The Cutting Edge

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:

1. Planning:

• Clinical site monitors should review the trial protocol and other relevant documents to understand the specific objectives and requirements of the clinical trial.
• Clinical site monitors should communicate with the clinical site to schedule the monitoring visit and provide the site with any necessary information and documents.
• Clinical site monitors should prepare any necessary monitoring tools and forms, such as case report forms and data monitoring tools.

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:

1. Planning:

• The clinical site monitor reviews the trial protocol and other relevant documents to understand the specific objectives and requirements of the clinical trial.
• The clinical site monitor communicates with the clinical site to schedule the monitoring visit and provides the site with any necessary information and documents.
• The clinical site monitor prepares any necessary monitoring tools and forms, such as case report forms and data monitoring tools.

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:

1. Planning:

• The clinical site monitor develops a Clinical Monitoring Plan (CMP) based on the trial protocol and GCP guidelines.
• The clinical site monitor reviews the CMP to ensure that it is comprehensive and in compliance with GCP guidelines.
• The clinical site monitor submits the CMP for review and approval by the sponsor or appropriate oversight body.
• Once the CMP is approved, the clinical site monitor communicates with the clinical site to schedule the monitoring visit and provides the site with any necessary information and documents.
• The clinical site monitor prepares any necessary monitoring tools and forms, such as case report forms and data monitoring tools.

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:

• You tell a bot to change the visit schedule in your protocol, and it makes the changes in all relevant sections.
• You give a bot your protocol, and it writes an informed consent form.
• You type in a prompt about the system you are validating, and the bot drafts a validation summary report.
• You tell a bot to add a new Data Management Plan version to the training curriculum, and it adds it for all relevant roles.

We’re not over our skis – this technology is here now, and it will be exciting to see how it is applied.