



Select “Make a Submission to the IRB” from the Quick Access Links



Select “Initial Review Submission”, then “Review of New Research Protocol.” Continued on next page

Submitting in Connexus

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

Follow the submission wizard instructions and submit the following:



Initial Review Submission Form (IRSF)



Attachments as directed during the completion of the IRSF



CHLA HSPP Clearance Notice, CHLA-WIRB Consent Form Checklist, CHLA assent template if using CHLA template



Site-specific recruitment or subject materials



PI medical license and CV (for PIs who have not previously submitted to WIRB)



Protocol and protocol support documents not included in the protocol



Additional Protocol document(s) provided by the Sponsor that require IRB review



All documents to be used or provided to subjects provided by the Sponsor

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All recruitment materials provided by the Sponsor

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Investigator brochure(s) provided by the Sponsor

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Submitting in Connexus

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 You will receive a Connexus acknowledgment receipt of submission  Multiple WIRB departments process your submission

• Data Entry – Checks your submission for completeness and sign-off
• Pre-Panel – Prepares your consent/assent form(s) from the checklist

and sends for pre-review first, then to Board for review

 A WIRB Board Panel or Expedited Reviewer reviews the research  WIRB staff assembles and finalizes documents  Outcome documents are sent to email list and posted to Connexus under

the PI Workspace

After You Submit: What to Expect

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 You will receive a Certificate of Action (COA):

• Board Action Date (Approval Date)
• Expiration Date
• All sites expiration dates are aligned with protocol expiration date, verify your

expiration date.

• Approved Research Location(s) and PI
• The documents that were reviewed
• List of study personnel on the email distribution list

 You can add others to the Connexus workspace for your PI.  Use the Contact Information Update Form for changes to study

contacts

After You Submit: What to Expect

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Ensure that you comply with your local CHLA post-approval requirement by:



Filing an amendment in iStar to upload approved documents:

• Certificate of action(approval letter), consent form(s) and assent information ONLY

Note: All approval documents provided by WIRB must be kept in your regulatory binder as usual per CHLA policy. Only documents listed above need to be uploaded in iStar for reliance reviews.

WIRB Approval Upload to iStar

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Managing Your Site in Connexus

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Locate in Connexus under My Investigators

Managing Your Site in Connexus

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Locate in Connexus under My Investigators

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Managing Your Site in Connexus

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Locate in Connexus under My Investigators

Approval documents displayed here Click to view or make submissions Click to manage access to this site workspace only

Helpful Resources Reminder

• Most of what you need is available on WIRB’s website:

www.wirb.com

• Submission Forms
• Promptly Reportable Information Form
• “Guide for Researchers” an aid to WIRB’s perspective
• n developing, submitting, and conducting research.

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Upcoming Trainings

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Date Time Description Thursday, May 7, 2020 9:30AM – 11AM Submitting studies to WIRB as a CHLA researcher

Initial Review Process, Connexus

Friday, May 8, 2020 9:30AM – 10:30AM Managing your WIRB approved study

Amendments, Continuing Review, Prompt Reporting

Tuesday, May 12, 2020 1PM – 2:30PM Submitting studies to WIRB as a CHLA researcher

Initial Review Process, Connexus

Wednesday, May 13, 2020 1PM – 2PM Managing your WIRB approved study

Amendments, Continuing Review, Prompt Reporting

Wednesday, May 20, 2020 11AM – 12:30PM Submitting studies to WIRB as a CHLA researcher

Initial Review Process, Connexus

Wednesday, May 27, 2020 3PM – 4PM Managing your WIRB approved study

Amendments, Continuing Review, Prompt Reporting

General Questions WIRB Client Services (360) 252-2500 | clientservices@wirb.com Escalated/Urgent Questions Carmen Thompson (360) 252-2447 | cbthompson@wirb.com

We Are Here to Partner With You – Contact Us!

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Thank You