Written by Nicole M. Palmer and John R. Nocero

If you’ve been keeping up with the weather in Florida, hurricane Ian was a category 5, which brought high winds and heavy rainfall that resulted in flooding and power outages. Several homes and businesses have been destroyed.

When it comes to hurricanes, there’s a lot of preparation that needs to be done before a tropical storm hits. It’s important to follow instructions from the local officials to ensure that you remain safe. The contents in your home or business are just things, but YOU are irreplaceable.

This got me thinking about the people who contribute to the Trial Master File (TMF). Some TMFs look like they have been through a hurricane and others are beautiful like a pot of gold at the end of a rainbow. The ones that have robust Standard Operating Procedures (SOP) and Working Instructions (WI) which aren’t dusty but are often referenced and followed. Where FDA guidelines are taken into consideration and ICH-GCP is followed.

+If you want to be successful and be TMF “GOLD” it’s imperative to be properly onboarded by your company’s organization by being trained on their SOPs and WI. This is your organization’s manual, and it should teach you how the company operates. Next, you should be properly trained on ICH-GCP and be familiar with the FDA’s current way of thinking on the guidelines and their recommendations.

-Don’t be the person who works in the TMF and comes in like a hurricane with high winds. You need a plan.

-Or the person who ignores the flooding of documents or files them in the wrong locations. Don’t ignore the warnings. There are warnings for a reason.

– Or worse a power outage -the person who doesn’t have appropriate permissions such as read/edit/delete. As an end result, you can’t find a document or don’t have permission to see it.

-Don’t be the hurricane that people talk about for years to come in a negative way.

What you DO want to do is, be proud of your work. Follow SOPs, FDA guidelines, ICH-GCP, and your local regulatory guidelines. Be the gold at the end of the rainbow. And set and follow a plan. If you don’t have one, make one.

When you start a new job, it’s important to know whom you can go to and ask questions. The person that you can TRUST that will give you gold advice.

It is so funny to me how many people do not know this or do this. Often we are expected to know everything, or we are judged for asking questions. I was talking with my boss the other day. I was telling him how you need visibility and people need to see what you do to be successful. You can no longer be the person who does their work behind the scenes…if you want to move up. You have to have people know what you are doing, and you have to make systems transferrable. How else can you move? I wonder – do people not teach anyone anymore?

I don’t know if they don’t teach, but people are definitely connected to what is in it for them. Things are moving so fast in many places that many people don’t think of this. It is why you need to come and be prepared for the ambiguity.

 I am lucky that I launched two professional development education initiatives here because we tried to address that gap. This is WHY is so important –WHY what you do is important here, WHY we do what is important.

Become TMF gold.

Become irreplaceable.

Remember your WHY. Don’t get caught in the storm. If you do, dance.