Clinical Research Associates (CRAs) have a plethora of responsibilities for the clinical trials they manage. One of their main responsibilities is the management of action items. CRAs are accountable for documenting action items, notifying the clinical research team of action items, and following up to make sure action items are successfully completed. 

It becomes a challenge when there is a breakdown in the process and action items stay open too long. Luckily, there are techniques CRAs can use to manage action items and ensure they are closed quickly. 

The Definition of an Action Item

An action item, also called an “open issue,” is a task that comes up during or in between monitoring visits that cannot be immediately addressed and resolved. 

The CRA discusses action items with site staff, develops a plan for how action items will be addressed, and follows up to make sure the action item is closed. Ideally, the action items are resolved prior to the next monitoring visit.

How to Effectively Track Action Items

Site visits can be very fast-paced and busy to allow for monitoring, meetings, documentation, etc. If action items are not recorded as they come up, there is a risk that they will be overlooked or forgotten, which could cause the trial to be out of compliance. 

CRAs who develop a process for recording and tracking action items will be more successful at making sure the action items are closed quickly. 

Below are three ways CRAs can effectively track action items: 

1. Keep monitoring reports open and take notes.

Record activities that are completed and write notes as action items arise. Even information that seems obvious in the moment can be forgotten or overlooked as the day goes on. 

Read more about taking notes when monitoring in this article from Mass Device.

2. Record all action items in one place. 

A simple way to keep a monitoring visit efficient and organized is to keep all action items in one place. 

CRAs can create their own log or spreadsheet, but ClinEssentials Action Item Carbonless Pads take it a step further. At the end of a site visit, the CRA keeps one copy and leaves the other copy with the research team. 

Then, at the next site visit, reviewing the previous Action Item Log is part of the agenda. 

3. Project Management Software

Some CROs and Sponsors provide a Clinical Trial Management System that CRAs can use for tracking, reporting, measuring, and providing insights. 

5 Important Things to Include for Each Action Item

Regardless of how the action items are tracked, it is most helpful for everyone involved when the tracking includes all of the following information:

1. Action Item Date 
2. Description/Details
3. Person Responsible
4. Timeline
5. Status (Open/Closed)

This blog post from Octalsoft discusses action item management in great detail.

The Use of Monitoring Letters and Reports

Monitoring letters are an effective communication technique for CRAs and trial sites, and are most successful when they are sent both before and after a site visit.

Pre-Visit Monitoring Letter

Monitoring letters sent prior to a visit allow the CRA to set expectations for the visit. This sets the stage for an efficient and productive visit.

Pre-visit monitoring letters should include:

1. List of action items that will be discussed
2. Documents, forms, and records that will be reviewed
3. Specific people the CRA would like to meet with

Post-Visit Monitoring Report

Taking detailed notes during a site visit makes it easier to write the post-visit monitoring report. Also, writing the report soon after the site visit (and before visiting another site), ensures greater accuracy. 

While it is best to only include essential information that cannot be found elsewhere, monitoring reports should contain discussions about or actions meant to prevent issues from recurring.

All monitoring letters and reports should be sent via email and a hard copy should be filed. These documents can be used to show the FDA that the study followed the rules and regulations, was properly and continuously monitored, and all issues were promptly resolved.

Developing an Action Item Process

An effective action item process will make certain that action items are closed quickly. Since CRAs work on multiple trials at a time, it is easy for action items to remain open or even be forgotten. A process will help – and it is an important part of the job!

Example of a 5 Step Action Item Process

1. Write a Pre-Visit Monitoring Letter using the actions items from the previous visit.

2. Track action items with Action Item Carbonless Pads. Keep the Action Item Pad with you at each site visit. Before leaving, give a copy to the team.

3. Write a Post-Visit Monitoring Report using notes and action items.

4. Add calendar reminders for any action items that need to be completed before the next site visit.

5. If you are responsible for an action item, take the necessary steps to close it.

Developing Positive Relationships with CRAs and Site Staff

Positive relationships at work lead to greater job satisfaction. It’s easier to communicate with a boss you like and respect, and it’s more comfortable to ask for assistance or advice from a co-worker you consider to be your friend. 

These personal relationships are especially important for CRAs and clinical research teams who regularly interact but may not often see each other in person. CRAs need help from their clinical research teams and teams need help from the CRA. A functional team that communicates and is responsive to requests will be more effective at completing action items, which will lead to high-quality trials.

Read more about the importance of developing positive relationships in this article from Clinical Trial Podcast.

More Tools for Clinical Research Associates

For more tools that help Clinical Research Associates work more efficiently, visit the ClinEssentials webshop.

If you have an action item process that works well for your team, please comment below!