The importance of testing all aspects and features of a study before Go-Live cannot be over-emphasized. That being said, testing can be a very messy process. If not undertaken with a great deal of planning and documentation, the whole process of testing a study can be rendered not only ineffective but counterproductive. In comes User Acceptance Testing (UAT) to the rescue!
First, you might ask, what is UAT and how is it different from other forms of testing? Think of UAT as a dress rehearsal before a play. The actors all know their lines, the lighting director knows all their queues, and the sets have all been built and tested for safety. But you need to see it all together before you fill the seats with spectators. What if those perfectly built sets don’t line up with the spotlights or what if the bulky costumes get in the way of the actors’ performances? All the parts are there and accounted for, but the picture as a whole has yet to be validated.
The study-build process is similar. After each form has been tested separately, and all of the summaries and reports have been set up to your satisfaction, there is still the issue of unforeseen scenarios. You won’t be able to find or fix all the potential conflicts until you test the entire study as one. Set up a new site, enroll several patients, take each one through the entire screening/dosing/withdrawal/etc., process. Then do it again with another patient and another, until you have ironed out as many eventualities as possible. Even then, there may still be unforeseen problematic scenarios, but the purpose of UAT is to mitigate the number of issues that might come up during the Live study as thoroughly as possible. UAT is also a good way to provide you and your team with a finalized, succinct idea of what, exactly, you are signing off on before your sites begin entering patients. Once you complete your final run-through of the study, you can rest assured that you have done everything you can to make your study run smoothly.
The study build is the most volatile and, therefore, the most important part of the study’s life cycle. Keeping a good record of the build gives the rest of the study a fighting chance at success. It’s a time for testing, training, re-testing, amending, testing and retesting again. Did we mention it’s a time for testing? Changes get added and reverted then added back in, the final protocol may not be ready, there are usually multiple people requesting updates to study forms, sometimes conflicting with each other. It is important to be able to see exactly when requests were made and by whom.
This “story” of the study build has a major impact on the study once it goes Live and after it has been completed. It even affects future studies. Being able to see all in one place where the build went right and where there is room for improvement makes site-training easier, it provides a starting point for future study builds, and it streamlines the development of future protocols.
The Prelude field spec and feedback features are the most powerful tools for telling this story. The field spec allows the team to see in a nutshell how every form and field is set up. If they are unsure the effects of a calculation or constraint on a specific field, they can go directly to the form in question and test it. Then they can add feedback directly into the system if they feel a change is needed. From there the request goes through the feedback cycle until it is resolved. Then it is tested again. Prelude provides more feedback categories than any other EDC provider for added clarity and efficiency.
Each team member can use these tools to see exactly what changes have been requested, which changes have been approved, and the completion status of the approved changes. They can view at a glance all roles, permissions, constraints, calculations, etc., to find everything they need to know about the progress of the build, and they can view a succinct record of the Prelude team’s responses to each feedback item. Furthermore, the audit trail provides information about who left what feedback or query and when. In this way, Prelude offers a full package of features to streamline the build process and keep a thorough record each study’s build.
An EDC improves efficiency and reliability while conducting clinical research. Here are some ways it does that:
1. Efficient Communication
The efficiency of communication between team members is what determines the success or failure of a clinical trial. If a team does not have a streamlined process for disseminating information throughout the life of a project that deals with the staggering amount of data typically generated by a drug trial, everything else can fall apart. An Electronic Data Capture (EDC) system provides a platform for making sure information gets to the proper people in a timely manner in a way that paper will never be able to match.
With an EDC, there is a much lower risk of communications being lost or seen by the wrong people. Updates can be shared instantly to ensure that everyone who needs to know will have the pertinent information at their fingertips with no waiting. The only thing you will have to wait for is federal approval (sorry, can’t help you there).
2. Instant Documentation
Every time a user changes a field or makes an entry into the EDC system, the time, date, and user information is captured and recorded instantaneously. Indeed, as soon as a user logs onto the study, the EDC system records how much time they spent on each form even if they simply left their browser open while they played Solitaire in another window (disclaimer: we do not, as yet, have a way to track for you who on your team is playing games and who is actually working).
The EDC system can also record signatures on forms along with accurate date/time stamps. Say an investigator forgot to sign off on a form, and it goes unnoticed until the end of the trial. With paper, the monitor would have to track down who the investigator at that site was and mail them the form to sign. Then the offending investigator would have to mail the signed form back to the Monitor. If the investigator forgot to sign the form initially, who is to say they won’t also forget to send the signed form back? This process is time-consuming and susceptible to errors. With electronic data-capture, signatures are a given and no one has to wait by the mailbox for clerical corrections.
3. Intuitive Summaries
Most clinical trial personnel would agree the most time-consuming aspect of a drug trial is the extrapolation of useful information from the massive amounts of data generated throughout any given study. Where paper fails, an EDC system thrives. The EDC platform is designed specifically to make combing through data as efficient as possible (we won’t go so far as to say it’s enjoyable, but efficient, definitely). An EDC accomplishes this by providing user-friendly summaries directly within the system, which saves time and energy by doing all the work of combing through patient data for you.
Summaries can be set up to meet almost any parameters you can think of, and they can be set up in a matter of seconds. You can compare infinite pieces of data (provided you have infinite pieces of data) to help you come up with the most accurate results possible for your study without wasting man-hours (or woman-hours). Most importantly, EDC summaries can be saved, altered, and shared as fast as thought, so you can keep up with the continuously evolving business of producing safe drugs for people and animals.
4. Real-time monitoring
Monitors can review data entered into an EDC System as soon as the person entering the data hits ‘Save’. There are even features which allow monitors to view data-entry live from a remote location to ensure that patients are kept safe during difficult or potentially dangerous procedures. An EDC system keeps a study moving forward by removing lag-time between clinical observations of patients and safety monitoring of documentation.
5. Error Minimization
The biggest shortcoming with recording data on paper might be the amount of errors that go undetected. When using an EDC system, where every field utilizes automatic constraints and calculations, often in tandem, errors are not only much easier to detect but they are also much easier to prevent.
Constraints can be placed on fields to restrict an impossible value from ever being entered in the first place. If there are unforeseen types of errors that the constraints do not account for, then the monitors can easily attach a query directly onto the field in question. Then the system can be updated to catch any future errors of the same kind. More levels of validation lead to less mistakes.
6. Customizable Forms
Every clinical trial is unique, and, therefore, every clinical trial has unique requirements when it comes to forms and fields. An EDC system, being highly customizable, offers the ability to only show the fields necessary to be filled out for each patient and visit. This saves time for the investigators when recording their observations. They do not need to waste time filling out an entire stock form as they would on paper.
Forms in an EDC system can be set up so that the next field or form becomes visible or remains suppressed depending on the answer to a previous field or form. In this way, the system guides the data entry personnel through the appropriate process and prevents a lot of headaches. Plus, not having papers means no paperwork!
One of the most important aspects of the clinical trial process is making sure that the right people have the right access to view and edit study data. One could argue that the success or failure of a drug trial hinges on the proper assignation of permissions to each team member. Permissions are the barriers that prevent important data from falling into the wrong hands or, equally as problematic, not being received by the right hands. The key to managing the user permissions for your trial is understanding what the basic user permissions are. From there you can customize them depending upon the needs of your unique trial, with help from your EDC provider.
The first and most important thing to note before you begin assigning permissions is that one, and only one, member from your team should be assigned to manage all user permissions. This is typically the job of your Project Manager (PM), and it is important for that person to be trained on permissions, in general, and your team’s needs, specifically. Your Prelude PM can help you set up the initial users if you are unsure where to start, and they can offer guidance and support throughout the life of the trial. It is up to you and your team, however, to ensure that you have the necessary users set up with the proper permissions before your trial begins. There is no one set process for determining your user permissions, but it is important that no more than one person should have the ultimate power to edit and manage the users and permissions in the system. This measure is in place to prevent conflicting user assignments or improper access to data being given to users. Having a streamlined process for managing user permissions is a vital pillar of Good Clinical Practice (GCP). It also mitigates confusion and promotes communication.
The second thing to note is that the earlier you get your users and permissions set up, the better. The farther into a study you get, the more complicated and potentially problematic it becomes to change the permissions. For example, if you determine that the Investigator should not have been able to view the treatment assignments of their patients halfway through the study, your results from the first half of the study might be deemed unusable. That would be bad!
Finally, do not rely on your EDC provider to know what permissions you need for your trial. It’s your study and your neck on the FDA chopping block! This is where proper training comes in. Here are four basic user-access categories to keep in mind when setting up and managing your user permissions and remember: your Prelude team is here to help and guide you should you need further customizations.
1. Prelude personnel
This includes your Prelude PM and Prelude Quality Assurance (QA) team. The PM will have Administrator access-only to your Live study so that they can assist you with user access issues and mid-study updates. QA will also be able view all study forms so they can ensure they meet industry standards. Neither of these roles will be given data-entry access to patient forms.
2. Non data-entry personnel – This category includes two sub-categories, both of which are given view-only access to patient forms:
- Roles which can view and edit all user/site/project forms, e.g., Project Manager, Monitor.
- Roles which have limited access to view and edit user/site/project forms, e.g., Coordinator, Medical Monitor.
3. Data-entry personnel – This category includes two sub-categories:
- Roles which can view and edit all patient data, e.g., Investigator
- Roles which have limited access to view and edit patient data, e.g., Patient, Lab Technician.
4. View-only personnel
These are the roles which, like Prelude personnel, cannot edit any data and can only view the forms which are necessary for them to view (again, as determined by you and your team), e.g., Sponsor, Statistician, Data Manager.
Of course, there will always be exceptions to these basic permissions. Perhaps your Medical Monitor should be able to enter patient data, or your Lab Technicians shouldn’t be able to view site data. You can also, of course, add or remove roles according to your every whim (well, maybe not every whim, but we’ll do our best). This is the beauty of using a highly customizable system like the one provided by Prelude. The possibilities are endless! Whatever your study needs, Prelude delivers. Our system is designed to make your study run as efficiently as possible by catering to your unique needs. Customize away!
Prelude Dynamics, LLC, has announced the release of their new VISION ePro mobile application. This application enables patients to input data directly into the electronic data capture (EDC) system on their phone for a simpler and more efficient clinical trial experience.
Traditionally, personnel have had to expend a great deal of effort to get patients to follow through with their part in trials. It is difficult for patients and other infrequent users to navigate EDC systems as they can be complex and difficult to use without proper training. The extra effort it takes to follow up with these kinds of users has translated into higher costs for sponsors and monitors. VISION, Prelude’s renowned EDC platform, is one of the most intuitive and user-friendly systems for electronic data-capture on the market today.
Prelude continues to develop products like the ePro mobile application that will make their clients’ clinical trials more efficient than ever. Patients and pet owners participating in clinical trials can now navigate the VISION software with more ease and reliability, and the costs for trials are projected to go down as Prelude continues to enhance this new capability.
As the developers of VISION, the #1 EDC software system in Animal Health, Prelude Dynamics has made sure that animal owners and human patients involved in clinical trials will benefit from this new streamlined process. Tommy Jackson, COO at Prelude Dynamics states,
“VISION ePro captures real-world study data straight from the source. Built on VISION, Prelude’s world-class integrated EDC platform, this new app will enhance the experience for all parties involved in the trial process.”
VISION ePro features many of the benefits of the VISION online system in one, easy-to-use mobile application for patients and pet owners who are on the go. Features include:
- Mobile patient-entry
- Scheduled survey forms
- Push notifications
- Media-upload capabilities
- Complete audit-trail functionality
- eConsent capabilities
Prelude Dynamics continues to work diligently to make the clinical trial process as smooth as possible for their clients because they understand the importance of efficiency and user-friendly technology in the data-capture and data-management industries.