Streamlining The Workflow of CRCs: Understand the Challenges, Provide Solutions

By Shruthi Bommireddy, Business Development Associate, Forte Research Systems

Clinical Research Coordinators (CRCs) play a crucial role at sites in ensuring that research is conducted in a GCP-compliant manner. They must balance multiple responsibilities while guiding the performance of clinical research activities. In many cases, processes could be streamlined to foster greater efficiency and quality in operations. In order to improve the processes, the challenges of current workflows must first be understood.

The following are insights that I have gained from my professional experience as a Clinical Research Associate prior to joining Forte. As a CRA, I interacted with several CRCs at about 12 individual sites.

CRCs are typically busy throughout the day with various activities that include:

•     Pre-screening subjects for the Principal Investigator's review
•     Assisting with the recruitment of subjects
•     Planning and preparing for subject visits
•     Conducting subject visits while ensuring protocol compliance
•     Assisting with source documentation
•     Managing study supplies and Investigational Product (IP) accountability
•     Completing case report forms (CRFs) and resolving queries
•     Maintaining and updating several tracking tools for visits, finances, etc.
•     Submitting data and reports to the IRB/EC
•     Maintaining the Investigator Site file

Tasked with so many duties on a daily basis, CRCs may feel overwhelmed. The fact that many CRCs work on multiple protocols makes it all the more challenging for them to be efficient and compliant. A CRC's role can be very demanding, time consuming, and stressful.

The reason for this is the lack of processes that help them function in a systematic and organized manner. The consequences of having to work in such an environment are clear — spending many hours retrieving information, working extra hours to catch up on other important activities, not being adequately prepared for monitoring visits, and compliance issues.

Let's take a closer look at the typical day of a CRC:

• A CRC takes about an hour or more when each subject is registered to calculate all the planned dates for the future visits (in the absence of Interactive Voice Response Systems (IVRS) providing that information). These dates (whether from IVRS printouts or manually calculated) are transcribed onto a paper grid or spreadsheet and reviewed on a daily basis. Many CRCs confess that there are occasional slip-ups as a result of their busy schedules and not having the subject contact information handy.
• Given that a typical CRC works on multiple protocols, on the day before the visit, the CRC spends half an hour or more reading the protocol to take notes on what needs to happen in that particular visit.
• During the subject visit, the CRC refers to these notes as the procedures are completed and the subject is taken to the PI for a consultation, during which assessments are made and the drug is administered.
• Depending on the form of the drug, the CRCs spend at least 45 minutes calculating IP accountability percentages.
• After the subject leaves, source documentation is completed and CRFs are entered with available data. Source documentation is completed based on the notes taken by the CRC during the visit, and many times the information is not transcribed accurately or thoroughly due to time constraints. CRF completion is often delayed and creates a lot of pressure on the days leading up to the monitoring visit.
• At the end of the day, the finance tracker is updated, which takes about four hours or more of the CRC's time per week. This is then sent to the PI for review. In spite of the PI reviewing it, there are usually discrepancies between invoiced and received amounts, which take additional time to reconcile.

In this environment, it's difficult for a CRC to handle more than two subject visits per day. The time required for the above adds up to two to three hours per subject visit. 

The Solution

There is plenty of room for process improvement in the daily tasks of CRCs. Streamlining operations can reduce stress and help CRCs to be more productive and efficient. This can be done with the use of an electronic Clinical Trial Management System (CTMS), which can automate several of the daily activities CRCs do on a daily basis. Below is a walkthrough of the tasks associated with study activity when a CRC uses one CTMS solution, Allegro CTMS@Site.

• A CRC takes about an hour or two to set up the protocol in the CTMS. This is a one-time activity that is done at the beginning of the study.
• Based on the setup, once a subject's first visit is marked as occurred, all the planned dates for the future visits are automatically generated and the calendar on the homepage is populated. The CRC no longer manually calculates the visit dates or creates a visit chart.
• The calendar lists all the subject visits that are upcoming for the next seven days along with the information of the protocol, the subject ID, the visit number, and the subject's contact information, making it easy to give reminder calls to the subjects. The calendar lists the visits from across the protocols that a CRC is handling so that all protocol visits can be managed from one system instead of referring to multiple visit trackers.
• During the subject visit, the CRC enters very minimal data on a single page, just five fields, that take as little as 30 seconds to fill out. This in turn accomplishes several tasks that would take hours to complete manually.
• Protocol compliance information is provided in the context of the visit in the form of re-consent alerts, and protocol procedures are displayed in the exact order in which they need to be completed, eliminating the need to refer to a protocol prior to the subject visit.
• Using an integrated CTMS eliminates the need to maintain subject visit trackers and finance trackers, or check on lab supplies, or spend numerous hours on IP accountability calculations. It also helps in gauging the CRC's readiness for a monitoring visit in terms of tracking CRF completion.

The CRC Experience with one CTMS

The numerous hours that are saved when a significant amount of the manual tracking is eliminated can be better used towards other tasks, such as source documentation, CRF completion and query resolution, IRB/EC submissions, maintaining the ISF, and more. Increased efficiency of CRCs with regards to visit management will mean more attention is given to other important study related activities, thereby, improving the quality of work at a site while creating a more manageable workload for CRCs.

Belgaum Diabetes Center in India has found greater efficiencies in operations with the use of Allegro CTMS@Site. Diwakar Reddy, CRC at Belgaum, has experienced a more streamlined workflow in several areas, including documentation of patient visit activity. "Allegro eases the life of a CRC to a great extent," he said. "From Patient Registries to Deviation Records, it has made the documentation on site a lot easier than before by keeping it all in one place."

Speaking about Subject Visit Conduct, Diwakar added, "Allegro not only tracks the Subject Visit Schedule but also keeps track of Drug Accountability, Protocol Compliance and Consent Status with enhanced availability. The backbone of Allegro is its skillful Financial Management and intelligent tracking of invoices for all the visit procedures conducted on site."

Allegro CTMS@Site has also eased the workload of CRCs at Bangalore Diabetes Hospital. "It helps us in Patient Management, Patient Visit Management, Supplies Management and Finance Management," said Divya Lakshman, CRC at Bangalore Diabetes Hospital. "It gives us accurate information about the patient conveyance, PI and Co-I, payment invoices to be raised, etc. We are also easily able to prepare the protocol calendar.

Overall, "it is a very good system for site management," Lakshman added.