Why Clinical Trials Begin with a Project Kick-Off Meeting (KOM)

by | Sep 13, 2023 | Clinical Research Associates, Clinical Trial Managers, CROs & Sponsors, Tips for Research Professionals | 0 comments

Congratulations: you have been awarded a new study! 

You made it through Request for Proposal (RFP) and Bid Defense (BD). The Statement of Work (SOW) has been executed, and Project Resourcing is underway. 

You are fully immersed in the hectic phase of Study Initiation (also called Study Start-Up) and are ready to take on the next step: the Kick-Off Meeting (KOM).

However, there is still so much to do. Do you really need to have a Kick-Off Meeting?

YES! (That is typed in bold, capital letters for a reason!)

The Project Kick-Off Meeting is an essential one-time meeting during which core representatives from the Sponsor and Clinical Research Organization (CRO) discuss study goals, timelines, and next steps for study activation. The KOM allows the team to meet one another and prepare for a successful trial start.

Continue reading to learn more about Kick-Off Meetings, who is involved, the expected outcomes, and why planning a KOM is a helpful experience for aspiring and new Clinical Trial Managers (CTMs). 

What is a Kick-Off Meeting?

A Kick-Off Meeting is typically an in-person meeting that occurs after Study Award during the Study Initiation phase. The CRO Clinical Trial Manager (CTM) works with their Sponsor representative (likely another CTM or Project Manager) to create an agenda, and the Sponsor approves the agenda and slide deck before the KOM.

Representatives from the Sponsor and CRO are invited to attend the KOM. This is often the first time team members get to meet one another.

The agenda includes presentations on various important topics for the new study. Attendees learn about the study rationale, expectations, timelines, core document status, feasibility, etc. A Medical Monitor may be invited to present on study indication or the role of medical monitoring. 

One goal for KOMs is to clearly communicate the information the team must know about the study and how to move forward with its activation. 

Which roles are typically included in a KOM?

Many roles from the Sponsor and CRO sides are invited to attend a Kick-Off Meeting. In addition, some individuals are also asked to present part of the agenda.

The following research team members from the Sponsor are typically invited to attend a KOM:

  • Clinical Trial Manager (CTM)
  • Clinical Trial Assistant (CTA)
  • Regulatory
  • Medical Monitoring
  • Data Management (DM)
  • Project Manager (PM) or Clinical Operations Director

The following research team members from the CRO are also invited to attend a KOM:

  • Clinical Trial Manager 
  • Clinical Trial Assistant 
  • Regulatory
  • Study Start-Up Associate 
  • Medical Monitoring
  • Data Management 
  • Project Manager or Clinical Operations Director

The abovementioned is a general list, and individuals in other roles may be included based on the study. Also, remember that job titles are not universal. A company may have a different name for the job titles listed in this article or not have the role at all (e.g., Study Start-Up Associate).

What are the primary outcomes of a KOM?

Generally, a Kick-Off Meeting aims to familiarize key study team members with each other and with a new clinical trial, provide information about the protocol, timelines, etc., and determine the next steps for study activation. 

There are four primary outcomes that most KOMs are expected to deliver.

  1. Meeting minutes
    A meeting attendee (often the CTA) is usually assigned to take minutes. It is important to capture each study decision made, accurately summarize the discussion, and outline all the next steps. 

    It is also helpful if the minutes include a list of questions asked, their answers, and if follow-up is needed. 

    Minutes are distributed to the attendees after the Kick-Off Meeting. Again, this helps keep the team cohesive by sharing the same information with everyone involved and ensuring all are aware of key decisions and their action items.
  1. Study Decision Log
    It is a best practice to create a Study Decision Log to keep major study decisions in a central location for future reference. 

    If a Study Decision Log is not created before a Kick-Off Meeting, the log should be started during the KOM when important decisions are made.

    The Study Decision Log should be kept up to date for the remainder of the study.
  1. Clear communication of study goals, timelines, and next steps
    Effective communication with key study team members begins at the Kick-Off Meeting. 

    A slide deck that is easy to read and understand is the best way to communicate information, including study goals, timelines, and action items. Speakers who excel at providing engaging presentations and discussing their slides clearly and concisely will keep attendees focused and interested. 

    All attendees should leave the meeting knowing the study protocol, their expectations, and the next steps to move toward study activation. 
  1. Motivation and excitement
    The Kick-Off Meeting is an exciting time! A team of professionals is coming together to research a potential medication or device that will improve lives in the future. 

    This outcome is important. The hope is that KOM attendees leave the meeting feeling excited, inspired, and motivated. Then, they are ready to jump in and face the challenges of a new clinical trial. 

    Think about it. If the presentation is dry, the information about the study is unclear, and the energy in the room is lacking, the attendees probably won’t feel compelled to push the trial forward actively.

    However, if the presentation is enthusiastic, the information about the study is understandable, and the room is lively and energized, the attendees are more likely to feel committed and passionate about the new trial. 

Kick-Off Meetings are successful when these four outcomes are delivered. If you attended or planned a KOM, what positive takeaway would you incorporate in your next KOM? On the flip side, is there an example of something that didn’t work that you’d ensure not to include?

Why is it helpful to get experience planning a KOM?

Clinical Research Professionals who want to grow in the industry can take advantage of opportunities to gain different experiences. Being involved with planning a Kick-Off Meeting is an example of a beneficial experience, especially if you aspire to be a Clinical Trial Manager. Here’s why:

Clinical Trial Managers are responsible for planning and hosting KOMs. If you want to level up, ask a CTM to help them plan their next KOM. You can add this experience to your resume and use it as an example during interviews. You’ll also feel more comfortable when you become a new CTM knowing you have experience planning a KOM. 

ClinEssentials created a guide for research professionals about transitioning to the Clinical Trial Manager role. Get the FREE download and use the suggested steps to take the guessing game out of your career path to CTM. 

Planning a Kick-Off Meeting is one of the many topics discussed in the ClinEssentials CTM Training Course. As a participant, you’ll receive guidance and proven strategies to perform CTM responsibilities from Study Start-Up to Study Close-Out successfully. Planning a KOM is one of the practical activities we do as a group during the All Access + LIVE course. Click here to learn more about the CTM Training Course.

A well-planned Kick-Off Meeting makes a meaningful difference by setting the stage for a study and getting it started positively. 

Tiffany Ashton, MAS, CCRA, has over twenty years of experience as a Clinical Research Professional. Tiffany is the Director of Operations for ClinEssentials, a consultant in the Clinical Trial Manager role, and the expert instructor for the CTM Training Course.


Submit a Comment

Your email address will not be published. Required fields are marked *