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Document Centre


Scheduled Meeting Dates


2017 Meeting Dates
(Additional meeting dates will be scheduled as needed)

Current Submission Documents


Check list for Study
Submission
Checklist for Amendment
or ICF Revision
Study Application
Submission
Investigator’s
Agreement

Current Report Documents


Protocol Deviations & Violations
Unanticipated Problems Form
Annual Review Report

End of Study Report

Serious Adverse Events
Reporting Form

Submission and Reporting Guidelines


Guidelines for
Application Submission
Guidelines for reporting Protocol Deviations,
Violations & Unanticipated Problems
Serious Adverse Events
Reporting System Guidelines