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

Submit an Amendment, Renewal or Status Report

How to Submit an Amendment, Renewal or Status Report

How to Submit a Study Amendment/Modification RIRC/IRB

  1. After the protocol has been given an initial RIRC approval, any subsequent change to the application, protocol or consent form, and any recruitment methods/tools to be used must be reviewed and approved by the RIRC. Submit to either:
    1. Email documents to rirc@queens.org. Word Documents are preferable but PDFs are also acceptable.
    2. Hard Copy:
      1. Prospective: (3) copies of all necessary materials (at least 1 copy single-sided)
      2. Retrospective: (1) single-sided copy
  2. Timeline: All documents should be received 4 weeks prior to the next scheduled meeting of the RIRC.
  3. Please send all hardcopies to:
    Chairman, Research & Institutional Review Committee (RIRC)
    The Queen’s Medical Center
    1301 Punchbowl Street, UH Tower 505
    Honolulu, Hawaii 96813

Study Amendment/Modification

All prospective continuing renewals may also include the following. Provide clean versions for any unchanged document. Provide track change version for any document with any edit.

  • Full Amendment/Revisions/Changes to protocol or informed consent form
  • Recruitment tools/methods – final verbatim text or photo proofs
  • Any other previously stamped approved document that will continue to be used.
  • Any other new study document
  • Summary of Amendment/Revisions/Changes
  • Informed Consent form

Pre-2019 Retrospective continuing renewals may also include the following. Provide clean versions for any unchanged document. Provide track change version for any document with any edit.

  • Full Amendment/Revisions/Changes to protocol or informed consent form
  • Any other pertinent documents

How to Submit a Study Continuing Renewal

Download Form 10
  1. All requests for continuing renewal request must be reviewed and approved by the RIRC.
  2. Fill in Form 10 and collect other required documents (see box to the right)
  3. Submit to either:
    1. Email documents to rirc@queens.org. Word Documents are preferable but PDFs are also acceptable.
    2. Hard Copy:
      1. Prospective: (3) copies of all necessary materials (at least 1 copy single-sided)
      2. Retrospective: (1) single-sided copy
  4. Timeline: All documents should be received 7 weeks prior to the next scheduled meeting of the RIRC.
  5. Please send all hardcopies to:
    Chairman, Research & Institutional Review Committee (RIRC)
    The Queen’s Medical Center
    1301 Punchbowl Street, UH Tower 505
    Honolulu, Hawaii 96813

All Study Renewals

All prospective continuing renewals may also include the following. Provide clean versions for any unchanged document. Provide track change version for any document with any edit.

  • Full Amendment/Revisions/Changes to protocol or informed consent form
  • Recruitment tools/methods – final verbatim text or photo proofs
  • Any other previously stamped approved document that will continue to be used.
  • Any other new study document
  • Summary of Amendment/Revisions/Changes
  • Informed Consent form

Pre-2019 Retrospective continuing renewals may also include the following. Provide clean versions for any unchanged document. Provide track change version for any document with any edit.

  • Full Amendment/Revisions/Changes to protocol or informed consent form
  • Any other pertinent documents

How to Submit a Minimal Risk Study Update/Status Report

  1. All requests for a (post-2018) Minimal Risk Study Update/Status Report must be reviewed the RIRC.
  2. Fill in Form 10B
  3. Submit to either:
    1. Email documents to rirc@queens.org. Word Documents are preferable but PDFs are also acceptable.
    2. Hard Copy:
      1. Prospective: (1) copy of all necessary materials
      2. Retrospective: (1) single-sided copy
  4. Timeline: All documents should be received 7 weeks prior to the next scheduled meeting of the RIRC.
  5. Please send all hardcopies to:
    Chairman, Research & Institutional Review Committee (RIRC)
    The Queen’s Medical Center
    1301 Punchbowl Street, UH Tower 505
    Honolulu, Hawaii 96813

All Minimal Risk Study Update/Status Report

Form 10B: Minimal Risk Continuing Renewal
If you have any questions, please contact
Denise Lin-DeShetler at dlindeshetler@queens.org / 808.691.7986

Please contact the managers of the respective areas to get the password for the protected pages. See the About Us page for contact information.


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