It’s tough trying to choose and implement new software and systems. And clinical metadata repositories are no exception. But, they’re a must these days. Everything’s moving towards efficiencies and automation. You don’t want to get left behind.
So what should you expect as a given when it comes to a clinical metadata repository?
Well if the MDR you’re looking at doesn’t meet these basic specifications, find another one that does! Or you could be wasting your time – and potentially a lot of money too.
Here’s a bunch of things that are really a no-brainer. A clinical metadata repository absolutely should:
- Be CDISC compliant
- Stay up to date with new standards and support older versions
- Let you reuse your standards
- Have versioning in place
- Have built in traceability
- Let you find your metadata easily and quickly
- Reduce time and complexity creating and managing standards and studies
In terms of extras that go above and beyond the bare minimum, there are additional MDR features that could make or break your clinical trials.
Every organization is different of course. But we’ve identified 4 really important considerations for successful clinical trials.
4 other considerations for your clinical metadata repository
It’s really important to understand how content is used in your organization. A metadata repository should provide clear visibility of where your metadata is used. How it’s used. And how often it’s used. For example when you have lots of change requests, you can easily see which ones you need to focus on.
If content is changed, you need to see what the impact of those changes are. Your metadata repository should provide this visibility so you can make better decisions about making updates.
Consider this. You’re thinking of making a change to a standard that’s used in many studies. Doing this change will mean making lots of changes to lots of studies. That’s quite a bit of work and it’ll take time and resources to do. You need to know if making the change is worth it.
Do the benefits of making the change outweigh the work and resources needed to make that change? If the answer is ‘yes’, then it’s worth it. Your metadata repository should give you the visibility to see the impact of that change before you make the change.
That way you can have greater flexibility, inheritance and control throughout the lifecycle of your standards and studies.
Metadata needs to be managed through the system lifecycle. If it isn’t, it can become out of date or invalid. This can lead to poor data quality and result in incorrect data collection or processing. And so it doesn’t meet the needs of any of the teams involved.
Here’s a simple example of a possible governance lifecycle:
Governance is one the most important features for a metadata repository. It helps you:
- Improve data quality
- Control and understand workflow
- Assess the impact of change
- Develop robust organizational standards
With good governance, you can trust your metadata is accurate. And if your metadata is accurate, your data will be accurate too.
If you can see the detailed lifecycle of a standard, there’s total transparency in your team. And you’ll avoid regulatory non-compliance.
Collaboration allows a team of people, in different locations, to work together more easily. For example, a group of people with different roles maintaining a set of global standards.
In a clinical trial there are many different roles, such as:
- Data Managers
- EDC Programmers
- Quality assurance and quality control
Each role requires attention to detail, organization, planning, multi-tasking, problem solving and excellent communication skills. To be able to work effectively, a system needs to be in place to allow professionals to do their job well.
A clinical metadata repository should focus on the needs of each role. By doing this, data transparency and business processes are improved. You can see the impact of other people’s changes clearly. Communication is opened up, so there’s less room for misinterpretation.
The end result is a better experience for all users. You get much more consistent, higher quality data, in a shorter amount of time, for less money. And your business processes become much more efficient.
A metadata repository should be at the centre of your organization. It should work with other systems and databases to make it more efficient and to increase data quality.
Having the ability to design studies and standards targeted at specific systems makes clinical trials much easier. All the required information specific to that system is built in.
A clinical metadata repository with EDC integration lets you fully design your CRFs, including complex behaviour like edit checks and conditions. You can see what your forms look like up front, before you upload it to the EDC. You can carry out a simple review and approval process. And you can generate specifications for review outside the system. Once you’re happy with your CRFs you can automatically build your EDC system, which saves time and money by removing manual interpretation of your specs. Overall your studies will be higher quality and more consistent!
Consider also whether you need your systems to be able to pull metadata from your chosen metadata repository. And push data to it. If your MDR has an API, your other systems can talk to it and make it the central hub for knowledge in your organization.
Can Formedix help?
The answer is yes! Our software delivers everything discussed in this blog, and more. So we can help you easily manage your standards and studies, and effortlessly comply with CDISC. We’ve been around for decades, working closely with CDISC to help them develop standards from the start. We support latest and previous versions, so you’re always aligned with CDISC.
Our clinical trial automation software has been built specifically for clinical metadata. You can get up and running straight away. No long, complex implementation. No software development or customization needed before you start. It’s off the shelf you see.
So, don’t get left behind with clinical trial automation. It’s easier to move to Formedix than you think. And we’ll be with you every step of the way. Request a demo and see how we could make managing standards much easier for you. Or we can call you and talk through your requirements. Don’t delay – let us know how we can help today and start becoming more efficient NOW!