Advarra’s IRB Handbook
Advarra has updated its Institutional Review Board (IRB) Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives to version 5. Along with a variety of other changes, clients will see updates to Advarra’s review and approval of legally authorized representative (LAR) requests as well as reduced submission requirements for the use of electronic informed consent (eConsent) and short forms. These updates are documented in an enhanced summary of changes section.
The revised Handbook is available in the Reference Materials section of the Advarra CIRBI Platform (login required). Clients are encouraged to check CIRBI for the latest version of the Handbook and applicable summary of changes.
In accordance with the modified eConsent submission requirements, the IRB will no longer require a separate submission of eConsent attestations in most cases.
In addition to the updated handbook, Advarra is pleased to announce enhancements to the self-serve reference materials available in the Advarra Center for IRB Intelligence (CIRBI) Platform (login required). New Tip Sheets and guidances offer Advarra customers additional guidance on a variety of topics including, but not limited to, eConsent, recruitment and participant-facing materials, and the use and review of LAR requests.
The purpose of the Handbook is to orient investigators, research staff, sponsors, clinical research organizations (CROs), and site management organizations (SMOs) to the IRB’s policies, procedures, guidelines, and expectations, including information related to the initial review process through management of ongoing research activities and study closure.
Because the Handbook includes links to external, web-based resources, Advarra recommends keeping an electronic version so that these hyperlinks remain accessible.
If you have questions about the updated Handbook, please contact your client services coordinator listed on each of your submissions.
Legacy Handbook Links
2019 IRB Handbook:
Advarra has updated its IRB Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives to incorporate Canadian regulations and to update certain policies and processes to align with current practices. Additionally, clarifications have been made regarding eConsent.
The revised IRB Handbook is available in the Reference Materials section of the Advarra Center for IRB Intelligence (CIRBI) Platform (login required).
This version includes an update to remove the requirement for investigator CVs to be signed and dated within the last 2 years; clarification on the reporting timeline for protocol deviations, violations, or exceptions; clarification regarding eConsent submissions; added reporting requirements to AAHRPP; and an updated resource for questions regarding CITI training. Because the Handbook now covers both US and Canadian regulations, this version replaces the previous Canada-specific handbook.
Clients are encouraged to check the Advarra CIRBI Platform for the latest version of the Handbook. The purpose of the Handbook is to orient investigators, research staff, sponsors, CROs, and SMOs to the IRB’s policies, procedures, guidelines, and expectations, including information related to the initial review process through management of ongoing research activities and study closure.