Office of Research Services
Toolkit & PoliciesSupported by the Clinical and Translational Science Awards (CTSA) grant UL1TR004419 from the National Center for Advancing Translational Sciences, National Institutes of Health
Toolkit and Policies
ORS maintains this portfolio of policies, tools, and templates.
ORS Policies
Regulatory Start-up
- Regulatory Binder Checklist
- Delegation Authority
- IRB Membership
- Site Initiation Checklist
- Site Initiation Visit (SIV) Attendance Sheet
- Site Initiation Visit (SIV) via Teleconference
Project Management
- Adverse Event (AE) Tracking
- Concomitant Medication Tracking Log
- Master Drug Accountability Log
- Monitor Log
- Protocol Training Record
- IND Safety Report Log
- Research Subject Recruitment Tools
- Agreement Wizard
- Protocol Review Wizard
- Grant Application Resource Center (GARC)
- Protocol Template
Investigational New Drug (IND) Documents
- Pre-IND Meeting Checklist
- Pre-IND Briefing Packet
- Request for Pre-IND Meeting with the FDA
- IND Decision Worksheet
- IND Application Template
- IND Application Cover Letter Template
- IND Annual Report Overview
- IND Annual Report Cover Letter
- Annual Report Template
- IND Transfer Overview
- IND Transfer Letter
- IND Withdrawal of Discontinuation Notice
- IND Withdrawal Letter
- IND Exemptions
- IND Exemption Determination Request Letter
- IND Exemption Application
- Statement of Request for IND Exemption
- What to include in a Non-Emergent Compassionate Use IND Application
- Single Patient IND (Non-Emergent Compassionate Use) Algorithm
- Request Cover Letter
Investigational Device Exemption (lDE) Documents
Meet Our Team
The ORS staff answers all categories of research questions or directs questions to the appropriate office or individual who can provide the answers to members of the research community.
Research Listserv
Email messaging system providing latest research newsletters and funding opportunities.
Research Social Media Hub
ISMMS Research Facebook, Twitter and Blog.
Contact Us
Submit a Research 411 Request