Читать книгу Project Management in Clinical Trials - Alexey Levashov - Страница 7

Scope means the volume of work to be performed to complete the project successfully and associated effort. It depends on many variables including but not limited to:

1. Therapeutic area and indication;

2. The number and list of countries;

3. The number and list of sites;

4. The number of patients to be enrolled;

5. Screen failure rate;

6. Full service versus clinical part only;

7. The number of vendors.

Normally these macroparameters are defined by the sponsor, but the problem is that originally they are not always defined correctly, especially in conjunction with timelines and quality (cost is defined by the CRO). Often the CRO has more experience in the given therapeutic area and indication and is able to assess better, for example, the number of sites necessary to complete patient enrollment on time. The CRO Project Manager’s capability to challenge the sponsor’s assumptions wherever needed is a trait of professionalism: the Project Manager is not supposed to be a “say-yes-to-all” person. Of course, different specialists and subject matter experts help the Project Manager in defining the project scope and challenging the client’s assumptions – clinical trials are a team game.