• What is the purpose of the CIRB initiative?

• Will the CIRB speed up the review and approval process for local IRBs?

• Who are the CIRB members, and how long is their tenure?

• What progress has been made to date?

• How many local IRBs have accepted CIRB review?

• How does my local IRB set up a procedure for utilizing the CIRB review?

• The IRB of my institution is very interested in joining this project. Is there a fee for using the CIRB?

• If we join the Initiative, does my IRB retain any control over the approval process or does it have to agree to accept all the CIRB reviews?

• How does the CIRB work day-to-day on a local institutional level?

• What happens with amendments, continuing reviews, and other CIRB decisions after CIRB approval?

• We are seriously considering joining the Initiative, but need to have an example of the CIRB's review of a study. Can we view CIRB reviewed and approved documents?

• My institution and IRB are interested in the CIRB Initiative, but we have several affiliated institutions that have designated our IRB as their IRB of Record. What do we have to do to join the Initiative?

• How do I update my assurance to include the Central IRB as an IRB of record?

• My institution previously joined the Adult CIRB and is now interested in opening studies through the Pediatric CIRB. What do we need to do?

• Once we join, what do we have to do so that the CIRB becomes the IRB of record for studies that our local IRB previously reviewed and approved prior to joining the Initiative?

• How does joining the CIRB impact my participation in the CTSU or Cooperative Groups?

• If we join the CIRB, where do we send our SAE's?

• What do I do about patient enrollment forms?

• What do I do about approval dates?

• My institution has a template for Informed Consents. Can I use this?

• My site previously accepted the CIRB review for a particular study, but is now planning on closing the study. What do I need to do?

• What is the CIRB policy for posting new studies on the CIRB website?

• My IRB has decided to accept the CIRB’s review for a study, but I’m having trouble finding the Facilitated Review Acceptance Form. Can you please help?

• I don’t seem to be getting the CIRB Study Activity Update emails on a regular basis - am I on the distribution list?

• I received a notice from the Cooperative Group/CTSU regarding a specific protocol amendment. When I look for this info on the CIRB website it isn’t posted. Why?

• How do I provide the CIRB with feedback about the Initiative, questions about the procedures,or comments about the website?

• In reviewing a study posted to the CIRB website I found the approval letter documenting the CIRB’s review of the Investigator Brochure however could not find the Investigator Brochure document. Where can I get a copy of the Investigator Brochure? Why?

• What are minimum technical requirement for using CIRB website?

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One of the primary goals of the CIRB is to enable local IRBs to review and open Cooperative Group studies more quickly. The CIRB reviews all CTEP-sponsored Phase 3 adult oncology treatment studies and Pilot, Phase 2 or Phase 3 pediatric clinical trials before they are distributed by the Cooperative Group to their investigators. An investment of some time is required when a local IRB joins the Initiative as they develop SOPs incorporating the CIRB’s review into their processes however use of the CIRB's reviews should save time in the long run. Local IRBs can perform facilitated reviews and accept the CIRB's review of a study without having to wait for a convened meeting of their entire Board.

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The CIRB Initiative consists of a Pediatric Board and an Adult Board. Both Boards are composed of distinguished and diverse groups of health professionals and consumer advocates with expertise in oncology from all over the country. The membership terms are planned to last approximately two years. None of the members or Chairs are employed by the NCI. To see a listing of current Board members, visit the CIRB website and click on the title ‘Board Members’ in the banner.

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The Adult CIRB has been reviewing adult studies since January 2001. Currently the CIRB has reviewed and approved over 116 Phase 3 adult Cooperative Group Trials. The Pediatric CIRB began reviewing pediatric studies in November of 2004 and has reviewed 63 studies.

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Currently over 302 institutions in over 45 states are participating in the Initiative. Of the sites currently in the Initiative, over half have accepted CIRB reviews of studies; others are developing internal procedures and familiarizing themselves with the CIRB reviews. As of December 2006, 4,318 facilitated reviews have been submitted to the CIRB by local IRBs.

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Participating institutions have the flexibility to develop their own facilitated review procedures as long as they conform to local policies and Federal guidance. The document, "Division of CIRB and Local Responsibilities" outline the issues to consider.

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There is no cost to the institution to use the CIRB; the NCI provides all funding for the CIRB.

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The local IRB decides on a study-by-study basis whether to accept the CIRB review or conduct its own full Board review. There is no minimum number of facilitated reviews required for a site to maintain enrollment in the CIRB Initiative.

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We have created a Quickguide to Facilitated Review, describing how the CIRB can work at the local level. A link to the Quickguide to Facilitated Review is found on the CIRB Website in the ‘How it Works’ title on the banner.

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The local IRB contact, the investigators, and their study coordinators/CRAs, will receive email notification semi-monthly from the CIRB concerning new review decisions and documentation. These emailed updates have the Subject line: NCI CIRB Study Activity Updates. These emails will list the documentation that was recently posted within the Participant’s Area of the CIRB website.  Staff from the local institution may view and/or download documents from the CIRB Website at any time.

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Yes, Upon request, the NCI CIRB Operations Office will provide 30-day access to the Participant's Area of the CIRB website for those IRBs that are interested in joining the Initiative. The local IRB receives access to the restricted side of the CIRB website so they may review documents prior to enrolling in the CIRB Initiative. Email the CIRB helpdesk with your request. Statement of confidentiality will be required.

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Your institution and each of the affiliates that could potentially enroll patients in the studies reviewed by the CIRB must revise their assurance with OHRP to include the Adult or Pediatric NCI CIRB (or both for some Institutions) as an IRB of record for the Institution. However, only your institutional official needs to sign and submit the NCI CIRB Authorization Agreement form. Each of the affiliated institutions must be listed on the Authorization Agreement.  Please see How to Join page for details and sample agreements.

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Your assurance should be updated though OHRP. To view the OHRP guidelines and forms, visit their website at http://www.hhs.gov/ohrp/humansubjects/assurance/renwfwa.htm

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The NCI Pediatric Central IRB Authorization Agreement will need to be signed and submitted by your institutional official. Your institution's Assurance will need to be updated to include the NCI Pediatric CIRB.

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The following steps must be taken in order for a study, previously opened at your local site, to be transferred to the CIRB's purview:

1. Confirm that your institution has joined the Initiative and the specific study(s) is on the CIRB’s list of approved studies.

2. Your IRB Chair should perform a facilitated review of the study.

3. Notify the CIRB that your site has accepted facilitated review. (Via the electronic Facilitated Review Acceptance form available on the CIRB Website.)

4. Close the study at your local site. The acceptance of facilitated review and local closure of the study should occur as closely together as possible with the acceptance of facilitated review occurring first. This ensures that the study will not be open under two different IRB's concurrently and that there are no gaps in IRB coverage of study participants.

5. Your IRB office must provide the CIRB with a copy of the local closure documentation.

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Participation in the CIRB does not in any way affect your obligations to the regulatory requirements of the CTSU or any Cooperative Group. Hard copies of regulatory documents may be printed directly from the CIRB website so a regulatory file may be maintained.

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Local institutions should follow their usual process for reporting SAEs that occur at their site to ensure the local IRB will remain informed. The CIRB reviews SAEs distributed by the Cooperative Groups and posts the results of their review in the study-specific section of the CIRB Website.

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The CIRB reviews forms intended for completion by study participants only.  Please contact the Lead Cooperative Group for the specific study with questions related to data capture.

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For those studies for which your site has accepted facilitated review, your site should use the CIRB approval dates as the CIRB has become the IRB of record for those studies.

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All CIRB member sites need to use the most current version of the informed consent document posted on the Cooperative Group’s Website. Your local site can modify the informed consent form to fit your local template as long as no information contained in the consent is deleted or removed.

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Please contact the CIRB Operations Office. The office will provide you with the necessary form(s) to complete. These form(s) need to be completed and returned if the study is being closed completely or if oversight of the study is being returned to your Local IRB.

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The policy for the CIRB is to post study documentation that is approved by the CIRB and posted or activated by the Lead Cooperative Group. Once notified of posting or activation by the Lead Cooperative Group, the CIRB posts the relevant documentation as quickly as possible.

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The link to the Facilitated Review Acceptance form is available within the Participant’s Area of the CIRB website and is only visible to IRB Office Staff. If you are a PI or Study Coordinator, please contact your local IRB regarding the submission of the Acceptance Form. If you are a member of the IRB Office and are having problems locating the Facilitated Review Acceptance Form, please email the CIRB helpdesk and we will provide you with a quick “How To” document.

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The CIRB Study Activity Update emails are sent in a plain text email format with a PDF attachment and are from ncicirbcontact@emmes.com. The emails are sent twice a month. With the increase in viruses spread through emails, many institution’s email/internet filters are blocking the CIRB’s emails or flagging them as spam. Please check with the IT or Systems personnel at your institution to see if the emails are being blocked. Also, please email or call the CIRB helpdesk with your problem. We will verify the information in our records.

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The CIRB’s policy is to only post amendment documentation that is approved by the CIRB and posted or activated by the Lead Cooperative Group. Once notified of posting or activation by the Lead Cooperative Group, the CIRB posts the relevant documentation regarding the CIRB’s review/approval as soon as possible.

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Email the CIRB helpdesk to send your thoughts and questions to the CIRB.

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For user machines recommended Configuration as given below:

• 500 MHz CPU
• At least 256 MB RAM
• VGA resolution or better
• Internet Explorer 5.5+ or Netscape 6+ or Mozilla Firefox 1.0.3+ browser
• Adobe Acrobat version 4 or better
• RTF viewer like Microsoft Word, WordPad

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There is a known problem with older versions of Microsoft Internet Explorer that may cause a PDF Acrobat file to be displayed as a blank page. CIRB has multiple documents in PDF format. If you see a blank page when accessing a study document that is in PDF format and you are using Microsoft Internet Explorer, try pressing the Refresh button on the browser. This will sometimes fix the problem and you should see the document. If the problem persists, please contact your IT support staff, or check the Microsoft support web site for other possible solutions. And please let the CIRB Contact know of your problem. This does not appear to be a problem on Netscape browsers.