Turning to software platforms for DSMB management is relatively new for most sponsors’ and CROs’ clinical teams. Yet, such tools can greatly help overcome most of the difficulties repeatedly encountered in clinical trials where DSMBs have become necessary. Here’s a few tips to not let the choice of your software platform become a daunting task. Keep in mind that in the end you will manage your DSMB with less stress, less efforts, less risks, and yet more efficiently.
As discussed in a previous blogpost electronic platforms help address some of the challenges faced by clinical teams and DSMB members by fostering collaboration, enhancing communication and supporting process adherence. In this article, we will step in the shoes of a clinical leader in the position of choosing a software platform for DSMB management and review some of the key aspects to consider for making a sound decision.#1 criterion: secure data management
Security and data management are undoubtedly the most important features clinical teams look at when choosing a software platform for DSMB management. If data handling is one of the main functions of any software platform for clinical committee management, security, confidentiality and control of data disclosure are of paramount importance in a DSMB process. Proper roles and privileges, for example, as well as communication constraints set in the software platform guarantee that no accidental or even intended disclosure of blinded or confidential information can occur.
Role-based access is the most secure way to ensure that the right people will have the right access to content in the DSMB process and that they will be called to perform required actions as per the plan when the time comes.
On the other end of the security thread, document permissions allow to determine which person with which role can access a document at any given time. Access can vary with the nature of the document but also with the status, for example a document may become accessible to additional people once it is final.
Finally, a robust electronic signature functionality is a basic requirement for any electronic system managing documents and should always be considered when building or when selecting such systems.
#2 criterion: flexibility to adapt to any DSMB scenario
Each DSMB is different and this is the reason why a specific charter needs to be written and signed every time. A software platform for DSMB management must be able to accommodate any composition, workflow and meeting schedule, easily apply roles and responsibilities according to the charter and support any process needed by the clinical specifics.DSMBs can have very different compositions and a software platform must have no limitations as to the number or the location of participant members.
Roles and responsibilities define the access and the part each person is called to play in the DSMB process. A robust platform where roles and responsibilities are clearly set helps manage the process better.
Workflows describe processes in an unambiguous way and guide each party in performing the right actions at the right time. However, workflows can be complex. Embedding them in a software platform can greatly help to follow them to the letter without additional burden to the participants.
# 3 criterion: fast and faultless deployment
Now you have a secure and flexible software platform for DSMB management. Have you made sure the provider you are choosing is agile and responsive enough to deploy the tool quickly and efficiently when time comes?There is nothing like a fast deployment and successful implementation to demonstrate a system’s qualities. The real-life test reveals any hidden weakness. Being able to demonstrate the robustness of a software platform with examples and testimonials from previous users is the best way to prove its value.
A picture paints a thousand words and an example provides a thousand points to illustrate the performance of any system. Always look for real-world implementation examples for proof of performance.
The best advocates of any tool are the people who have successfully used it. Look for testimonials of satisfied users and you will know what to expect from a software platform including those dedicated to DSMB management.
Demos and specifications can be useful when assessing a software platform but real-life experience is definitely the most informative way to prove the capabilities of the system. Always ask for references and check back with them on their experience.
In conclusion what will be most helpful when planning and setting up a DSMB is a robust, flexible, versatile software platform for DSMB management capable of embedding the specific requirements of your clinical trial based on roles, permissions and workflows that reproduce the requirements as set in the DSMB charter. Make sure you ask your vendor for references from customers who can speak about their experience from implementation to deployment and actual use. Nothing can be left to chance.
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A single, integrated handbook regrouping various sources of information on when, why and how to set up and use DSMBs and DMCs.
