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 electronic 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.
Digital dilemma.
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 research teams?
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.
Approach 1
Providing the eCRF system environment without technical assistance - configuration of the study
on the Sponsor's IT side
Approach 2
ECRF system configured for a specific study based on a finished CRF provided by the Sponsor
or CRO, external data management
Approach 3
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
Frequently asked questions.
Is there a possibility to minimize the researcher's workload?
Certainly! It's beneficial to relieve oneself from work as much as possible by:
Utilizing the capabilities of electronic systems – alerts, reminders, clarifications,
Creating concise explanations and warnings related to deviations from the protocol,
Using control questions,
Minimizing the number of variables at the research planning stage,
Integration with a central laboratory or local laboratories,
Avoiding the need for double data entry – importing previously entered data into the eCRF.
What standards and norms can be distinguished that Biostat uses for eCRF?
Implementation of the Clinical Data Acquisition Standards Harmonization (CDASH) standard,
Standardization of eCRFs,
An extensive report generation system based on the R statistical language,
As-you-type suggestions system,
Dynamically generated messages,
Coding of adverse events,
Close cooperation between DM and Statistician,
Automating data management tasks using R.
What is the preparation time for the eCRF.biz™ system for a clinical trial?
The waiting time to set up the eCRF.biz™ system configured for a specific clinical trial is always tailored to the client's expectations, but the average time is about 1.5-2 months.
