March 1 2021 Melissa Ricker, M. Ed

So, your organization has made the decision to transition to a new eTMF system. Congratulations on taking this step! Depending on your organization and your role, you may or may not have been part of the decision-making process for choosing the system. You may be somewhat familiar with the system or encountering it for the first time. Either way, now that the ink on the contract is dry, it is time to begin making the most of your new eTMF.

1. Get to know your system before uploading begins.

Before you begin uploading documents to the system, it is important to truly understand the ins and outs of how the system functions. If you are performing a transfer of existing documents to your new eTMF, it is especially vital to understand the system prior to beginning a high-volume migration. Beginning your migration without a proper understanding of the system could lead to errors and the need for work to be repeated. It is also important to consider if migrating the documents to your eTMF solution provides a benefit that outweighs the risk of not doing so. When getting to know your eTMF, it is helpful to consider the following:

  • Will you be using the eTMF to track documents or only to store them? If you plan to use your eTMF for tracking, which features of the eTMF might support this work?
  • What, if any, reports can be pulled from the system? When uploading your documents, are there any document properties or information you must enter that impacts the data for these reports?
  • What are the different user roles that can be assigned? How do the roles differ in terms of access and capabilities? Will the roles you have assigned meet your users’ needs?
  • Are there any risks while using the system that you should be aware of and plan mitigation strategies for?

When using your eTMF for the first time, you may discover that it does not function exactly as you had expected. It is helpful to identify any system quirks or errors as soon as possible so that they can be addressed prior to the first document upload.

At any organization, uninterrupted time for learning can often seem like a luxury. However, taking the time to fully grasp your system up front will prevent errors, prevent the need for repeated work, and save time down the road.

2. Put the proper resources and processes in place.

Fully reaping the benefits of your new system requires having the necessary resources in place. Ask yourself the following questions:

  • Who will be responsible for configuring the eTMF? Who will be responsible for controlling access rights to the eTMF? How many staff members will be needed to manage the ongoing eTMF and, if applicable, perform the migration of documents that are already stored elsewhere? What other responsibilities might those individuals have that could compete with this work?
    • Staffing needs are especially important to consider if you are planning high-volume document migrations for ongoing trials. Managing the influx of new documents while also performing existing document migration can be a daunting task.
    • If you are performing a historical migration, how many documents will need to be uploaded? Is there a hard deadline for the completion of the migration? Are certain documents more critical to support the day-to-day monitoring and management of the study?
  • What is the anticipated timeline and volume for ongoing document review and filing?
  • Is there a guidance document that explains how to use the system?
  • Have you developed a written process for how documents will be filed to the eTMF? Does this document also outline roles and responsibilities?
  • Will sites interact with the eTMF?
  • Will the review and approval of documents occur within the system or outside of it?
  • Who will have the ability to file documents to the eTMF?
    • Consider limiting this role to only a few specialized people in order to prevent errors.
  • Which documents will require a documented quality control review step and who is responsible for this review?
    • Consider implementing a risk-based approach when deciding the volume of documents requiring review.
  • Do you have document naming conventions?
    • Implementing naming conventions from the beginning will make your eTMF more organized and user-friendly.
  • Do your sponsors have any particular eTMF requirements that should be taken into consideration?
  • How often will you perform an eTMF reconciliation?
    • Consider doing this activity bi-annually at minimum. The eTMF should be audit ready and as complete as possible at all times.

An eTMF with all the bells and whistles is great, but proper resources and organized processes are necessary for it to be utilized to its potential.

3. Train users and clarify roles and responsibilities.   

After you have learned your new eTMF system and put your processes in place, it is time for your users to be trained. The eTMF software provider may or may not be involved in training users on the system. However, defining roles, determining responsibilities, and supporting processes will fall to you and your organization.

Make sure everyone interacting with the system has been fully trained and understands his or her responsibilities. Each user should know:

  • What tasks he or she is responsible for.
  • How to perform those tasks.
  • The expected frequency for completing the tasks.
  • The reasons for his or her responsibilities and how they contribute to the overall purpose of the eTMF.
  • The support resources available if they require assistance and the process for contacting these resources.

Preparing your users can take time, but your efforts will pay dividends down the road.

When the proper preparation and support are in place, an eTMF can be a wonderful tool that leads to greater organization and efficiency. By taking the time to learn your system, put the proper resources in place, and train your users, you can maximize contemporaneous quality oversight and management of your trial.

Share This Article