1. Initial Submission Forms

2.1A-Application-Form-Initial-SubmissionDownload
2.2 Requirement Checklist Initial SubmissionDownload
2.5 Protocol SummaryDownload
2.7A-Protocol-InformationDownload
2.7B Protocol Evaluation FormDownload
2.8-Informed-Consent-Evaluation-FormDownload

2. Resubmission Forms

2.1B-Application-Form-ResubmissionDownload
2.4-Requirement-ChecklistDownload
2.7A Protocol InformationDownload
2.7C-Protocol-Evaluation-Form-for-ResubmissionDownload

3. Amendment Forms

2.1C-Application-Form-AmendmentDownload
2.4-Requirement-ChecklistDownload
2.7A-Protocol-InformationDownload
3.2-Protocol-Amendment-ReviewDownload

4. Protocol Deviation Forms

2.5-Protocol-SummaryDownload
3.5-Protocol-Deviation-FormDownload

5. Serious Adverse Event Form

SAE 3.1 FORM LINK https://forms.office.com/Pages/ResponsePage.aspx?id=IEx2RVwuOU-OmUJpz4WH-8-EJvxUBT5Nio-gZrF0lBJURUtETkZIQjlSREZJSk9aOUpESzRTMjFYTi4u

6. Early Study Termination Form

3.8-Early-Study-TerminationDownload

7. Progress Report Form

3.3A Continuing Review ApplicationDownload
3.3B Progress Report Evaluation FormDownload
3.9 Expired Study ReportDownload
3.11 Requirement ChecklistDownload

8. Final Report Form

3.11-Requirement-Checklist Download
3-4-Final-ReportDownload

Note: Kindly email all submissions to [email protected]