All data management activities are performed by computing specialists, using standardized or customized software. The most common software used for data management remains the SAS system (version 8.x for PCs, 9.x for Windows Server) and its related modules (SAS Base, FSP, STAT, GRAPH Macros and SQL language). The data management group is also familiar with the use of ORACLE 8i, 9i, 10g and superior versions, and related modules together with specific administration software and request language (PL-SQL). Oracle Database may be deployed easily with the use of Projection™ software, a dedicated interface developed by ASCOPHARM. Also specific language may be used for web-based database development, including, Dot.Net technologies, pHp meta-language and mySQL Database.
Most of the tools which are used in Data Management at ASCOPHARM, have been validated for the use in Clinical Trials. ASCOPHARM has also developed in-house standard operating procedures to fulfil ICH and GCP recommendations. These SOPs may be provided on request.
Typical Data Management process includes :
- Construction of Data base (Oracle 10g),
- Construction of data-entry screens (Projection™, Oracle DB administrator)
- Manual or semi-automatic coding of variables by a qualified coding expert,
- Dual independent data-entry by experienced personnel,
- Adherence, coherence and validation testing, and request management,
- Automatic data extraction as SAS DATASETS creation (SAS 9.1 server)
- Manual or semi-automatic coding of variables by qualifies coding expert (MedDRA, WHO DRUG)
- End-of-study database blind reviews and audits.
Security of data is assured by a range of measures, including limited data access to personnel with defined codes and passwords, regular data saves (on both CD ROM, streamers and distant mirroring) and regular data print-outs.
ASCOPHARM's data management personnel and biostatisticians typically produce a range of documents for quality purpose and/or for the use of final reporting, including:
- Data management books,
- Case report forms,
- Data management reports,
- Study tables and patient data listings.