The purpose of this worksheet is to provide support for IRB staff members who send communications after an IRB review where the letter needs to include approval and Expiration Dates. This worksheet describes how to make these calculations. TYPE OF REVIEW APPROVAL DATE EFFECTIVE DATE END APPROVAL DATE Convened IRB granted approval Date of convened IRB meeting Date of convened IRB meeting Date of the convened meeting Date the IRB Office verified that plus the approval interval minus Convened IRB required modifications to secure approval; subsequently verified Date of convened IRB meeting the required modifications had one day by Non-Committee Review been made Date the Designated Reviewer Date the Designated Reviewer Review Designated Reviewer granted approval granted approval granted approval APPROVAL DATE plus the approval interval minus one Date the Designated Reviewer Date the IRB Office verified that Designated Reviewer required modifications to secure approval; subsequently Initial day. None for exempt research. required modifications to secure the required modifications had verified by Non-Committee Review approval been made Convened IRB granted approval Date of convened IRB meeting Date of convened IRB meeting Date of the convened meeting Date the IRB Office verified that plus the approval interval minus Convened IRB required modifications to secure approval; subsequently verified Date of convened IRB meeting the required modifications had one day by Non-Committee Review been made Review Date the Designated Reviewer Date the Designated Reviewer Designated Reviewer granted approval granted approval granted approval APPROVAL DATE plus the Date the Designated Reviewer Date the IRB Office verified that approval interval minus one day Designated Reviewer required modifications to secure approval; subsequently Continuing required modifications to secure the required modifications had verified by Non-Committee Review approval been made Convened IRB granted approval to modifications to previously approved Date of convened IRB meeting Date of convened IRB meeting research. Date the IRB Office verified that Convened IRB required modifications to secure approval of modifications to Date of convened IRB meeting the required modifications had previously approved research; subsequently verified by Non-Committee Review Previous END APPROVAL been made DATE, except no end date for Designated Reviewer granted approval to modifications to previously approved Date the Designated Reviewer Date the Designated Reviewer exempt research. research granted approval granted approval Modifications Designated Reviewer required modifications to secure initial approval of Date the Designated Reviewer Date the IRB Office verified that modifications to previously approved research; subsequently verified by required modifications to secure the required modifications had Review approval been made
The purpose of this worksheet is to provide support for IRB staff members who send communications after an IRB review where the letter needs to include approval and Expiration Dates. This worksheet describes how to make these calculations. TYPE OF REVIEW APPROVAL DATE EFFECTIVE DATE END APPROVAL DATE Initial Review Convened IRB granted approval Date of convened IRB meeting Date of convened IRB meeting Date of the convened meeting plus the approval interval minus one day Convened IRB required modifications to secure approval; subsequently verified by Non-Committee Review Date of convened IRB meeting Date the IRB Office verified that the required modifications had been made Designated Reviewer granted approval Date the Designated Reviewer granted approval Date the Designated Reviewer granted approval APPROVAL DATE plus the approval interval minus one day. None for exempt research. Designated Reviewer required modifications to secure approval; subsequently verified by Non-Committee Review Date the Designated Reviewer required modifications to secure approval Date the IRB Office verified that the required modifications had been made Continuing Review Convened IRB granted approval Date of convened IRB meeting Date of convened IRB meeting Date of the convened meeting plus the approval interval minus one day Convened IRB required modifications to secure approval; subsequently verified by Non-Committee Review Date of convened IRB meeting Date the IRB Office verified that the required modifications had been made Designated Reviewer granted approval Date the Designated Reviewer granted approval Date the Designated Reviewer granted approval APPROVAL DATE plus the approval interval minus one day Designated Reviewer required modifications to secure approval; subsequently verified by Non-Committee Review Date the Designated Reviewer required modifications to secure approval Date the IRB Office verified that the required modifications had been made Modifications Convened IRB granted approval to modifications to previously approved research. Date of convened IRB meeting Date of convened IRB meeting Previous END APPROVAL DATE, except no end date for exempt research. Convened IRB required modifications to secure approval of modifications to previously approved research; subsequently verified by Non-Committee Review Date of convened IRB meeting Date the IRB Office verified that the required modifications had been made Designated Reviewer granted approval to modifications to previously approved research Date the Designated Reviewer granted approval Date the Designated Reviewer granted approval Designated Reviewer required modifications to secure initial approval of modifications to previously approved research; subsequently verified by Review Date the Designated Reviewer required modifications to secure approval Date the IRB Office verified that the required modifications had been made
HRP-302-Worksheet-Approval%20Intervals.docx