Study coordinators are an integral part of successful clinical trials. Taking steps to help them work more efficiently can significantly increase the success of your clinical research site. A robust clinical trial management system (CTMS) has the ability to make a large improvement in your study coordinator’s workflows.
Here are five common challenges a CTMS can help coordinators combat on the job:
1. Maintaining accurate and complete source documents, regulatory documents and task management.
The paper trail for clinical research is critical to ensuring that the study was completed with good clinical practice principals and by qualified individuals. There are many details and deadlines to track, from subject visit windows to document expiration dates and IRB reporting deadlines.
With a CTMS, you can create and save documents within the system and enter expiration dates and triggers that allow you to keep up with your data automatically. A CTMS houses all of your data in one place, and lets you pull reports and compile information so you remain compliant. Imagine being able to give your IRB and sponsor a report that shows the entire list of deviations or reportable adverse events.
2. Answering queries in a timely fashion.
Task management at research sites can be daunting. Often, coordinators spend precious time locating and updating spreadsheets from each study. A CTMS provides instant visibility into all tasks related to a protocol, without needing to refer to multiple folders, binders and documents. The daily schedule and task list is all in one location, saving valuable time and promoting compliance.
Using a CTMS to house your protocol calendars, subject visits and financials means less time is needed to search for the necessary information. This allots more time for coordinators to do other parts of their job, such as answering queries in a timely fashion.
3. Knowing when subjects need to sign a revised consent.
Frequently, a consent revision will come along after your site has enrolled a number of patients. The new consent may include information critical to already enrolled subjects, such as additional visits or procedures. Rather than manually entering a reminder in your calendar for each patient, a CTMS allows you to track all of your regulatory items in one place. It also triggers a reminder to notify coordinators on a per-patient basis when re-consent is needed.
4. Tracking investigational drugs and devices.
Entering and dispensing the IP electronically decreases the opportunity for errors. A CTMS tracks your investigational product and assists the IP process. With good reporting tools, you can see at a glance what you have on hand and avoid dispensing outdated IP.
5. Speeding up patient recruitment and study enrollment.
Along with tracking all your documents and subjects in one place, a CTMS allows you to track your recruitment efforts in the same location. Some systems allow you to track your patient recruitment initiatives and capture the efforts from start to finish. This provides visibility into what efforts are working or why recruitment is falling short.
There are dozens of ways that a CTMS can assist the “spread too thin” research coordinator and sites. Other ways include effort tracking, error reduction and financials management. A CTMS also allows a research site to standardize its procedures across studies and personnel.
To learn more about how a CTMS can help your site function more efficiently, download the free eBook, “How to Increase Site Productivity with a CTMS.”