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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 Clinicaltrials.gov - Cox
December 7 Investigational Drug Services - Rogers/Safavi
2010 Dates

 Links to Presentations

August 11
*7:00-8:30

The Finer Points of Eligibility
Quality Data and Case Report Form
Internal Monitoring
August 25
*7:00-8:30
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