Read NCI Central IRB Protocol Activity Update text version

NCI Central IRB Website Postings Summary November 1, 2010

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

The CIRB SOPs and the Division of Responsibilities document have been revised to reflect the updates per the notification distributed on April 1, 2010. This is a link to the cover memorandum describing the updates: http://www.ncicirb.org/AE_SOP_Memo_102810(4).pdf This is a link to the SOPs: http://www.ncicirb.org/CIRB_SOPs.pdf. This is a link to the Division of Responsibilities document: http://www.ncicirb.org/Division%20of%20Responsibility.pdf.

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.

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Adult Studies

GOG-0262 Initial Review (IR): 2010 Documents Posted: Support Documents o GOG Quality of Life Form - Proof o GOG Quality of Life Form - Sample Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

Pediatric Studies

COG-ADVL0221 Initial Review (IR): 2005 Documents Posted: Informed Consent o Informed Consent Document for Protocol Version Date 06/28/05

Primary Reviews o 02/24/05: Primary Reviewer 1 Comments o 02/24/05: Primary Reviewer 2 Comments o 02/24/05: Primary Reviewer 3 Comments

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AGCT0521 Initial Review (IR): 2006 Documents Posted: Informed Consent o Informed Consent Document for Protocol Version Date 01/25/07 Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ARST0921 Initial Review (IR): 2010 Documents Posted: Protocol o Protocol Version Date 09/15/10 o Protocol Version Date 09/15/10 - Highlighted Changes

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Protocol Version Date 07/22/10

Informed Consent o Informed Consent Document for Protocol Version Date 09/15/10 [Per 10 IR] CIRB Application o CIRB Application (Protocol Version Date 09/15/10) o CIRB Application (Protocol Version Date 09/15/10) - Highlighted Changes o CIRB Application (Protocol Version Date 07/22/10) Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 07/22/10) o Primary Reviewer 2 Comments (Protocol Version Date 07/22/10) o Primary Reviewer 3 Comments (Protocol Version Date 07/22/10) Correspondence o 10/25/10: CIRB Acknowledgement of COG-ARST0921 Activation Memo o 10/25/10: COG-ARST0921 Activation Memo o 09/29/10: CIRB Final Approval of COG-ARST0921 Letter (Protocol Version Date 09/15/10) o 09/15/10: COG Response to CIRB Approval Pending Modification Letter of Initial Review of COG-ARST0921 (Protocol Version Date 09/15/10) o 08/23/10: CIRB Approval Pending Modification Letter of Initial Review of COG-ARST0921 (Protocol Version Date 07/22/10) Minutes o Minutes - Initial Review (Protocol Version Date 07/22/10) Support Documents o Information Sheet for COG-ARST0921 (Protocol Version Date 09/15/10)

Posted Documents Related to Amendment Reviews: Adult Studies

CALGB-10501 Amendment Review (AR): Update #4 (Protocol Version Date 09/23/10) Documents Posted: Amendments o Change Memo (Protocol Version Date 09/23/19)

Correspondence o 10/04/10: CIRB Approval Letter Update 4 (Protocol Version Date 09/23/10)

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Protocol o Protocol Version Date 09/23/10 Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 09/23/10 [up4]

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CIRB's Informed Consent Document for Protocol Version Date 09/23/10 [up4]: Addendum

CALGB-30607 Amendment Review (AR): Update #6 (Protocol Version Date 10/04/10) Documents Posted: Amendments o Change Memo (Protocol Version Date 10/04/10)

CIRB Application o CIRB Application (Protocol Version Date 10/04/10) o Summary of CIRB Application Revisions (Protocol Version Date 10/04/10) Correspondence o 10/07/10: CIRB Approval Letter Update 6 (Protocol Version Date 10/04/10) Support Documents o OHRP: Institutional Review Board Review of Protocol and Informed Consent Changes Protocol o Protocol Version Date 10/04/10 Informed Consent o CIRB's Informed Consent for Protocol Version Date 10/04/10 [Up6]

CALGB-30801 Amendment Review (AR): CIRB Acknowledgement - Notification regarding Carboplatin Follow-Up Action Letter Documents Posted: Correspondence o 10/20/10: CIRB Acknowledgement of CALGB 30801 Notification regarding Carboplatin Follow-Up Action Letter o 10/19/10: CALGB Notification regarding Carboplatin Follow-Up Action Letter o 10/15/10: DHHS Carboplatin Follow-Up Action Letter

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CALGB-90202 Amendment Review (AR): Update #8 (Protocol Version Date 10/15/10) Documents Posted: Amendments o Change Memo (Protocol Version Date 10/15/10)

CIRB Application o CIRB Application (Protocol Version 10/15/10) o Summary of CIRB Application Revisions (Protocol Version Date 10/15/10) Correspondence o 10/22/10: CIRB Approval Letter Update 8 (Protocol Version Date 10/15/10) Protocol o Protocol Version Date 10/15/10 Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 10/15/10 [Up8]

ECOG-E1105 Amendment Review (AR): CIRB Acknowledgement - ECOG Notification regarding Carboplatin Follow-Up Action Letter Documents Posted: Correspondence o 10/27/10: CIRB Acknowledgement of ECOG E1105 Notification regarding Carboplatin Follow-Up Action Letter o 10/26/10: ECOG Protocol Notice o 10/15/10: DHHS Carboplatin Follow-Up Action Letter ECOG-E1305 Amendment Review (AR): CIRB Acknowledgement - ECOG Notification regarding Carboplatin Follow-Up Action Letter Documents Posted: Correspondence o 10/27/10: CIRB Acknowledgement of ECOG E1305 Notification regarding Carboplatin Follow-Up Action Letter o 10/26/10: ECOG Protocol Notice o 10/15/10: DHHS Carboplatin Follow-Up Action Letter ECOG-E2603 Amendment Review (AR): CIRB Acknowledgement - ECOG Notification regarding Carboplatin Follow-Up Action Letter Documents Posted: Correspondence

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10/27/10: CIRB Acknowledgement of ECOG E2603 Notification regarding Carboplatin Follow-Up Action Letter 10/26/10: ECOG Protocol Notice 10/15/10: DHHS Carboplatin Follow-Up Action Letter

ECOG-E2905 Amendment Review (AR): CIRB Acknowledgement - Epoetin Alfa Recall Documents Posted: Minutes o Minutes - Unanticipated Problem Determination (Protocol Version Date 08/18/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. ECOG-E5508 Amendment Review (AR): CIRB Acknowledgement - ECOG Notification regarding Carboplatin Follow-Up Action Letter Documents Posted: Correspondence o 10/27/10: CIRB Acknowledgement of ECOG E5508 Notification regarding Carboplatin Follow-Up Action Letter o 10/26/10: ECOG Protocol Notice o 10/15/10: DHHS Carboplatin Follow-Up Action Letter GOG-0241 Amendment Review (AR): CIRB Approval of GOG 0241 Update of 10/12/10 Documents Posted: Amendments o Change Memo (Protocol Version Date 09/27/10)

Correspondence o 10/18/10: CIRB Approval Letter Update of 10/12/10 (Protocol Version Date 09/27/10) Protocol o Protocol Version Date 09/27/10 Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 09/27/10 [up101210]

GOG-0249 Amendment Review (AR): CIRB Acknowledgement - Notification regarding Carboplatin Action Letter Documents Posted: Correspondence

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10/27/10: CIRB Acknowledgement of GOG 0249 Notifications regarding Carboplatin Action Letters 10/18/10: GOG 0249 Notification for Follow Up Action Letter 10/15/10: DHHS Follow Up Action Letter 10/06/10: GOG 0249 Carboplatin Action Letter and Notification

GOG-0250 Amendment Review (AR): Revision #4 (Protocol Version Date 10/04/10) Documents Posted: Amendments o Change Memo (Protocol Version Date 10/04/10)

CIRB Application o CIRB Application (Protocol Version Date 10/04/10) o Summary of CIRB Application Revisions (Protocol Version Date 10/04/10) Correspondence o 10/11/10: CIRB Approval Letter Revision 4 (Protocol Version Date 10/04/10) Protocol o Protocol Version Date 10/04/10 o Protocol Version Date 10/04/10 - Highlighted Changes o Appendix I: Uterine Sarcomas FIGO Classification 2009 o Appendix II: Appendix II: NCI/ DCTD Standard Protocol Language o Appendix III: Specimen Procedures o Appendix IV: Congestive Heart Failure ­ New York Heart Association Criteria o Appendix V: Anaphylaxis Precautions o Appendix VI: Patient Pill Calendar and Patient G-CSF Calendar o Appendix VII: Blood Pressure Check Calendar Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 10/04/10 [Rev4] o CIRB's Informed Consent Document for Protocol Version Date 10/04/10 [Rev4] - Highlighted Changes

GOG-0252 Amendment Review (AR): CIRB Acknowledgement - Notification regarding Carboplatin Action Letter Documents Posted: Correspondence o 10/27/10: CIRB Acknowledgement of GOG 0252 Notifications regarding Carboplatin Action Letters o 10/18/10: GOG 0252 Notification for Follow Up Action Letter o 10/15/10: DHHS Follow Up Action Letter o 10/06/10: GOG 0252 Carboplatin Action Letter and Notification

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GOG-0258 Amendment Review (AR): CIRB Acknowledgement - Notification regarding Carboplatin Action Letter Documents Posted: Correspondence o 10/27/10: CIRB Acknowledgement of GOG 0258 Notifications regarding Carboplatin Action Letters o 10/18/10: GOG 0258 Notification for Follow Up Action Letter o 10/15/10: DHHS Follow Up Action Letter o 10/06/10: GOG 0258 Carboplatin Action Letter and Notification GOG-0261 Amendment Review (AR): CIRB Acknowledgement - Notification regarding Carboplatin Action Letter Documents Posted: Correspondence o 10/27/10: CIRB Acknowledgement of GOG 0261 Notifications regarding Carboplatin Action Letters o 10/18/10: GOG 0261 Notification for Follow Up Action Letter o 10/15/10: DHHS Follow Up Action Letter o 10/06/10: GOG 0261 Carboplatin Action Letter and Notification GOG-0262 Amendment Review (AR): CIRB Acknowledgement - Notification regarding Carboplatin Action Letter Documents Posted: Correspondence o 10/27/10: CIRB Acknowledgement of GOG 0262 Notifications regarding Carboplatin Action Letters o 10/18/10: GOG 0262 Notification for Follow Up Action Letter o 10/15/10: DHHS Follow Up Action Letter o 10/06/10: GOG 0262 Carboplatin Action Letter and Notification NCCTG-N0147 Amendment Review (AR): CIRB Acknowledgement - Addendum 12 Clarification Memo Documents Posted: Correspondence o 10/15/10: CIRB Acknowledgement of NCCTG N0147 Addendum 12 Clarification Memo o 10/12/10: Addendum 12 Clarification Memo

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NSABP-C-11 **Suspension of Accrual­ Effective October 8, 2010** Amendment Review (AR): CIRB Acknowledgement - Suspension of Accrual Documents Posted: Correspondence o 10/18/10: CIRB Acknowledgement of NSABP C-11 Suspension to Accrual o 10/08/10: NSABP Suspension Memo SWOG-S0500 Amendment Review (AR): Revision #5 (Protocol Version Date 09/20/10) Documents Posted: Amendments o Change Memo (Protocol Version Date 09/20/10)

CIRB Application o CIRB Application (Protocol Version Date 09/20/10) o Summary of CIRB Application Revisions (Protocol Version Date 09/20/10) Correspondence o 10/04/10: CIRB Approval Letter Revision 5 (Protocol Version Date 09/20/10) Protocol o Protocol Version Date 09/20/10 Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 09/20/10 [Rev5]

Pediatric Studies

COG-AALL0433 **Temporarily Closed to Accrual by COG - Effective September 7, 2010** Amendment Review (AR): CIRB Potential Unanticipated Problem Review of the COGAALL0433 - Temporary Study Closure (Effective 09/07/2010) Documents Posted: Correspondence o 10/21/10: CIRB Potential Unanticipated Problem Review of the COGAALL0433 - Temporary Study Closure/Patient/Family Letter o 09/17/10: COG Participant Notification Letter - COG-AALL0433 Temporary Suspension o 09/07/10: COG-AALL0433 Temporary Suspension of Accrual

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Amendment Review (AR): CIRB Approval of COG - Temporary Shortage of Elspar (E. coli L-asparaginase)

Minutes o Minutes - Unanticipated Problem Determination (Protocol Version Date 05/07/09)

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AALL0434 Amendment Review (AR): Amendment #5 (Protocol Version Date 09/29/10) Documents Posted: Amendments o 08/12/10: COG Change Memo (Protocol Version Date 08/06/10)

CIRB Application o CIRB Application (Protocol Version Date 09/29/10) o CIRB Application (Protocol Version Date 09/29/10) - Highlighted Changes o CIRB Application (Protocol Version Date 08/06/10) o CIRB Application (Protocol Version Date 08/06/10) - Highlighted Changes Correspondence o 10/06/10: CIRB Approval of COG-AALL0434 Amendment #5 (Protocol Version Date 09/29/10) o 09/29/10: COG-AALL0434 Response to CIRB Approval Pending Modification Letter (Protocol Version Date 09/29/10) o 09/15/10: CIRB Approval Pending Modification Letter of COG-AALL0434 (Protocol Version Date 08/06/10) Protocol o Protocol Version Date 09/29/10 o Protocol Version Date 09/29/10 - Highlighted Changes o Protocol Version Date 08/06/10 o Protocol Version Date 08/06/10 - Highlighted Changes Informed Consent o Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part I - Induction Therapy for Subjects with T-cell Acute Lymphoblastic Leukemia o Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part I - Induction Therapy for Subjects with T-cell Lymphoblastic Lymphoma o Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part II - Post Induction Therapy for Subjects with Low Risk T-cell Acute Lymphoblastic Leukemia o Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part II - Post Induction Therapy for Subjects with Intermediate Risk Tcell Acute Lymphoblastic Leukemia

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Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part II - Post Induction Therapy for Subjects with Standard Risk T-cell Lymphoblastic Lymphoma Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part II - Post Induction Therapy for Subjects with T-cell Acute Lymphoblastic Leukemia for whom Induction Therapy Failed Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part II - Post Induction Therapy for Subjects with T-cell Lymphoblastic Lymphoma for whom Induction Therapy Failed Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part II - Post-Induction Therapy for Subjects with High Risk T-cell Acute Lymphoblastic Leukemia Informed Consent Document for Protocol Version Date 09/29/10 [Per Amd. #5]: Part II - Post-Induction Therapy for Subjects with High Risk T-cell Lymphoblastic Lymphoma

Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 08/06/10) Minutes o Minutes - Amendment Review (Protocol Version Date 08/06/10)

COG-AALL05B1 Amendment Review (AR): Amendment #1 Documents Posted: Minutes o 06/14/07: Continuing Review Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AALL0622 Amendment Review (AR): CIRB Approval of COG - Temporary Shortage of Elspar (E. coli L-asparaginase) Documents Posted: Minutes o Minutes - Unanticipated Problem Determination (Protocol Version Date 05/13/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AALL0631 Amendment Review (AR): Amendment #2 (Protocol Version Date 09/15/10) Documents Posted: Amendments o 09/15/10: COG Change Memo (Protocol Version Date 09/15/10)

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CIRB Application o CIRB Application (Protocol Version Date 09/15/10) o CIRB Application (Protocol Version Date 09/15/10) - Highlighted Changes Correspondence o 10/11/10: CIRB Approval of COG-AALL0631 Amendment #2 (Protocol Version Date 09/15/10) Protocol o Protocol Version Date 09/15/10 o Protocol Version Date 09/15/10 - Highlighted Changes Informed Consent o Informed Consent Document for Protocol Version Date 09/15/10 [Per Amd. #2]: Part 1 Non-Phase 1 o Informed Consent Document for Protocol Version Date 09/15/10 [Per Amd. #2]: Part 1 Phase 1 o Informed Consent Document for Protocol Version Date 09/15/10 [Per Amd. #2]: Part 2

Amendment Review (AR): CIRB Approval of COG - Temporary Shortage of Elspar (E. coli L-asparaginase) Documents Posted: Minutes o Minutes - Unanticipated Problem Determination (Protocol Version Date 07/08/09) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AALL07P1 Amendment Review (AR): CIRB Approval of COG - Temporary Shortage of Elspar (E. coli L-asparaginase) Documents Posted: Minutes o Minutes - Unanticipated Problem Determination (Protocol Version Date 05/17/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

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COG-AAML0431 Amendment Review (AR): CIRB Approval of COG - Temporary Shortage of Elspar (E. coli L-asparaginase) Documents Posted: Minutes o Minutes - Unanticipated Problem Determination (Protocol Version Date 02/03/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AAML0523 **Permanent Closure to Accrual for ALL Stratum by COG - Effective October 22, 2010** Amendment Review (AR): CIRB Acknowledgement of COG-AAML0523 Permanent Closure to Accrual for ALL Stratum (Effective 10/22/10) Documents Posted: Correspondence o 10/22/10: CIRB Acknowledgement of COG-AAML0523 Permanent Closure to Accrual for ALL Stratum o 10/22/10: COG-AAML0523 Permanent Closure to Accrual for ALL StratumEffective October 22, 2010 COG-AAML0531 Amendment Review (AR): CIRB Approval of COG - Temporary Shortage of Elspar (E. coli L-asparaginase) Documents Posted: Minutes o Minutes - Unanticipated Problem Determination (Protocol Version Date 07/14/09) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ACCL0431 Amendment Review (AR): Amendment #1A (Protocol Version Date 03/31/10) Documents Posted: Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 03/31/10)

Minutes o Minutes - Amendment 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.

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COG-ACNS0621 Amendment Review (AR): Amendment #3 (Protocol Version Date 05/10/10) Documents Posted: Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 05/10/10)

Minutes o Minutes - Amendment Review (Protocol Version Date 05/10/10)

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ADVL0221 Amendment Review (AR): Activation Amendment (Protocol Version Date 01/15/07) Documents Posted: Informed Consent o Informed Consent Document for Protocol Version Date 01/15/07

Minutes o 07/13/06: Minutes - Amendment Review

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ADVL06B1 **Reopening to Accrual of Strata 3, 5, and 7 by COG - Effective October 22, 2010** Amendment Review (AR): CIRB Acknowledgement of COG-ADVL06B1 Reopening to Accrual of Strata 3, 5, and 7 (VCR Alone) (Effective 10/22/10) Documents Posted: Correspondence o 10/22/10: CIRB Acknowledgement - COG-ADVL06B1 Strata 3, 5, and 7 (VCR Alone) Reopening to Accrual o 10/22/10: COG Notice - COG-ADVL06B1 Strata 3, 5 and 7 (VCR Alone) Reopening to Accrual COG-ADVL0821 Amendment Review (AR): Amendment #5 (Protocol Version Date 09/30/10) Documents Posted: Amendments o 09/30/10: COG Change Memo (Protocol Version Date 09/30/10)

CIRB Application o CIRB Application (Protocol Version Date 09/30/10) o CIRB Application (Protocol Version Date 09/30/10) - Highlighted Changes

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Correspondence o 10/11/10: CIRB Approval of COG-ADVL0821 Amendment #5 (Protocol Version Date 09/30/10) Protocol o Protocol Version Date 09/30/10 o Protocol Version Date 09/30/10 - Highlighted Changes Informed Consent o Informed Consent Document for Protocol Version Date 09/30/10 [Per Amd. #5]

COG-ANBL00P3 Amendment Review (AR): Amendment #3 (This amendment is equivalent to the final version of the study for the Continuing Review for December 2006) Documents Posted: Minutes o 12/14/06: Minutes: Continuing Review Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AREN0534 Amendment Review (AR): Amendment #1 (Protocol Version Date 05/13/10) Documents Posted: Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 05/13/10) Minutes o Minutes - Amendment Review (Protocol Version Date 05/13/10)

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ARST08P1 Amendment Review (AR): Amendment #3 (Protocol Version Date 09/30/10) Documents Posted: Amendments o 09/30/10: COG Change Memo (Protocol Version Date 09/30/10)

CIRB Application o CIRB Application (Protocol Version Date 09/30/10) o CIRB Application (Protocol Version Date 09/30/10) - Highlighted Changes Correspondence o 10/11/10: CIRB Approval of COG-ARST08P1 Amendment #3 (Protocol Version Date 09/30/10)

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Protocol o Protocol Version Date 09/30/10 o Protocol Version Date 09/30/10 - Highlighted Changes Informed Consent o Informed Consent Document for Protocol Version Date 09/30/10 [Per Amd. #3]: Pilot 1 o Informed Consent Document for Protocol Version Date 09/30/10 [Per Amd. #3]: Pilot 2 o Informed Consent Document for Protocol Version Date 09/30/10 [Per Amd. #3]: Pilot 3

Posted Documents Related to Continuing Reviews: Adult Studies

CALGB-80303 **COMPLETED (No Further Activity is being Conducted), as of October 22, 2010** Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application ( Protocol Version Date 08/17/07)

Correspondence o 10/22/10: CIRB Closure of CALGB 80303 Due to Study Completion o 09/02/10: Continuing Review Reminder Notice Protocol o Protocol Version Date 08/17/07 Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 08/17/10 [Completion] Support Documents o DSMB Statements (Protocol Version Date 08/17/07) o Study Summary (Protocol Version Date 08/17/07) o Journal of Clinical Oncology Abstract (Protocol Version Date 08/17/07)

CALGB-90203 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 09/01/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

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CALGB-90401 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 03/09/09)

Correspondence o 10/22/10: CIRB Continuing Review Approval Letter (Protocol Version Date 03/09/09) o 09/03/10: Continuing Review Reminder Notice Protocol o Protocol Version Date 03/09/09 Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 03/09/09 [CR10] Support Documents o DSMB Information (Protocol Version Date 03/09/09) o Study Summary (Protocol Version Date 03/09/09) o American Society of Clinical Oncology - Abstract (Protocol Version Date 03/09/09)

ECOG-E1305 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 08/02/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. NCCTG-N0723 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 07/08/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. NCIC CTG-MA.27B Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms

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CIRB Continuing Review Application (Protocol Version Date 05/22/07)

Correspondence o 10/26/10: CIRB Continuing Review Approval Letter (Protocol Version Date 05/22/07) o 09/03/10: Continuing Review Reminder Notice Protocol o Protocol Version Date 05/22/07 Informed Consent o CIRB's Informed Consent Document for Protocol Version Date 05/22/07 [CR10] Support Documents o Study Summary (Protocol Version Date 05/22/07)

SWOG-S0337 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 12/16/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

Pediatric Studies

COG-AALL0331 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 05/11/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AALL03B1 Continuing Review (CR): Continuing Review September 2006 Documents Posted: Minutes o 09/14/06: Minutes - Continuing Review Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

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COG-AALL0433 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 05/07/09)

Correspondence o 10/19/10: CIRB Continuing Review Approval Letter (Protocol Version Date 05/07/09) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 05/07/09 Informed Consent o Informed Consent Document for Protocol Version Date 05/07/09 [Per October 10 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 05/07/09) Support Documents o 01/25/10: DSMC Report - Spring 2010 o 01/22/10: Study Progress Report - Spring 2010

COG-AALL0434 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 09/29/10)

Correspondence o 10/21/10: CIRB Continuing Review Approval Letter (Protocol Version Date 09/29/10) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 09/29/10 Informed Consent o Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part I - Induction Therapy for Subjects with T-cell Acute Lymphoblastic Leukemia o Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part II - Post Induction Therapy for Subjects with Low Risk T-cell Acute Lymphoblastic Leukemia

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Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part II - Post Induction Therapy for Subjects with Intermediate Risk T-cell Acute Lymphoblastic Leukemia Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part II - Post-Induction Therapy for Subjects with High Risk T-cell Acute Lymphoblastic Leukemia Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part II - Post Induction Therapy for Subjects with T-cell Acute Lymphoblastic Leukemia for whom Induction Therapy Failed Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part I - Induction Therapy for Subjects with T-cell Lymphoblastic Lymphoma Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part II - Post Induction Therapy for Subjects with Standard Risk Tcell Lymphoblastic Lymphoma Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part II - Post-Induction Therapy for Subjects with High Risk T-cell Lymphoblastic Lymphoma Informed Consent Document for Protocol Version Date 09/29/10 [Per Oct. 09 CR]: Part II - Post Induction Therapy for Subjects with T-cell Lymphoblastic Lymphoma for whom Induction Therapy Failed

Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 09/29/10) Support Documents o 04/07/10: DSMC Report - Spring 2010 o 01/22/10: Study Progress Report - Spring 2010

COG-AALL06N1 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 08/13/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AALL07P1 Continuing Review (CR): Continuing Review June 2010 Documents Posted: Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 05/17/10)

Minutes o Minutes - Continuing Review (Protocol Version Date 05/17/10)

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

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COG-AAML0531 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 07/14/09) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ACNS0221 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 11/15/05) Correspondence o 10/21/10: CIRB Continuing Review Approval Letter (Protocol Version Date 11/15/05) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 11/15/05 Informed Consent o Informed Consent Document for Protocol Version Date 11/15/05 [Per Oct. 10 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 11/15/05) Support Documents o 04/07/10: DSMC Report - Spring 2010 o 01/22/10: Study Progress Report - Spring 2010 COG-ACNS0333 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 11/07/08) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ACNS0334 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 06/15/07)

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November 1, 2010

Correspondence o 10/19/10: CIRB Continuing Review Approval Letter (Protocol Version Date 06/15/07) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 06/15/07 Informed Consent o Informed Consent Document for Protocol Version Date 06/15/07 [Per October 10 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 06/15/07) Support Documents o 01/25/10: DSMC Report - Spring 2010 o Study Progress Report - Fall 2010

COG-ADVL0221 Continuing Review (CR): Continuing Review April 2007 Documents Posted: Protocol o Protocol Version Date 01/15/07

Informed Consent o Informed Consent Document for Protocol Version Date 01/15/07

Continuing Review (CR): Continuing Review August 2006 Documents Posted: Protocol o Protocol Version Date 06/28/05

Informed Consent o Informed Consent Document for Protocol Version Date 06/28/05

Continuing Review (CR): Continuing Review November 2005 Documents Posted: Protocol o Protocol Version Date 06/28/05

Informed Consent o Informed Consent Document for Protocol Version Date 06/28/05

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

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November 1, 2010

COG-AGCT0521 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 03/22/10)

Correspondence o 10/21/10: CIRB Continuing Review Approval Letter (Protocol Version Date 03/22/10) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 03/22/10 Informed Consent o Informed Consent Document for Protocol Version Date 03/22/10 [Per October 10 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 03/22/10) Support Documents o 07/27/10: DSMC Report - Fall 2010 o Study Progress Report - Fall 2010

COG-AHOD03P1 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 09/30/09)

Correspondence o 10/19/10: CIRB Continuing Review Approval Letter (Protocol Version Date 09/30/09) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 09/30/09 Informed Consent o Informed Consent Document for Protocol Version Date 09/30/09 [Per October 10 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 09/30/09) Support Documents o 07/27/10: DSMC Report - Fall 2010

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November 1, 2010

o

Study Progress Report - Fall 2010

COG-AHOD0431 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 05/11/07)

Correspondence o 10/19/10: CIRB Continuing Review Approval Letter (Protocol Version Date 05/11/07) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 05/11/07 Informed Consent o Informed Consent Document for Protocol Version Date 05/11/07 [Per October 10 CR]: Initial Treatment o Informed Consent Document for Protocol Version Date 05/11/07 [Per October 10 CR]: Relapse Treatment Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 05/11/07) Support Documents o 10/12/09: DSMC Report - Fall 2009 o Study Progress Report - Fall 2010

COG-ANBL00P3 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 09/25/09)

Correspondence o 10/19/10: CIRB Continuing Review Approval Letter (Protocol Version Date 09/25/09) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 09/25/09 Informed Consent o Informed Consent Document for Protocol Version Date 09/25/09 [Per October 10 CR]: Low Risk o Informed Consent Document for Protocol Version Date 09/25/09 [Per October 10 CR]: Intermediate/High Risk

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November 1, 2010

Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 09/25/09) Support Documents o 10/12/09: DSMC Report - Fall 2009 o Study Progress Report - Fall 2010

COG-ANBL0931 Continuing Review (CR): Continuing Review June 2010 Documents Posted: Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 12/17/09)

Minutes o Minutes - Continuing Review (Protocol Version Date 12/17/09)

Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AOST0331 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 04/15/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-AREN0321 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 01/19/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ARET0332 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 08/03/09) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

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November 1, 2010

COG-ARST0332 Continuing Review (CR): Continuing Review October 2010 Documents Posted: Continuing Review Forms o CIRB Continuing Review Application (Protocol Version Date 04/07/09)

Correspondence o 10/19/10: CIRB Continuing Review Approval Letter (Protocol Version Date 04/07/09) o 09/03/10: CIRB Continuing Review Reminder Notice Protocol o Protocol Version Date 04/07/09 Informed Consent o Informed Consent Document for Protocol Version Date 04/07/09 [Per October 10 CR] Primary Reviews o Primary Reviewer 1 Comments (Protocol Version Date 04/07/09) Support Documents o 07/27/10: DSMC Report - Fall 2010 o Study Progress Report - Fall 2010

COG-ARST0431 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 06/26/07) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website. COG-ARST0531 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 08/20/09) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

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November 1, 2010

COG-ASCT0631 Continuing Review (CR): Continuing Review September 2010 Documents Posted: Minutes o Minutes - Continuing Review (Protocol Version Date 03/17/10) Additional documents associated with this action have been previously posted to the Website Posting Summary and are available on the website.

Serious Adverse Events Posted: Adult Studies

Documents Posted: NONE

Pediatric Studies

Documents Posted: Study Number: COG AALL0631 SAE Posted: 2010004444 Study Number: COG AALL07P1 SAE Posted: 1164386 1398066 1617319 FU1 1658762 FU1 Study Number: COG AALL07P4 SAE Posted: 1705612 FU1 2009EN000023 FU2 2009EN000117 FU5 2009EN000143 Fu2 2009EN000147 FU2 2009EN000190 FU2 2009EN000190 FU3 2009EN000213 FU1 2009EN000264 FU2 2009EN000266 FU2 2009EN000288 FU2 2009EN000310 FU3 2010EN000102 FU3 2010EN000126 2010EN000126 FU1

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November 1, 2010

2010EN000164 FU1 2010EN000173 2010EN000179 2010EN000179 FU1 2010EN000213 2010EN000224 2010EN000227 2010EN000243 FU1 2010EN000246 2010EN000248 Study Number: COG AAML06P1 SAE Posted: 2010001454 FU3 2010002397 FU1 2010003399 2010004444 Study Number: COG AAML07P1 SAE Posted: 1164386 1617319 FU1 1705612 FU1 Study Number: COG ACNS0621 SAE Posted: 6055702 FU1 Study Number: COG ADVL0821 SAE Posted: 10-13-00250 FU2 10-13-00301 1069295 1652234 1791272 FU1 1926485 Study Number: COG ARST08P1 SAE Posted: 10-13-00301 1069295 FU1 1097524 1203166 FU1 1559936 FU1 1652234 1664754 1664754 FU1 1769965 FU1 1791272 FU1 1791876 1926485

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November 1, 2010

Corrections to Previous Postings: Adult Studies

Study Number 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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November 1, 2010

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