Continuation Review Report

DHHS regulation 45CFR46.109(e) requires that the IRB review human subjects research at intervals appropriate to the degree of risk, but not less than once per year.

To ensure that all studies are reviewed and approved on an annual basis, the IRO will send you a reminder notice through interoffice mail several weeks before you CRR is due.

If you are doing a Clinical Research Division or Cancer Consortium study, the Protocol Office will email you all appropriate forms and current study documents, and submit your documents to the IRB.

• Continuation Review Report [download Word doc] updated July 01, 2009
• Expedited Review Checklist for Minimal Risk Activities [download Word doc]
• Modification [form and instructions] updated August 07, 2009
• Scientific Review Revision Form  [download Word doc]
• Modification Checklist for Scientific Review Committee (for PHS) [download Word doc]
• CSS Case Subject Recruitment Method Form [download Word doc]
• Prisoner Certification Checklist for Investigator [download Word doc]
• Waiver of Consent Supplement [download Word doc]  *New*

• Dataset Submission Supplement for NIH GWAS and Other Central Genetic Data Repositories  [download Word doc]  *New*

• Statistical Center Supplement [download Word doc]
• Coordinating Center Operations Supplement [download Word doc]
• International Research Performance Site Assessment Supplement [download Word doc]
• Repository, Registry or Databank Supplement  Form [download Word doc]
• University of Washington (UW) Confidentiality Agreement [access UW Confidentiality Form]
• Seattle Children's Oath of Confidentiality[download Word doc]
• Health Insurance Portability and Accountability Act (HIPAA) Compliance Forms
• Funding Source Supplement [download Word doc] updated November 16, 2009

Submission Instructions

• Submit original documents only (no copies required).
• All documents must be single-sided. Please do not use staples. 
• It is recommended that a complete set of the documents submitted to the IRB is kept for your records.

Full Review

Please submit the following original document.

• CRR Form

Submit the following documents, if applicable.  Submit only the documents that the study is currently using or will use in the next approval period.

• Synopsis
• Protocol
• Consent Form(s)
• Flyers/Advertisements
• Approach Letters
• Questionnaires
• Investigator Brochure (include a summary of changes)
• Data Safety Monitoring Board (DSMB) and Multi-center reports
• PDMC/SRC Result Letter(s)
• Summary of the current approval period's Modifications
• Approved Modifications Forms from the current approval period
• Other study documents
• Current Protocol Modification Form
• Prisoner Certification Checklist for Investigator
• Statistical Center Supplement
• Coordinating Center Operationis Supplement
• International Research Performance Site Assessment Supplement
• Repository, Registry or Databank Supplement Form
• UW Confidentiality Agreement Form or Seattle Children's Oath of Confidentiality Form
• HIPAA Form
• Funding Source Supplement [download Word doc] and one copy of the Funding Source Document and face page (if a new funding source is being added to the IR File)

Miminal Risk

Please submit the following original documents.

• CRR Form
• Expedited Review Checklist for Minimal Risk Activities  [download Word doc]
• Protocol
• Consent (the most current approved consent form used by research participants)

Submit the following documents, if applicable.  Submit only the documents that the study is currently using or will use in the next approval period.

• Synopsis
• Flyers/Advertisements
• Approach Letters
• Questionnaires
• Investigator Brochure (include a summary of changes)
• Data Safety Monitoring Board (DSMB) and Multi-center reports
• PDMC/SRC Result Letter(s)
• Summary of the current approval period's Modifications
• Approved Modifications Forms from the current approval period
• Other study documents
• Current Protocol Modification Form
• Prisoner Certification Checklist for Investigator
• Statistical Center Supplement
• Coordinating Center Operationis Supplement
• International Research Performance Site Assessment Supplement
• Repository, Registry or Databank Supplement Form
• UW Confidentiality Agreement Form or Seattle Children's Oath of Confidentiality Form
• HIPAA Form
• Funding Source Supplement [download Word doc] and one copy of the Funding Source Document and face page (if a new funding source is being added to the IR File)

Cooperative or IRB Authorization Agreement Review

Submit one copy of:

• Page 1 of the CRR [download word] 
• Approved (signed, with current dates of approval) copies of the cooperative institution's continuation review document(s)
• Protocol or Activity Plan (only if modified)
• Consent Form(s) (only if modified)

Exempt Review

Original documents only.

• Page 1 of the CRR [download Word doc]
• Exempt Checklist [download Word doc]
• Funding Proposal(s)

Other Considerations

If you have questions regarding the Cancer Consortium IRB and/or the submission process, please go to www.cancerconsortium.org.

If you are reporting a "Closure", a CRR that includes a final summary is required. If the study was never activated (i.e., no subjects entered), you may indicate this on page 1 of the CRR.

If any documents, such as consent forms use acronyms, please be sure to spell each acronym completely when first using them. For example, Institutional Review Board (IRB).

Once the application receives final approval, the IRO will forward one copy of the approved documents to the Contact Person.