Annoucements Archive

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

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,

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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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,

Here is a memo providing interim guidance for patients on clinical trials supported by CTEP and the NCORP due to concerns regarding the spread of the novel coronavirus.  CTEP and the NCORP are providing clarification on measures to address some of the current challenges in providing care to patients enrolled on trials supported by CTEP and the NCORP in order to mitigate immediate hazards to the patients.

Please distribute this information to the appropriate staff and participating sites in your organization.

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,

An updated version of the CIRB SOPs is now available on the CIRB website.

If you have any questions regarding the changes to the SOPs, contact the CIRB Helpdesk: ncicirbcontact@emmes.com or 1-888-657-3711.

An overview of the changes to the SOPs is detailed below.

Section 2.3 Scope of Review Activities

• 2.3.1.4 defines electronic
• 2.3.1.5 defines written or in writing
• 2.3.1.6 defines eSignature
• 2.3.1.7 defines eConsent
• 2.3.8 now states that the CIRB reviews eSignature and eConsent formats

Amanda P. Sly, MS, CIP
Director of Central Operations
NCI CIRB Operations Office

CIRB Participants,

The CIRB Standard Operating Procedures (SOPs) have been updated.  The changes were made to reflect updates to the CIRB’s review process for of recruitment videos, changes to the length of CIRB meeting agendas and other administrative changes.  A detailed summary of the changes may be found in the Summary of Changes to the SOPs.  
The CIRB Operations Office has updated the review and approval process for recruitment videos.   As making changes to videos post-production can be costly and time consuming, the CIRB requires submission of draft materials, such as scripts and storyboards, prior to production. If the CIRB approves the draft materials for production the final video must be submitted to the CIRB for review.  

To facilitate submission of the final video we have created a new form entitled CIRB Participant Recruitment Materials Video Submission Form.  Once completed this form should be submitted to the CIRB Operations Office for CIRB review of the final video. This review is generally conducted via an expedited review and a final determination letter will be issued This form will be posted to CTSU for sites to utilize and easily locate the approved video online.   If you do not utilize CTSU for posting of documents, a version of the form will be provided via your standard document sharing processes.

To assist you in understanding the process we have created a Quickguide entitled Submitting Recruitment Material For Review which may be found on the CIRB website. 

Please contact the CIRB Helpdesk if you have any questions or comments.

An updated version of the CIRB SOPs is now available on the CIRB website.

If you have any questions regarding the changes to the SOPs, contact the CIRB Helpdesk or 1-888-657-3711.

An overview of the changes to the SOPs is detailed below.    

Section 5.6 Time Allocations for Review of Study Submissions

1. Section 5.6.1 – Updated to allow for CIRB Agendas to be five hours instead of four.    

Section 5.9.9 Translated Documents 

1. Section 5.9.9.1.1 – Updated to clarify that translated documents may use a version date independent of the Protocol Version Date. 

Section 8.7 Review of Recruitment Material and Advertisements

1. Section 8.4 – Updated to state that review of scripts and draft materials is required for recruitment videos.  Added text stating the finalized videos must be submitted for review to the CIRB.

DEAR CIRB STAKEHOLDERS,

The CIRB Standard Operating Procedures  (SOPs) have been updated.  The changes were made to state the CIRB reviews for eSignature and eConsent.  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.