NC East / RTP Area

The DECEMBER 2017, meeting of the Clinical Research Professionals of North Carolina (a chapter of SOCRA also referred to as NC East or the RTP chapter) will be held on Monday, 04 December 2017, from 6:00 to 7:00 PM.

RTP Location: IQVIA™ (Formerly Quintiles)
Greensboro Remote Location: Cone Health Cancer Center

OUR TOPIC: Good Clinical Data Management Practices (GCDMP) Review and Update

SPEAKER: Marysasser Hedrick Holloway – Principal and Owner of H3CTC Data Management Consulting, Adjunct Instructor and Advisory Board Member for Durham Technical Community College, ACRP RTP Chapter President, GCDMP Chair and former SDCM Board Member

OVERVIEW:

Ms. Holloway will provide an overview of the Good Clinical Data Management Practices (GCDMP) document, describe how it came to exist and define what has happened with the document throughout the years.  She will highlight the most recent revisions and explain the mapping or content alignment of the GCDMP to the Certified Clinical Data Manager (CCDM) certification exam. It is the Society for Clinical Data Management’s intent that the GCDMP be evidence-based, which has resulted in thousands of hours of content review and article searching. The document has been translated into Japanese and Mandarin and, as new chapters are produced, those translations are scheduled. There will also be time for discussion of how to contribute to chapter task forces, provide feedback, and access the document.

At the conclusion of this presentation, attendees should be able to:

1.     Define the following terms:  GCDMP, CCDM

2.    Apply for access to the good clinical data management practices document

3.   Determine which study team members would be most likely to seek and qualify for clinical data management certification

4.    Discuss the relevance of good clinical data management practices to clinical operations study start up processes

5.    Draw conclusions about the value of a collaborative data management plan

6.    Explain the relationship of the good clinical data management practices document to the preparation for the clinical data manager certification exam

ABOUT OUR SPEAKER:

Marysasser Hedrick Holloway is a Durham native and currently the Principal and Owner of H3CTC where she consults to provide her clients with expertise in clinical data management matters.  She has worked on both domestic and international studies in Phases I through III.  She established the Data and Analytical Outsource Services Division at ClinForce for Cross Country Healthcare in 2002 and gained her practical experience during her 14-year tenure at Quintiles.  Additionally, she has worked for Clinical Solution Group, DataTrak, and Premier Research.  She has nearly 30 years of experience in the clinical trial research industry.

Ms. Holloway is a certified clinical data manager through the Society for Clinical Data Management.  She is also an adjunct instructor at Durham Technical Community College, an Advisory Board Member of the DTCC CTRA Program, President of the RTP Chapter of ACRP, ACRP Global Data Management Interest Group Leader, Chair of the GCDMP Committee and Marketing Advisory Board and former Trustee of the Board and Executive Secretary for SCDM. She holds a BA in English and Philosophy from Salem College in Winston-Salem, NC. 

If you have any questions, please contact Laurin Mancour at atheneumconsulting@gmail.com or 919-452-7821

SOCRA members may claim 1.0 CE credit hour. SOCRA members will receive Certificates of Attendance.

 

NC East/RTP SoCRA Chapter FUTURE MEETINGS:

January 1, 2018 – No meeting (Happy Holidays)

February 5, 2018 at iQVia Plaza

March 5, 2018 - speaker needed

 

CHAPTER MEETING LOCATION DIRECTIONS AND CONTACTS:

RTP:

IQVIA™ (Formerly Quintiles, Inc.)

Bradford Building, Rm. 6346
5827 S. Miami Blvd,
Durham, NC 27703 
Contact:  Laurin Mancour at 919-452-7821

 

Greensboro:

Lead Clinical Research Nurse
Cone Health Cancer Center
2nd Floor Conference Room 2-024
501 N. Elam AvenueGreensboro, NC 27403
Direct Dial: 336.832.0827 | Fax: 336.832.0841
cindy.shaw@conehealth.com

Pinehurst:

FirstHealth of the Carolinas
220 Page Road
Pinehurst, NC 28374
Contact: Pam Mason
(910) 715-2200    pmason@firsthealth.org