Digitization of the
data collection process..
ECRF system in clinical and observational studies.
There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial, with the exception of the protocol, which specifies the conduct of that trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.
— Good Clinical Data Management Practices, Version 4, October 2005, Society for Clinical Data Management
Paper CRF versus lectronic CRF.
- Randomized study comparing data entry time into electronic CRF (eCRF) versus paper CRF (pCRF) - Fleischmann et al. 2017 - the use of tablets to enter data by nurses (clinical data) and patients (patient reported outcomes) shows a significant reduction in time compared to data collection on paper and its transcription
- Meta-analysis by Le Jeannic et al. 2014 - comparison of 16 studies conducted with pCRF and 11 eCRF - estimated costs of eCRFs are lower
- The obvious trend to carry data through electronic solutions
- Longer time to develop the eCRF, but greater control over the transfer of protocol assumptions to variables that can be analyzed
- Possibility of reusing the forms in further phases or other studies
- Application of open standards of data collection and storage - CDASH, SDTM, ADAM
- Risky trials (phase 1 and 2) with a small number of patients, especially conducted within one center - the prevalence of pCRFs
- The satisfaction of researchers and data managers with both types of tools is similar, but when choosing between pCRF and eCRF, most of them chose eCRF
- The perfect eCRF is one that can be completed next to the patient - this is the advantage of eCRFs filled in on tablets and phones
- Bigger research - better eCRFs.
Reasons for aversion to eCRFs.
- Easier data entry into eCRF
- Lack of appropriate software in the hands of researchers
- Disruption of the work rhythm (still based on paper documentation) with the need to enter data into the computer system
- High implementation and maintenance costs
- The doctor bears a burden of data entry
How does the digital transformation translate into the efficiency of
- Better supervision over the course of the study
- React quickly to potential problems
- Easier implementation of changes resulting from changes to the protocol and obtaining missing data by means of inquiries to researchers
- Automation and standardization of tasks related to Data Management
- Improving the explanations and comments of the eCRF to the questions arising from researchers
- Faster database preparation for analyzes (interim and final)
- Combining eCRF-related tools with documentation gathering and reporting tools (CTMS, eTMF)
Implement but also make the most of it. Which approach should I choose?
The full in-house team is the best strategic advisor to the sponsor.
Providing the eCRF system environment without technical assistance - configuration of the study on the Sponsor's IT side
ECRF system configured for a specific study based on a finished CRF provided by the Sponsor or CRO, external data management
ECRF system with human resources with experience in designing eCRFs - comprehensive system configuration based on the test protocol and full data management in one place
3 in 1 The next step in w digitization.
Advanced technologies in combination with intelligent and well-chosen teams are very successful and always bring fantastic results.
The perfect trio
The future is for these systems to be fully integrated, bringing all these software together into a single, easy-to-use platform that maximizes productivity while minimizing risk.
- Single sign-on will provide access to the role-based user interface for all platform components
- Eliminate redundant tasks, reduce errors, and simplify training by centrally managing system security
- Visibility of key performance indicators to proactively identify issues at an early stage
- Assessment of the researcher's performance using objective and subjective data from the CTMS and EDC modules
Functions of electronic data capture (EDC) system.