Improving Study Communications for Clinical Research Teams

by | Dec 6, 2021 | CRA/CRC Tools, CROs & Sponsors | 0 comments

Clinical Research Associates (CRAs) are often thought of as “the glue that holds a study together.” While their work on a clinical trial is more behind-the-scenes and less visible, CRAs offer significant contributions to the success of the trial.

Since most clinical trials involve many different people who may or may not work at the trial site, effective communication is essential for success. CRAs have an opportunity to design and implement a communications plan to be utilized by all members of the clinical team. 

The Importance of Communication for Clinical Research Teams

Clinical research teams share a common purpose and goal: conducting a clinical study that stays in compliance and produces quality results on time and within budget. 

A good clinical research team is one in which team members have a shared understanding, mutual expectations, aligned commitment, and trust. 

Communication is the foundation for these vital factors that lead to successful clinical research teams. 

Communication is a two-way process that requires a common understanding. Teams that openly communicate, listen, ask questions, and agree to the action steps are better equipped for goal accomplishment.

Read more in this article from Clinical Trials Arena.

Benefits of Effective Communication for Clinical Research Teams

The best CRAs build relationships and maintain close communication with the trial’s Sponsor or Clinical Research Organization (CRO.) Since the CRA is the trial’s liaison between the Sponsor or CRO and the clinical research team, prioritizing these connections is important to this long-term relationship. 

While effective communication can start at the top, it is also the cornerstone of any and all clinical research teams. When a team is communicating well, there is a collective understanding of common goals. Knowledge sharing is a common practice among teams that communicate well. 

Additionally, a major benefit of effective team communication is that all team members feel valued. Teammates who feel in-the-know and appreciated are more connected to their work and more committed to their role on the team. 

Possible Consequences of Poor Communication 

The challenges caused by poor communication negatively impact a clinical research team and can be detrimental to a clinical trial.

Here are 5 possible consequences of poor communication in a clinical trial:

  1. Added stress
  1. Conflicts and relationship challenges among team members
  1. Decreased effectiveness, efficiency, and organization
  1. Increased opportunity for delays and inaccurate results
  1. Greater possibility of non-compliance

In most circumstances, poor communication and its effects can be avoided! With the proper planning and techniques, a CRA can set up their teams for communication success!

Read more in this article from SOCRA.

Using the Right Tools for Effective CRA Communication

These 6 tools will lead to more effective communication for CRAs and clinical research teams.

1. Thorough, detailed, strategic Communication Plans (CP)

A CP is an important tool for CRAs to create and use with each clinical research team. (CPs will be discussed in detail below.) 

2. Shared Drive / Dropbox / Portal 

Storing the information for a trial in a secure place that all team members can access keeps everyone on the same page. Keeping the file folders neatly organized helps team members find the information they need.

3. Online Calendars and/or Scheduling Tools 

Online calendars are useful so team members can access each other’s schedules. Another option is to utilize an online scheduling tool to avoid multiple calls, texts or emails to schedule a meeting. 

4. Emails

Communicating via email rather than through text or messenger makes it easier to find and refer to the conversations. Email is a way to copy anyone who may need the information discussed. 

A Pro Tip is for the team to use the trial name as the beginning of the subject line so that everyone knows which trial the email is regarding. If something is time sensitive, “URGENT” can be typed first in the subject line.

5. Phone Calls

As hard as it can be to pick up the phone, sometimes a phone conversation can result in a question answered or a decision reached in far less time than multiple back-and-forth emails. 

A phone call can be particularly helpful when working through a disagreement or other sensitive matter.

6. CRA Audit Notes

ClinEssentials created a variety of CRA Audit Notes designed to help Clinical Research Professionals communicate more effectively. These adhesive notepads have headers that are color-coded with industry phrases. 

Through the use of CRA Audit Notes, teams have a better understanding of the action items and next steps. Each Audit Note includes a check box to mark when a task is complete. 

The Action Item Carbonless Pads are particularly helpful for CRAs and clinical research teams because the CRA can keep one copy and give the other to the team. CRA Audit Notes have become an extremely effective communication tool among teams that use them for their trials.

Read more about best practices for clinical research team communication in this article from Clinical Trials Arena.

Using a Communications Plan to Establish Effective Communication

A comprehensive CP will help CRAs initiate effective communication from the start of a research trial! A CP should be simple, easy-to-navigate, and should be read and understood by all members of the clinical research team. 

What Sections Does Your Communications Plan Need?

Providing the following information in writing will assist with maintaining compliance.

  1. Clear expectations, objectives, and goals
  2. Team Roster with well-defined roles and responsibilities
  3. Org Chart that includes the proper channels for communications
  4. Standard formatting, content, and methods of communication
  5. Discussion of issue identification, escalation documentation, corrective actions, and resolution

Defining Expectations for Productive, Efficient Team Meetings

Defining expectations for team meetings and including this information in a CP will help avoid an abundance of time-consuming meetings when little is accomplished. 

1. Limit Attendance to Necessary Participants

Meetings should only include people who are actually needed.

2. Agendas

An agenda should be written for each meeting and sent to participants in advance to allow time for preparation. Each participant is expected to be ready to share or present about their section of the agenda. 

The meeting should stick to the agenda, using time limitations if/when needed.

3. Minutes

Minutes should be written and distributed as soon as possible after a meeting concludes. The minutes should include discussions, action items, and who is responsible for any assigned tasks. 

Outlining communication tools, skills, and methods will show the team what is important and expected. Study success will ensue when everyone on a clinical research team is on board with the CP. 

It is the CRA’s responsibility to lead the CP, make it a priority, stick to it, and ultimately show team members how the CP is setting their team up for success.

Improved Study Communication Starts with the CRA!

As leaders of the clinical research team, CRAs are responsible for improving study communications. There are substantial benefits for teams that communicate effectively, and the benefits will be showcased with successful, compliant, reliable research studies. 

Developing a CP to use from the start is most advantageous, but making changes to improve communication can happen at any time. Whether it’s CRA Audit Notes, updated meeting formats, or a scheduling tool, CRAs just have to take the time to communicate about communications! 

If you have a tool or method that resulted in improved communications with your clinical research teams, we’d love to hear about it! Please comment below. 


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