Kick-off meeting provides the opportunity to both the sponsor and CRO organizations to come together and develop a shared vision toward the project. Its purpose is to develop a plan and nailing down all the high level details. They make discussions about the project from startups to completion.
Study projects can last for years depending upon the criteria of the project. This is the reason why the kick-off meeting last longer for four to ten hour to discuss all the vital aspects of the project.
The meetings can occur at specified spots, hotels or in the headquarters of the sponsors. The CRO representatives go to the sponsor’s headquarters where all the discussions are made during the meeting.
It is also important to volunteer the representatives who are going to represent their organizations in the meeting from both CRO and sponsor side. The company representatives can be global clinical operation person, lead CRAs, managers, directors, clinical project leader, clinical trial manager, clinical operation leader, data management person, vendor person, regulatory affair person, TMF person and various other responsible persons. Kick-off meeting includes all the personalities who are going to play an important role in the managements of the project and study trials.
During the meeting, the representatives make discussions as follows:-
1. Goals and objectives of the project.
2. Development plans.
3. Clinical monitoring plans, strategies, monitoring calls.
4. Sites contracts and feasibility criteria.
6. Protocols for the study.
7. Training plans for the study and SOPs.
8. Communication plans for the exchange of information, ideas, emails and documents.
9. Milestones for the sponsors.
10. TMF management plans.
Vendor management and their responsibilities.