External IRB Key Personnel List
EXTERNAL IRB KEY PERSONNEL LIST(Quorum/WIRB/CIRB/MultiCare IRB)
Note: a) each question must be answered or marked “N/A”; e) cannot be handwritten. See the Clinical_Research_Glossary for definitions. Password to unlock form is “benaroya”. Contact the IRB with questions: [IRB Staff]
IRB Number: / VM/BRI funding #(s): / Date:TITLE OF RESEARCH PROPOSAL (PROTOCOL TITLE):
Principal Investigator (PI): / Study Coordinator:
Dept & Mailstop: / Dept & Mailstop:
Phone: / Phone:
Email: / E-mail:
Address (if not VM/BRI): / Address (if not VM/BRI):
GCP Ethics FDS (IRB use only) / GCP Ethics FDS (IRB use only)
IRB Regulatory Contact(optional)
(if designating someone other than the study coordinator) / GCP/Ethics/FDS (IRB use) / Phone: / Email:
/ /
Dept. & Mailstop: / Address (if not VM/BRI):
- Which external IRB is the IRB of Recordfor this study: Quorum WIRB CIRB* MultiCare IRB
*(NOTE: No Financial Disclosures need to be submitted to BRI IRB for CIRB studies unless a positive disclosure is reported.)
- Has this study already received initial IRB approval? Yes No (If NO, skip question 1 below)
- If YES, what is the new approval period (i.e. Continuing Review approval dates. For CIRB studies only)?
From: To:
- List all VM/BRI“Key Personnel” for this study (excluding listed personnel above). Key_Personnel_defined
Note:Key personnel that have not completed the required training within 30 days of this notice will be unable to participate in the conduct of the study. Training link is located atCITI_Ethics_and_GCP_training_information.
Name / GCP/Ethics/FDS(IRB use) / Title/Role (e.g. Sub-I, coordinator) / Dept. / Institution Affiliation / /
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- Are any “Key Personnel” non-VM/BRI employees that come to VMMC/BRI? Yes No If yes, define the role each individual in the study below:
Name / GCP/Ethics/FDS(IRB use) / Role in study (e.g. pulling files, consenting, etc.) / Institution Affiliation
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- Have any“Key Personnel” listed last year been removed from the study? Yes No (refer to previous lists submitted to the IRB) N/A(for new studies)
List all names:
- Have any key personnel reported a “positive” financial disclosure? Yes No N/A(i.e. no underlying drug/device provided)
If YES, have you included the mitigation plan from VM legal to BRI IRB (if addressed at the initial review),or the positive disclosure with the approved consent? Yes No N/A If N/A, Explain:
Benaroya Research Institute at Virginia Mason Institutional Review Board (BRI IRB)Version 2.2– Rev: 01/29/15
1201 Ninth Ave., Mail stop IN-RC, Seattle, WA 98101 Page 1 of 2