Minimum Documents Required for Research Activities

CTC&SR

• EPASS
• 700U Forms
• PI Exception Letter (unless PI is Policy 900 PI)
• Draft CTA (usually provided by sponsor but UCLA has template if necessary)
• Draft ICF
• Draft Budget
• IRB # (CTC&SR will not accept contract into queue for review without IRB #). IRB does not need to be approved to get into queue, just submitted.

TDG

• EPASS
• 700U Forms
• PI Exception Letter (unless PI is Policy 900 PI)
• Draft CTA (usually provided by sponsor but UCLA has template if necessary)
• Draft Budget converted into TDG Budget Template
• ISR Checklist (internal document unique to TDG)
• Online MTA / DUA submission
• HDOC approval may be required to complete this submission if there is outgoing PHI leaving UCLA

OCGA

• EPASS
• 700U Forms
• PI Exception Letter (unless PI is Policy 900 PI)
• Draft Budget
• Draft Budget Justification
• Sponsor’s Guidelines
  • Depending on contents of sponsor guidelines other pieces may be needed for OCGA to accept submission

HDOC

• Protocol
• Consent documents
• Case report forms
• Department Chair approval
• Funding amount
• COI
• IRB approval (not required but recommended)
• Information about data: recipient, amount, frequency, extraction method, level of de-identification