Read NCI Central IRB Protocol Activity Update text version

NCI Central IRB Website Postings Summary March 1, 2011

The NCI CIRB Operations Office is distributing this Website Postings Summary to all CIRB sites to provide a summary of the review documents posted to the CIRB website (http://www.ncicirb.org/) since the last update. Please note: for a complete listing of all documents pertaining to a specific review, visit the study-specific webpage. Although these summary posting updates are provided on the 1st and 15th of every month, the CIRB Operations Office posts review documents and updates to the CIRB website on a daily basis. All review documents are posted on the study-specific webpages. All notices are posted under the "What's New" section of the CIRB homepage. If you are unsure of your username and password or have difficulty accessing the website, please email [email protected] or call the CIRB HelpDesk toll-free at 888-657-3711.

CIRB Notices

NONE

Study-Specific Review Documents Recently Posted Posted Documents Related to Initial Reviews:

The review documents listed below pertain to initial CIRB reviews. These new studies are now available for facilitated review.

Adult Studies

ECOG-E2108 Initial Review (IR): 2010 Activation Notice Documents Posted: Correspondence o 02/15/11: CIRB Acknowledgement of ECOG E2108 Activation

Support Documents o ECOG Activation Memo

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Pediatric Studies

COG-ADVL0921 Initial Review (IR): 2010 Activation Notice Documents Posted: Correspondence o 02/16/11: CIRB Acknowledgement of COG-ADVL0921 Activation Effective February 14, 2011 o 02/14/11: COG-ADVL0921 Activation Memo

CIRB Approval - Activation Amendment (Protocol Version Date 12/17/10) Documents Posted: Protocol o Protocol Version Date 12/17/10 o Protocol Version Date 12/17/10 - Highlighted Changes o Protocol Version Date 11/10/10 o Protocol Version Date 11/10/10 - Highlighted Changes

Informed Consent Document o Informed Consent Document for Protocol Version Date 12/17/10 [Per Activation Amd.] CIRB Application o CIRB Application (Protocol Version Date 12/17/10) o CIRB Application (Protocol Version Date 12/17/10) - Highlighted Changes o CIRB Application (Protocol Version Date 11/10/10) o CIRB Application (Protocol Version Date 11/10/10) - Highlighted Changes Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 11/10/10) Correspondence o 12/22/10: CIRB Approval of COG-ADVL0921 Group Response to Activation Amendment (Protocol Version Date 12/17/10) o 12/17/10: COG-ADVL0921 Response to CIRB Approval Pending Modification Activation Amendment Letter (Protocol Version Date 12/17/10) o 12/15/10: CIRB Approval Pending Modification of COG-ADVL0921 Activation Amendment (Protocol Version Date 11/10/10) Minutes o Minutes - Amendment Review (Protocol Version Date 11/10/10)

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Amendments o 11/10/10: COG Change Memo (Protocol Version Date 11/10/10)

Initial Review 2010 Documents Posted:

Protocol o Protocol Version Date 05/10/10 o Protocol Version Date 05/10/10) - Highlighted Changes o Protocol Version Date 01/07/10 Informed Consent Document o Informed Consent Document for Protocol Version Date 05/10/10 [Per 10 IR] CIRB Application o CIRB Application (Protocol Version Date 05/10/10) o CIRB Application (Protocol Version Date 01/07/10) Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 01/07/10) o Primary Reviewer 2 Comments (Protocol Version Date 01/07/10) o Primary Reviewer 3 Comments (Protocol Version Date 01/07/10) Correspondence o 06/04/10: CIRB Final Approval of COG-ADVL0921 Letter (Protocol Version Date 05/10/10) o 05/10/10: COG Response to CIRB Approval Pending Modification Letter of Initial Review of ADVL0921 (Protocol Version Date 05/10/10) o 03/08/10: CIRB Approval Pending Modification Letter of Initial Review of COG-ADVL0921 (Protocol Version Date 01/07/10) Minutes o Minutes - Initial Review (Protocol Version Date 01/07/10)

Posted Documents Related to Amendment Reviews: Adult Studies

CALGB-80405 Amendment Review (AR): Update #11 (Protocol Version Date 01/21/11) Documents Posted Amendments o Change Memo (Protocol Version Date 01/21/11)

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CIRB Application o CIRB Application (Protocol Version Date 01/21/11) o Summary of CIRB Application Revisions (Protocol Version Date 01/21/11) Correspondence o 02/22/11: CIRB Approval Letter Update 11- Corrected (Protocol Version Date 01/21/11) o 02/22/11: Update 11 Correction Cover Memo o 01/28/11: CIRB Approval Letter Update 11 (Protocol Version Date 01/21/11) Protocol o Protocol Version Date 01/21/11 Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 01/21/11 [Up11]

ECOG-E2905 **Re-Open to Accrual ­ effective February 4, 2011** Amendment Review (AR): CIRB Acknowledgement - Re-Open to Accrual Documents Posted: Correspondence o 02/14/11: CIRB Acknowledgement of ECOG E2905 Re-Open to Accrual

Support Documents o ECOG Reactivation Memo

ECOG-E5202 **Closure to Accrual ­ effective February 11, 2011** Amendment Review (AR): CIRB Acknowledgement - Closure to Accrual Documents Posted: Correspondence o 02/16/11: CIRB Acknowledgement of ECOG E5202 Closure to Accrual

Support Documents o ECOG Closure Memo Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 08/03/10 [Clos]

RTOG-1010 Amendment Review (AR): Update 02/03/11 (Protocol Version Date 12/13/10) Documents Posted: Amendments o Change Memo (Protocol Version Date 12/13/10

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Correspondence o 02/14/11: CIRB Approval Letter Update of 02/03/11 (Protocol Version Date 12/13/10) Protocol o Protocol Version Date 12/13/10 Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 12/13/10 [Up020311]

SWOG-S0226 Amendment Review (AR): Revision #5 (Protocol Version Date 02/02/11) Documents Posted: Amendments o Change Memo (Protocol Version Date 02/02/11)

Correspondence o 02/11/11: CIRB Approval Letter Revision 5 (Protocol Version Date 02/02/11) Protocol o Protocol Version Date 02/02/11 Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 02/02/11 [Rev5]

Pediatric Studies

COG-AALL0331 Amendment Review (AR): CIRB Potential Unanticipated Problem Review/Treatment Recommendations for COG-AALL0331 Based on Results from COG-AALL0232 Documents Posted: Correspondence o 02/16/11: CIRB Potential Unanticipated Problem Review of the Treatment Recommendations for COG-AALL0331 Based on Results from COGAALL0232 o 01/31/11: COG Letter - Patients/Parents of Patients on COG-AALL0331 o 01/28/11: COG Letter - Treatment Recommendations for Standard Risk high Patients Enrolled in COG-AALL0331

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COG-AALL07P4 Amendment Review (AR): CIRB Potential Unanticipated Problem Review/Treatment Recommendations for COG-AALL07P4 Based on Results from COG-AALL0232 Documents Posted: Correspondence o 02/16/11: CIRB Potential Unanticipated Problem Review of the Treatment Recommendations for COG-AALL07P4 Based on Results from COGAALL0232 o 01/28/11: COG Letter - Patients/Parents of Patients on COG-AALL07P4 o 01/26/11: COG Letter - Treatment Recommendations for Patients Enrolled in COG-AALL07P4 Based on Results of COG-AALL0232 COG-AALL08P1 **Temporarily Closed to Accrual by COG - Effective January 24, 2011** Amendment Review (AR): CIRB Potential Unanticipated Problem Review of the Temporary Study Closure and Treatment Recommendations for COG-AALL08P1 (Effective 01/24/11) Documents Posted: Correspondence o 02/16/11: CIRB Potential Unanticipated Problem Review - Temporary Study Closure/Treatment Recommendations for COG-AALL08P1 Based on Results from COG-AALL0232 o 01/28/11: COG Letter - Patients/Parents of Patients on COG-AALL08P1 o 01/24/11: COG-AALL08P1 Temporary Study Closure o 01/24/11: COG Letter - Treatment Recommendations for Patients Enrolled in COG-AALL08P1 Based on Results of COG-AALL0232 COG-AALL0932 Amendment Review (AR): CIRB Acknowledgement of COG-AALL0932 Post Induction ALL Therapy Documents Posted: Correspondence o 02/23/11: CIRB Acknowledgement of COG-AALL0932 Post Induction ALL Therapy o 11/12/10: COG Memo - Post Induction ALL therapy for patients who will not be able to continue on COG-AALL0932 COG-ACCL0431 Amendment Review (AR): CIRB Acknowledgement of COG-ACCL0431 Memo regarding the Recall of Commercially Available Sodium Thiosulfate (STS) Documents Posted: Correspondence o 02/18/11: CIRB Acknowledgement of COG-ACCL0431 Memo - Recall of Commercially Available Sodium Thiosulfate (STS) o 02/11/11: COG Memo - Recall of Commercially Available Sodium Thiosulfate (STS)

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COG-ADVL06B1 Amendment Review (AR): CIRB Acknowledgement of COG-ADVL06B1 Stratum 6 Reservations Re-opened (Effective 02/04/11) Documents Posted: Correspondence o 02/22/11: CIRB Acknowledgement of COG-ADVL06B1 Stratum 6 Reservations Re-opened o 02/04/11: COG Memo - COG-ADVL06B1 Stratum 6 - Reservations Reopened COG-ANBL0532 Amendment Review (AR): CIRB Acknowledgement of COG ANBL0532 NBL Disease Committee Guidance on Recent SIOP-EN Clinical Trial Results Documents Posted: Correspondence o 02/25/11: CIRB Acknowledgement of COG-ANBL0532 NBL Disease Committee Guidance on Recent SIOP-EN Clinical Trial Results o 01/07/11: COG Memo - NBL Disease Committee Guidance on Recent SIOP-EN Clinical Trial Results Amendment Review (AR): CIRB Acknowledgement of COG ANBL0532 Corrections Documents Posted: Correspondence o 02/23/11: CIRB Acknowledgement of COG-ANBL0532 Corrections o 12/03/10: COG Memo - Corrections in COG-ANBL0532 COG-AOST0331 **Temporary Suspension to Accrual - Effective January 27, 2011** Amendment Review (AR): CIRB Acknowledgement of Temporary Suspension to Accrual - Effective January 27, 2011 Documents Posted: Correspondence o 02/16/11: CIRB Acknowledgement of AOST0331 Temporary Suspension to Accrual o 01/28/11: COG-AOST0331 Temporary Suspension to Accrual COG-ARET0231 **Closed to Accrual by COG - Effective January 28, 2011** Amendment Review (AR): CIRB Acknowledgement of COG-ARET0231 Closure to Accrual - Effective January 28, 2011 Documents Posted: Correspondence o 02/18/11: CIRB Acknowledgement of COG-ARET0231 Closure to Accrual o 01/21/11: COG-ARET0231 Closure to Accrual - Effective January 28, 2011

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COG-ARST08P1 ** Suspend Accrual for Cohort 2 by COG - Effective February 4, 2011** ** Open Accrual for Cohort 1B by COG - Effective February 4, 2011** Amendment Review (AR): CIRB Acknowledgement of COG-ARET0231 Closure to Accrual - Effective January 28, 2011 Documents Posted: Correspondence o 02/18/11: CIRB Acknowledgement of COG-ARST08P1 Accrual Goal to Cohort 2 Met / Starting Accrual to Cohort 1B o 02/04/11: COG Memo - COG-ARST08P1Accrual Goal to Cohort 2 Met / Starting Accrual to Cohort 1B

Posted Documents Related to Continuing Reviews: Adult Studies

CALGB-140503 Continuing Review (CR): February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 02/02/10)

Correspondence o 02/22/11: CIRB Continuing Review Approval Letter (Protocol Version Date 02/02/10) o 01/03/11: Continuing Review Reminder Notice Protocol and Embedded Informed Consent Document o Protocol Version Date 02/02/10 Approved Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 02/02/10 [CR11] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 02/02/10) Support Documents o Study Summary (Protocol Version Date 02/02/10) o DSMB (Protocol Version Date 02/02/10)

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ECOG-E3F05 Continuing Review (CR): February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 08/24/10)

Correspondence o 02/22/11: CIRB Continuing Review Approval Letter (Protocol Version Date 08/24/10) o 01/04/11: Continuing Review Reminder Notice Protocol and Embedded Informed Consent Document o Protocol Version Date 08/24/10 Approved Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 08/24/10 [CR11] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 08/24/10) Support Documents o Study Summary (Protocol Version Date 08/24/10) o DMC Recommendations (Protocol Version Date 08/24/10)

ECOG-E1900 Continuing Review (CR): February 2011 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 03/31/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. ECOG-E2902 Continuing Review (CR): February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 03/22/10)

Correspondence o 02/22/11: CIRB Continuing Review Approval Letter (Protocol Version Date 03/22/10) o 01/04/11: Continuing Review Reminder Notice Protocol and Embedded Informed Consent Document o Protocol Version Date 03/22/10

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Approved Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 03/22/10 [CR11] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 03/22/10) Support Documents o Study Summary (Protocol Version Date 03/22/10) o DMC Recommendations (Protocol Version Date 03/22/10)

GOG-0249 Continuing Review (CR): February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 11/08/10)

Correspondence o 02/18/11: CIRB Continuing Review Approval Letter (Protocol Version Date 11/08/10) o 01/04/11: Continuing Review Reminder Notice Protocol o Protocol Version Date 11/08/10 Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 11/08/10 [CR11] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 11/08/10) Support Documents o Study Summary (Protocol Version Date 11/08/10) o Safety Review Committee (Protocol Version Date 11/08/10)

NSABP-B-40 Continuing Review (CR): February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 02/15/08)

Correspondence o 02/18/11: CIRB Continuing Review Approval Letter (Protocol Version Date 02/15/08) o 01/03/11: Continuing Review Reminder Notice

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Protocol o Protocol Version Date 02/15/08 Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 02/15/08 [CR11] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 02/15/08) Support Documents o Study Summary (Protocol Version Date 02/15/08) o 10/15/10: DMC Minutes (Protocol Version Date 02/15/08) o 04/09/10: DMC Minutes (Protocol Version Date 02/15/08)

RTOG-0522 Continuing Review (CR): February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 12/09/10)

Correspondence o 02/23/11: Continuing Review Approval Letter (Protocol Version Date 12/09/10) o 01/04/11: Continuing Review Reminder Notice Protocol and Embedded Informed Consent Document o Protocol Version Date 12/09/10 Approved Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 12/09/10 [CR11] Support Documents o Study Summary (Protocol Version Date 12/09/10) o DMC Minutes (Protocol Version Date 12/09/10)

SWOG-S0819 Continuing Review (CR): February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 12/10/10)

Correspondence o 02/22/11: CIRB Continuing Review Approval Letter (Protocol Version Date 12/10/10) o 01/04/11: Continuing Review Reminder Notice

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Protocol and Embedded Informed Consent Document o Protocol Version Date 12/10/10 Approved Informed Consent Document o CIRB's Informed Consent Document for Protocol Version Date 12/10/10 [CR11] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 12/10/10) Support Documents o Study Summary (Protocol Version Date 12/10/10) o DSMC Minutes (Protocol Version Date 12/10/10)

Pediatric Studies

COG-AAML0431 Continuing Review (CR): Continuing Review February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 07/27/10)

Correspondence o 02/14/11: CIRB Continuing Review Approval Letter (Protocol Version Date 07/27/10) o 01/05/11: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 07/27/10 Informed Consent Document o Informed Consent Document for Protocol Version Date 07/27/10 [Per February 2011 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 07/27/10) Support Documents o 10/20/10: DSMC Report - Fall 2010 o Study Progress Report - Fall 2010

COG-AAML0631 Continuing Review (CR): Continuing Review February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 08/03/10)

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Correspondence o 02/16/11: CIRB Continuing Review Approval Letter (Protocol Version Date 08/03/10) o 01/05/11: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 08/03/10 Informed Consent Document o Informed Consent Document for Protocol Version Date 08/03/10 [Per Feb 11 CR]: PARENTAL PERMISSION o Informed Consent Document for Protocol Version Date 08/03/10 [Per Feb 11 CR]: BONE MARROW Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 08/03/10) Support Documents o Study Progress Report ­ Spring 2011 o 07/27/10: DSMC Report - Fall 2010

COG-ACNS0927 Continuing Review (CR): Continuing Review February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 11/10/10)

Correspondence o 02/16/11: CIRB Continuing Review Approval Letter (Protocol Version Date 11/10/10) o 01/05/11: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 11/10/10 Informed Consent Document o Informed Consent Document for Protocol Version Date 11/10/10 [Per Feb 11 CR]: PART A o Informed Consent Document for Protocol Version Date 11/10/10 [Per Feb 11 CR]: PART B o Information Sheet for COG-ACNS0927 Protocol Version Date 11/10/10 [Per Feb 11 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 11/11/10)

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COG-ADVL0921 Continuing Review (CR): Continuing Review November 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 05/10/10)

Correspondence o 11/24/10: CIRB Continuing Review Approval Letter (Protocol Version Date 05/10/10) o 10/07/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 05/10/10 Informed Consent Document o Informed Consent Document for Protocol Version Date 05/10/10 [Per Nov 10 CR]

COG-AEWS07B1 Continuing Review (CR): Continuing Review February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 02/10/09)

Correspondence o 02/15/11: CIRB Continuing Review Approval Letter (Protocol Version Date 02/10/09) o 02/08/11: CIRB Continuing Review Reminder Notice Informed Consent Document o Informed Consent Document for Protocol Version Date 02/10/09 [Per February 2011 CR]: At Initial o Informed Consent Document for Protocol Version Date 02/10/09 [Per February 2011 CR]: Recurrence Primary Reviews o Protocol Version Date 02/10/09 Support Documents o 10/20/10: DSMC Report - Fall 2010 o Study Progress Report - Fall 2010

COG-ANBL0532 Continuing Review (CR): Continuing Review February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 03/09/10)

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Correspondence o 02/16/11: CIRB Continuing Review Approval Letter (Protocol Version Date 03/09/11) o 01/05/11: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 03/09/10 Informed Consent Document o Informed Consent Document for Protocol Version Date 03/09/10 [Per Feb 11 CR]: Induction o Informed Consent Document for Protocol Version Date 03/09/10 [Per Feb 11 CR]: Non-Randomly Consolidation Therapy o Informed Consent Document for Protocol Version Date 03/09/10 [Per Feb 11 CR]: Randomized to Consolidation Therapy Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 03/09/10) Support Documents o 07/27/10: DSMC Report - Fall 2010 o Study Progress Report - Fall 2010

COG-ARET0231 Continuing Review (CR): Continuing Review February 2011 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 08/17/10)

Correspondence o 02/18/11: CIRB Continuing Review Approval Letter (Protocol Version Date 08/17/10) o 02/17/11: COG Response to CIRB Approval Pending Modification of Continuing Review Letter (Protocol Version Date 08/17/10) o 02/14/11: CIRB Approval Pending Modification of Continuing Review Letter of COG-ARET0231 (Protocol Version Date 08/17/10) o 12/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 08/17/10 Informed Consent Document o Informed Consent Document for Protocol Version Date 08/17/10 [Per Feb 11 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 08/17/10)

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Support Documents o 01/25/10: DSMC Report - Spring 2010 o 01/22/10: Study Progress Report - Spring 2010

Serious Adverse Events Posted:

Adult Studies

Documents Posted: NONE

Pediatric Studies

Documents Posted: NONE

Corrections to Previous Postings: Adult Studies

Documents Posted: Correction:

NONE

Pediatric Studies

Documents Posted: Correction:

NONE

If review of this Website Postings Summary has prompted any questions, please forward them to the NCI CIRB Operations Office Helpdesk at [email protected] or call the CIRB HelpDesk toll-free at 1-(888) 657-3711.

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