Designing eCRF.

Effective monitoring methods

ECRF system in clinical and observational studies.
Projektowanie eCRF
Interdisciplinary team
involved in the development of the eCRF.
Schedule of Assessment (visit's overview) - an initial template when starting working on the eCRF.
The most important thing is communication: protocol author - data manager - statistician - clarifying the relationship between the procedures described in the schedule and the variables that will be collected and analyzed.
The doctor should always be in the center of the action. .

The aim of each study is to collect data that will confirm the hypotheses in the final analysis. The success of the research depends largely on the researcher. The data collection process is extremely complex and it is easy to make mistakes while entering data. The less work on the investigators' side, the greater the chance of engagement. The lower the involvement of the doctor, the worse the quality of the research and data, therefore the overriding goal in the development of eCRF should be improvements for researchers - minimizing their work.

Researchers should be encouraged rather than discouraged from systematically completing the eCRF.
The eCRF system should be researcher-friendly.
Minimalizacja nakładu pracy po stronie badacza
How to minimize the
workload of the researcher?
eCRF powinien prowadzić badawcza za rękę
The eCRF should lead
the researcher by the hand..
  • Often, researchers read the protocol and the investigator's brochure once - CRF acts as a "reminder"
  • CRF should reflect the sequence of planned procedures and facilitate protocol compliance - avoiding protocol deviations
  • Some questions in the CRF are placed in order to check the completeness and correctness of the entered data:
    • Are all inclusion / exclusion criteria met?
    • Has the study been conducted?
    • Has the patient experienced any adverse events since the previous visit?
Effective methods of monitoring the study progress.

From 20 to 40 percent of the amount of the implementation of a clinical trial is the cost of conducting and monitoring - employing monitoring specialists who verify the centers and supervise them. Over 80 percent clinical trials are significantly delayed - this is due to the fact that doctors do not complete the documentation for the trial sponsor on time, so the sponsor sends monitors to the centers to support the process.

  • Built-in reports to track recruitment, the level of completion of visits
  • Monitoring the status of inquiries
  • Real-time Security Monitoring - Tracking Potential Panic Values
  • Notification system - adverse events, randomization, blinding, drug status in the center
  • SDV verification progress
Skuteczne metody monitorowania postępów badania
Potential difficulty
eCRFs are usually completed after the patient's visit, so if the period between the visit and data entry is long, the reports may not reflect the actual recruitment.
How to optimize monitoring costs and reduce
the time spent in the center?
Optymalizacja kosztów monitorowania
  • Notifications sent to researchers from the eCRF system.
  • Notifications sent to Monitors.
  • As many reports / listings as possible that can be generated from the system, which will speed up the verification process, but also reporting after completed activities.
EHR (electronic health records) - scientific research shows that despite the initial greater workload, EHR leads to an increase in the completeness and readability of medical records and a reduction in costs.
  • EHR simplifies pre-screening of patients
  • Systems are being developed to enable the transfer of data collected by EHR to eCRFs and remote data monitoring
Programs for EHR vs eCRF - the ability to automatically download data based on previously defined parameters based on the electronic patient observation card (API / HL7 protocols).
source: Holroyd-Leduc 2011, Cowie 2017
Electronic health records
How to effectively carry out an (r)evolution in eCRF
at the stage of research implementation?
During the study, it may turn out that it is necessary to modify the protocol, collect additional data, and change the method of collecting additional data. When choosing an EDC system, you should consider:
Is change possible?
How can it be carried out efficiently?
Will it disrupt data collection?
BioStat®’s standards.
  • Implementation of the Clinical Data Acquisition Standards Harmonization (CDASH)
  • Standardization of eCRFs and a system enabling rapid prototyping of forms that reduces costs - to the level where, even with small funds at the disposal of academic centers, we propose solutions that are competitive with pCRF
  • An extensive system of generating reports based on the statistical programming language R.
  • Hint system (as you type suggestions)
  • Dynamically generated messages and reminders
  • Coding of adverse events
  • Flexibility in introducing new solutions - external AE forms, cohort management
  • Close cooperation between Data Manager and Statistician
  • Automation of data management tasks with the use of R language - will introduce to the natural use and validation of the code between the creation of the database, verification by the Data Manager and the creation of table wireframes (shells) by the statistician
Data Digital Transformation
Functions of electronic data capture (EDC) system.
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