Useful Research Tools

The appropriate management tools are critical to the success of your clinical research.

The following are tools are available as a guide:

Feasibility Checklist [PDF]

Regulatory start up

• Regulatory Binder Checklist [PDF]
• Delegation of Authority [PDF]
• IRB Membership
• Documentation of Protocol Training [PDF]
• Site Initiation Checklist [PDF]
• Site Initiation Visit (SIV) Attendance Sheet [PDF]

Project Management

• Adverse Event (AE) Tracking (2) [PDF]
• Concomitant Medication Log Tracking (2) [PDF]
• Telephone Tracking Log [PDF]
• Master Drug Accountability Log [PDF]
• Monitor Log [PDF]
• Protocol Training Log [PDF]
• IND Safety Report Review Form [PDF]

IND/IDE FDA Compliance

• FDA Communication Log [PDF]
• FDA Forms (FDA 1571, 1572, 3454, 3455, 3674)
• FDA Contacts [PDF]

Pre-IND Tools

• Pre-IND Meeting Checklist [PDF]
• Pre-IND Briefing Packet [PDF]
• Request for Pre-IND Meeting with the FDA [PDF]

IND Templates

• IND Decision Worksheet [PDF]
• IND Application Template [PDF]
• IND Application Cover Letter Template [PDF]
• Annual Report Template [PDF]
• Transfers [PDF]

IDE Templates

• IDE Progress Report Template [PDF]
• IDE New Application Template [PDF]

IND/IDE Exemptions

• IND Exemptions [PDF]
• Statement of Request for IND Exemption [PDF]
• IND Exemption Determination Request [PDF]
• IND Exemption Application [PDF]

IND Single Patient

• Compassionate Use Request Instructions – Single Pt. IND [PDF]

If you would like to request a Microsoft Word version of these documents, please e-mail research.services@mssm.edu.