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 the study was completed with good clinical practice (GCP) principals and by qualified individuals. There are many details and deadlines to track, from subject visit windows to document expiration dates and institutional review board (IRB) reporting deadlines.
With a CTMS, you can create and save documents within the system and enter expiration dates and triggers, allowing you to keep up with your data automatically. Housing all of your data in one place, a CTMS lets you pull reports and compile information so you remain compliant. Imagine being able to give your IRB and sponsor a report showing the entire list of deviations or reportable adverse events.
2. Answering queries in a timely fashion
Task management at research sites can be daunting. Coordinators often 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 allows 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
Typically, 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 investigational product (IP) electronically decreases the opportunity for errors. A CTMS tracks and assists in the IP process. With good reporting tools, you see at a glance what is 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 a CTMS can assist the “spread too thin” research coordinator. 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.
Editor’s note: This article was originally published on August 30, 2016.
To learn more about how a CTMS can help your site function more efficiently, download our free eBook, “How to Increase Site Productivity with a CTMS.”