The electronic case report format (eCRF), which is very well-liked, performed a pioneering role in the digitalization and introduction of continually new technology into clinical research.
The benefits of the eCRF in clinical and non-interventional studies include the constant availability of your data, the quick transfer of data also from external devices, automated alerting processes, predefined plausibility checks, and the ability to use the EDC system as an information sharing platform.
We’d like to provide you with a brief summary of how an eCRF develops over the course of a study right now.
1. The data management plan
A data management strategy is prepared at the outset of any data management engagement in the study to specify the scope, standard operating procedures (SOPs), the appropriate templates, and the roles for data management procedures inside a study.
2. The structure and data validation plan
The final study protocol serves as the basis for creating an eCRF. The structure of the eCRF, including the names and qualities of all CRF items and accompanying database tables, can be defined once the purpose of the study and its contents are known.
To that end, a structure plan is developed and reviewed by all stakeholders concerned before the setup and validation of the eCRF structure within the EDC system’s development environment.
The standards for both online and offline plausibility checks are established once the eCRF’s structure has been decided upon. Furthermore, requirements for email alerts are listed (such as warnings for adverse events or if a patient is screened or randomly assigned). As a result, the data validation plan is added to the finalised structure plan.
The deployment and validation of the online edit checks and e-mail alerts can be carried out within the development environment of the EDC system after the data validation plan has been reviewed and approved by all parties involved.
3. Reports
Study-specific status updates are developed and validated on demand to help with ongoing study and patient care (e.g. patient status by country, query report, adverse event listing).
4. Workflow definition
The project-specific EDC roles, their unique rights, and workflows must be defined in addition to the structure and check criteria within the EDC system (e.g., who is permitted to enter/read/modify data, raise/respond to queries, and sign the eCRF).
The workflow definition document is produced for that purpose, and after it has been reviewed and approved by all parties concerned, it is implemented and validated within the EDC system’s development environment.
5. User acceptance testing
Before going live, test users who are, ideally, unfamiliar with the relevant eCRF test the EDC system’s functioning and usability. The user acceptance test is a comprehensive evaluation to see if the eCRF achieves its goals. As a result, all system parts that are relevant to practise are tested (e.g. data entry, monitoring, query process).
Each tester must record their observations and findings in the user acceptance test report. The user acceptability test report examines these conclusions and details the anticipated fixes. The EDC system then incorporates the fixes and modifications and, if necessary, validates them.
6. Release of the EDC system / Go-Live
The EDC system is moved from the development environment to the productive environment as a final step prior to Go-Live once it has been authorised by all parties concerned.
7. User and access management
All EDC system users must receive training on how to utilise the system in their respective roles in order to have access to the productive environment of the EDC system. The data management plan outlines the training requirements.
In accordance with the various user roles already in place, user guides are typically also developed within the project-specific EDC system (e.g. investigator, monitor). The manuals are distributed to EDC system users following assessment and approval by all parties concerned. Users may also be given an introduction to them on the system’s welcome page for download.
8. External electronic data – if applicable
Data from an electronic patient-reported outcome (ePRO) or data from an external laboratory must occasionally be included into the eCRF.
If study data are imported and exported electronically from external data providers, project-specific information is provided in the data management plan.
The content, organisation, and frequency of the external electronic research data transfers are described in the data transfer specifications (DTS).
Before the first anticipated data transfer takes place, the DTS are developed in cooperation with the external data supplier. Before the first scheduled data transfer, a test data transfer should be conducted to ensure that the DTS is being followed and that it is technically feasible.
Either directly through the EDC system, or by integrating the exported database, external data must be incorporated into the research database. If external data needs to be directly loaded into the EDC system, an interface needs to be programmed and tested within the EDC system’s development environment.