road map: getting a cancer study done at jefferson sylvia o’neill, md associate director of...

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ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

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Page 1: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

ROAD MAP: Getting a Cancer Study Done at JeffersonSylvia O’Neill, MDAssociate Director of Regulatory Affairs and Quality AssuranceClinical Trials Office

Page 2: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

NCI Guidelines AKA: the CORE Grant

• As an NCI Designated Cancer Center we are mandated to follow the current NCI guidelines.

• All cancer trials enrollment need to be registered• All status changes are done through Alex Lebrun

Page 3: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

Org chart

Page 4: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

The submission process

MDG

PRC

IRB

PRC and IRB Simultaneous

Amendments

New trial

Page 5: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

Multi-disciplinary Groups

• GI• Aero-Digestive• Hematologic• Women’s Cancer• GU• Melanoma and Cutaneous Malignacies• Solid Tumors

Page 6: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

Protocol Review Committee (fka: CCRRC)

comprises investigators broadly representing basic and clinical sciences that:

• Reviews scientific integrity of cancer clinical trials• Meetings occur the second and fourth Monday of the month• Deadlines are two weeks prior to the meeting• Reviewers are not confidential and there is open communication• Cancer trials are not reviewed by IRB without written PRC

approval • IRB copied on correspondence from PRC to PIs regarding trial

closure for compliance or accrual • Assures protocol compliance by monitoring accrual

Page 7: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

Protocol Review Committee Approval Format:

• Approved

• Approved with administrative changes• Changes must be made but do not need to come back to PRC

                                              • Approval with the following recommendations    --- optional

• The PRC will sign off on protocols with no further review and the IRB will be made aware of the recommendations.

• Changes are not required and do not need to come back to PRC

  • Conditional approval with mandatory stipulation changes 

• The PRC final approval letter will not be sent to the PI until the issues raised here are completed satisfactorily • Changes come back to the Administrative Chair for verification of change but do not go back to the full

board for approval

 • Disapproved- revisions needed• Disapproved

Page 8: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

PRC Amendment review

When must an amendment get PRC approval?

The amendment changes at least one of the following: a. Inclusion/exclusion criteria

b. Objectives

c. Statistics

d. Subject population

How do amendments get submitted to PRC? Send an email to: [email protected] and attach the following documents:

1. MCSF with tracked changes 2. Summary of changes 3. Tracked

Page 9: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

Closure Policy

• Per NCI Guidelines we must close trials that are not or have low accruals.

• Zero accrual at 6 months after activation

• Have less than 15% after 6 months of activation

• Have less than 30 % after one year of activation

We are allowed to suspend the clock on a trial, please notify us at [email protected]

Page 10: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

Data Safety Monitoring Committee

• Policy established in collaboration with the NCI in 2011• Meets quarterly • Currently oversees 42 IIT clinical trials • The DSMC coordinator assigns a Medical Monitor – recommends

continuation, suspension, or termination • May call for an adhoc meeting to discuss action plans • Assign a category of risk to every IIT

Page 11: ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office

In a nutshell…..

Call our Clinical Trials Office (fka CRMO) 215-955-1661

Email the PRC at : PRC @Jefferson.edu