Methods of the monitoring efficacy.
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.
The eCRF system should be friendly for them.
- Make use of electronic systems capabilities - alerts, reminders, explanations
- Short explanations and warnings regarding the protocol deviations
- Warnings pertaining to data indicating the occurrence of adverse events
- Use of control questions
- Minimization of the number of variables at the planning stage of the study
- Integration with a central or local laboratories
- Use of auto-fill systems (suggestions) - Naziyok et al. 2017 - demonstration of significant acceleration and reduction of errors in the case of drug data completion. This system can also be used in case of adverse events (MedDRA dictionary)
- Avoidance of double entry - import of data previously entered into the eCRF
- 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?
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.
- 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
- 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.
- EHR make patient's pre-screening easier
- Transfer of data collected by EHR to eCRF systems and remote data monitoring
- 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