“With the new day comes new strength and new thoughts.”
- Eleanor Roosevelt
It’s that time of year when the notebooks come out and those high achievers put pen to paper to write out their personal 2019 New Year's Resolutions. Exercise more. Eat Healthier. Learn a new language or instrument.
The list goes on...
But what about bringing some of those resolutions into the workplace?
In homage to the new year, we’ve put together a checklist of 19 New Year’s Trial Master File Improvements to strive towards in an effort to unleash your team’s full potential (as 2,019 items would have been a little much). From improved oversight, to active management, to better electronic TMF implementation - pick out a few actionable resolutions you feel are missing in your organization and ring in the New Year with a confident team and a concrete plan.
Without further ado, these are the goals we recommend adding to your TMF Resolutions in 2019!
Better Sponsor Oversight
If you represent a sponsor organization outsourcing all or parts of TMF management, the last thing you’ll want to do upon notice of inspection is be unprepared – here are some resolutions to consider for obtaining better sponsor oversight.
1. Perform a health check in the TMF system.
Begin the New Year with a health check to see if your TMF or eTMF is operating as it should be, if content is properly filed in the correct location, and if there are any outstanding tasks that need to be squared away before the next milestone.
2. Develop a clearly defined oversight plan.
Revisit your electronic Trial Master File plan and quality agreements, then identify and gather all the materials and documents that can demonstration oversight. For best practice, sponsors and vendors will need to be clear with one another on how to handle paper and electronic records from the get-go.
3. Create a governance process.
Many sponsors do not have a governance process in place when they outsource to external service providers – this process should be clearly defined in the oversight plan. Take into account whether you have SOPs in place to properly govern the TMF system and services that will be provided.
4. Demonstrate traceability and transparency.
Often, TMF findings are caused by study personnel being unable to find requested documents. Show responsibility and accountability by properly documenting oversight of the TMF (e.g. artifact review, meeting minutes, activity logs). Remember if you did not document it, it did not happen!
Applying TMF Regulation
Integrating and applying TMF regulation can be a daunting task, but if you designate the appropriate personnel and resources to manage it, you’ll stay on schedule towards study completion.
5. Stay vigilant and check regulatory updates.
Regulations are evolving, and technology is evolving – at the crossroads of this, the role of the TMF is too – and it's up to life sciences organizations to lobby regulators to come up with better descriptions and requirements for TMF systems. In the meantime, keep on the alert for your regulatory authority(ies) updates in the new year!
6. Build out the TMF plan around the TMF Reference Model v3.0.
With the Reference Model as your guide, identify what you consider to be TMF content, what content is being held in which systems, and which of those systems hold TMF relevant content. This will help solve challenges with TMF exchanges and preparing for inspection.
7. Identify authoritative sources.
To remain compliant, it’s vital to go through your artifacts in the eTMF/TMF and ensure everything is labelled either authoritative source or shadow copy. If shadow copies are being stored in the primary TMF, then this should be clear in the TMF plan. In addition, ensure that placeholders are shown for artifacts being maintained outside of the primary TMF.
Active TMF Management
Pursuing Active TMF Management means actively tracking the clinical trial process, for a more accurate depiction of TMF completeness and quality. To some, this is an abstract concept, so here are some pointers to help break it down.
8. Implement a centralized model to encourage collaboration.
Have structured processes and procedures in place that promote collaborative exchange of artifacts between the sponsor and CRO study teams, to ensure that each team’s TMF version accurately reflects the other. Most eTMF systems have collaborative features which allow you to author, review and approve artifacts directly within the system.
9. Gather feedback from all study stakeholders.
When building out this active management model, engage with your internal and external clinical sites and gather feedback during training to yield significant benefits in improving quality during trial execution.
10. Submit content in a timely manner for consistent inspection readiness.
The TMF is not just a repository and contemporaneous filing is key! You’ll need to tell the story of how the study has been conducted and how the TMF has been managed – to do this, avoid having a culture of reactive TMF management, where documents are uploaded in bulk upon inspection notice or study completion.
11. Have an eTMF? Align artifact exchange with the eTMF-EMS standard.
By following the standard, you can automate artifact transfer and exchange between study sites for more centralized content management. Teams that follow this standard have a better prediction of required artifacts based on completeness components, for active workflows that help drive processes and improve compliance with SOPs.
Stay Inspection Ready
Have an inspection coming up? Here are some tips to help you stay inspection-ready and pass with flying colors!
12. Prepare the system for inspector access.
Be ready to provide the inspector with direct and facilitated access to your electronic systems holding TMF content, even for content not primarily stored in the TMF. Then, provide login credentials for your inspector with appropriate permissions, ensure the inspector is familiar with your platform, and assign personnel to assist the inspector as they move through the system.
13. Before inspection, ensure adequate oversight.
It’s so important that we’ve listed it twice! An MHRA report in 2016 found that 31% of inspections must be extended due to critical and major TMF findings – don't let your team fall behind on inspection planning and become a part of this statistic. Prepare to share anything relevant to the study and study management between internal and external teams.
14. Run the team through a mock inspection.
This true-to-life mock inspection should simulate a real GCP inspection from a regulatory authority and is meant to help decrease inspection anxiety to test and improve your TMF before the actual inspection date. Plan ahead and schedule some preventive mock inspection exercises throughout the upcoming year!
Stay up to date!
The Future of eTMF is all about process improvement and how technology can evolve to improve clinical operations while meeting changing regulations, you’ll want these resolutions on your list to stay ahead of industry developments and foster thought leadership in the life science landscape.
15. Keep in the loop on life sciences & biotech developments.
This is an easy one but is all too important in this digital day and age. To be sure that you are staying on top of industry trends and updates, subscribe to individuals and organizations on our updated influencers in the life sciences checklist, and consider attending a few top clinical conferences in 2019 as well!
16. Define Key KPIs and Metrics to help reach strategic goals.
Stay mindful of the three fundamental pillars of the TMF: Completeness, Timeliness, and Quality when defining your goals. Discuss and agree on these metrics with your internal team and your vendor – be reasonable with your expectations. Then, establish a framework for reporting on the metrics including the frequency and method of reporting.
17. Implement a risk-based quality management plan.
Establish mechanisms to address potential deficiencies should your defined metrics not be met, to address potential performance issues. Then, build out a strategy focusing on the identification and management of risks to study data integrity, and patient safety. Remember that GCP risk-based management involves robust protocol design and study design based on feedback from each site.
Build a Business Case to Invest
Don’t have an eTMF but are looking to move make the transition in 2019? Here are some checklist considerations to begin with building a business case, the first step to internal buy-in.
18. Identify the problem(s), and your rationale for making the switch.
Bear in mind what are the issues you’re currently experiencing - do they include the following; non-compliance, no collaborative workspace, reactive planning and resulting stress, too much paper with nowhere to store it? Etc.
19. Next, identify the solution.
This could involve many solutions such as deploying a collaborative workspace on the cloud, outsourcing TMF management to CROs, or even moving forward with implementing an eTMF. Then, work through your options by completing a cost analysis, weighing the pros and cons, and determining feasibility of implementation.
Let's Make 2019 the Best Yet!
Do these Trial Master File checklist resolutions ring true to you and your team? Note them down, stick them to the office fridge, share this link with your colleagues, and address these action items in your upcoming team meeting. These are goals that everyone working in clinical research can get behind and rally around!
To meet growing needs, goals and expectations life science organizations need systems that reflect industry trends, can adapt to regulations, and simplify processes without compromising functionality. Montrium’s latest eTMF application update, eTMF Connect 5 is a modern solution for clinical research projects that has been completely re-engineered with the end-user in mind – to help you tick off these resolution goals faster than any other application out there.
Wishing you a joyful, healthy, prosperous and happiest New Year ahead from Montrium!