Inheriting a study from an outgoing Clinical Research Associate (CRA) or Clinical Trial Manager (CTM) happens frequently in the Clinical Research industry. If you have been involved with a study transition, you know that it can be a challenge for the incoming team member – and for the research team as a whole.
Replacing a key team member who has been part of a study from the beginning and is an expert on the protocol can negatively impact the study and/or slow the study’s progress. The incoming team member has to learn every aspect of the study, decipher someone else’s notes and/or past study decisions, and jump right in so that the study stays on track and within budget. This is not an easy task!
However, there are things an incoming CRA or CTM can do to make the study transition run smoothly, quickly get up to speed, and put the Sponsor’s mind at ease that everything is under control.
In this article, we focus on the CRA and CTM roles, but the study transition scenario is common for any role in a research study.
What is a study transition?
A study transition occurs when someone leaves a research team before a study is complete and a different individual inherits the outgoing person’s role.
There are many reasons someone may not be with a research study for its entirety. However, the high turnover rate in Clinical Research is contributing to study transitions becoming more commonplace.
Ideally, a study handover takes about two weeks and involves the outgoing and incoming team members working together to provide all of the important information, documents, and resources pertaining to the study. Study transition calls are usually more frequent during this time period to ensure the incoming team member is well-versed on the trial. The new team member is expected to use this as an opportunity to ask questions and become familiar with the ins and outs of the study, key players, and upcoming deliverables.
When a two week study transition is not possible and there is only one opportunity for the new team member to meet with the outgoing personnel, it is even more important to get all of the essential details about the study. Knowing what questions are the most integral to ask is key!
Why study transitions are important
If you have been part of a study transition that went well and a study transition that did not go well, you understand the importance of the process!
The difference between an effective study transition versus an ineffective study transition (or no study transition at all) is immense. It has the potential to make or break a study.
A productive study transition can positively impact a study when the new team member:
- Has all or most of the essential background knowledge
- Knows where to look or who to ask for information
- Receives access to all of the files, contacts, SOPs, systems, etc.
- Is well-versed in the protocol, timelines, and deliverables
- Uses all of the above to continue moving the study forward with little to no delay
An unproductive study transition can negatively impact a study when the new team member:
- Has to spend a lot of time finding study information by reading files and digging through notes or emails (written or sent by other people)
- Does not have the resources and contacts they need
- May not have access to the necessary files, SOPs, and systems
- Spends a considerable amount of time on all of the above, which takes them away from learning the protocol, onboarding with the team, and moving the study forward
Since the three overall goals for every CRA and CTM on each study are providing high-quality results, on time, and within budget, productive study transitions are of utmost importance to their success.
Learn more about study transitions in the CTM Training Course
This article offers great information and helpful tips about study transitions (so keep reading!) If you would like to go more in depth about study transitions and other important parts of the Clinical Trial Manager role, ClinEssentials offers a CTM Training Course!
The course focuses on key strategies CTMs use to manage a study from Start-Up to Close-Out! Click here to learn more about CTM Training, register for the current course (if available), or sign up for the waitlist for the next course.
Through professional guidance, learning proven methods, access to top-notch resources, and practical application, you will gain the confidence you need so you feel prepared to tackle anything that comes your way as a CTM!
7 steps to a successful research study transition
Your goal, whether you are outgoing or incoming, is to have a successful study transition! There are specific ways to make this happen.
Start the study transition as soon as possible by following these steps:
- Schedule a meeting (or multiple meetings) between the outgoing and incoming team members.
- If you are outgoing, send the incoming team member the study protocol and any other information that can be reviewed in advance. If you are incoming, request the study protocol, study plans, the last Sponsor meeting minutes (if you are a CTM) or the last monitoring visit report and follow-up letter (if you are a CRA.)
- Gather the questions you would like to ask. Your company may have an official transition document, however it can be lengthy and not ask pertinent questions. Use a free robust Study Transition Checklist to help supplement your company’s transition document! Access your free checklists here.
- Prepare for the meeting.
- Take good notes.
- Ask clarifying questions.
- Schedule follow up meetings with other team members (as needed.)
These steps will help you reach your goal for an effective, efficient study transition that will set you – or the person taking your role – up for success from the start!
How a study transition can go wrong
It is easy for a study transition to go wrong! Even though the importance of the study transition process is obvious, external, unavoidable factors can easily present themselves.
Here are 4 reasons a study transition can go wrong:
- The official handover does not happen
- The outgoing and/or incoming personnel is not prepared for the study transition
- The incoming personnel does not know what questions to ask
- The outgoing personnel does not have answers to the questions asked
Unfortunately, the factors that can lead to a failed study transition cannot always be controlled. However, be proactive and do what you can to make your study transition a success!
What to do when a study transition is not successful
When a study transition is not successful, there are still things that can be done to help keep the study running.
5 ways an outgoing team member can help an incoming team member without an official study transition:
- Leave detailed notes
- Make sure the incoming personnel has access to all of the necessary information and systems
- Provide a list of important contacts and resources
- Meet with current team members so that everyone is as updated as possible
- Invite the incoming team member to contact you via email or phone
This situation happens quite often when there is not a back up team member identified prior to the outgoing team member’s departure from the trial.
5 things an incoming team member can do without an official study transition
- Block time on your calendar to review all of the information provided
- Keep a running list of questions – and determine who may have the answers
- Clarify expectations, timelines, deliverables, etc. with management
- Schedule meetings with current team members to get to know them, ask questions about the study, etc.
- Don’t be afraid to ask for help!
What to do if a study is off track
Studies can get off track and it can be challenging to figure out where things went wrong and how to fix it – especially for new team members. When a study is failing and the team is not making progress in attempts to save it, you may need help from an outside, neutral source.
Luckily, Study Rescue is a service offered by ClinEssentials. Industry experts determine where the study went wrong, figure out how it can be corrected, and formulate an action plan. You can learn more about Study Rescue and sign up here.
If and when possible, it is important to successfully transition a study to the new CRA or CTM. It makes a world of difference for the research team and the study as a whole.
Don’t forget to use the free resources that are available!
What tips and tricks do you have for CRAs and CTMs who are working through a study transition?