A drug trial sponsor insists that a database of study results be locked for analysis even though the data managers know queries remain unresolved. A poorly printed informed consent form leads to an inspection finding of protocol deviations for every subject enrolled in a study at a particular site. An amendment to a protocol that is not shared with the full study team is not noticed by key members until nearly four weeks into the study’s conduct.
These were some of the real-world examples of the perils and pitfalls of miscommunication in clinical research settings shared by the presenters of a session on “Effective Communication Strategies to Drive Program Success” at the ACRP 2017 Meeting & Expo in Seattle on April 29.
Because participant safety and investigational products’ success are at stake, Katharine Garrett, CCRA, a contract monitor with Garrett Monitoring Services, and Louis Grue, RN, BSN, CCRA, a clinical project manager with Leidos Biomedical Research, Inc., urged attendees to focus their communications about research projects on:
- Listening actively
- Being attentive and observant
- Using common language and definitions
- Responding in a timely manner
- Closing the loop (acknowledging the completion of the work and saying “thank you”)
Such tactics are all the more important in light of a survey of clinical researchers Garrett and Grue conducted recently that found 62% of more than 200 respondents favored e-mail communication with their colleagues, 74% admit to multitasking on other chores while engaged in teleconferences, and 40% had experienced a large, negative impact on a project due to miscommunication of some sort.
Author: Gary Cramer