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Form libraries and their significance
Creating electronic case report forms (eCRFs) from scratch consumes a lot of time and involves multiple steps, including the collection of programming elements such as code lists, variables, and ensuring compliance with Clinical Data Interchange Standards Consortium (CDISC) data standards.
This eventually leads to a long gestation period for the development and rollout of drugs. On the other hand, data standards and repositories are a collection of eCRFs grouped as per therapeutic areas along with the afore mentioned programming elements. As a result, organizations have begun making use of form libraries in clinical data management. Form libraries serve as repositories of institutional knowledge that benefit future research. Researchers and organizations are leveraging it to expedite the entire life cycle of data collection, identification of discrepancies and its resolution, and the submission of clean, validated, and verified clinical data to the regulatory authorities.
The impact of data standards on stakeholder functioning
The use of form libraries, however, is not limited only to the data management function but also extends to clinical operations, biostatistics, and project management teams.
Data standards that comply with CDISC requirements are periodically updated and guarantee the capture of correct and relevant data in considerably lesser time.
The use of global standards allows for traceability enabling tracing of all data from medical sources through its ultimate interpretation and submission. Transparency of generated data allows regulatory bodies to analyze them during submissions, thereby minimizing time across the entire medication life cycle.
Proven benefits of data standards in the clinical trial life cycle
CDISC data standards are based on clinical needs, provided by clinical monitoring teams present at the clinical sites, and biostatisticians who examine and interpret data insights prior to regulatory submissions.
As a result of these data standards, the creation of forms with lengthier code lists requires a lesser turnaround time. In addition, data mapping becomes an effortless task with the usage of standard mapping that has been created basis data standards present in the global libraries.
Data standards within a form library facilitate uniform data collection throughout the research and protocol mandated visits. This makes it straightforward and less cumbersome in nature for statisticians and medical monitors to gain insights and discover patterns. It also enables them to decide the outcome of an interim analysis in a seamless manner. Hence, research time is reduced and studies with complicated code lists can be maintained properly. It can be concluded that clinical data standards improve the scheduling and implementation of interim analyses of the safety and effectiveness of the Investigational Product (IP) being investigated.
Existing form libraries have the potential to be rebuilt and upgraded by leveraging next-gen technologies such as artificial intelligence (AI) and Machine Learning (ML). Form libraries that have been validated and are in conformity with CDISC standards do not require quality check testing and can be used directly in research. Contemporary Electronic Data Capture (EDC) databases have form libraries integrated within them for ease of form creation, modification, and replication in multiple studies across a therapeutic area.
Few challenges faced by form library stakeholders
The bigger issues that form library administrators face include:
Providing access to a large user database as well as its maintenance and control.
Form indexing inside the library for allowing users with quick access to the eCRFs, thereby making eCRF selection and deployment within the research an extremely simple procedure.
Governance of forms within the library to necessitate continuous monitoring for compliance with regulatory submission requirements. This is crucial since it enables a significant reduction of study build time and provides ample time for investigators to work on the efficiency of a drug molecule and market the same in the post-marketing surveillance phase.
These issues, however, can be solved with the assistance of CDISC standards that lay the foundation for Contract Research Organizations (CROs) and clinical data management service providers to readily transform raw data using standard dataset templates and standards during the final data interpretation and data release milestone.
To summarise, global libraries or data collecting standards, as they are sometimes referred to, are increasingly being mandated within pharmaceutical organizations.
They serve a crucial purpose in providing high-quality data by improving the data input, programming, and data cleaning processes, hence improving the entire data submission process considerably.
Validated global libraries or standards will pave the way for widespread automation assistance. Global libraries would provide a platform for both internal and external parties to follow rules and meet regulatory criteria. However, there needs to be a well-developed mechanism for governance of these global library forms and other corresponding programming elements through consistent version-revisioning.
As a result, it is evident that form libraries are extremely important for all stakeholders participating in clinical trials and can be instrumental in a more agile and seamless clinical data management process.