Working in clinical trials is akin to operating in a prism, in the sense that different people have different angles on the same item or issue, advises Steve Pope, MSHS, CCRP, senior clinical research associate with PRA Health Sciences. It’s especially true when looking at the world through the eyes of a study coordinator or a trial statistician, he notes.
“They are looking at things with different perspectives,” Pope says, making it vital to ensure everyone understands clearly the roles and viewpoints of everyone on the data management team.
The objective of a clinical trial is to collect quality clinical data that can be used to show efficacy and safety, Pope notes. The challenge becomes evident when it’s time to handle data queries, he says.
Coordinators and monitors will improve their job performance—and the overall trial—if they make an effort to “walk in the shoes” of the other professional when raising and addressing queries, Pope says.
For example, he suggests that when responding to a query, the respondent answer in the actual response section of the form, and at the same time indicate “what you did to respond so that [later the] data team knows what to look for,” he says. Otherwise, they have to fish around to find the information in two different places. “It’s very helpful” and saves both time and efficiency, Pope adds.
Without clear guidance, it can be a challenge for “coordinators because they don’t always understand different types of queries,” Pope says.
He’ll offer insights and proven tips on data quality for study coordinators and monitors at a May session of the ACRP 2021 virtual conference.
Author: Michael Causey