Annoucements Archive

Unanticipated Problem and/or Serious or Continuing Noncompliance Application

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.  

Translation Application 

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.

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

On April 10, 2023, President Biden signed the bill officially ending the COVID-19 national emergency for the United States. All allowed COVID-19 deviations and reporting requirements are now discontiunued.

The following section will be retained for archival purposes.

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Please find attached a memo providing additional guidance for clinical trials supported by CTEP and the NCORP due to concerns regarding the spread of the novel coronavirus.  CTEP and the NCORP are providing additional guidance on alternative procedures that can be used for trials supported by CTEP and the NCORP to address some of the current challenges in providing care to patients in order to mitigate immediate hazards to the patients.

Please distribute this information to the appropriate staff and participating sites in your organization, as needed.  Please note that this information will also be sent out by the CTSU to all participating sites in the various CTEP/NCORP trials networks, so some investigators and research staff may receive the notification twice.

In addition, the guidances from FDA and NIH (for grant related items) listed below may also be useful to you in managing cancer clinical trials patients under the current public health emergency.

• FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic
• Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (Notice Number: NOT-OD-20-87)
• Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 (Notice Number: NOT-OD-20-86)

We will continue to monitor closely the studies being conducted across all the CTEP/NCORP clinical trials network programs to see if additional accommodations can be made to help maintain continuity of care of patients on trials as much as possible in this challenging situation.  Please do not hesitate to contact the Program Director for your specific trials program with any questions/concerns that may arise during this outbreak of the novel coronavirus.

Sincerely,
Meg Mooney, MD, Associate Director, CTEP
Worta McCaskill-Stevens, MD, Director, NCORP, DCP, NCI

Dear CIRB Stakeholders,

We are happy to announce that CIRB-approved short form consents have been updated per the 2018 Common Rule and are now available in 42 languages on CTSU’s website under Resources.   Tetum is planned to be the 43rd language and is in process of finalization.  This will be posted once completed.

Sites can use these approved short forms for any study approved by the CIRB if:
1.    There is no eligibility restriction in the protocol based on language that would prohibit enrollment of the participant;
2.    The Signatory Institution’s policies permit the use of short form consents;
3.    These policies have been reported to the CIRB on either the Annual Signatory Institution Worksheet or the Annual PI Worksheet.

A Short Forms Q & A is available on the CIRB Website.   

If you have any questions regarding the use of short forms, contact the CIRB Helpdesk:  ncicirbcontact@emmes.com or 1-888-657-3711.

Kind regards,

NCI CIRB Operations Office

On April 10, 2023, President Biden signed the bill officially ending the COVID-19 national emergency for the United States. All allowed COVID-19 deviations and reporting requirements are now discontiunued.

The following section will be retained for archival purposes.

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DEAR COORDINATING GROUPS,

The NCI CIRB Continuing Review Application has been updated to collect information on minor protocol deviations related to the COVID-19 public health emergency. 

The following changes were made to the CIRB Continuing Review Application: 

1. Question 4.8 has been added requesting confirmation if any minor protocol deviations related to the COVID-19 public health emergency have been collected for the study. 
2. The Summary of CIRB-Requested Supporting Documents added a selection to indicate if a minor deviation report will be attached with the submission.

This application is located on the CIRB Website under the Quickguides for Submitting Studies and is provided with the CIRB Continuing Review Reminder Notice.

The revised applications are effective Wednesday, July 15, 2020 and should be used for all submissions submitted for review on or after that date.  

Please contact the CIRB Central Inboxes with any questions: 

• Adult CIRB – Late Phase Emphasis
• Adult CIRB – Early Phase Emphasis
• Pediatric CIRB
• Cancer Prevention and Control CIRB

Dear CIRB Stakeholders,

The CIRB Operations Office has updated the Study Chair Response (SCR) instructions to provide additional clarity regarding formatting requirements when submitting a SCR to the CIRB. These changes were made in collaboration with the CTEP and DCP Protocol Information Office (PIO).

These instructions should be followed when preparing and submitting revised documents in response to a CIRB determination of Approval Pending Modification (APM) or Tabled. The purpose is to provide a tool to promote consistency in both the content and formatting of SCR submissions to the CIRB. 

Primary changes to the document include changes required in the change memos as well as updating specific requirements for formatting which may vary between the CTEP and DCP PIOs.

The Study Chair Response instructions are available on the CIRB website and are also provided in each of the CIRB’s APM or Tabling outcome emails along with the official outcome letter.

In addition to updating the content of the SCR Instructions, the CIRB is now providing sample Change Memos on the CIRB website as a tool for the sites to utilize when developing a SCR.

Please contact the appropriate CIRB Central Inbox with any questions: 

• Adult CIRB – Early Phase Emphasis
• Adult CIRB – Late Phase Emphasis
• Cancer Prevention and Control CIRB
• Pediatric CIRB

NCI CIRB Operations Office

Dear CIRB Stakeholders,

The CIRB Standard Operating Procedures (SOPs) have been updated.  The changes were made to clarify the Assent Requirements, Translation of Participant Directed Instruments, and Review of Editorial or Administrative Amendments.  Other minor administrative updates were also made and are summarized in the Summary of Changes to the SOPs.  

Please contact the CIRB Helpdesk with any questions.

Dear CIRB Participants,

The NCI CIRB has received notification that as of February 1, 2021, IRBManager will no longer support Internet Explorer. All users of IRBManager should begin using current versions of Edge, Chrome, Firefox, or Safari.

Starting on January 1, 2021, users accessing IRBManager with Internet Explorer will see a warning on the login page that they are using an outdated browser and should move to an alternate browser. This message will only be shown to users using IE, any user using a modern browser will not see any change. Beginning on February 1, 2021, IRBManager will start using coding practices that are not supported in IE and will begin removing IE-specific code.

It should be noted that this change applies to Internet Explorer and the old Microsoft Edge, it does not apply to the new Microsoft Edge (based on Chromium) browser.

Please contact the IRBManager support team with any questions you may have about this announcement.

Dear CIRB Stakeholders,

The NCI CIRB Helpdesk phone line issue has been resolved.  

If you require assistance from the NCI CIRB Helpdesk, you may contact the Helpdesk via phone at 1-888-657-3711 or email at ncicirbcontact@emmes.com.

Thank you for your patience,

NCI CIRB Helpdesk
 

Dear CIRB Stakeholders,

CTSU has redesigned the CIRB Documents Section on the CTSU website.  The goal is to combine the Initial Review, Amendment Review, and Continuing Review sections into a single chronological listing of events. The page will display all CIRB documents which will be sorted by most recent event and grouped by event name. This change will not affect CIRB Details section listing the most current Informed Consent and Protocol documents. For more information, please see: Memorandum: Redesign of the CIRB Documents Section on the CTSU website.

If you have any questions, please call the CTSU Help Desk at 1-888-823-5923 or ctsucontact@westat.com.