eCRFs: Ensuring quality for your clinical trial results
27-10-2023
What does the eCRF include?
As the clinical data are introduced on the eCRF web platform, the information is refined, detecting and resolving discrepancies. This is known as "data cleaning." This task is generally performed by the research sponsor's data managers, usually staff from a contract research organization (CRO) that regularly review the information in the eCRF and issue requests and queries to the respective participating site to correct any data discrepancies or complete missing data. This process continues until the data are complete and no discrepancies are detected.
Once the clinical data have been cleaned, the information is exported for subsequent analysis. eCRF applications usually include data export mechanisms that generate files that can be used in statistical software tools, such as SAS or SPSS.
Some eCRFs include advanced features, such as automatic query mechanisms, automatic medical term codification, customized report preparation, or robust data cleaning modules. All eCRFs must have the necessary mechanisms to ensure the safety and traceability of the data, which can be used to trace each user's access date and time, identity, IP address, and type of access and activity performed on the eCRF pages.
- Customized forms to collect all the information needed to evaluate your results.
- Validation system to detect incorrect data, ensure authenticity and manage traceability.
- Information security by using security measures that, among other things, guarantee data confidentiality, integrity, and availability. This system must ensure compliance with all legal, regulatory, and information security best practice requirements (FDA 21 CRF Part 11, EMA Annex 11, ICH, GDPR, ISO/IEC 27001, etc.), considering the risks it may entail.
- Export of data on formats compatible with statistical analysis software.
- Reports showing significant data on the development of the study, such as the number of patients enrolled, withdrawals, etc.
- Notices or warnings when a significant event occurs, for instance, an adverse event involving a patient.
As the clinical data are introduced on the eCRF web platform, the information is refined, detecting and resolving discrepancies. This is known as "data cleaning." This task is generally performed by the research sponsor's data managers, usually staff from a contract research organization (CRO) that regularly review the information in the eCRF and issue requests and queries to the respective participating site to correct any data discrepancies or complete missing data. This process continues until the data are complete and no discrepancies are detected.
Once the clinical data have been cleaned, the information is exported for subsequent analysis. eCRF applications usually include data export mechanisms that generate files that can be used in statistical software tools, such as SAS or SPSS.
Some eCRFs include advanced features, such as automatic query mechanisms, automatic medical term codification, customized report preparation, or robust data cleaning modules. All eCRFs must have the necessary mechanisms to ensure the safety and traceability of the data, which can be used to trace each user's access date and time, identity, IP address, and type of access and activity performed on the eCRF pages.
