European Statement:
- Education and Research
What was done?:
Evaluation of the use of an Integrated Research Management System based on a retrospective analysis of all clinical trials introduced into the software since 2020.
Why was it done?:
How was it done?:
The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)
What has been achieved?:
With the introduction of an integrated management system as a registration platform of investigational product receipt, dispensing and return, were introduced into the software 204 clinical trials.
Since its implementation in 2020, the integrated system has been authorised by the sponsor as a registration platform in 55 clinical trials, corresponding to 79% of clinical trials initiated since that date.
The clinical trials Unit grants remote access to the clinical trials information to CRAs through the filling out of a declaration. Since the adoption of this system, remote access to the platform has been granted to 35 CRAs.
According to the survey distributed between July and August:
-85.7% of CRAs use the system in their monitoring work.
-The use of System has been exclusively approved to replace paper records in 88.9% of active clinical trials (with the exception of receipt confirmation via IWRS - Interactive Web Response System).
-All the CRAs who answered the questionnaire consider remote access to clinical trial data to be an advantage.
- 77.8% believe that by using the platform the time spent on presential visits has been reduced.
What next?:
Keywords:
- Education and research›Research
- Management›Project management
- Quality›Process improvement
