SCDM Education Portal

Education Resources

Category Resource Topic(s) URL
Guidance Document 21 CFR part 11.10(e) Clinical Trials Processes, Roles, and Responsibilities link
Book A Guide to the Project Management Body of Knowledge (PMBOK Guides) (3rd Edition), 2004 Project Management buynow
Book A Manager’s Guide to the Design and Conduct of Clinical Trials (2nd Edition), 2006 Protocol Review buynow
Book Beginning Database Design: From Novice to Professional, 2007 Clinical Database Design/Relational Data Bases buynow
CDISC Publication CDISC ADAM Standard Version 2.0 CDISC Standard link
CDISC Publication CDISC CDASH Standard Version 1.0 CDISC Standard link
CDISC Publication CDISC LAB Standard Version 1.0.1 CDISC Standard link
CDISC Publication CDISC ODM Standard Version 1.3 CDISC Standard link
CDISC Publication CDISC SDTM Implementation Guide Version 3.1.1 CDISC Standard link
CDISC Publication CDISC Terminology Document CDISC Terminology link
Book Clinical Data Management (2nd Edition), 2000 Data Query Processing and Tracking
Project Management
Clinical Database Design/Relational Data Bases
Protocol Review
Data Base Quality Control Audits
buynow
Industry Article Cost: Benefit of EDC Data Base Lock Procedures link
CTC Publication CTCAE v 3.0 Lay Term and Mapping Document SAE Reconciliation and Safety Review link
SCDM Publication Data Basics, Volume 10, No. 1, 2004 Spring Processing External Data
Processing Local Lab Data
link
Book Database Design for Mere Mortals: A Hands-on Guide to Relational Database Design Database Design buynow
Book eClinical Trials: Planning and Implementation, 2003 Data Base Lock Procedures
Electronic Data Capture
buynow
Guidance Document FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications (April 2006) Clinical Database Design/Relational Data Bases link
SCDM Publication Good Clinical Data Management Practices (GCDMP), 2007 Project Management
Electronic Data Capture
Clinical Trials Processes, Roles, and Responsibilities
Protocol Review
CRF Design
Data Query Processing and Tracking
Data Base Updates
Coding Medications
Data Management Plans
Processing Local Lab Data
Processing External Data
CRF Tracking and Communication of Data Trends
SAE Reconciliation and Safety Review
Data Base Lock Procedures
Clinical Database Design/Relational Data Bases
Data Base Quality Control Audits
link
Guidance Document International Conference of Harmonization (ICH) E9: Statistical Principles for Clinical Trials, 1998 Application of Randomization Schemes
Protocol Review
CRF Design
Processing Local Lab Data
link
Guidance Document International Conference of Harmonization (ICH) Good Clinical Practices E6: Consolidated Guidance, 1996 Clinical Trials Processes, Roles, and Responsibilities
Application of Randomization Schemes
Project Management
SAE Reconciliation and Safety Review
link
Book Management of Data in Clinical Trials (2nd Edition), 2007 Protocol Review
Data Query Processing and Tracking
SAE Reconciliation and Safety Review
Application of Randomization Schemes
Data Management Plans
buy now
Regulation NDA regulations, 21CFR 314.50 SAE Reconciliation and Safety Review link
Book Practical Guide to Clinical Data Management (2nd Edition), 2007 Clinical Trials Processes, Roles, and Responsibilities
Protocol Review
Project Management
Data Management Plans
CRF Design
Processing Local Lab Data
Processing External Data
CRF Tracking and Communication of Data Trends
Data Query Processing and Tracking
Data Base Updates
SAE Reconciliation and Safety Review
Data Base Quality Control Audits
Data Base Lock Procedures
Electronic Data Capture
Coding Medications
buy now
Book Software Testing: Testing Across the Entire Software Development Life Cycle Validation & Quality Assurance buy now
Book Spectacular Support Centers: Best Practices for Small and Mid-Sized Help Desks and Technical Support Centers (1st Edition), 2007 Electronic Data Capture buy now
White Paper

US PhRMA’s EDC Position Paper Revision 1

(Article is on page 4 of 5)

Electronic Data Capture link
Book XML in a Nutshell: A Desktop Quick Reference Guide Programming Languages link