Effective monitoring methods
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.
The eCRF system should be researcher-friendly.
- 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
- 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?
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
- 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 simplifies pre-screening of patients
- Systems are being developed to enable the transfer of data collected by EHR to eCRFs and remote data monitoring
- 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