CPMP Working party on efficacy of medicinal products, note for guidance. Good Clinical Practice for Trials on medicinal products in the European Community. Commission of the European Communities, July 1990;111/3976/88-EN Final.
2.
SprietADupin-SprietT.Circuit et traitement des données. In: Bonne Pratique des Essais Cliniques des Medicaments. Basel: Karger, 1990;94–114.
3.
BlomerR.Practical relevance of relational database properties for clinical database management. Drug Inf J.1989;23: 65–70.
4.
PalmerKR, Database development of a clinical trial. Drug Inf J.1985;19: 43–47.
5.
TealTWMcLaughlinSL. Data management. Drug Inf J.1982;16: 65–69.
6.
GellerNLPocockSJ. Interim analyses in randomized clinical trials: Ramifications and guidelines for practioners. Biometrics.1987;43: 213–223.
7.
JohnsonMF. Issues in planning interim analyses. Drug Inf J.1990;24: 361–370.
8.
MitchardM.Remote data entry. Pharmaceutical Med.1987;2: 175–176.
9.
ArnoldJDHaydenDM. Role of contract research organization. In: MatorenGM, ed. The Clinical Research Process in the Pharmaceutical Industry. New York: Marcel Dekker; 1984.