Proven Ways to Meet Key Study Start-up Timelines within Clinical Data Management

By 2043, the cost to brings a new drug to market is estimated to be USD16 billion per compound, according to Moore’s Law. This is partly due to clinical trials becoming more complex and requiring longer follow up timeframes during studies. To mitigate the cost impact, having the right clinical data management team to handle incoming clinical data and maintain the high standards needed is paramount.

What’s needed is a purpose-built clinical data management system to lessen unplanned changes which can cause clinical trial delays, timeline extensions, and budget impacts. As studies become more complex with increasingly more unplanned updates during study conduct, a streamlined approach is vital (Smarter Clinical Data Managment, 2023).

Approaching time and task management

Time and Task Management have many definitions, and most focus on simply getting things done on time. When juggling tight timelines and overlapping deadlines – as most clinical data management professionals know all too well – it is not always about how much you can get done; it is about making sure the right things are done well.

The main difference with Time and Task Management is the term ‘focus’. With time management, the primary focus is creating and sticking to schedules. But, in task management, the primary focus is completing tasks.

When combined, these methods can help clinical data management professionals be more effective. Successfully balancing all commitments requires an organized approach to both time and task management, thus creating more quality in the process.

How to achieve better time management in EDC start up

Clinical data management requires strict time management processes, especially in study start up within an electronic data capture (EDC) system. Three steps that clinical data management teams can take to outline the planning and executing of each task that needs to be considered are as follows:

• Make a List: Create a daily or weekly task list and schedule when each task will be completed. This strategy will assist you in maintaining focus and staying organized.
• Set realist goals: Be realistic about what you can finish in the amount of time you have. When setting unrealistic goals, failure is almost certain to follow.
• Explore time-saving techniques: Examples of techniques that could help save time include grouping similar tasks together or using a timer to stay focused.

To help get started, here is a list of EDC considerations for Study Start-Up deadlines:

• Protocol finalization and study enrollment
• Split go-live considerations
• eCRF Specification meetings (this will ensure proper collaboration and minimize any back-and-forth communication)
• EDC add-on modules (which will be required and need validation?)
• ePRO/eCOA used with licensed questionnaires.
• IRB requirements for add-on modules (eConsent/ePRO)

Now that a list has been created of what needs to be done, task management can be applied.

Guidelines for task management:

Effective timing of tasks and resource allocation is crucial for the successful completion of clinical data management projects. Breaking a large goal into smaller, more manageable steps can be the deciding factor between success and failure.

Taking the clinical data management EDC considerations in the section above, we can apply the following five task management ideals:

• Planning: Proper planning can often be overlooked. Take a moment to do task planning accurately. Getting side-tracked or overwhelmed will almost surely be a factor without a clear plan.
• Set realistic deadlines: Remember that giving yourself too much time to complete a task can make it harder to start. On the other side of the coin, setting unrealistic deadlines can lead to frustration and burnout.
• Determine the ideal point by establishing deadlines that are demanding but within reach.
• Group similar tasks: Do not look at the whole study start-up at once. Break the tasks down into smaller and simpler steps to make the mounting clinical data management needs easier to handle.
• Resources: Delegate where possible to help ease the pressure on any one clinical data management professional.
• Make use of technology: Many great tools help with task management, from Microsoft Project to simple calendar apps. Utilize these tools to stay informed and up-to-date.

Timelines provide milestone time points for various clinical data management tasks of start-up to be completed. They are crucial and should be revised as needed to align with the pace of each individual study.

When developing a clinical data management timeline, the Project Manager starts with the expected date of the first randomization/enrollment or site activation and begins to work backwards. The timeline maps the amount of time necessary for each step involved in study start-up, and establishes clear goals for study team members so that each member knows the due date for assigned tasks. (Project Management: Introduction to Tools and Templates, 2023).

As a clinical data management team it has been a rewarding experience to partner with project managers to achieve stronger time and task management across global clinical studies. The steps outlined in this article are just the beginning of an entire internal process designed to maintain clear and accountable timelines across teams, individuals, and locations.

For questions related to clinical data management timelines and expectations, Please click here to connect with the right scientist to respond.

Authored by: Natasha Le Roux, Associate Data Team Lead, Biometrics.

References:

Project Management: Introduction to Tools and Templates – SOCRA Blog
IBM Watson Health is now Merative | IBM