Robust electronic Trial Master File solutions are now available that can transform and optimize end to end capture, maintenance, and storage of regulated clinical trial documentation. Regulatory Agency encouragement has accelerated the maturation of these tools and increasingly complex clinical trial requirements are making the adoption of these tools more and more attractive. As a result, a growing base of knowledge is emerging that details how to best integrate these tools, compressing the learning curve and accelerating benefits realization. If you are anticipating the option of a new eTMF tool or if you are looking for tips on how to manage the change associated with a transformation of your current TMF technology and processes, then you might enjoy this posting. Designed to be an outline for success, this post provides an overview of some change management best practices that can be used to transform your TMF landscape.
The best electronic TMF solution is tailored to the organization. Overall trial scope and breadth is a key to selecting the best of many products that are available. The change processes can be simplified and generalized however and following these key points will lift your organizations TMF capabilities no matter what solution is selected. The 7 best change management practices for an eTMF solution include:
1. An honest evaluation of where you are and where you want to go.
Start by detailing your current processes, summarizing the various documents generated, the processes followed, and the result expected. Summarize the steps, keeping an eye out for duplication that can be removed and steps that can be automated. Adopting key principles, like minimizing paper, maximizing automation, and utilizing electronics to the maximum extent possible, will help you define the end state vision. Regulatory requirements have you document these processes already, the honesty here is to identify where you really want to go, and how much savings and how much work is likely involved.
2. Development of a solid plan to guide your approach.
The plan to achieve your end state must include alignment of all affected parties. The plan will include organizational change enablement of study managers, document originators, quality, and inspection readiness personnel, with numerous supporting staff and functions affected as well. This should be a comprehensive approach to ensure everyone who contributes to, views, manages, evaluates, or adjusts the TMF or any essential document is treated with special change tips, treatment, or involvement. The best way to find success is through a well-documented and approved plan.
3. Engagement to assess and lift your organization’s readiness for change.
Engagement is essential in determining your organizations readiness for change. Important hints about an organizations ability and willingness to accept change can be determined through various engagement means: workshops, surveys, SME topic reviews, and interviews all provide important data points. Engagement can help you by uncovering pockets of potential resistance and engagement is key to revealing important requirements. While every organization is different, human nature points towards the value of engagement as the new system is implemented, people like to be part of the solution. The importance of engagement is highlighted at every level from sponsor all the way through end-user.
4. Development of a well thought out governance approach.
A solid governance approach supports the change initiative with intuitive models and representations of the new landscape. Since every organization is unique, a top down strategy is recommended in support of business-goals is reinforced by a well-defined governance and communication structures. Feedback follows the governance structure allowing for a two way understanding of the roles and responsibilities to ensure the system is aligned and supporting, and so document quality flows to the originator. Responsibility, accountability, and self-correcting behaviors are key tenants of the governance approach recommended.
5. Alignment with the technology project.
The change management approach should be regularly aligned with the technology project. Delays and adjustment will undoubtable occur and the change management plan should remain aligned to the greatest extent possible. Timing and scope of change are both likely as the technology is implemented, the eTMF change team should be prepared for either eventuality.
6. Measurement against expected results.
Establish a performance measurement program to accompany the change initiative as measurement is a key component of any eTMF change project. You can’t acknowledge that you have achieved success without first understanding where you are going, and you can’t acknowledge you have arrived unless you determine where you are. Best practices have companies measure against predicted or desired end points. Intermediate points are equally as important to make sure progress is consistently positive. Surveys. observations, and system reported outcomes can be base-lined and are equally important as the measurements are compared against predicted or desired results.
7. Reinforcement to ensure change objectives are sustained long-term.
After the new eTMF Landscape is established it will be important to reinforce behaviors and to encourage the continued journey towards excellence. Reinforcement provides tools and policies that enable the institutionalization of change sought. Refresher training, system user tips, and internal eTMF best practices can be provided to all users to make sure all stakeholders maximize adoption and realize the benefits sought.
Knowing and following these best practices will help ensure your electronic TMF transformation project succeeds.