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 |