OFFICE OF RESEARCH AND DEVELOPMENT (ORD)

Office of Research and Development

Office of Research and Development
The Queen’s Medical Center
1301 Punchbowl Street, UHT 508
Honolulu, HI 96813

Submissions

Industry Sponsored - Initial Submissions

Information about Initial Submission.

Section 1: Complete the corresponding check lists​

Please note that several processes may need to be processed in parrallel. For example:

Based on your type of research:

Info…

If funding is not available:

  • Feasibility & Study Resource Allocation [Link].
  • IRB submission [Link to IRB or Regulatory Services Initial submission]
  • Proceed with Study [Link].

If funding is present (Industry, Grant/Foundation):

  • Feasibility & Study Resource Allocation [Link].
  • IRB submission (in parallel) [Link to IRB or Regulatory Services Initial submission]
  • Contract (in parallel) [Link to initial submission]
  • Award (in parallel; cannot finalize until budget is final)
    • Sponsor Contract [Link to Budget & Contract Services Initial submission]
    • Grant/Foundation [Link to Grant Proposal Services Initial submission]
  • MCA Request [Link to MCA Services Initial submission]
  • Budget build & approval [Link to initial submission]
  • Consistency check [Link to initial submission]
  • Study Activation (IRB Determination, Shell/Calendar, Budget and Contract/Award) [Link to initial submission]

Info…

If funding is not available:

  • Feasibility & Study Resource Allocation [Link].
  • IRB submission [Link to IRB or Regulatory Services Initial submission]
  • Budget (internal only, if needed) [link to budget determination or email?]
  • Consistency check [Link].
  • Study Activation (IRB Approval or Exemption, Budget if needed) [Link].

If funding is present (Industry, Grant/Foundation):

  • Feasibility & Study Resource Allocation [Link].
  • CDA/NDA execution (if needed) [Link to Budget & Contract Services Initial submission]
  • IRB submission (in parallel) [Link to IRB or Regulatory Services Initial submission]
  • Contract (in parallel) [Link to initial submission]
  • Award (in parallel; cannot finalize until budget is final)
    • Sponsor Contract [Link to Budget & Contract Services Initial submission]
    • Grant/Foundation [Link to Grant Proposal Services Initial submission]
  • MCA Request [Link to MCA Services Initial submission]
  • Budget build & approval [Link to initial submission]
  • Consistency check [Link to initial submission]
  • Study Activation (IRB Determination, Shell/Calendar, Budget and Contract/Award) [Link to initial submission]

Info…

If funding is not available:

  • Feasibility & Study Resource Allocation [Link].
  • IRB submission [Link to IRB or Regulatory Services Initial submission]
  • Budget (internal only, if needed) [link to budget determination or email?]
  • Consistency check [Link].
  • Study Activation (IRB Approval or Exemption, Budget if needed) [Link].

If funding is present (Industry, Grant/Foundation):

  • Feasibility & Study Resource Allocation [Link].
  • CDA/NDA execution (if needed) [Link to Budget & Contract Services Initial submission]
  • IRB submission (in parallel) [Link to IRB or Regulatory Services Initial submission]
  • Contract (in parallel) [Link to initial submission]
  • Award (in parallel; cannot finalize until budget is final)
    • Sponsor Contract [Link to Budget & Contract Services Initial submission]
    • Grant/Foundation [Link to Grant Proposal Services Initial submission]
  • MCA Request [Link to MCA Services Initial submission]
  • Budget build & approval [Link to initial submission]
  • Calendar build [Link to initial submission]
  • Consistency check [Link to initial submission]
  • Study Activation (IRB Determination, Shell/Calendar, Budget and Contract/Award) [Link to initial submission]

Info…

If funding is not available:

  • Feasibility & Study Resource Allocation [Link].
  • IRB submission [Link to IRB or Regulatory Services Initial submission]
  • Budget (internal only, if needed) [link to budget determination or email?]
  • Consistency check [Link].
  • Study Activation (IRB Approval or Exemption, Budget if needed) [Link].

If funding is present (Industry, Grant/Foundation):

  • Feasibility & Study Resource Allocation [Link].
  • CDA/NDA execution (if needed) [Link to Budget & Contract Services Initial submission]
  • IRB submission (in parallel) [Link to IRB or Regulatory Services Initial submission]
  • Contract (in parallel) [Link to initial submission]
  • Award (in parallel; cannot finalize until budget is final)
    • Sponsor Contract [Link to Budget & Contract Services Initial submission]
    • Grant/Foundation [Link to Grant Proposal Services Initial submission]
  • MCA Request [Link to MCA Services Initial submission]
  • Budget build & approval [Link to initial submission]
  • Calendar build [Link to initial submission]
  • Consistency check [Link to initial submission]
  • Study Activation (IRB Determination, Shell/Calendar, Budget and Contract/Award) [Link to initial submission]

Info…

If funding is not available:

  • Feasibility & Study Resource Allocation [Link].
  • IRB submission [Link to IRB or Regulatory Services Initial submission]
  • MCA Request [Link to MCA Services initial submission]
  • Internal budget (to track institutional cost) [Link]
  • Calendar build (if tracking or participant visits) [Link]
  • Consistency check [Link].
  • Study Activation (IRB Approval or Exemption, Budget if needed) [Link].

If funding is present (Industry, Grant/Foundation):

  • Feasibility & Study Resource Allocation [Link].
  • CDA/NDA execution (if needed) [Link to Budget & Contract Services Initial submission]
  • IRB submission (in parallel) [Link to IRB or Regulatory Services Initial submission]
  • Contract (in parallel) [Link to initial submission]
  • Award (in parallel; cannot finalize until budget is final)
    • Sponsor Contract [Link to Budget & Contract Services Initial submission]
    • Grant/Foundation [Link to Grant Proposal Services Initial submission]
  • MCA Request [Link to MCA Services Initial submission]
  • Budget build & approval [Link to initial submission]
  • Calendar build [Link to initial submission]
  • Consistency check [Link to initial submission]
  • Study Activation (IRB Determination, Shell/Calendar, Budget and Contract/Award) [Link to initial submission]

You do not need to proceed to Section 2 until the DOR staff instructs you to do so.

Section 2: Study Pre-Activation and RA Number Request

Once all of the checklists of Section 1 have been completed, the DOR staff will direct you to complete this section.

  • Once the MCA, Budget and Calendar are finalized, the Study Coordinator will initiate the Pre-Activation Evaluation Form and should have the PI approve the MCA and/or Calendar. 
  • The Study Coordinator will request the “Study Activation” by email to Rebecca Ohta with the following:
    • Completed Coordinator Pre-Activation Evaluation Form (please make sure that the ICF and Protocol are consistent with MCA)
    • IRB Approval Letter(s)
    • Waiver of HIPAA Authorization, if applicable
    • Any exemption letter, if applicable
    • Final IRB Approved Documents including, but not limited to:
      • Protocol
      • ICF
    • Funding Sheet, if applicable
    • MCA/Calendar grid used
    • List of investigators and study personnel
  • RBO or SPO will initiate a Finance Pre-Activation Evaluation Form if Industry or Grant funded. Rebecca will do for UHC NCI studies with Funding Sheets.
  • Denise will assign RA#.
  • Once Rebecca receives all, a “Study Activation” email will be sent out that starts the cascade of events to turn on the study in Clinical Conductor and EPIC, with final green light to begin from Sheila.

 

  1.