CDI

Minimum Documents Required for Research Activities

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

Ancillaries:

Ancillary Service Submission Website Required Documents
Investigational Drug Service None - automatic review based on selections in IRB application
  • Protocol
  • Pharmacy manual (provide via email)
    		•
    Center for Pathology Research Services (CPRS) CAFÉ
  • Lab manual or sample processing instructions
    		•
    Nuclear Medicine CAFÉ
  • Imaging manual or image acquisition parameters and transfer instructions
    		•
    Clinical and Translational Research Center (CTRC) CAFÉ
  • Protocol Schedule of Activities with CTRC procedures highlighted
    		•
    Stem Cell Services CAFÉ
  • Protocol
  • Investigational Product Manual
    		•
    Anesthesiology CAFÉ
  • N/A
    		•
    Ophthalmology CAFÉ
  • Data collection forms for ophthalmology procedures
    		•
    Radiology Radiology Research Application
  • Imaging manual or image acquisition parameters and transfer instructions
    		•

    Review Committee:

    Committee Submission Website Required Documents
    UCLA IRB

    WebIRB

    BruinIRB - for the following:

  • UCLA relying on other IRB
  • Emergency Use
  • HUD
  • Right to Try
  • Expanded Access 
    		•
  • Protocol
  • Consent materials
  • Test article information (Investigator's Brochure, Device Brochure, etc.)
  • Consent materials
  • Recruitment materials
  • Other patient-facing materials
    		•
    JCCC Disease Site Group (DSG) DSG Application
  • N/A
    		•
    JCCC Internal Scientific Peer Review Committee (ISPRC) CAFÉ
  • Data and Safety Monitoring Plan (if available)
    		•
    JCCC Data and Safety Monitoring Board N/A - request for support indicated in ISPRC application
  • N/A
    		•
    CTSI Scientific Review Committee N/A - routed by IRB application
  • N/A
    		•
    Medical Radiation Safety Committee SafetyNet
  • Protocol Schedule of Activities
  • Radiopharmaceutical information (if applicable)
    		•
    Institutional Biosafety Committee SafetyNet
  • Investigator's Brochure
  • Protocol
  • IP/Pharmacy Manual
  • Lab SOPs
    		•