Today’s guest post is written by Stacey Carmody, a clinical research coordinator. It discusses what you can expect to go through from a research clinic’s perspective, when a PI leaves your site for any reason. Thank you Stacey and any others who would like to contribute articles please email me dan@southcoastclinicaltrials.com

When a PI Leaves: Surviving the Transition

-Stacey Carmody, CCRP

I had been a clinical research coordinator with the same principal investigator for over a decade. Then, with little warning, a bombshell was dropped: I learned that this principal investigator was leaving his position at the site.

Aside from all the sad emotions you experience when an enduring professional relationship ends, there is the also feeling of crisis, and the feeling of “What do I do next?” Transitions are not easy. I would like to share what I learned from my experience and give tips for getting through what will be a chaotic period.

Firstly, call a meeting. If possible, meet with your departing PI along with the sub-investigators and other research staff. Come up with a plan about who will assume the role as PI. The quicker you have a new PI in place, the better. Make sure the new PI knows the studies throughly and knows all the responsibilities that come with being a PI. Conducting a study without a PI in place is not only prohibited, but can spell disaster for your participants and anyone else involved. Studies must have PI oversight at all times!

Let the sponsors know. The sponsors of your studies selected your site partly based on your PI’s experience and credentials, so a change in PI is a huge deal to them. You want to let your sponsors know right away about the change in PI and you must be willing to supply any information they want to know about the new PI (CV, licence, clinical trials experience, etc) . They will need to give their approval for the new PI. If the sponsor approves the new PI, get the approval in writing, as you’ll need to give this to your IRB. Work with the sponsors to get the appropriate regulatory paperwork changed from the outgoing PI’s name to the new PI’s name. Many papers will need this change such as the contract, the 1572, the consent forms and central lab reports. The delegation logs in your regulatory binders will have to reflect the change in PI as well. And, of course, your study subjects will need to be informed of the change.

Contact your IRB. When I got the news that my PI was leaving, I contacted my IRB the next day. I needed to know what kind of paperwork I had to submit . If your outgoing PI needs to sign any IRB paperwork, if possible, obtain the signatures before he or she leaves. Also, if possible , obtain a signed letter from the outgoing PI denoting the date of departure from the site, the reason for departure, and the date the new PI took over. If it is not possible to get a letter , then make a note to file with this information. It is important that you document that the studies have oversight from a PI and that there is not a “gap” between PI’s when the studies are in progress.

Meet with the new PI often. This will be a transitional for him or her, and we all know how much PI’s depend on us coordinators! Be there to help with any questions regarding the conduct of the studies and keep the PI abreast of any communication from the sponsors, and set up meetings with the study monitors/CRA’s so communication will flow and the transition will go smoother.

Lastly, don’t panic. And have a plan. I know that is easier said than done! But keeping calm and focused makes a big difference. It also helps to have a plan in place in case your PI leaves unexpectedly. Even if your PI seems like a permanent fixture, you never know when life will throw a curve. It is a good idea to keep a list of what steps to take and who to contact. Preparedness makes all the difference. The dust will settle in time.