All local, state, and/or special authorizations Local Regulatory related to the protocol are maintained and Approvals up-to-date. Current Federal Wide Assurance and IRB Registration documents for governing Federal Wide regulatory bodies (e.g., IRB), issued from Assurances (FWA) OHRP, are present and include expiration dates. The IRB Roster or Membership composition is on file and has been updated annually. If the IRB does not provide a roster, official IRB IRB Membership documentation is present stating that names are not released. The initial IRB Approval for the Protocol and the Consent Document(s) is present. Continuing Review Approval(s) are present (annually). IRB Approvals for information given to study subjects are on file (advertisements, IRB Approvals recruitment scripts, subject information materials). Periodic reports are present (if applicable). Approvals for any protocol/consent/assent amendments are present.
Local Regulatory Approvals All local, state, and/or special authorizations related to the protocol are maintained and up-to-date. Federal Wide Assurances (FWA) Current Federal Wide Assurance and IRB Registration documents for governing regulatory bodies (e.g., IRB), issued from OHRP, are present and include expiration dates. IRB Membership The IRB Roster or Membership composition is on file and has been updated annually. If the IRB does not provide a roster, official IRB documentation is present stating that names are not released. IRB Approvals The initial IRB Approval for the Protocol and the Consent Document(s) is present. Continuing Review Approval(s) are present (annually). IRB Approvals for information given to study subjects are on file (advertisements, recruitment scripts, subject information materials). Periodic reports are present (if applicable). Approvals for any protocol/consent/assent amendments are present.
QM_Studywide_Review_ver1_07-17-2015.docx