The TMF is the official record of the clinical study for Regulatory Authorities, be it…
CRAs with Key Soft Skills Leads to Honest Communication and Better Risk Management at Sites
Open communication with sites is essential to detect risks before they become an issue. According to a collaborative study conducted by CRO Analytics and ACRP, the majority of 300 sites surveyed expressed that frequent and open communication between Sites, Sponsors and CROs are the most important factor in clinical trial quality.
The ICH E6 R2 revision places more pressure on quality risk management plans and Sponsor oversight. A quality risk management plan is an excellent way to ensure risks are reported and escalated consistently and effectively throughout a study team and organization.
However, these plans may assume a level of communication frequency and openness whereby risks and concerns are flagged before an issue arises. In reality often, a risk may only be noticed after it has become an issue and impacted study data and/or subject safety.
Communication frequency has an easy fix: one can hold monthly study coordinator calls, biweekly CRA calls and send out frequent email blasts. On the other hand, ‘open’ communication is more difficult because certain CRA soft skills are overlooked as critical to the effectiveness of risk management.
With the right approach, and key soft skills a CRA can establish and maintain a good, team-player relationship with site personnel that encourages them to express concerns, no matter how seemingly minor, before they develop into a bigger issue.
Key Soft Skills CRAs Can Use to Their Sponsor’s Advantage
The following are a few of the soft skills Scimega CRAs employ on a regular basis to foster a productive relationship with site personnel. These skills are key to open communication and effective risk mitigation.
Language and tone matter. By staying positive and avoiding blame, CRAs focus on what can be done to rectify a situation and propose improvements to prevent recurrence. This approach is helpful and encouraging: creating a safe-space for site personnel to report mistakes or minor concerns, where they know that their disclosures will be met with a desire to ameliorate the situation.
Keeping up morale with the study team is also a great motivator for all those involved. This can be fostered through simple gestures, such as sending the data coordinator a congratulatory email (and copying the PI) to thank them for answering all queries ahead of a deadline.
Most Scimega CRAs have experience working at an investigative site. This first-hand knowledge is invaluable to understanding the challenges faced by site personnel. Rather than a lot of back-and-forth, a CRA who knows how site personnel may see a situation can anticipate their perspective, concerns and objections and will more often than not provide a complete answer to any questions right away. This saves time and avoids frustration for everyone. Empathy also builds trust, and promotes honest communication.
Every site has slight nuances in the way they operate. An important building block to a good relationship is a willingness to understand and adapt to these particularities. For instance, site personnel appreciate it when a CRA learns how the site team is organized and thereby contacts the correct team member with a certain request or inquiry. Saving everyone time.
In addition, site personnel notice and appreciate when a CRA communicates with them according to the site’s schedule. If a phone call is needed to check in on potential patients, the afternoon or morning after a clinic day might be the best time. Perhaps a study coordinator sets aside an administrative day every week and therefore appreciates an email on that particular morning to remind them of the data entry and/or queries in need of their attention.
By making a conscious effort to adapt to site personnel preferences, a CRA is seen as an understanding team-player. As a result, site personnel are more likely to reciprocate by communicating their needs and any concerns that could become a study risk if not addressed in a timely, efficient manner.
Monitoring visits are a crucial time to evaluate site compliance with protocol and regulatory requirements as well as protection of patient safety and well-being. These in-person settings are also an opportunity to build rapport with site personnel.
In between monitoring visits, site personnel notice when their calls and emails are prioritized. If a CRA makes themselves available when they are needed, site personnel recognize how easy it is to approach the CRA and are more likely to contact them regularly in return.
More than Meets the Eye
Extraordinary CRAs have skills beyond what appears on their resumé. These soft skills lead to team coherence between the CRA and site personnel.
As a result, the CRA is seen as helpful and available to collaborate and troubleshoot. In this sort of environment, concerns or misunderstandings can come up in conversation, and be addressed before there is an impact on data quality and/or study participant safety.
A quality risk management plan is only ever as good as the CRAs involved in assuring it is effectively implemented on an ongoing basis with their site personnel colleagues – working together to assure the quality of the Sponsor’s clinical trial.