Managing your WIRB approved study Presented by: Carmen Thompson, - PDF document

5/8/2020 Managing your WIRB approved study Presented by: Carmen Thompson, CIP Agenda  Managing your site in Connexus  Changes in Research (Modifications)  Other Submissions • Continuing Reviews • Promptly Reportable Information (PRI) • Closures 2 1

5/8/2020 Managing Your Site in Connexus Managing Your Site in Connexus If you are listed as a site contact on the initial review submission form, you will be added to the workspace automatically if you have a corresponding Connexus account  Email address on form must match the registered Connexus email address 4 2

5/8/2020 Connexus https://portal.wcgclinical.com http://www.wirb.com 5 Managing Your Site in Connexus Locate in Connexus under My Investigators 6 3

5/8/2020 Managing Your Site in Connexus Locate in Connexus under My Investigators 7 Managing Your Site in Connexus Locate in Connexus under My Investigators Click to view or make submissions Click to manage access to this site workspace only Approval documents displayed here 8 4

5/8/2020 Managing Your Site in Connexus  View submissions for this Investigator Allows you to see all submissions made for the site • Auto restricted to the last 30 days • Submitted since field: change to Anytime, Last Week-Month-Year • 9 Managing Your Site in Connexus  Make a submission for this Investigator - all Submissions Options Protocol Changes (Revised Protocol, Amendments, etc.) • Change in Research Location • Modified or Additional Recruitment Materials • New or Changed Subject Materials • New Consent Forms • Consent Form Modifications • Continuing Review Reports Form • Contact Information Update Forms • Closure Reports • Promptly Reportable Information Forms • Planned Protocol Deviations • 10 5

5/8/2020 Changes in Research (Modifications) Change in Research Submissions Smart PDF forms are available in two locations:  WIRB.com > Download Forms Page  Via Connexus Quick Access Links > IRB Forms and Guides 12 6

5/8/2020 Change in Research Submissions CHLA allows sponsors to submit on your behalf  Be sure to confirm with the sponsor/CRO if they will be submitting to WIRB for you  If they will not, you will need to make all amendments, revisions, and modifications change in research submissions to WIRB 13 Change in Research Submissions Consent Form Modifications  CHLA initiated changes must have CHLA clearance before submitting to WIRB  Changes initiated by the sponsor do not require CHLA clearance  When CHLA makes changes to consent forms, they must include: • Updated language using tracked (redline) changes • Use the latest CHLA-specific WIRB approved version 14 7

5/8/2020 Change in Research Submissions Change in Principal Investigator (PI)  This would be a CHLA initiated change, must have CHLA clearance before submitting to WIRB  WIRB submission will require: • An initial review submission form for the new PI – be sure to complete PI transfer section • Submit PI medical license and CV, if not on file at WIRB • Financial disclosure form and COI Management plan, if applicable • CHLA Clearance letter 15 Change in Research Submissions Change in Principal Investigator (PI)  Will there be consent/assent form updates with the change in PI? • If PI contact information is the only update required - WIRB use the information from the submission and update the consent and assent form (if using sponsor assent template) • NOTE : If using the CHLA assent form template, please submit an updated CHLA assent form and submit as subject material • Additional changes to the consent/assent form(s), must follow the process outlined on the previous slide (i.e. updated language must be tracked (redlined) on the latest WIRB approved version) 16 8

5/8/2020 Change in Research Submissions If you have to submit, amendments and modifications can be submitted using our “ Change in Research ” form  Check all the required changes and submit all supporting documents for the change 17 Change in Research Submissions Planned Protocol Deviations Must Have IRB Approval  Allow 2-3 business days to process  All parties must be in agreement: • Correspondence from PI and sponsor/CRO/monitor  Use the change in research form to provide • Date, Description, How it deviates from the protocol, Reason for deviating from the protocol  Submit via Connexus, type “Planned protocol variance” 18 9

5/8/2020 Change in Research Submissions Ensure that you comply with your local CHLA requirements for amendments:  When amendments are approved by WIRB, submit an amendment in iStar and upload the certificate of action (approval letter), approved consent/assent form(s)  The revised protocol and other WIRB approved documents do not need to be uploaded in iStar. Keep these documents in your regulatory binder per CHLA policy. 19 Other Submissions 10

5/8/2020 Continuing Review Continuing Review Report Form (CRRF) will be sent automatically to all individual(s) listed on the Initial Review form NOTE: The above fields will be filled in for you. This form is emailed to the all study contacts listed on the Initial Review Submission form. 21 Continuing Review  If you receive initial approval within 90 days of the protocol expiration date, you will automatically be brought on to the next continuing review period – no need to provide a CRRF  Forms are sent out approximately 80 days before the study expiration date, and are due approximately 56 days before the study expiration date • All study contacts will receive the CRRF via email  All sites expiration dates are aligned with protocol expiration date • Be sure to check you protocol expiration on your certificate of action  CRRF are reviewed up to 30 days before expiration date 22 11

5/8/2020 Continuing Review Reminder: Failure to complete and return the attached report will be considered non- compliance. If you do not complete and return the continuing review report, the Board may take action to suspend or terminate approval of this research at your location. If approval is suspended or terminated, this will be reported to the FDA or other appropriate regulatory agencies. 23 Continuing Review Ensure that you comply with your local CHLA requirements for continuing reviews:  When continuing review is approved by WIRB, submit an amendment in iStar and upload the certificate of action (approval letter).  NOTE: WIRB does not issue new approval of consent/assent form(s) at continuing review.  New approval of consent/assent form(s) are only Issued when an action is taken on the consent/assent form(s). 24 12

5/8/2020 Contact Information Update Form IMPORTANT: Update the contacts who receive IRB correspondence 25 WIRB Reportable Information Form Promptly Reportable Information (PRI) form is used to report all items that require reporting to WIRB within 5 business days of discovery Refer to WCG Guide for Researchers to determine the kind of information that requires Prompt Reporting. This may differ from CHLA’s reporting requirement. 26 13

5/8/2020 WIRB Reportable Information  Audit, inspection, or inquiry by a federal agency  Written report from a federal agency (e.g., FDA Form 483)  State medical board action or hospital medical staff action  Allegation of Noncompliance or Finding of Noncompliance  Suspension or premature termination by the sponsor, investigator, or institution  Incarceration of a subject in a research study not approved to involve prisoners  New or increased risk  Change in financial interest disclosure 27 WIRB Reportable Information  Protocol deviation that harmed a subject or placed subject at risk of harm  Protocol deviation made without prior IRB approval to eliminate an immediate hazard to a subject  Breach of confidentiality  Subject complaint that cannot be resolved by the research team  Unanticipated adverse device effect  Adverse event or IND safety report that requires a change to the protocol or consent  Adverse event or IND safety report that does NOT require a change to the protocol or consent 28 14

5/8/2020 Promptly Reportable Information Form  The form will guide you information is required based on the event you are reporting  WIRB will review the report and if significant, communicate with appropriate parties  If we find that the event does not constitute an increased risk to subjects and there are no remaining subject safety concerns, we will file it without action.  If the sponsor/CRO requires documentation that the event was reported to WIRB, you can provide them the Connexus acknowledgment of receipt.  If the sponsor/CRO needs documentation that the event was filed, contact WIRB Client Services. 29 Reportable Information Ensure that you comply with your local CHLA requirements for reportable new information:  After submitting your promptly reportable information form to WIRB, send the report by email to the CHLA HSPP office to irbreliance@chla.usc.edu  The CHLA HSPP office will communicate with the CHLA Investigator and Reviewing IRB to assure resolution of all reportable events 30 15