An electronic case report form (eCRF) serves as a fundamental tool in the collection of data for clinical studies and research participants. It functions as a digital questionnaire that captures essential information crucial for biostatisticians to analyze and draw meaningful conclusions from a study. The data collected within eCRFs plays a pivotal role in evaluating whether the endpoints of clinical trials have been successfully achieved.
eCRFs come in various types, with the most common being a digital or web-based questionnaire designed to gather data about each study participant. The pathway through which data enters an eCRF can differ, and several methods are commonly employed:
- Manual Data Entry: Clinical research coordinators are responsible for manually inputting data into the eCRF. They meticulously enter the relevant information obtained from study participants or other sources.
- Direct Participant Input: In some instances, study participants themselves may directly input their data into the eCRF. This approach promotes a more active involvement of participants in the research process.
- Bulk Upload: Data can also be uploaded in bulk, wherein a large set of information is transferred into the eCRF simultaneously. This method is particularly useful when dealing with a substantial volume of data.
- Integration with External Data Sources: Another approach involves integrating the eCRF with external data sources. This can be achieved by establishing connections via application programming interfaces (APIs) or linking with databases such as imaging databases. Through this integration, data can be seamlessly transferred and updated in real-time, enhancing efficiency and accuracy.
The utilization of eCRFs not only streamlines the data collection process but also facilitates data management and analysis. By embracing digital platforms, researchers can harness the benefits of automation, real-time updates, and enhanced data accuracy. This promotes greater efficiency and reliability in clinical studies and contributes to the overall advancement of medical research.
eCRF Validation: General Considerations
The validation of electronic case report forms (eCRFs) holds paramount importance in ensuring the proper collection of clinical data with a high level of confidence in terms of security and confidentiality. To fully comprehend the significance of computer system validation, one can refer to the EMA Notice to Sponsor published in 2020, specifically addressing software validation. This document provides valuable insights into the validation process and emphasizes the responsibilities of sponsors.
According to the EMA Notice, the sponsor bears the ultimate responsibility for validating the computerized system and must furnish sufficient documented evidence of the validation process. It is crucial for sponsors to be capable of granting GCP inspectors from EU/EEA authorities access to the requested documentation pertaining to the qualification and validation of computerized systems, regardless of whether these activities were performed internally or by external parties.
Additionally, the document highlights the following important statement:
“It is not acceptable to use computerized systems in clinical trials for which the validation status is not confirmed or for which appropriate documentation on system validation cannot be made available to GCP inspectors.”
This assertion underscores the necessity of confirming the validation status and ensuring the availability of comprehensive documentation on system validation when utilizing computerized systems in clinical trials. Compliance with these requirements is crucial to maintain the integrity and reliability of clinical data, safeguard patient safety, and meet regulatory standards.
By adhering to stringent validation processes and providing thorough documentation, sponsors can demonstrate their commitment to upholding the highest standards of data integrity, security, and confidentiality. This proactive approach helps instill trust in the use of eCRFs and contributes to the overall success and credibility of clinical trials.
In fact, as we have already been discussing, software validation is one of the key activities related to Good Clinical Practice and many different standards are regulation may apply, such as GAMP-5 and 21 CFR Part 11: both these standards and regulations are essential for an efficient validation of eCRF. Other regulations may apply, for example GDPR and related considerations.
GAMP-5 is in fact a very powerful guideline and methodology used to perform computer system validation, especially for application in the life science sector, such clinical trials / clinical operations.
eCRF Validation Documentation
Validation is a crucial procedure that involves testing and verifying all system functions to ensure the correct configuration and fulfillment of requirements for electronic case report forms (eCRFs) and Electronic Data Capture (EDC) systems.
Validation, in essence, serves as the culmination of evidence that confirms the system’s ability to perform its intended functions and maintain its performance over time.
The development of an eCRF commences with the finalization of the study protocol. Once the specific objectives of the study have been determined, the structure of the eCRF is defined. This involves specifying the names and characteristics of all case report form (CRF) items and their corresponding database tables.
To facilitate this process, a comprehensive structure plan is created, which undergoes thorough review and approval by all involved parties. This ensures that the eCRF structure is properly set up and validated within the development environment of the EDC system.
After finalizing the eCRF structure, criteria for online and offline plausibility checks are established. The data validation plan is reviewed and approved, enabling the implementation and validation of online edit checks and email alerts within the development environment of the Electronic Data Capture system.
In order to conduct validation activities effectively for the eCRF, the following documentation should be prepared:
- Data Validation Plan: This document outlines the approach, strategies, and procedures for validating the data collected through the eCRF. It provides guidance on performing various data validation tasks, including edit checks, consistency checks, and verification of data quality.
- CRF/eCRF Matching Report: This report ensures that the CRF items and their corresponding fields in the eCRF are accurately aligned. It verifies that the data captured in the eCRF corresponds to the intended information from the CRF.
- Test Case Report: This report documents the testing scenarios and results of various test cases conducted during the validation process. It provides an overview of the tests performed, any issues encountered, and their resolutions.
By diligently preparing and adhering to these essential documentation requirements, organizations can ensure a robust and comprehensive validation process for their eCRFs. This meticulous approach guarantees that the eCRF is configured correctly, meets all necessary requirements, and enhances the overall integrity and reliability of data captured in clinical studies and research.
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