Are You Taking Advantage of Prelude EDC’s CTMS?

Traditional Clinical Trial Management Systems (CTMS) are separately purchased tools that include a variety of features to help keep track of, plan and manage a study from beginning to end. They are sold to help manage multiple studies and typically do not include automated patient eCRF information. What information exists is redundantly, manually entered.

Prelude EDC includes integrated CTMS features that track the patient database so there is no extra work to keep up with the events and tasks of organizing and conducting a trial, before – during – after.  Even the end of study archives for prior completed projects can be retrieved and viewed.

Prelude EDC CTMS includes features like these, and more, with all the normal Prelude EDC role permissions and audit trails:

• Track and share protocols versions with text change controls and sign off.
• Track IRB submission documents from draft form to final approval through FDA concurrence.
• Document communications and visits with investigators, partners and vendors
• Track inventory and supply shipping information
• Facilitate budgeting and site payments allowing the generation and tracking of invoices
• Provide a searchable master list of sites to identify and evaluate potential sites for the most current study from sites that have participated in previous studies as well as assess (even self assess) potential new sites
• Generate metrics and reports for individual studies as well as aggregate across study information such as queries per site, time to query response, and current enrollment
• Provide a calendar scheduling function and task list tracking in order to help keep ongoing studies on track.

Prelude can provide a CTMS platform where one can access information on all studies done with Prelude EDC, or other EDC vendor files, and track new study development. You are probably using some of the features but may not yet be taking advantage of all of them. For example, have you ever accessed the Summaries for the patient and site level list pages? What do you have on the pages at the study level?  Here’s more details:

Certainly searching, reporting, statistics and graphing are the most common features you probably use to track the progress of the study and analyze patient study data. The patient status summary provides a by patient listing of all key study visit dates. The form and query status shows the number of forms per form state (in-work -> final) as well as the number of queries per case and the query age/status.

The site level query summary shows the total queries per site versus the unresolved queries making it evident which sites have the most queries, which opens the door to risk-based monitoring review of a site. The site form graph quickly provides a view of all form states at a given site. The site level enrollment graph provides an at a glance graph of current enrollment versus planned enrollment on a study and site level to help you quickly track study enrollment success. Ad hoc reports, statistics and graphs put customization and immediate access to information about the study at your fingertips on demand. These summaries are included with Prelude EDC for no extra cost.

Some clients might also be taking advantage of Prelude EDC’s invoicing feature, which automatically generates invoices for activities completed once the monitor reviews and signs off on each pertinent form. But did you know there is a study budget management section where you can keep track of the study’s complete budget, and payments to sites based on patient activity is automatically incorporated? Here you can access a listing of all invoices paid/unpaid, a form where you can track the study budget, view per site payments or per vendor payments. While not an accounting system, it does manage the budget at macro-levels where you can include information about each study and billing as the patients progressed..

Others are using Prelude EDC’s inventory management feature which tracks current and dispensed inventory as well as reconciles it. Some take advantage of the automatic re-ordering and notification feature. There is also a shipment tracking feature. Together these provide a full inventory management solution typical of any CTMS system.

Prelude EDC contains an extremely powerful document management tool. This allows specification of required documents to be uploaded at the patient, site or user level. It provides a summary of whether the documents have been uploaded as well as aggregates an easy to use summary of all documents tracking which have been collected or not collected. The summary provides hyperlinks to the actual documents (pdf, doc, xls, etc.) for quick access and the audit trail collects an audit trail on any document downloaded. This makes it easy to track who has downloaded the document for review. The document management module can be used to track and share things like protocol and amendments, CRF development, SOPs, documents that are shared with sites, communication with sites, patient documents and much more with the intent to eliminate paper-based site binders and provide a wealth of information in one easy to access portal for communicating vital information with sites.

The document management module can also be used to track document evolution and approval through different management levels and external groups such as FDA and IRB committees. Any unloaded version of the document can be accessed at any time.

Use the document management module at the user level to track credentials, curriculum vitae, and other site staff qualifications including expiration dates. Add notifications 30 days in advance of expiration in order to automatically be alerted about any certifications that are about to expire.

Prelude EDC also has the ability to help in qualifying and managing sites. Custom site pre-qualification forms can be integrated at the site level. A site inventory and assessment form can also be added as well as an on demand mid study monitoring visit form and close out form. Basically any information that is currently being collected on paper can be turned into an electronic form and included in Prelude EDC.

To enable full study planning, Prelude EDC offers a task list where tasks can be assigned to an individual user, scheduled to a calendar, and placed on their user level task list, individual or site calendar. Tasks can be marked as completed and time for task completion tracked. The task list can be used to track monitoring efforts and time by the monitors so metrics such as time to monitor per site can be analyzed and average queries per patient by study can be aggregated in the multi-study CTMS.  The study manager can track all study tasks in one location and review their completion by assigned staff at any time making study management more efficient.

With VISION 9, Prelude introduced the next patient event and expected date on the list page. Now you can view it on a site calendar or study level color coded by site calendar making it easy to quickly review upcoming patient visits. This helps monitors know when and how to monitor sites allowing them to better plan their daily activities.

These are just some of the many ways in which your current study contains see CTMS functions. By using all of Prelude EDC’s robust functionality you can manage your study more efficiently.

For those of you wanting the multi study CTMS functionality, Prelude can it set up. It would list all studies, contain a master site list which could be searched for inclusion in future studies and invited directly from within Prelude EDC. Once they accept the site demographics can be pushed to your new study. This master list can also be used to track new sites that might be included in future studies. A site level rating sheet contains information about previous studies and metrics such a total recruitment, total enrollment, total queries, average time to query resolution and queries per patient as well as a section for notes and rating of the overall site.

The multi study CTMS contains a task list with assignment and tracking capability as well as a calendaring function so important tasks and milestones can be tracked in order to ensure smooth study setup and operation. As with any Prelude EDC study custom forms can be added at the site, project, and user level to help manage your studies better. For example if there is a desire to track site personnel credentials and expirations within this system, we can set up that form and functionality. We can even import the users from prior studies. No other CTMS provides this level of flexible customization. Additionally, search, reporting, statistics and graphing of data allow complete control over analysis of all CTMS data fields. This is just another way Prelude helps you accelerate and streamline your clinical study operations.