SCDM Education Portal

Certification Resources

Topic Resource  
Application of Randomization Schemes International Conference of Harmonization (ICH) E9: Statistical Principles for Clinical Trials, 1998  
International Conference of Harmonization (ICH) Good Clinical Practices E6: Consolidated Guidance, 1996  
Management of Data in Clinical Trials (2nd Edition), 2007 Buy Now
CRF Design CDISC SDTM Implementation Guide version 3.1.1  
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
International Conference of Harmonization (ICH) E9: Statistical Principles for Clinical Trials, 1998 (6.2)  
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
CRF Tracking and Communication of Data Trends Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Clinical Database Design/Relational Data Bases Beginning Database Design: From Novice to Professional, 2007 Buy Now
Clinical Data Management (2nd Edition), 2000 Buy Now
FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications (April 2006)  
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Clinical Trials Processes, Roles, and Responsibilities Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
International Conference of Harmonization (ICH) Good Clinical Practices E6: Consolidated Guidance, 1996  
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Reference: 21 CFR part 11.10(e)  
Coding Medications Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
MedDRA TERM SELECTION: POINTS TO CONSIDER release 3.2 based on MedDRA version 6.1; ICH-Endorsed Guide for MedDRA Users Application to Adverse Drug Reactions/Adverse Events and Medical and Social History and Indications Pg 6 10 November 2003  
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Data Base Lock Procedures Cost: Benefit of EDC (www.eclinicalforum.com/content/Knowledge/Articles/articles.htm), 2001  
eClinical Trials: Planning and Implementation, 2003 Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Data Base Quality Control Audits Clinical Data Management (2nd Edition), 2000 Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Data Base Updates Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Data Management Plans Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Management of Data in Clinical Trials (2nd Edition), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Data Query Processing and Tracking Clinical Data Management (2nd Edition), 2000 Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Management of Data in Clinical Trials (2nd Edition), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Electronic Data Collection eClinical Trials: Planning and Implementation, 2003 Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Spectacular Support Centers: Best Practices for Small and Mid-Sized Help Desks and Technical Support Centers (1st Edition), 2007 Buy Now
US PhRMA's EDC Position Paper Revision 1  
Processing External Data CSUC1 (May Edition), 2001  
Data Basics, Volume 10, No. 1, 2004 Spring Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Processing Local Lab Data CSUC1 (May Edition), 2001  
Data Basics, Volume 10, No.1, 2004 Spring Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
International Conference of Harmonization (ICH) E9: Statistical Principles for Clinical Trials, 1998 (pg 31)  
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Project Management A Guide to the Project Management Body of Knowledge (PMBOK Guides) (3rd Edition), 2004 Buy Now
Clinical Data Management (2nd Edition), 2000 Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
International Conference of Harmonization (ICH) Good Clinical Practices E6: Consolidated Guidance, 1996  
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
Protocol Review A Manager's Guide to the Design and Conduct of Clinical Trials (2nd Edition), 2006 Buy Now
Clinical Data Management (2nd Edition), 2000 Buy Now
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
International Conference of Harmonization (ICH) E9: Statistical Principles for Clinical Trials, 1998  
Management of Data in Clinical Trials (2nd Edition), 2007 Buy Now
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now
SAE Reconciliation and Safety Review CTCAE, table (ctep.cancer.gov/forms/CTCAEv3.pdf), http://ctep.cancer.gov/forms/index.html scroll to protocol development and assembly section and download the "CTCAE v 3.0" and "Lay Term and Mapping Document"  
Good Clinical Data Management Practices (GCDMP), 2007 Buy Now
International Conference of Harmonization (ICH) Good Clinical Practices E6: Consolidated Guidance, 1996  
Management of Data in Clinical Trials (2nd Edition), 2007 Buy Now
NDA regulations, 21CFR 314.50  
Practical Guide to Clinical Data Management (2nd Edition), 2007 Buy Now