What do I need to submit?
Step 2

New Study submissions must include (as appropriate):

IRB Application

IRB forms must be submitted where applicable.

Human Subjects Protection Training Certicates

All members of the study team must complete Human Subject Protection Training within the past 4 years.  See the Training page for instructions.

Funding Proposal Document

A copy of the submitted proposal or Sponsored Research Agreement is needed if the research is funded by a Sponsored Project.

Consent Documents
  • UTD consent form(s)
  • Child assent form(s)
  • Debriefing Scripts
  • Sponsor or lead site-approved consent form(s)
  • IRB-approved consent forms from prior studies for use of secondary data or specimens
Recruitment Materials
  • Advertisements (including printed, audio and video)
  • Recruitment materials and scripts (flyers, verbal scripts, email scripts, etc.)
  • Press Releases (when the study is open to accrual)
Data collection instruments (surveys, interview questions, stimuli, etc.)
  • Survey questions
  • Interview questions
  • Focus group questions
  • Scales and measures
  • Participant observation checklist
  • Case report forms
  • Audio/Video/Image prompts
Device Details
  • Package Insert/Investigator Brochure
  • Product labeling/Investigator Brochure
  • Device instructions
  • Verification of each Investigational Device Exemption (IDE) number:
    • Sponsor protocol with the IDE number
    • Communication from the FDA or sponsor with the IDE number
Special documents for International Studies
  • IRB approval letters or the equivalent from International Sites
  • Non-English versions of materials for participants
  • Translation Verification (See Template)
All Other Relevant Documents (may include items not listed below)
  • Data Safety Monitoring Board Report
  • Executed Agreements
    • Letters of support from sites where research will be conducted (site authorization letters, Memorandum of Understanding, Master Reliance Agreement)
    • Institutional Authorization Agreements (IAAs)
  • Certificates of Confidentiality (CoC)
  • Data Use Agreements (DUA) for Protected Health Information
  • Material Transfer Agreement (MTA)
  • Site Specific Authorizations or Letters of Support (i.e., public schools or other educational settings, private clinics, hospitals, nursing homes, government agencies or any other outside business or field site)

Plan ahead:  It is important that you have all required supporting documents in place before you submit your application to the IRB so as not to delay IRB review. Some documents such as site authorization, approval from other compliance components, or relevant agreements with collaborating institutions may take extra time to acquire.

Helpful Links

Who may serve as PI

Submission Review

I am ready to submit – now what?

Read More Step 3