Clinical Trial Forms

Names
ANNEX1 Clinical Trial Application Form
ANNEX2_Clinical Trial Protocol Format
ANNEX3_Joint Declaration for Sufficient Funds
ANNEX4_Investigational Product Quality Overall Summary
ANNEX5_Declaration by Principal Investigator or Co-investigator
ANNEX6_Protocol Pre-submission Synopsis
ANNEX7_Clinical Trial Amendment Application Form
Application-form-for-Importation-of-investigational-medical-product
FDISMPVSMFOM013-ADR_AEFI Reporting form
Template for Participant Information sheet
Template for Material Transfer agreement
Template for Informed Consent ICF
FDISMPVSMFMT012-TRIAL PROGRESS REPORT
FDISMPVSMFMT013-TRIAL SITE CLOSE OUT REPORT
FDISMPVSMFMT014-FINAL TRIAL REPORT
FDISMPVSMFMT037-Clinical Trial Protocol Format
FDISMPVSMFMT038-Investigational Product Quality Overall Summary Template
FDISMPVSMFMT039-Protocol Pre-Submission Synopsis Template
FDISMPVSMFOM007-Clinical Trial Application Form-CTA
FDISMPVSMFOM033-Joint Declaration for Sufficient Funds
FDISMPVSMFOM034-Declaration by principal investigator or co-investigator
FDISMPVSMFOM035-Clinical Trial Amendment Application Form-CTA