|
|
|
|
|
|
|
inadequate; this lost profit could be recovered later if the CRO brings the project back on schedule. Ultimately, the payment schedule and contract as a whole should target a win-win outcome for both sponsor and CRO. |
|
|
|
|
|
|
|
|
Upon formal authorization to begin work, the CRO must establish the project team. Frequently, core members of the team will already have been identified and introduced to the sponsor during the final selection process and the full complement of staff will become involved in accordance with the proposal as their support is required. |
|
|
|
|
|
|
|
|
An initial or project launch meeting which requires the active participation of key team members from both the sponsor and CRO is essential for project success. This session should result in a practical understanding of the following: |
|
|
|
 |
|
|
|
|
Features of an initial project launch meeting: |
|
|
|
|
|
|
|
|
the development status of the project under study, |
|
|
|
|
|
|
|
|
project scope and detailed plans for implementation, |
|
|
|
|
|
|
|
|
protocol and other study documents, |
|
|
|
|
|
|
|
|
assignments of responsibility and authority, |
|
|
|
|
|
|
|
|
regulatory requirements, |
|
|
|
|
|
|
|
|
time lines, |
|
|
|
|
|
|
|
|
contract terms (if agreed), |
|
|
|
|
|
|
|
|
lines and methods of communication, |
|
|
|
|
|
|
|
|
performance measures, |
|
|
|
|
|
|
|
|
team member training plans, |
|
|
|
|
|
|
|
|
operating procedures for key activities, such as serious adverse event reporting, clinical monitoring and data management guidelines, and criteria for releasing drug supply, |
|
|
|
|
|
|
|
|
reporting requirements, |
|
|
|
|
|
|
|
|
quality assurance plans, etc. |
|
|
|
|
|
|
|
|
In essence, the entire team must leave the meeting with a common recognition of objectives and how they will be achieved. |
|
|
|
|
|
|
|
|
In concert with the launch meeting or at another early point during project initiation, protocol-specific training should be provided to clinical monitors, data managers, and other critical members of the team. Medically qualified representatives from both the sponsor and CRO are often required to take a central role in this training. The clinical monitors, who will be interacting with study investigators, must have a good understanding of the disease or condition being treated, the product being evaluated, the types of data being collected, and any data review conventions or criteria which the data managers and statisticians will be using. Because data man- |
|
|
|
|
|