IRB or IEC Trial Approval 04.01.03 IRB or IEC Composition IRB or IEC Composition 04.01.03 IRB or IEC Composition X X Version Version date Documentation that the IRB/IEC consists of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial.
Trial Committee 01.03.03 Committee Output “DSMB Output
DMC Output
Data Adjudication Output
Steering Committee Output
Dose Escalation Output
Device Output
Committee Output: Other” 01.03.03 Committee Output X Version Version date To document any agreements or significant decisions regarding trial conduct, protocol violations, adverse event reporting, to include minutes, reports, notifications, recommendations from a Trial Committee. Can be applicable to interim and final analyses.
This is our filing sections according to our reference model filings