When it comes to efficient clinical study build, content is king. Most importantly: metadata content. Metadata is the building blocks of your study. It’s the forms, terminologies and datasets you need to structure your study and start collecting data.
Managing clinical trial metadata can be challenging. You have to find the right content, make sure it’s compliant with CDISC standards, and get it approved before you start collecting data.
That's where automated metadata management comes in. Automation can help streamline your clinical trial process, meaning more efficient processes, easier study build, and faster submission.
In this blog, we'll explore the role of metadata in clinical trials, the benefits of automating metadata management, and how to implement standardization to help you build trials more quickly and efficiently.
Let’s dive in!
The number of global clinical trials is increasing every year and there are more regulations than ever before. This means trials are becoming increasingly complex to manage. There’s a vast amount of data to be collected, organized and analyzed. Study teams must consider not only the study data, but the metadata too.
Metadata is often described as ‘data about data’. In other words, it gives detail and context to data elements. By doing so, it helps to organize and optimize data, and makes it easier to use. Some examples of clinical metadata are case report forms (CRFs), datasets, controlled terminologies, mappings, and edit checks.
Metadata is a crucial part of any clinical trial. The FDA has made it mandatory for submissions to comply with CDISC standards – SDTM, ADaM, and Define-XML. Not only must the study submission comply with these standards, it must also include information describing the submitted data. Study metadata lets regulatory reviewers understand and interpret clinical trial data. And, the higher the quality the metadata, the quicker it is to review.
Many organizations use manual processes, such as Excel spreadsheets and Word documents, to manage metadata. Here are challenges of doing it this way:
To stay ahead of the competition, clinical trial organizations are increasingly embracing technology solutions to help them effectively manage and automate metadata processes.
Implementing automated metadata management for your clinical trial requires careful planning and execution. The process can broadly be broken down into two phases, which we’ve explored below. Note, there isn’t necessarily a right or wrong order regarding how to implement automated metadata management, and you might run both phases in tandem. It all depends on what works best for your organization.
Metadata management is done best when using a CMDR. A CMDR is a centralized repository for storing and governing clinical metadata. It has a user-friendly interface that allows planning, communication, and collaborative working between different teams. All your metadata is kept in one place, so it’s available for all stakeholders to easily find, edit, and share. Standards and automated processes are built into its framework to streamline clinical studies from inception to completion. A CMDR allows organizations to connect disparate metadata siloes often present in clinical trial design. For example, different teams using different metadata, which is stored in various places, often resulting in inconsistencies and poor version control.
Typically, this phase might involve the following activities:
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This means creating metadata (forms, standards, annotations etc) that meets the requirements of the organization and getting these approved internally by all stakeholders. Once a metadata asset has passed quality checks, it is stored within the CMDR for use and reuse across studies.
Standardizing metadata reduces the resources, effort, and time spent setting up studies. Metadata is more consistent, higher quality, and the likelihood of a successful submission is increased.
Standardizing content also saves time that you’d otherwise be spending searching for the right forms, terminologies and annotations to use.
Typically, this phase might involve the following activities:
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Don’t be put off by the steps above or the efforts required to create, implement and maintain a CMDR. Remember – the time you put into learning the new platform will pay dividends in the future because your clinical trials will become much faster and easier to build with automated metadata management in place.
A CMDR and automation go hand-in-hand:
Automatic study build
A study can be built automatically from existing standards – there’s no need to manually look for content. You’ll only need to create new content when the specific study requires it.
Automatic compliance
Because content is standardized in alignment with regulatory standards, as well as sponsor-driven standards, studies are automatically compliant with CDISC. For example, controlled terminology (a form of metadata) is used to ensure consistency across trials. This means regulatory bodies can quickly locate, view, and analyze data, making the review process much more straightforward.
Automatic change control
Changes are automatically entered into a thorough approvals cycle, and tracked before being accepted. Meaning there’s no need for a complex manual cycle, with long email trails detailing changes, or potential version confusion.
Automatic impact analysis
The upstream or downstream impact of changes to standards is automatically identified - there’s no need to track this manually. You can review metadata adjustments (for example standards updates) and perform an impact analysis on all parts of the trial and connected studies before changes are approved and implemented.
Automatic quality control
Quality control is enforced through a customizable metadata lifecycle, meaning all stakeholders can see exactly which state a standard or study is in (i.e. draft, in progress, in review or approved) and only perform the actions allowed at that stage. Read our blog about improving clinical trial data quality with a metadata repository.
CMDRs facilitate automated metadata management, meaning clinical trial efficiencies and lasting changes to your study build process. In fact, we believe a CMDR could be one of the best investments a sponsor organization could make. In the next section, we take a look at some of the key benefits to automated metadata management.
Automated metadata management offers many benefits over manual management.
Building an effective clinical trial starts with metadata. With quality, standardized and approved metadata in place, trials can start faster and, with less manual work. Insights can be gained earlier, and the trial can proceed more quickly.
Implementing a CMDR with automated metadata management can deliver many long-term benefits. As CDISC standards continue to be updated, and more and more regulations come into play, CMDRs will play a central role in organizing and standardizing this data to speed up the clinical trial process and make life easier for organizations. With clinical metadata standardized, organized and automated processes in place, organizations can focus on getting treatments to market more quickly.
Want to read more about CMDRs and automation? Why not download our free whitepaper: 'The importance of a clinical metadata repository in clinical trials'?
Author's note: this blog post was originally published in February 2021 and has been updated for accuracy and comprehensiveness.
Gilbert Hunter
Customer Success Manager | Formedix
Gilbert joined Formedix nearly ten years ago as a technical writer. The system knowledge he gained from content development, together with his existing customer service skills, marked him out for transition to the Professional Services (PS) team.
Gilbert has worked with the PS team for over four years, providing both CDISC-based training and software training, as well as support and consultancy services to Pharmaceutical, Biotechnology and Clinical Research Organizations. He helps organizations build studies faster and to a higher quality by making their clinical trial design and regulatory submissions far more efficient.
Today, as Customer Success Manager, Gilbert’s focus is to ensure customers maximize the benefits they can achieve from ryze by overcoming their challenges and achieving their goals.