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

5/8/2020 Submitting studies to WIRB as a CHLA researcher Agenda  Overview of WCG and WIRB  Initial Review  Preparing to Submit  How to submit  Connexus and Submission Overview 2 1

5/8/2020 Overview of WCG and CHLA Agreement WIRB-Copernicus Group Overview 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. 4 2

5/8/2020 WIRB-Copernicus Group Overview WCG Family of IRBs  Western IRB “WIRB”  Copernicus “CGIRB”  Aspire IRB  Midlands  New England 5 Important Facts 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 6 3

5/8/2020 Important Facts 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) 7 Initial Review Preparing to submit to WIRB 4

5/8/2020 Local or Central? 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 9 Has WIRB reviewed the study? 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 10 5

5/8/2020 Preparing your Consent Form Checklist 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 11 Preparing your Consent Form Checklist Complete the grey fill-in fields where applicable. 12 6

5/8/2020 Preparing your Consent Form Checklist  Check the checkboxes where applicable  Where there is sample language, complete the Similar alternate language field only if required 13 Preparing your Consent Form Checklist 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 14 7

5/8/2020 Preparing your Consent Form Checklist Assent  Last question on the checklist 15 Preparing your Consent Form Checklist 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. 16 8

5/8/2020 Meeting your institutional requirements 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 17 Meeting your institutional requirements 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! 18 9

5/8/2020 Initial Review How to submit to WIRB How to submit to WIRB 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) 20 10

5/8/2020 How to submit to WIRB Smart PDF forms are available in two locations:  WIRB.com > Download Forms Page  Via Connexus Quick Access Links > IRB Forms and Guides 21 Completing the Submission Form Select WIRB as Destination IRB 22 11

5/8/2020 Completing the Submission Form Select Submission Type (2 Common Options) 23 Completing the Submission Form CPUS – No / IRB Determinations – No 24 12

5/8/2020 Completing the Submission Form Site Contacts List sponsor, CRO, SMO and CHLA study coordinators that need to receive IRB correspondence 25 Completing the Submission Form 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 26 13

5/8/2020 Completing the Submission Form 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. 27 Completing the Submission Form 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) 28 14

5/8/2020 Completing the Submission Form 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 29 Completing the Submission Form Institutional Services Select YES to and Indicate Institution Name/Number:  CHLA Institution#: 130163 30 15

5/8/2020 Completing the Submission Form Research Locations  List where research activity conducted CHLA studies should NOT list any research locations that are not CHLA. 31 Completing the Submission Form Consent  Complete the sections for Consent Setting, LAR, Consent Process  Consent Documentation 32 16

5/8/2020 Completing the Submission Form 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 33 Submission Documents  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 34 17

5/8/2020 Connexus and Submission Processing Connexus http://www.wirb.com https://portal.wcgclinical.com/WCG/Home.aspx 36 18

5/8/2020 Connexus https://portal.wcgclinical.com/WCG/Home.aspx 37 Connexus - Dashboard 38 19