Course Description:
This course presents the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The expectations of the FDA, the sponsor and the site are covered. Participants are exposed to the process of site selection, budgeting, initiation visits, source documentation, regulatory documentation, and adverse event reporting. The use of tracking tools for compliance, screened and valid patients, product accountability and medical record review are also covered.
Prerequisite(s):
"Good Clinical Practices" or equivalent course or experience.
Applies Towards the Following Certificate(s) & Award(s):
Accrediting Associations:
CA BRN/LVN Credit - Provider #CEP13114 21.0 Hours
Sections:
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0608 - 042
Clinical Trials Site Monitoring I
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Status:
Available
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Section Note(s):Early Enrollment Fee: ($675 through Sept. 3).
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.
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For Credit
2.0 Units
Fri
2:00PM
to
6:00PM
Sep 17, 2010
Sat
9:00AM
to
5:00PM
Sep 25, 2010
to Oct 02, 2010
Fri
2:00PM
to
6:00PM
Oct 08, 2010
Number of Sessions:
4
Recommended Text(s):
None
| Tuition: |
$750.00 |
| Early Enrollment |
$675.00
|
|
Method of Instruction:
CLASSROOM
Campus:
SANTA CLARA
|
| |
|
| |
0608 - 043
Clinical Trials Site Monitoring I
|
Status:
Available
|
| |
Section Note(s):Early Enrollment Fee: ($675 through Jan. 7).
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.
|
|
| |
For Credit
2.0 Units
Fri
2:00PM
to
6:00PM
Jan 21, 2011
Sat
9:00AM
to
5:00PM
Jan 29, 2011
to Feb 05, 2011
Fri
2:00PM
to
6:00PM
Feb 11, 2011
Number of Sessions:
4
Recommended Text(s):
None
| Tuition: |
$750.00 |
| Early Enrollment |
$675.00
|
|
Method of Instruction:
CLASSROOM
Campus:
SANTA CLARA
|
| |
|
| |
0608 - 044
Clinical Trials Site Monitoring I
|
Status:
Available
|
| |
Section Note(s):Early Enrollment Fee: ($675 through Apr. 22).
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.
|
|
| |
For Credit
2.0 Units
Fri
2:00PM
to
6:00PM
May 06, 2011
Sat
9:00AM
to
5:00PM
May 14, 2011
to May 21, 2011
Fri
2:00PM
to
6:00PM
May 27, 2011
Number of Sessions:
4
Recommended Text(s):
None
| Tuition: |
$750.00 |
| Early Enrollment |
$675.00
|
|
Method of Instruction:
CLASSROOM
Campus:
SANTA CLARA
|
| |
|
|
