While returning home from the MAGI East 2015 Conference, I happened upon an article about time management. The article offered the observation by psychologist Guy Winch that people who are chronically late for meetings typically suffer from “. . . blind spots in the calculation of time. They’ll figure out how long it takes to drive from point A to point B, but they won’t account for the time needed to leave their apartment, get to the parking lot, and get in their call. Small-ticket items add up, causing them to be late.”[i] The article seemed particularly timely.
In more than one session at the conference, either in those I presented or attended, there was discussion about the disparity between how much time is budgeted by a sponsor to complete various protocol required procedures versus the actual time required.
Discussions like those above are necessary and beneficial for maintaining a healthy relationship between Sponsors, CROs, and Investigative Sites. However, talking simply is not enough. So let me offer a solution.
The solution is to conduct a time study. Developed by Frederick Winslow Taylor, the principals and processes for performing a time study are detailed in his book The Principles of Scientific Management.[ii] Applying this to clinical research, a study is done in which those responsible for performing the individual procedures and tasks required by the protocol (including other study documentation such as the lab manual, eCRFs, training materials, Informed Consent Form (ICF), and monitoring plan) perform “mock” procedures, capturing the actual time required under real-world conditions to conduct the series of tasks required to complete the procedures. When done properly, a time study provides a realistic view of the time and effort required to conduct the procedures as they would be performed in an actual clinical research site setting.