3N-Q Internal Operations

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

Attachment 3N – Internal Plaque Order Form

Plaque Order Form

To be sent from NCI to Chris at [email protected]

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.

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.

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

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)

Date all educational elements completed:      

Attachment 3Q – Operations Checklist for Retiring Board
Members

Member:      

Step 1

Notify member in advance (see attachment 14a)

Try to provide final meeting date when possible

Step 2

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

Version 3.0 Page 6 of 6 CIRB-WF-XX