So I got asked a great question today from a researcher out there who shall remain anonymous. He asked what he can do when he is promised one study from a sponsor, but is given another with a smaller budget. In this video I break down his question piece by piece and get into some suggestions that I hope other research professionals out there can benefit from.
Posts tagged physician
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 firstname.lastname@example.org
When a PI Leaves: Surviving the Transition
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.
Don shares some valuable information for how he personally approaches physicians when he is recruiting study participants for clinical trials. Let us know what your strategies are, and also if Don forgot to mention anything. Don also shares how he recruits from residential facilities as well as in the community at large. Watch this video so that the next time you go out there and recruit for clinical trials, you don’t get the door smashed in your face!
Don received a question from a viewer out there who would like to expand his clinical trial research company from one site into three sites. He asked Don for some advice in regards to the best ways to go about doing this efficiently. Don and Dan thought it would be great to do a video on this subject in order to help this viewers and any other viewers who may be interested in planning the future of their clinical trial business.