HREC REQUEST FOR REVIEW OF UPDATED DOCUMENTATION STUDY MONITORING REPORTING (RRUD) This RRUD is to be completed for submission of all documentation and information which requires HREC review. The completed form is to be submitted with accompanying documentation to the CALHN HREC via HREC review is mandatory for all of the outlined below in accordance with the , the , and as directed by the CALHN HREC STUDY DETAIL HREC Reference Number: CALHN Reference Number: Site Name Study Title Site Principal Investigator Email: Name: Department: Employer: Trial Coordinator Email: Name: Department: Employer: Status of the study Recruitment pending Participants on active treatments Recruiting Participants on the same drug in other studies No active participants Participants in follow up List documents requiring Name Version Date review *Documents will appear in approval as documented Does the PICF(s) require Yes ► Attach updated documentation amendment? No Do you believe these Yes ► Provide detail below changes raise ethical No concerns? REPORT INTENT *Mark all boxes that apply – Amendments to Protocols Amendments to Investigator Brochures (IBs) Amendments to Participant Information Consent Forms (PICFs) Amendments to other supporting documents Protocol Deviations/Violations Serious Adverse Event (SAEs) Notifications Safety Reports including: Suspected Unexpected Serious Adverse Reactions (SUSAR), Development Safety Update Reports (DSUR), Data Safety Monitoring Board (DSMB) Reports, Dear Investigator letters Notifications includes site visits, site closures, file notes – NOTIFICATION OF PROTOCOL DEVIATION/VIOLATION Deviation: any change, divergence or departure from the project design or procedures defined in the Protocol. Selected Protocol Deviations are only required to be reported to CALHN HREC annually with the Annual Review Report. Refer to Protocol Violation: a more serious non-compliance that may significantly affect the completeness, accuracy or reliability of research data, or that might significantly affect a participant’s rights, safety or wellbeing.
HREC REQUEST FOR REVIEW OF UPDATED DOCUMENTATION STUDY MONITORING REPORTING (RRUD) This RRUD is to be completed for submission of all documentation and information which requires HREC review. The completed form is to be submitted with accompanying documentation to the CALHN HREC via HREC review is mandatory for all of the outlined below in accordance with the , the , and as directed by the CALHN HREC STUDY DETAIL HREC Reference Number: CALHN Reference Number: Site Name Study Title Site Principal Investigator Name: Email: Department: Employer: Trial Coordinator Name: Email: Department: Employer: Status of the study Recruitment pending Recruiting No active participants Participants on active treatments Participants on the same drug in other studies Participants in follow up List documents requiring review *Documents will appear in approval as documented Name Version Date Does the PICF(s) require amendment? Yes ► Attach updated documentation No Do you believe these changes raise ethical concerns? Yes ► Provide detail below No REPORT INTENT – *Mark all boxes that apply Amendments to Protocols Amendments to Investigator Brochures (IBs) Amendments to Participant Information Consent Forms (PICFs) Amendments to other supporting documents Protocol Deviations/Violations Serious Adverse Event (SAEs) Notifications Safety Reports including: Suspected Unexpected Serious Adverse Reactions (SUSAR), Development Safety Update Reports (DSUR), Data Safety Monitoring Board (DSMB) Reports, Dear Investigator letters Notifications – includes site visits, site closures, file notes NOTIFICATION OF PROTOCOL DEVIATION/VIOLATION Deviation: any change, divergence or departure from the project design or procedures defined in the Protocol. Selected Protocol Deviations are only required to be reported to CALHN HREC annually with the Annual Review Report. Refer to Protocol Violation: a more serious non-compliance that may significantly affect the completeness, accuracy or reliability of research data, or that might significantly affect a participant’s rights, safety or wellbeing.
HREC-Request-for-Review-of-Updated-Documentation-Form-CALHN-v4.0-March-2018.docx