BIOT2100
GOOD CLINICAL PRACTICE
- Department
- Biotechnology
- Terms offered
- 1
- Data refreshed
- Jun 27, 2026
Description
The course will provide an overview of the stages and fundamentals of Good Clinical Practice (GCP), which is recognized globally as a standard and ethical way of testing human subjects. During the course, students will learn relevant US FDA regulations for GCP which meets the guideline from the Society of Quality Assurance (SQA). Other guidelines from agencies such as ICH or ISO will be discussed. Students will be presented a comprehensive view of the GCP practices in human clinical trials and the auditing process of parties and sites involved in the clinical study.
Syllabi
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Offering history & forecast 2024
2024
| Year | Fall | Spring | Summer | Intersession |
|---|---|---|---|---|
| 2030 | 2030 Fall: not enough history to forecast. | 2030 Spring: not enough history to forecast. | 2030 Summer: not enough history to forecast. | 2030 Intersession: not enough history to forecast. |
| 2029 | 2029 Fall: not enough history to forecast. | 2029 Spring: not enough history to forecast. | 2029 Summer: not enough history to forecast. | 2029 Intersession: not enough history to forecast. |
| 2028 | 2028 Fall: not enough history to forecast. | 2028 Spring: not enough history to forecast. | 2028 Summer: not enough history to forecast. | 2028 Intersession: not enough history to forecast. |
| 2027 | 2027 Fall: not enough history to forecast. | 2027 Spring: not enough history to forecast. | 2027 Summer: not enough history to forecast. | 2027 Intersession: not enough history to forecast. |
| 2024 | Not offered | 1 section | Not offered | Not offered |
Future estimates combine recent offering frequency with detected multi-year cycles. Hover a cell for confidence and evidence; low-confidence estimates are marked with ~.
Meeting times
Most recent firstNo meeting times recorded for this course.
| Term | Professor | Type | Credits | Enrollment | CRN |
|---|---|---|---|---|---|
| Spring 2024 | Bernadette M. Bowen | Online | 1 | 2 of 12 enrolled | 33209 |