The NCI CIRB Operations Office will be closed Monday, January 20, 2025, for the Martin Luther King Holiday. If you need to reach the CIRB Operations Office, please do so before close of business Friday by sending an email to support@ncicirbcontact.zendesk.com, or by calling us toll-free at 1-888-657-3711.
Thank you and have a great day!
The CIRB’s Annual Signatory Institution Worksheet and Quickguide have been revised to reflect changes to the following questions:
These changes may require additional information to supplement what was provided in the previously approved submission.
If you have any question or comments, please contact the NCI CIRB Helpdesk.
Hello,
The NCI CIRB is announcing its annual ‘open call’ for new board members. Our goal is to populate the boards with members who represent diverse backgrounds and experiences, and who can review NCIs research with competence and confidence. This year, we are recruiting medical oncologists, pharmacists, statisticians, and patient representatives. We will be accepting applications through July 19th, 2024.
Complete information about the boards, board member qualifications, and the application process are available on this Board Members page of the CIRB web site.
Please share this email with individuals who you feel are well-suited for this important role.
Thank you for your support for the NCI CIRB and for your participation in our annual recruitment process.
Please feel free to contact me at cirbmembership@emmes.com with any questions.
Sincerely,
Vanessa Loyola
NCI CIRB Membership Administrator
As of Wednesday, May 22, 2024, Outcome Letters for Initial Reviews, Amendments, and Continuing Reviews will now include the Adult Risk category. Stakeholders will also continue to find the Adult Risk category in the Applications.
This change was made in response to requests from CIRB stakeholders. The NCI CIRB hopes this change will help to streamline work processes for all stakeholders.
Please contact the NCI CIRB Helpdesk if you have any questions or comments.
Sincerely
NCI CIRB Operations
CIRB Stakeholders,
As of January 2, 2024, each study closure will require the completed and approved Early Study Closure Confirmation form. The Early Study Closure Confirmation form will be required for all studies, even those where no participants have been enrolled.
The Study Closure Confirmation form is required to document the Lead Protocol Organization’s (LPO) review and approval of early study closure regardless of the accrual status of the site. Approval is not guaranteed (e.g., registration trials).
Once completed, save a copy of the form and submit it to the applicable LPO at the email below.
NCTN
i. ALLIANCE* - regulatory@alliancenctn.org
ii. COG – cogqa@childrensoncologygroup.org
iii. CCTG – CCTGStudyClosureRequest@ctg.queensu.ca
iv. ECOG-ACRIN – EAStudyClosureRequest@ecog-acrin.org
v. NRG* - regulatory-phl@NRGOncology.org
vi. SWOG – SWOGStudyClosureRequest@crab.org
ETCTN and CITN
i. Theradex – CTMS-DM@theradex.com; and
ii. LAO Leading the study (see protocol contact table); or
iii. CITN - citn.core.reg@hvtn.org
Other networks
i. Submit to the statistician/data manager per the protocol contact table.
If, after receiving an approved form back from the LPO, you are closing the study at all of the participating sites under your CIRB Signatory Institution, complete the Study Closure Worksheet via IRBManager.
If after receiving an approved form back from the LPO, you are closing the study at some, but not all, of the participating sites under your CIRB Signatory Institution, or if you are closing the study through your local IRB, use the Regulatory Submission Portal with the CTSU.
Please note, this new process supersedes the previous Alliance and NRG early closure processes.
Please refer to the CTSU Bimonthly Broadcast for December 22, 2023 for more information.
CIRB Operations Office
The CIRB’s Amendment Review Application has been revised to include a new section - Section 4.0 Investigational Medical Device.
If you have any question or comments, please contact the NCI CIRB Helpdesk.
The NCI CIRB is announcing its annual ‘open call’ for new board members. Our goal is to populate the boards with members who represent diverse backgrounds and experiences, and who can review NCIs research with competence and confidence. This year we are recruiting for medical oncologists and statisticians. We will be accepting applications through July 21st.
Complete information about the boards, board member qualifications, and the application process are available on the Become a Board Member page of the CIRB web site.
Please share this email with individuals who you feel are well-suited for this important role.
Thank you for your support for the NCI CIRB and for your participation in our annual recruitment process.
Please feel free to contact me at cirbmembership@emmes.com with any questions.
Sincerely,
Vanessa Loyola
NCI CIRB Membership Administrator
Hello,
The NCI CIRB is announcing its annual ‘open call’ for new board members. Our goal is to populate the boards with members who represent diverse backgrounds and experiences, and who can review NCIs research with competence and confidence. This year we are recruiting for medical oncologists and statisticians. We will be accepting applications through July 21st.
Complete information about the boards, board member qualifications, and the application process are available on the Become a Board Member page of the CIRB web site.
Please share this email with individuals who you feel are well-suited for this important role.
Thank you for your support for the NCI CIRB and for your participation in our annual recruitment process.
Please feel free to contact me at cirbmembership@emmes.com with any questions.
Sincerely,
Vanessa Loyola
NCI CIRB Membership Administrator
The NCI CIRB has created an application for the submission of potential unanticipated problems and/or serious or continuing noncompliance for trial-wide review by the boards.
A copy of the application is available on the CIRB website here. To submit and complete an application in IRBManager, email the board that reviewed the study and request that an application be assigned to the study team.
A summary of the SOP changes can be found here.
The Quickguide with instructions called “Completing the Unanticipated Problem and/or Serious or Continuing Noncompliance Submission Application” is available on the CIRB website.
The NCI CIRB has created an application for the submission for trial-wide translations. A copy of the application is available on the CIRB website here. To submit and complete an application in IRBManager, email CIRBConsentForms@emmes.com.
A summary of the SOP changes can be found here.
The Quickguide with information about the types of translations and expectation for each translation can be found here. The Quickguide for completing the Translation Application can be found here.
If you have any questions, please contact the NCI CIRB Helpdesk or call 1-888-657-3711.
The NCI CIRB has updated its guidance regarding the requirements for a witness. Witnesses will no longer be required by NCI. The inclusion of a witness in the remote consent process is now dictated by local institutional policy and must follow FDA and OHRP requirements.
Thank you
CIRB Operation Office