3. Clinical Sites

Question 1

According to the GCP who is responsible for the selection of a suitable site?

Answer 1

The Sponsor (often helped by CRO)

Question 2

Name 4 site related relevant costs (7)

Answer 2

1. Initiation
2. Traveling
3. Recruiting & Retention
4. Training
5. Monitoring
6. Labor
7. Contractors / Vendors for equipment and consumables

Question 3

Name 4 Site selection criteria (8)

Answer 3

1. Geographical Location
2. Strength of Patient Database
3. Regulatory Timelines
4. Secure and ambient storage areas
5. Competing trials that might interfere
6. Experience in conducting trials
7. Workloads of trial vs capacity of site (manpower)
8. Estimated costs per completed participant