eCRF design

Effective monitoring methods

ECRF system in clinical and observational studies.

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.

design phases

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?

Using the possibilities of electronic systems - alerts, reminders, explanations
Brief explanations and cautions regarding protocol deviations
Warnings related to data that indicate the occurrence of adverse events
Use of control questions
Minimizing the number of variables at the planning stage of the study
Integration with a central laboratory or local laboratories
Application of auto-fill (suggestion) systems - Naziyok et al. 2017 demonstration of significant acceleration and reduction of errors in the case of completing drug data. This system can also be used in the event of adverse events (MedDRA dictionary)
Avoidance of double data entry - import of data previously entered into eCRF

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?

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.

- THE FUTURE OF CLINICAL RESEARCH

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

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.