eCRF design.

Methods of the monitoring efficacy.

eCRF system in clinical trials and non-interventional studies.
eCRF design
An interdisciplinary team
involved in eCRF development.
Schedule of Assessment, Visit's overview - good starting point for eCRF development.
Communication between protocol author, statistician and data manager is crucial part of the process. The primary goal is to establish of relations between procedure described in schedule of assessment and variables which will be collected and analyzed.
Investigators should be always in the center of attention.

The goal of each study is to collect data that will confirm the hypotheses in the final analysis. The success of the study depends in the largest part in Investigators. The process of data collection is extremely complex and it is easy to make mistakes during data entry. The smaller part of work on the Investigators spent learning the EDC system, the greater involvement. The less physician's involvement, the worse quality of study realization and collected data. Therefore the main goal in eCRF development should be to minimize work necessary to enter clean and usable data.

Encourage and not discourage Investigators to systematically complete eCRFs.
The eCRF system should be friendly for them.
Minimalizacja nakładu pracy po stronie badacza
How to minimize
Investigator's workload?
eCRF powinien prowadzić badawcza za rękę
eCRF should lead the Investigator
"by the hand".
  • Often Investigators will get acquainted with the protocols and the investigator's brochure once - the CRF acts as a "reminder"
  • The CRF should reflect the order of the planned procedures and make it easier to follow order of procedures in accordance with the protocol – thus avoiding the protocol deviations
  • Some of the questions in the CRF are placed to check the completeness and correctness of the data entered:
    • Are all inclusion / exclusion criteria met?
    • Was the test performed?
    • Has patient experienced any adverse events since previous visit?
Effective methods of study progress monitoring.

As much as 20 to even 40% of the cost of implementation of the clinical trial is related to conduct and monitoring - employing monitoring specialists who verify the sites and supervise them. Over 80% clinical trials are significantly delayed - this is due to the fact that Physicians do not complete the documentation on time, so the Sponsor sends Monitors to the sites to support the process.
(source: https://innpoland.pl/117163,rewolucja-na-rynku-testowania-lekow-polska-firma-chce-obnizyc-koszt-monitorowania-badan-o-40-zaoszczedzimy-miliony)

  • Automatically generated reports tracking recruitment, completeness of visits, etc.
  • Monitoring of the query status
  • Real-time security monitoring - tracking of potential Panic Values
  • Notification system - adverse events, randomization, blanking, drug status in the site, cohort open-up, cohort close-out
  • 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 the data entry is long, the reports may not reflect the actual recruitment.
How to optimize monitoring cost and reduce
time in site?
Optymalizacja kosztów monitorowania
  • Notifications sent to Investigators from the eCRF system.
  • Notifications sent to Monitors.
  • As many reports / listings as possible to be generated from the system, which will speed up the verification process, but also reporting on completed activities.
Implementation of the Electronic Health Record (EHR)
- clinical trial future
Scientific study indicates that despite of the initial increased workload, EHR leads to an increase in the completeness and readability of medical records and a cost reduction.
  • EHR make patient's pre-screening easier
  • Transfer of data collected by EHR to eCRF systems and remote data monitoring
EHR vs eCRF - the ability to automatically retrieve data based on predefined parameters based on the electronic patient card (API / HL7 protocols).
source: Holroyd-Leduc 2011, Cowie2017
Electronic health records
How to effectively make a (r)evolution in eCRF
on the study realization stage.
During the trial, it may be necessary to modify the protocol, collect additional data, change the method of collecting additional data. When choosing an EDC system, keep in mind:
Is change
possible?
How can it be performed
efficiently?
Will it cause interference in
data collection?
BioStat®
suggestions in eCRF design process.
  • Implementation of the Clinical Data Acquisition Standards Harmonization (CDASH) standard
  • Standardization of eCRF systems and a system enabling rapid prototyping of forms that reduces costs
  • A comprehensive reporting system based on statistical language R
  • A hint system (as you type suggestions)
  • Dynamically generated messages, reminders
  • Coding of adverse events
  • Flexibility of 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 package - will introduce to the natural use and code validation between a database creation, verification by DM and creation of skeleton tables (shelves) by the statistician
Data Digital Transformation
Functions of electronic data capture (EDC) system.
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