Like many people, I’ve been entertaining myself over the past week playing around with the newly-release ChatGPT artificial intelligence bot. For example, I asked it to write a limerick about skiing, and I got this gem:
There once was a skier name Pete Whose turns were quite tricky to beat He glided with grace Down the slopes at high pace And left all the others to eat his ski feet!
The last line doesn’t scan at all, but I like it, and I’m sure I will think of it every time my husband, Pete, passes me on the slopes this winter.
I decided to give the bot some work tasks, too. I typed in the following prompt: “Write a Standard Operating Procedure for clinical site monitoring. Include sections for objective, scope, roles and responsibilities, and procedure. In the Procedure section, divide it into subsections for Planning, Monitoring Visits, and Follow-Up. Include all relevant elements of site monitoring as referenced in Good Clinical Practice.” The chat bot returned a passable SOP with all the requested sections, starting with, “The objective of this Standard Operating Procedure (SOP) is to establish a consistent approach for clinical site monitoring in accordance with Good Clinical Practice (GCP) guidelines. This SOP outlines the roles and responsibilities of clinical site monitors and the procedure for planning, conducting, and following up on clinical site monitoring visits.” A pretty good start!
The “Planning” section was as follows:
Next, I asked, “Same request, but instead of using the construction ‘clinical site monitors should…’ Change it to ‘The clinical site monitor finalizes…’ or similar.” The section was rewritten as follows:
Then, I prompted, “Same request, but add some steps to the Planning section to include development, review, and approval of a Clinical Monitoring Plan,” resulting in the following:
Still a bit clunky – CRAs don’t typically prepare case report forms for on-site monitoring visits – but the bot effortlessly handled the aspect of SOP writing that most people struggle with: the writing part.
Unclear writing is a contributing cause of almost every deviation I’ve ever worked on. Poorly-written protocols, SOPs, specifications, plans, manuals, and informed consent forms lead to deviations. As discussed in previous blog posts, writers struggle with structure, concision, and consistency. Imagine:
We’re not over our skis – this technology is here now, and it will be exciting to see how it is applied.