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Mastering Clinical Research

This course series provides useful information to improve the quality of clinical research at Winship. Courses are held quarterly on Wednesday, 7:30 – 8:30 AM (*except as noted) in room 5012, on the 5th floor of Winship. Presentations will be posted for download as available. 

2014 Dates  Links to Presentations
March 12 Enrolling Non-English Speakers in Clinical Research: An easier way to use the ‘short form’
Obtaining Informed Consent: Refresher of SOP 2.1 and 2.2
New Research Imaging Assessment Procedure
May 14  TBD
August 13  TBD

2013 Dates

 Links to Presentations
February 6 Clinical Trials Updates:Things You Should Know - Rodger, Torlak, Wojcik
April 3

Changes to HIPAA  Regulations/Consent Process
Amendments Documenting Change

June 26 AE and UP Reporting Requirements, SOP Updates, Regulatory News
October 9 CTRC Updates and PRA Development
December 18 SOPs and Research Misconduct

2012 Dates

 Links to Presentations 
January 4 HIPAA: Breach Notification Process - K. West
February 1 ONCORE Review - Wojcik
March 7 IRB Issues - Deryck
April 4 FDA Safety Reporting - West - this has been postponed
May 2 New PHS Conflict of Interest Regulations - Mindingall/Taylor
June 6 No meeting this month
July 11 FDA Safety Reporting - K. West
August 1 Compliance with CTO SOP's - J. Jarrell   #2 Post Test
September 12 Delegation of Authority SOP 8.3 - D. Francis
November 7 Common Audit Findings - deRijke; Common QA Findings - Torlak
2011 Dates

 Links to Presentations 

January 5 Data Safety Monitoring Committee - Ramalingam
February 2

Successfully Preparing and Submitting a P01 - Khuri
Successfully Preparing and Submitting a P01 -Fox

March 2 FDA Inspection: The Basics - Ramalingam
May 4 Process Improvements for Successful Conduct of Clinical Trials - Khoury
June 1 Standard Operating Procedures Revisited - Safavi
July 6 Winship CTO Quality Management Plan - Torlak
August 3 Proposed Changes to DHHS Rules for Human Subjects Research - Putney
September 7 Clinical and Translational Research Committee - Owonikoko
October 12 Standard Operating Procedures-Revisited- Safavi
November 9 - Cox
December 7 Investigational Drug Services - Rogers/Safavi
2010 Dates

 Links to Presentations

August 11

The Finer Points of Eligibility
Quality Data and Case Report Form
Internal Monitoring
August 25
Root Cause Analysis and Corrective and Preventive Action
For Investigators
Research Professionals
RECIST and the Response Assessment
September 8 Reporting an SAE or UP to the IRB
October 6 
Clinical Trials Office SOP's
CRC/CRN Orientation Plan
November 3           Cancelled
December 1 Common Audit Findings - deRijke