FIERC FORM- Initial Review
1. Form 03-01 v.2 Application Form for Protocol Review_02Jan2025_21Feb2025
2. Form 03-02 v.2 Protocol Assessment Form_02Jan2025
3. Form 03-03 v.2 Informed Consent Assessment Form_02Jan2025
4. Form 03-04 v.2 Protocol Summary Sheet_02Jan2025
5. Form 19-03 v.1 COI for Researchers_21Feb2025
6. Form 06-01 v.2 Review of Resubmitted Protocol Form_02Jan2025
7. FIERC ICF Template v.2_19Jan20258. FIERC Protocol Template v.2_19Jan2025

FIERC FORM - Post Approval Reports
1. Form 07-01 v.2 Progress Report Form
2. Form 08-01 v.2 Protocol Deviation and Violation Report
3. Form 09-01 v.2 Protocol Amendment Application
4. Form 09-02 v.2 Review of Resubmitted Protocol Amendment Form
5. Form 10-01 v.2 SAE and SUSAR Form
6. Form 11-01 v.1 Reportable Negative Event Form
7. Form 12-01 v.2 Continuing Review Application Form
8. Form 13-01 v.2 Final Report Form
9. Form 14-01 v.2 Early Study Termination Report
10. Form 21-08 v.1 Response Form to the Action Letter for Post Approval Reports_31Mar2025

FIERC FORM- Communication Forms
1. Form 21-01 v.2 Notification Letter of FIERC Decision
2. Form 21-02 v.2 Approval Letter
3. Form 21-03 v.2 Certificate of Exemption from Review
4. Form 21-04 v.2 Action Letter for Post Approval Reports
5. Form 21-05 v.2 NotificationLetter for Post Approval Reports
6. Form 21-06 v.2 Reminder Letter for Progress Reports_Continuing Review Application_Final Report
7. Form 21-07 v.2 Approval Letter to the Protocol Amendment Application
8. Form 24-02 v.1 Notification Letter for Archiving
9. Form 25-01 v.2  Request for Copies of Documents Form
10. Form 26-01 v.2 Queries and Complaint Form

 

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