Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs)are research professionals whose main responsibilities are to adhere to clinical trial protocol and assuring subject safety in clinical trials. One of the first things that CRA’s/CRC’s learn are fundamental industry standards, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Thanks to the guidance that these standards offer, CRA’s/CRC’s can effectively oversee and resolve many situations in translational research. However, CRA’s/CRC’s sometimes discount the fact that their training and understanding of ICH GCP is not enough. There are some things, however, that training does not teach. For example, Human Subject Protection training teaches clinical research professionals how to protect the subject from harm but does not teach them that bilateral communication is the first way to prevent the harm. In addition to familiarity with the clinical protocol, clinical research professionals must possess the ability to communicate articulately. Good communication is critical to productive work and error prevention in research.
Communication is not only used to exchange information but also to voice reservations and inquiries. In fact, most protocol deviations can be prevented when CRA’s/CRC’s express their concerns to others. But, some get so accustomed to following the standard operating procedures (SOPs) established by sponsors, guidelines created by institutional review boards (IRB) and regulatory agencies, that they hesitate to ask a question just because it seems unimportant or diverges from the sponsor’s, IRB’s, and regulatory agencies’ standards. Although CRA-CRC communication is pivotal in clinical research, they are not the only ones who share this responsibility. All parties involved in clinical research are responsible for communicating candidly. Choose to be a part of a research team that doesn’t have any past regrets because its members carefully examine each material presented before them and openly communicate to one another.
It is then necessary to note two things. First, each Sponsor has its own SOP. SOPs differ from organization to organization, so, CRA’s /CRC’s should not make choices based on their previous learning experiences because what they learned may not apply to every situation or organization thereafter. Second, they may feel cautious seeking clarification because they may think that the inquiry is trivial but in truth, what may seem as a senseless question or concern may actually be very significant. For instance, a clinical research coordinator may read a certain page in a protocol and understand that the investigational product (IP) needs to be administered once daily after meals, but the principal investigator (PI) reads the same page and understands that the IP needs to be administered two times a day. Both the CRC and PI read the same page but understand two different things. If the coordinator follows the PI’s instructions of administering the dose two times a day and does not question the PI’s interpretation of the protocol, the situation can result in a major safety deviation. The CRC not only failed to fulfill his or her duties, but may have put the study or the research subject at risk. Bear in mind that humans both read and write the research protocol. Communication is vital in issuing protocol review and changes the way the clinical trial is performed. If the same question or concern is asked various times across multiple research sites, a protocol review will be initiated by the sponsor. Research staff, especially CRA’s/CRC’s whose main responsibilities are enforcing subject safety and maintaining quality research data must voice their concern. A concern that is not promptly externalized through communication can result in a major protocol violation, including adverse effects on subjects or lost clinical data. Unlike the CRC in the example, a CRC should not hesitate to voice his or her concerns before taking their next step. If he/she is unsure about a certain matter, it should be probed for more information, asking as many questions as needed, until a clear explanation is available. The choices clinical research professionals make can have irreversible consequences.
It is a good idea for a CRA/CRC to be as explicit and elaborate as possible when asking questions and providing answers. This will assist him or her in understanding and communicating consistent and straightforward information. It falls upon CRA’s/CRC’s to act as the initial communicators and mediators between sponsors and study subjects. For example, research subjects would ideally follow all the instructions set by the clinical trial protocol but in reality, research subjects deal with real-life issues, such as unexpected situations and family concerns. Therefore, in a clinical trial, a research subject may end up taking the investigational product two times instead of three. When events like these take place, communication is imperative. Besides robust communication skills, it is crucial for CRAs/CRCs to uphold a strong communication channel between other members of the clinical trial protocol team and collaborators. Indeed, the key to fruitful results in research is a strong, communicative bilateral relationship between CRA and CRC. Keeping the CRA-CRC communication channel continuously open will ensure team cooperation and support, especially regarding the safety of the research subject. Clinical research professionals should remember that they work with human lives and subject safety is always first priority.
In conclusion, good communication is key to almost all aspects of research.
Author: Saul Alvarez, Gomez CRS-CCRC, CRS-CCRA, Research Professional. Site Director
Collaborator: Laiyen Suarez, Regulatory Coordinator.
The author’s years of experience as a CCRC/CCRA and project manager has taught him that it is better to speak up than to regret a mistake later. The author encourages all CRA/CRCs to become meticulous workers and bold communicators. There are several ways to become a CRA/CRC but there is only one way to become an exceptional CRA/CRC: Good Communication.
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