Enable faster study start through digitalized protocol creation 

20 years of discussing fully automated clinical data flows has now taken a step further with the development of electronic protocols (eProtocol). eProtocol systems are now reaching a maturity level that significantly contributes to an effective data-driven clinical organization and an opportunity to shorten the time to first-patient-first-visit.
Protocol optimization and utilization in downstream clinical systems    

The protocol functions as the blueprint for a clinical trial and the surrounding processes, making it essential that the protocol data is easily accessible and flows smoothly through processes and systems supporting clinical trials. 

There are two main areas to focus on when digitalizing the clinical protocol 
  • Optimization of the protocol creation (using metadata) 
  • Automatic utilization of protocol data in downstream clinical systems 
eProtocol creation

The protocol content contains the schedule of activities, study design, inclusion/exclusion criteria, statistical considerations, and numerous other study descriptors. All the protocol content can be standardized into a systemized library, leaving behind the old way of creating a protocol based on word templates in a SharePoint.

Writing the protocol can be a long and challenging task. Numerous protocol authors and reviewers participate and provide input to different topics from pharmacokinetics to statistical hypotheses. Multiple people are involved across different roles and departments e.g. Medical Writers, Trial Managers, Biostatisticians, etc. This often results in uncontrolled protocol versions and word templates flying around in SharePoint, mail inboxes, and locally on desktops.

eProtocol systems enable efficient protocol creation through systemized workflows and the use of metadata. A few vendors also offer several protocol metrics e.g. who reviewed what, and how much time was spent on the specific section, review dashboard, etc. Digitalizing the protocol ends uncontrolled protocol versions and inefficient authoring and reviews.

Standards management

Optimization of protocol creation is not only about people and workflows. A key element is standardization.

Through efficient standards management, protocol metadata helps to support the trial from study startup to study closure and submission. Having standardized trial design data helps to avoid many of the typical errors encountered when pooling data prior to submission.

An eProtocol system enables standards management through a controlled library of standards. A library of standards should function as building blocks in the protocol creation process to empower study teams to easily generate a protocol with minimal need for adjustments.

Having standards speeds up the protocol creation process, lowers the risk of human errors, and minimizes downstream issues. Creating protocol standards enables key metadata to be defined and streamlined early in the trial process to the benefit of the entire clinical organization, and a smooth submission process. To create a solid foundation, it is advised that consistency with CDISC and support of SDTM is built into the protocol standards.

Utilization of protocol data in downstream clinical systems

The protocol contains core information for nearly every downstream system or process that is used in a clinical trial. Fully digitalized eProtocol systems enable protocol data to run smoothly through the entire organization.

For your organization, that means that systems such as EDC, MDR, and SCE can leverage the protocol data to automate processes e.g. easing the support of SDTM or building eCRFs. Case report forms are based on the protocols and through machine-readable protocol data, automated eCRF creation is taken a step further.

The key to automation and utilization of the protocol data is the ability to export standardized CDISC aligned protocol data in a human- and machine-readable format. Direct interfaces can be setup for easy export and to enable data use in downstream processes and systems.

Standardizing and enabling protocol data to be utilized in downstream systems is a high impact decision for every clinical organization and will optimize the process from draft protocol to trial submission.

When implementing an eProtocol system – plan to avoid downstream issues by making protocol standards consistent with CDISC and spend time on developing future processes.

Natasja Lund

Natasja Lund is a life science business consultant. She specializes in analyzing and optimizing clinical processes, developing quality documentation, and implementing process improvements and IT solutions in Life Science companies.

Natasja has a BSc. and a MSc. in Quantitative Biology and Disease Modeling from the Technical University of Denmark with a focus on mathematical modeling and human biology. Her academic background has provided her with a broad set of research skills from making disease models to data analysis and problem solving.