Attachment 3N-Q - Internal Operations_2009

Attachment 3 N - Q:
INTERNAL OPERATIONS

Attachment 3N - Internal Plaque Order Form
Attachment 3O - Operations New Member Checklist
Attachment 3P - Educational Checklist for Member File
Attachment 3Q - Operations Checklist for Retiring
Board Members

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Attachment 3N – Internal Plaque Order Form

Plaque Order Form
To be sent from NCI to Chris at damec@ors.od.nih.gov

Hello Chris,
Hope this finds you well. I have just been informed that we will need a plaque to honor a retiring
CIRB member.
I would like to use the same specifications as previous certificates for previous CIRB members,
the certificate style, font type, wording, layout and framing will be the same as follows:
• Certificate bond size 8.5 inches x 11 inches
• Double matted with red and white
• Gold wooden frame
• “National Cancer Institute” centered near the top in red
• “Presented to” in black and centered
• “
” in the center in gold
• “For his/her Significant Contribution to the NCI Pediatric/Adult Central
Institutional Review Board” in black
• Month Year – Month Year
• NIH logo in gold centered
• Signed by Dr. Niederhuber and Dr. Abrams, Associate Director, Division of
Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program – both
signatures on file
Our CAN number is 8332942 and our AO is Jackie Robinson.
Please confirm receipt.
Thank you very much once again for your assistance.

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Attachment 3O – Operations New Member Checklist

Operations Office Checklist for New Member
Orientation
Nominee Name:
Step 1:

Send Welcome Letter including:
Biosketch questionnaire
W9
NDA
Contact Information sheet
Meeting Schedule
Orientation Steps
Mail Orientation Packet including:
Institutional Review Board Member Handbook (Amdur, R)
CIRB Meeting Schedule
Copy of DDHS regulations
Copy of FDA regulations
CIRB Operations Office Organizational Chart
Helpful URLs
CIRB Initiative Contact Information
Copy of Orientation Powerpoint
CIRB Administrator’s business card.
Update status to Nominee in MAT database
Notify ePanel © for orientation.

Step 2
Collect:
Completed contact information form
Completed W9
Completed Non-Disclosure Agreement (NDA)
Certification of HSP training (CITI or NIH)
Completed biosketch questionnaire, or pre-prepared
biosketch.
Headshot
CV (if not up to date, or if not previously provided)
Schedule or Confirm the following:
CIRB Operations Office teleconference Orientation
ePanel© training.
Observation meeting.

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Step 3

Confirm Humanitas Training and log in information
Date:
Complete new member training orientation via teleconference
Date:
Notify CIRB Chair of attendance at observational meeting
Date:
Notify Board Coordinators
Date:
Update MAT database status from nominee to premember
Date:

Step 4

Confirm attendance at observational meeting
Date:
Conduct observational meeting debrief if requested or
warranted.

Step 5

Confirm all prior steps are complete.
Update OHRP registration adding new member.
Date:
Update Mat database status from premember to member
Notify Coordinators of status change
Update CIRB website with:
Member name, degree and affiliation
Biosketch
Headshot
Contact Outreach to obtain log in info for CIRB
participants’ side.
Add member to internal rosters as appropriate
Add member to IRB Manager
Add member to distribution lists
Update minutes template

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Attachment 3P – Educational Checklist for Member File
New Member Education Checklist—Areas members were
trained in per CIRB Orientation Powerpoint
Member Name:
Orientation Presentation conducted by:
Ethical Decision Making Principles
Belmont Report
Nuremberg Code
Declaration of Helsinki
Regulatory Elements
OHRP and FDA roles in HSP
45 CFR 46
21 CFR 50 & 21 CFR 56
Informed consent elements
NCI Consent Template
Role as IRB member
IRB decision making (how to vote, criteria for approval, etc)
Procedures of the Board and Board members
Responsibilities of the Board and Board members
CIRB Member Orientation Manual
IRB Member Handbook
Outside Training
Completion of valid human subjects protections training module
(NCI, CITI, etc)

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Date all educational elements completed:

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Attachment 3Q – Operations Checklist for Retiring Board
Members
Member:
Step 1

Step 2

Notify member in advance (see attachment 14a)
Try to provide final meeting date when possible
Confirm receipt of notice of rotation off.
Confirm final meeting date.
Notify Operations Office Staff
Notify CIRB Chair and Vice Chair
Add notice to agenda for final meeting

Step 3 (after final meeting)
Remove as a reviewer (IRB Manager)
Remove Member from “Board” Distribution/Email Lists
Remove Member from ePanel
Remove Member from website/access
IRB Membership Roster
Send email to staff notifying them that new roster is
ready
Update with OHRP
Step 4
Forward plaque order to NCI

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