Infosüsteemid kliiniliste uuringute monitoorimise toetajatena
Abstract
Magistritöös uuritakse monitoride rahulolu kliinilistes uuringutes kasutatavate infosüsteemidega ja nende infosüsteemide vastavust monitoride töö spetsiifikale. Antakse lühiülevaade kliiniliste uuringute valdkonnast, kirjeldades ravimiarenduse etappe, seotud osapooli, kliiniliste uuringute monitori rolli uuringute läbiviimisel ja monitoorimistegevusi. Samuti tutvustatakse enamlevinud infosüsteeme, mida kliinilistes uuringutes kasutatakse. Küsitluse abil selgitatakse välja, milliseid infosüsteeme ja kui sageli monitorid kasutavad ning monitoride rahulolu nende infosüsteemidega. Küsitluse tulemusi vaadeldakse kliiniliste uuringute infosüsteemide hetkeolukorra ja tulevikutrendide kontekstis ning antakse soovitused, milliseid muudatusi tasuks teha, et infosüsteemid toetaksid monitoride tööd rohkem.
The Master's thesis examines Clinical Research Associates (CRAs) satisfaction with the information systems used in clinical trials, and how well these systems comply with specific needs of CRAs. A brief overview of the clinical research is given by describing drug development stages, related parties, role of a CRA in clinical trials and monitoring activities. Also an overview is given of the information systems most commonly used in clinical trials. Types of information systems the CRAs use, frequency of the use and level of satisfaction with these information systems are identified by the means of a survey. Results of the survey are discussed in the context of the current situation and future trends of clinical trial information systems, and recommendations are given on what changes should be implemented in order the information systems would provide more support to CRAs.
The Master's thesis examines Clinical Research Associates (CRAs) satisfaction with the information systems used in clinical trials, and how well these systems comply with specific needs of CRAs. A brief overview of the clinical research is given by describing drug development stages, related parties, role of a CRA in clinical trials and monitoring activities. Also an overview is given of the information systems most commonly used in clinical trials. Types of information systems the CRAs use, frequency of the use and level of satisfaction with these information systems are identified by the means of a survey. Results of the survey are discussed in the context of the current situation and future trends of clinical trial information systems, and recommendations are given on what changes should be implemented in order the information systems would provide more support to CRAs.