First CCDM designation received by Staff

Congratulations to Dr. Karina Loyo for becoming the first in our office to be a Certified Clinical Data Manager by the Society of Clinical Data Managers. Dr. Loyo passed the certification exam on August 22nd. This represents the first step towards SCDM industry partner certification for Prelude.

Prelude’s staff are integral in implementing best clinical data management practices to Client’s studies. Gaining recognition through SCDM’s CCDM certification provides an independent qualification and assurance to our clients about the quality of the staff they interact with and who manage their studies.

Richard Tieken, CEO, said, “We want every client to know they are in the best hands possible. Providing staff who are Certified Clinical Data Managers is just one way in which we continue to elevate the bar of excellence for our customer service, and show our commitment to the industry to always be at the leading edge of technology.” Prelude expects for other project managers to obtain their CCDM in the near future and is on track to achieve SCDM’s designation of CCDM® Industry Partner in the following months.

Prelude Commits to Excellence in Data Management

Clients trust Prelude’s expertise in helping them with their electronic data capture (EDC) and data management needs. This trust has been honed through years of dedication to providing the gold-standard in EDC functionality.  We have taken VISION™ beyond EDC to provide an all-in-one comprehensive platform that provides not only EDC, but also Clinical Trial Management System (CTMS) and Clinical Data Management System (CDMS) functionality.

Now, Prelude is taking our excellence in Data Management to the next level by committing to obtain recognition from the Society of Clinical Data Management as an industry partner in Data Management Excellence. Obtaining this designation is no easy feat. At least 25% of all personnel or a minimum of 10 employees engaged in data management must be Certified Clinical Data Managers (CCDM). The CCDM certification exam is comprehensive and rigorous. The passing rate is around 55% of those who take the exam. Currently, there are less than 20 industry partners.  Achieving it truly represents excellence in data management.

Prelude is committed to obtaining the SCDM CCDM Data Management Industry Partner status in the next 6 months.

Richard Tieken, CEO at Prelude said, “Showing our clients that they are dealing with only the best and most qualified company is as important to us as making sure our Client’s data is clean and safe. Becoming an industry partner is a natural step in letting our Clients know how committed we are to ensuring excellence in our software system and in their data.”

About half of Prelude’s staff is directly engaged in data management functions which include project management and building of studies. All project managers currently meet the qualifications to take the certification exam and most of them have already been approved to take it.

VISION™ Dashboard: The Future of Study Monitoring is Here

With the newest advancement of VISION’s Dashboard tool, monitoring your study or trial has never been easier or more adaptable! With more monitoring capability located in one place, you have the power to review what you need at a glance and dive deeper for further review.

Gone are the days of scattered summaries and reports. With the updated Dashboard you can now monitor what you want, when you want and all on one page with data summaries that you control. At Prelude Dynamics, we understand the importance of quick, convenient monitoring that you don’t have to dig for and in this article we’ll showcase some enhancements to the Dashboard that give you exactly that!

Similar to a news feed, VISION’s Dashboard enables you to decide what data criteria you want to see. No matter what your data monitoring preferences are, we give you full control to arrange and filter your data within the dashboard to your needs while also including fundamental tracking tools like a Quick Stat overview, messaging module, and a built-in study calendar. Real-time data reports and summaries are now all conveniently located in one place – the VISION™ Dashboard.

To access the Dashboard, simply click the dedicated Dashboard icon in the main navigation while logged into VISION™:

When you first arrive you’ll be prompted to take an automated tour of the new dashboard features. One new feature is that your dashboard is fully configurable to show you the data that you need to monitor. You can choose from a variety of summaries, graphs and charts, display the ones you want, hide those you don’t and sort them in any order. Just click the +/- icon to show a list of active and disabled summary modules. Any module you want to view, simply drag it into the “Active” column, click Save and you’re done! Your dashboard is customized and you are ready to monitor.

The Dashboard has 3 Main sections: Overview, Messages and Calendar…

In the Overview section, the Quick Stats module lets you select from important monitoring data counts, like: number of adverse events, serious adverse events, monthly enrollment, number of unresolved queries or total queries, form status data and more. You can then add numerous charts and graphs showing at-a glance visual representation of various data within the study.

Within Overview, you decide which data points to monitor and in what order they are displayed. For a more detailed breakdown on any of the summaries, simply click on the label to access additional information which will display within a table or chart.

In the Messages section, notifications are conveniently displayed in a list so you can quickly review sent or pending notifications, acknowledge them or even compose new ones. The list can also be filtered by category such as adverse event, new patients enrolled, queries, protocol deviations and more to show you only what you want to see.

In the Calendar section, you get a view of the current month showing personal, site and study created events that are color-coded to help keep track of each. You can navigate to view past, present and future months, add and schedule new events and filter them by type to focus on only those events that are relevant to you to help plan and schedule accordingly.

As a Monitoring tool, the Dashboard is a comprehensive one-stop shop. You can pull in any existing subject, site or user summary or any ad-hoc report that you created. This provides you with the ability to view all the important study data in one place, and eliminates the need to click through reports and summaries in separate locations.

It gets even better! You can now also filter the dashboard by a given site or view data for all the sites as a whole. Each report and summary can be filtered separately by any custom search you create. If you want to see only data for enrolled patients, select that filter. Create new reports and filters at any time and they become immediately available for use in the dashboard. You can even pull in shared reports and searches from other users.

That’s a quick dive into our enhanced Dashboard monitoring tool available for all studies with our newest version of VISION™. At Prelude, we believe in the power of convenience, configuration, and time-saving tools for you and your team. Welcome to VISION™ Dashboard!

VISION™ Tips & Tricks: Utilizing Summaries


Did you know that each VISION™ study comes with a set of standard Summaries?  They aggregate Subject and Site-level data, enabling faster monitoring and data validation. Standard Subject-level summaries may include Subject Status, Form Status, Query Details, and Comments (Note to Field).  Standard Site-level summaries may include Site Status, Enrollment, Form Status, Queries and Comments (Note to Field). Custom summaries are also available upon request (and include, but are not limited to Adverse Events, Deviations, Note to File, etc.).

 

To access a Subject or Site Summary, navigate to the Subject or Site list page and Click the “Summaries” button in the footer of the page.
Summaries
Also, please note that if any Searches or Filters have been applied, the Summary data will only display the filtered data set. At the Subject level, you can view Summaries for all sites, or a specific site by specifying in the site dropdown (see Figure 1).

Figure 1. Site selection dropdown can be found in the page header.

You can then narrow the scope of the subjects you’re viewing by applying search criteria (see Figure 2).

Figure 2. Adding Search criteria can help narrow the scope.

See our Tips and Tricks on Layering Data Searches for more details on applying search criteria.

Below is a table of examples found in VISION™:

Summary cohortSummary dataDescription of Summary
SubjectSubject Visit StatusShows the most important dates per subject. (Study visit dates, study completion dates, etc.)
SubjectForm StatusShows the # of forms in-work, in-review, reviewed, finalized for each subject. Also shows the # of unresolved, resolved and reviewed queries per subject.
SubjectQuery Details Summary contains two sub-tabs, one for "Unresolved Queries" and one for "All Queries." Details include subject ID, form/field query was entered on, date, who entered the query, the query, and the time it took to resolve the query (or the time it has been open).
Subject and SiteNote to FieldShows an aggregate of the notes made to subject (or site) fields
SiteSite StatusShows aggregate enrollment by gender, screen failures, and completed study status. It can also display Form and Query status.
SiteEnrollmentShows a graph and/or table of expected versus actual enrollment per site.
SiteQuery GraphShows total versus unresolved queries. Excellent for a quick view of query status overall and for site comparison.

Please contact your Prelude Project Manager for more details or questions on this article.

VISION™ Tips & Tricks: Layering Searches & Reports

Do you want to view only those Subjects who have been randomized?  Do you also want to only view those Subjects who are of a certain age? The VISION™ Search function is a great way to filter data during your study and multiple searches can be applied to your data! Additionally, Reports can be run on top of applied searches (or already filtered data).
You can navigate to the list of study Subjects and click on the “Search Subjects” button. Any form and field you have access to will appear in the drop-down list to be selected. You can set up as many search criteria as needed, keeping in mind that the criteria must all be met for the search to return any results. You have the option to search for Subjects that meet all criteria by using the “And” radio option. Alternatively you can find Subjects that meet at least one of the criterion by selecting the “Or” radio option.

Figure 1. Displays the Search user interface.  You can add as many search criteria as needed using the drop down selections.  Please note you can also select whether the criteria should work as an “And” or an “Or.”  (And = the results must meet ALL the criteria listed; Or = the results must meet at least one of the criterion.)

Upon clicking the “Apply” button at the bottom of the Search Subjects page, the results, if any, will populate on the Subject list page. Once that search has been applied, go back to Search Subjects and add a new Search and enter new criteria. Click “Apply” again to apply the new criteria on top of the previously applied search, further filtering the Subject population. The layering of searches will always operate as an “or”, meaning that results will be returned if it meets Search 1’s criteria OR Search 2’s criteria.
Any applied Search or Searches can also be layered with Reports. After applying your search(es), click on Reports. The Report results will only display those Subjects that were part of the Search results. Questions? For more information on this and other EDC & CTMS solutions please contact us.

Lessons from SCDM 2017: The changing role of Data Managers in EDC-driven studies

Prelude recently presented at the Society of Clinical Data Manager’s Annual Conference held in Orlando, Florida. Alicia Browner, Ph.D., our CTO, was joined on a speaking panel by Karen Lane, Ph.D. from John Hopkins University and Jess Wofford, DVM from Aratana Therapeutics. Together, they provided an overview of the changing role of Data Managers in a technology-infused clinical trial environment. For those that did not have the opportunity to attend, we would like to share some of the key points presented:

  • Early engagement of the data manager(s) for an EDC-implemented study is imperative – especially in the initial phases of electronic study development and design. Data managers are experts for cleaning data, quality-controlling data input and entry, and are invaluable in testing an EDC system against data capture compliance and regulations and adherence to protocol.
  • One of the roles of data managers is to become the knowledgeable advisor that can look at the EDC critically and leverage all of it’s functionality to clean data as it is entered, in real-time. This is achieved through automatic edit checks, custom calculations and algorithms. All this reduces the amount of monitoring necessary and improves the quality of the data.
  • When it comes to monitoring, the data managers are instrumental in identifying risk within the study. If risk-based monitoring will be implemented, the data managers could help identify areas in which there might be a protocol deviation, where data might not be entered contemporaneously and how that might be monitored. Data managers could find what fields should be strategically scrutinized to ensure patient safety. This includes requiring certain users to be automatically notified if certain criteria are met and how to identify fraudulent data or deal with missing data.
  • Data managers can also influence day to day operations by helping the team understand and use other EDC functionality such as inventory management, automatic reordering, invoicing, document management, and more. These automated functions can streamline operations while improving data quality dramatically – definitely a winning strategy!

During the panel, Karen Lane of John Hopkins University shared how they used the system to track performance and enrollment metrics. One graph showed the significant increase of efficiency they experienced in enrollment when they moved to EDC. They also created a friendly competition among sites to encourage enrollment and had a dashboard where sites could quickly view their ranking. The result was a dramatic improvement in enrollment.

 

Jess Wofford of Aratana Therapeutics shared their lessons learned in adopting EDC. One issue they had previously experienced was that sites used different units of measurement for weight and the subsequent human errors in converting those to a consistent unit. They solved this with EDC by enabling the sites to select only lbs or kgs and the system automatically calculating the conversions (lbs to kgs and vice versa.) While this might sound simple, it really was genius; some scales measuring in lbs read out both lbs and ounces while others provide lbs with decimal points. To account for this two text fields were provided in the EDC. The fields for lbs could be used to enter whole lbs or lbs with decimals depending on what the scale displayed, and for those scales showing ounces, the information was entered into the corresponding field. (See Figure 1) This was extremely helpful in helping accurately track the weight.
Figure 1. Body weight measurements and automatic conversions.

Aratana also took advantage of the EDC capability which hides forms once they’ve been signed off. Why is this so important? It helps to reduce bias when conducting repeated measures. During the session, Dr. Wofford also mentioned that they added a function where the monitor could make the form reappear if there was an outstanding query so the query could be answered and resolved. They thought of everything!

We greatly appreciate Aratana’s Dr. Wofford and Johns Hopkins’ Dr. Lane for sharing their experiences and providing lessons learned from their own perspective and illustrating the importance of the data manager role in EDC-driven studies. One thing is clear from the presentation: Data Managers can serve a crucial role in the development, design and risk assessment of EDC-driven clinical studies and we at Prelude look forward to working alongside DMs to deliver study data capture that is clean, accurate, risk-averse and quality-driven.