Guest Editor’s Note: The Impact of Technology on the Future of Clinical Data Management Ronald D. Fitzmartin OriginalPaper 30 December 2001 Pages: 639 - 641
Biostatistics and Data Management in Global Drug Development Regina Esser OriginalPaper 30 December 2001 Pages: 643 - 653
Management of Clinical Data—Issues from a Research Perspective Don C. WalkerKatherine M. DuszynskiJohn E. Marley OriginalPaper 30 December 2001 Pages: 655 - 663
The Role of the Statistician in the Data Management Process Anneke C. GroblerSharon L. HarrisHanna-Liza Jooste OriginalPaper 30 December 2001 Pages: 665 - 670
A Survey of Industry Best Practice Metrics in Clinical Data Management and Biostatistics Ronald D. FitzmartinKim Nitahara OriginalPaper 30 December 2001 Pages: 671 - 679
Metrics and Best Practices in Clinical Data Management: Conclusions of a Dia Roundtable Workshop Ronald W. HelmsRon FitzmartinRosemary Murphy OriginalPaper 30 December 2001 Pages: 681 - 694
Organization of Clinical Research Services at Investigative Sites: Implications for Workload Measurement Clement GwedeStephanie DanielsDarlene Johnson OriginalPaper 30 December 2001 Pages: 695 - 705
The Role of Data Management in Health: A Case Study in Developing Countries L. K. Yamuah OriginalPaper 30 December 2001 Pages: 707 - 712
Transitioning Clinical Data Management from the 1980S to the 2010S: Strategies for Corporate Decision Making Ronald S. Waife OriginalPaper 30 December 2001 Pages: 713 - 719
Electronic Record Challenges for Clinical Systems Lisa Olson OriginalPaper 30 December 2001 Pages: 721 - 730
Integrated Web-Based Clinical Data Handling Solutions Richard J. Piazza OriginalPaper 30 December 2001 Pages: 731 - 735
Internet-Intellignt Clinical Data Management: Using The Internet For Clinical Data Capture Jim Scibetta OriginalPaper 30 December 2001 Pages: 737 - 744
Clinical Operations Online (Cool)—A World Wide Web-Based Approach to Running Clinical Trials: Results from Two International Multicenter Gastrointestinal Trials Elof DimenäsDaniel JohanssonMichael Wrangstadh OriginalPaper 30 December 2001 Pages: 745 - 753
Collecting Reliable and Valid Real-Time Patient Experience Data Michael R. HuffordTeri E. StokesJean A. Paty OriginalPaper 30 December 2001 Pages: 755 - 765
Process Intelligence: Using Internet Technology to Improve Effective Drug Trial Throughput Philip J. HoltJane Light OriginalPaper 30 December 2001 Pages: 767 - 779
Clinical Information Platforms: Infrastructure for Clinical Development Toby BloomGraham Bunn OriginalPaper 30 December 2001 Pages: 781 - 789
Practical Issues in and Applications of Clinical Data Mining David OlaleyeBarbara E. Tardiff OriginalPaper 30 December 2001 Pages: 791 - 808
Validation: Never an Endpoint: A Systems Development Life Cycle Approach to Good Clinical Practice Bucky WalshGreg A. Johnson OriginalPaper 30 December 2001 Pages: 809 - 817
A User’s Perspective on Data Systems Validation Steven SvindlandPaula Regan OriginalPaper 30 December 2001 Pages: 819 - 825
Data Quality Issues in Electronic Data Capture Ronald W. Helms OriginalPaper 30 December 2001 Pages: 827 - 837
Data Management And Quality Assurance Daniel Y. T. Fong OriginalPaper 30 December 2001 Pages: 839 - 844
Using Meddra for Adverse Events in Cancer Trials: Experience, Caveats, and Advice Lothar T. TremmelLynn Scarpone OriginalPaper 30 December 2001 Pages: 845 - 852
Clinical Data Interchange Standards Consortium (CDISC) Standards and Their Implementation in a Clinical Data Management System Frederick E. Wood JrMichael J. Fitzsimmons OriginalPaper 30 December 2001 Pages: 853 - 862
Guidelines on Dissolution Profile Comparison Gudrun Freitag OriginalPaper 30 December 2001 Pages: 865 - 874
The All Randomized/Full Analysis Set (ICH E9)—May Patients be Excluded from the Analysis? Stefan Lange OriginalPaper 30 December 2001 Pages: 881 - 891
Some Conceptual Issues in the Evaluation of Average, Population, and Individual Bioequivalence Volker W. Steinijans OriginalPaper 30 December 2001 Pages: 893 - 899
Introduction to Abstracts: Dia 2001 Euromeeting: Best Practices in the Management of Global Drug Development Rolf F. Tiggemann OriginalPaper 30 December 2001 Pages: 901 - 901
Euromeeting Abstracts: Best Practices in the Management of Global Drug Development OriginalPaper 30 December 2001 Pages: 903 - 919
Streamlining the Information Retrieval Process in the Drug Information Department Charles F. CurranMarlene M. Buxton OriginalPaper 30 December 2001 Pages: 921 - 933
Transition Challenges for Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries: Focus on Bulgaria Borislav N. BorissovMaria J. PopovaRozalina A. Koulaksazova OriginalPaper 30 December 2001 Pages: 935 - 939
Low-Cost Quality Assurance of Medicines Using the Gphf-Minilab® Richard W. O. JähnkeGabriele KüstersKlaus Fleischer OriginalPaper 30 December 2001 Pages: 941 - 945
Rank-Based Procedures for Linear Models: Applications to Pharmaceutical Science Data Asheber AbebeKimberly CriminThomas J. Vidmar OriginalPaper 30 December 2001 Pages: 947 - 971
The Marketplace for Dietary Supplements: Recent Studies Mary K. MuthClark NardinelliRobert H. Beach OriginalPaper 30 December 2001 Pages: 973 - 983
Core Concepts Suitable for Education and Training for the Biopharmaceutical Industry Gary Walsh OriginalPaper 30 December 2001 Pages: 985 - 991
Transmissible Spongiform Encephalopathy and Medicinal Products in the United States and Europe Sharon S. Rowland OriginalPaper 30 December 2001 Pages: 993 - 1001
Antibiotics—New Indications Inge ErikssonÖrjan MortimerMarje Reinans OriginalPaper 30 December 2001 Pages: 1003 - 1006
“Drug Safety: A Shared Responsibility.” Proceedings of the Dia Meeting Held in Gauteng, South Africa Karen BarnesGeney GunstonUshma Mehta OriginalPaper 30 December 2001 Pages: 1007 - 1011
A Comparative Study of Some Approaches for Estimating Tolerance Limits Max Petzold OriginalPaper 30 December 2001 Pages: 1013 - 1018
Why Are Some Meta-Analyses More Credible Than Others? Armin KochJoachim Röhmel OriginalPaper 30 December 2001 Pages: 1019 - 1030
Financial Concepts to Conducting and Managing Clinical Trials Within Budget Milan KovacevicOlalekan E. OdeleyeCarl R. Torchio OriginalPaper 30 December 2001 Pages: 1031 - 1038
The Planning Paradigm: The Marriage Between Clinical Operations and Project Management Denise R. Wills OriginalPaper 30 December 2001 Pages: 1039 - 1042
