General Study Processes
Each study has different requirements, however most contain the following four parts:
1. Screening: Screening involves attending an appointment where a nurse and a doctor will assess whether or not a volunteer is eligible for a given study. This usually includes blood tests, an ECG, physical examination, questions about the volunteer's medical history, and weight and height measurements are taken. A urine sample for a drugs of abuse test isalso taken during the initial visit.
2. Eligibility: Eligibility is confirmed by the clinical team once all results are reported. Criteria for eligibility for each study varies according to the investigational product.
3. Inpatient Visits: This often involves volunteers staying overnight in the unit so the trial medication can be administered under controlled conditions. The unit's comfortable in-house facilities include TV, Sky, DVDs and Playstation. Meals are provided during the volunteer's stay.
4. Outpatient Visits: Most studies include outpatient visits where blood and/or urine samples may be taken in order to gather study data and ensure volunteer safety.
House rules: CCST requires all volunteers to comply with house rules during each visit to the unit. Dietary restrictions, e.g. no caffeine, can sometimes apply during studies. A volunteer information handout is available from CCST.
