eCRF for Academic Oncology Clinical Trials

eCRF for Academic Oncology Clinical Trials

eCRF for Academic Oncology Clinical Trials

If you need an eCRF system for an academic clinical trial, please contact us at info@klindat.com  

In the field of academic oncology trials, the collection, processing, and assessment of data play a fundamental role in advancing research and improving patient outcomes.

Electronic Case Report Forms (eCRFs) have emerged as a vital tool in this process, providing academic institutions and investigators with the technological infrastructure needed to effectively manage clinical trial data.

In this article, we will explore the various aspects of eCRF implementation in academic oncology trials, including eCRF specification, implementation, testing and validation, training, technical support, data cleaning, export, and analysis.

eCRF Specification

One of the initial steps in implementing an eCRF for academic oncology trials is the specification of the electronic data forms and fields.

This process involves defining the data elements that will be used to collect the necessary information for the study.

These requirements are documented in an annotated CRF, which serves as a comprehensive specification document outlining all the forms, questionnaires, and variables required for the trial.

In the context of cancer studies, eCRF specifications encompass a wide range of data forms, including initial diagnosis, previous cancer therapies, tumor progressions or relapses, treatment information, adverse events, concomitant medications, tumor assessments, and disease progression, among others.

Additionally, quality of life questionnaires, survival follow-up, and subsequent cancer therapies are integral components of the eCRF specification for academic oncology trials.

eCRF Implementation

Once the eCRF specification is finalized, the implementation phase begins.

This step involves building the actual eCRF system, which includes creating the necessary data forms and fields using specialized software tools.

The implementation of an eCRF requires a certain level of technical expertise, typically handled by experienced data managers.

The implementation process is not limited to setting up data collection forms and screens but also involves configuring workflows and data discrepancy detection mechanisms.

These mechanisms include automatic queries and hard edit checks, which help ensure data accuracy and integrity throughout the trial.

eCRF Testing and Validation

Following the implementation of the eCRF, rigorous testing and validation are essential to ensure its functionality and compliance with the specified requirements.

User acceptance testing (UAT) is conducted to verify that the eCRF system aligns with the agreed-upon specifications.

This validation step is essential in certifying the reliability and effectiveness of the eCRF software before it is used to enter patient data.

eCRF Training

To ensure the successful adoption and utilization of the eCRF system, comprehensive training is provided to the clinical site personnel involved in the academic oncology trial.

This includes principal investigators, clinical research coordinators, and data entry staff.

eCRF system vendors and clinical research organizations (CROs), who act as partners to academic institutions and investigators, offer online tutorials and remote training sessions via teleconference to ensure the proper use of the eCRF tool.

eCRF Technical Support

Throughout the duration of the academic oncology trial, the eCRF provider or CRO staff provides ongoing technical support.

This support includes addressing user inquiries, resolving technical issues, and ensuring the smooth operation of the eCRF system.

The eCRF vendor’s personnel also take responsibility for software updates and maintenance of the data servers, ensuring the integrity and security of the collected data.

eCRF Data Cleaning

As clinical data is entered into the eCRF system, data cleaning becomes a critical task.

Data entry errors and inconsistencies are common, necessitating a thorough review and cleaning process.

Data cleaning aims to ensure the quality and consistency of the data for subsequent analysis.

Experienced data managers —belonging to CROs— possess the necessary expertise to conduct comprehensive reviews of cancer patient data.

Their meticulous approaches ensure that the final datasets are robust, error-free, and ready for analysis.

eCRF Data Export

Once the eCRF data has been cleaned and validated, it can be exported into datasets suitable for analysis.

Most eCRF systems facilitate the extraction and export of data in various formats, such as Excel or CSV files.

These datasets are then shared with statisticians, statistical programmers, and clinical investigators responsible for generating the final results and publications.

eCRF Data Analysis

Statistical expertise is required to perform in-depth data analysis for academic oncology trials.

Specialized CROs can provide experienced statistical programmers, particularly those with expertise in oncology, to assist in the creation of comprehensive reports.

These reports typically include tables, figures, and listings (TFL) that serve as the basis for abstracts, posters, manuscripts, and the Clinical Study Report (CSR).

Conclusion

The utilization of electronic case report forms (eCRFs) has revolutionized the management of data in academic oncology trials.

By partnering with academic institutions and investigators, eCRF system providers and CROs offer a comprehensive suite of services for eCRF specification, implementation, testing and validation, training, technical support, data cleaning, export, and analysis.

These services contribute to the seamless conduct of academic oncology trials, ultimately enhancing the understanding and treatment of cancer.

If you need an eCRF system for an academic clinical trial, please contact us at info@klindat.com  

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