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Call for Certification Exam Beta Testers: References

Title Edition Year Author Publisher Address
Overall Exams
Good Clinical Data Management Practices (GCDMP)   2007 SCDM Society for Clinical Data Management (SCDM) 555 East Wells Street, Suite 1100
Milwaukee, WI 53202-3823
Ph:414-226-0362 F:414-276-3349
www.scdm.org
CDM Exam
Management of Data in Clinical Trials 2nd 2007 McFadden, Eleanor Wiley Publishing, Inc. 10475 Crosspoint Blvd.
Indianapolis, IN 46256
800.434.3422
www.wiley.com/WileyCDA
Practical Guide to Clinical Data Management 2nd 2007 Prokscha, Susanne Taylor and Francis Group 6000 Broken Sound Parkway, NW, Suite 300
Boca Raton, FL, 33487
561-994-0555
F: 561-241-7856
www.taylorandfrancis.com
Clinical Data Management 2nd 2000 Rondel, Varley, and Webb Wiley West Susex, UK
Clinical Trials: A Practical Guide to Design, Analysis, and Reporting     2006 Duolao Wang and Ameet Bakhai Remedica Medical Education and Publishing Commonwealth House
1 New Oxford Street, London, WC1A 1NU, UK,
Tel: +44 (0)20 7759 2999
Fax: +44 (0)20 7759 2951
www.remedica.com
A Manager’s Guide to the Design and Conduct of Clinical Trials 2nd 2006 Good, Phillip Wiley  
Clinical Studies Management: A Practical Guide to Success Jan. 15 2004 Cook, Simon Informa Healthcare 52 Vanderbilt Avenue
New York, NY 10017,
T: (212) 262-8230 Fax: (212) 262-8234
catalogue.informahealthcare.com
Beginning Database Design: From Novice to Professional Jan. 15 2007 Churcher, Clare Apress, Inc. 2855 Telegraph Avenue, Suite 600
Berkeley, CA 94705
Phone: (510) 549-5930
Fax: (510) 549-5939
catalogue.informahealthcare.com
Project Management Exam
A Guide to the Project Management Body of Knowledge (PMBOK Guides)   3rd 2004 PMI Project Management Institute Four Campus Boulevard
Newtown Square, PA 19073-3299
Tel: (610) 356-4600
Fax: (610) 356-4647
www.pmi.org
Succeeding in Project-Driven Organizations: People, Processes and Politics   2001 Knutson, Joan   Wiley West Susex, UK
Quality Software Project Management 1st 2002 Futrell, Robert T., Shafer, Donald F. Lind Shafer Prentice Hall Pearson Education
One Lake Street
Upper Saddle River, NJ 07458
800-922-0579
vig.prenhall.com
Introduction to Help Desk Concepts and Skills 1st 2003 Sanderson, Susan Career Education/McGraw-Hill 1333 Burr Ridge Parkway
Burr Ridge, IL 60527
800-338-3987
FAX: 614-755-5645
catalogs.mhhe.com
Spectacular Support Centers: Best Practices for Small and Mid-Sized Help Desks and Technical Support Ce nters 1st 2007 Robertson, Kristin E. Customer Service Press Bolton, MA  
EDC Exam
EDC Chapter of Good Clinical Data Management Practices (GCDMP)   2007 SCDM Society for Clinical Data Management (SCDM)  
PhRMA White Paper Print-outs
(www.eclinicalforum.com/ frameknowledge.htm)
  2007   eClinical Forum 68 rue de Rhinau, 67860
Friesenheim. France
www.eclinicalforum.com
The Terminology Used Within the eHealth Environment
(www.eclinicalforum.com/ content/Knowledge/ Articles/articles.htm)
  2006   eClinical Forum  
The Future of Electronic Clinical Trials
(www.eclinicalforum.com/ content/Knowledge/ Articles/articles.htm)
  2006   eClinical Forum  
US PhRMA’s EDC Position Paper Revision 1       Society for Clinical Data Management (SCDM)  
eCR Presentation to EMEA GCP Inspectors on EDC
(www.eclinicalforum.com/ content/Knowledge/ Articles/articles.htm)
2003   eClinical Forum    
Regulatory Environment for EDC
(www.eclinicalforum.com/ content/Knowledge/ Articles/articles.htm)
  2003   eClinical Forum  
Cost: Benefit of EDC
(www.eclinicalforum.com/ content/Knowledge/ Articles/articles.htm)
  2001   eClinical Forum  
eClinical Trials: Planning and Implementation   2003 Danials Kush; Rebecca, Bleicher, Paul; Raymond, Stephen A Centerwatch 22 Thomson Place, 47F1
Boston, MA 02210-1212
Phone: 617-856-5900
Fax: 617-856-5901
www.centerwatch.com
International Conference of Harmonization (ICH) Good Clinical Practices E6: Consolidated Guidance   1996 ICH Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane
Rockville, MD 20857
(301) 827-4573
www.fda.gov/cder/ guidance/index.htm
International Conference of Harmonization (ICH) E9: Statistical Principles for Clinical Trials   1998 ICH Center for Drug Evaluation and Research (CDER)  
International Conference of Harmonization (ICH) E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting   1994 ICH Center for Drug Evaluation and Research (CDER)  
CSUC1 May 2001      
ACDM DHP Guidelines
(www.acdm.org.uk/ publications.cfm)
  1996 ACDM Association for Clinical Data Managem ent (ACDM) 105 St Peter's Street
St Albans, Herts, AL1 3EJ
Tel: +44 (0) 1727 896080
www.acdm.org.uk


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