Submission Forms

1. Initial Submission

• 2.1A-Application-Form-Initial-Submission
• 2.5-Protocol-Summary
• 2.7A-Protocol-Information
• 2.7B-Protocol-Evaluation-Form
• 2.8-Informed-Consent-Evaluation-Form
• MMCIRB- Informed Consent Template- Guidelines.docx
• Confidentiality and NDA for Non-MMC Staffs and Members

2. Resubmission

• 2.1B-Application-Form-Resubmission
• 2.4-Requirement-Checklist
• 2.7A-Protocol-Information
• 2.7C-Protocol-Evaluation-Form-for-Resubmission

3. Amendment

• 2.1C-Application-Form-Amendment
• 2.4-Requirement-Checklist
• 2.7A-Protocol-Information
• 3.2-Protocol-Amendment-Review

4. Protocol Deviation

• 2.5-Protocol-Summary
• 3.5-Protocol-Deviation-Form

5. Serious Adverse Event (SAE)

• All on-site Serious Adverse Events (IRB SAE Form 3.1A) must be reported within seven (7) days by accomplishing the SAE MS Form 3.1 using this link: https://forms.office.com/Pages/ResponsePage.aspx?id=IEx2RVwuOU-OmUJpz4WH-8-EJvxUBT5Nio-gZrF0lBJURUtETkZIQjlSREZJSk9aOUpESzRTMjFYTi4u.

*Afterwards, ensure to save a copiable PDF version of the accomplished MS Form 3.1 and send it to the IRB via email. The PDF version must be submitted with a cover letter intended for the SAE submission.

6. Progress Report

• 3.3A-Continuing-Review-Application
• 3.3B-Progress-Report-Evaluation
• 3.9-Expired-Study-Report

7. Final Report

• 3-4-Final-Report
• 3.11-Requirement-Checklist 

8. Early Study Termination

• 3.8-Early-Study-Termination

Note: All requirements must be submitted online to the official IRB email: [email protected] for screening.