No clinical trial can begin until a protocol has been written, and no clinical trial is complete until the final report is assembled, signed, and submitted to the FDA. Good documentation for clinical trials must be clear and scientifically sound, and it must conform to instructions. This course provides an overview of key regulatory documents; their central purpose and content; and the regulations and/or procedures that govern them. Students will also have the opportunity to review, write, and discuss different aspects of regulatory documents. The course is intended for individuals who want to start or further a career in clinical research as most members of a clinical research team are asked to write, review, or edit these regulatory documents.
Note: Elective for Professional Certificate in Clinical Trials Design and Management.
PREREQUISITES: Medical Terminology, Drug Development Process, and GCP courses, or proven experience or mastery of content.
Course Number: FPM-40685
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management, Medical Writing
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6/26/2023 - 9/16/2023
$645
Online
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CLASS TYPE:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Mikyas, Yeshi
Dr. Yeshi Mikyas has 23 years experience in different areas of clinical trial conduct (academic and industry setting), with 16 years specifically in Medical Writing. She earned her BSc in Biology and PhD in Molecular Biology and Medical Pharmacology from UCLA. Her Medical Writing experience includes the preparation of regulatory and safety documents, and journal articles, reviews, abstracts, and presentations. Yeshi is currently the Senior Director, Medical Writing at Pfizer overseeing the preparation of regulatory documents for submission and disclosure. She has been involved with the UCSD Extension Medical Writing program since 2015, and has led the Regulatory Writing Capstone since its first offering in 2017. She is passionate about empowering and encouraging ...Read More
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NOTE:
***STUDENTS MAY ENROLL ANYTIME IN QUARTER, until JULY
14, 2023. Students must complete course by SEPTEMBER 1
6, 2023, regardless of date of enrollment***Refund dead
line: one week after enrollment or start date of sectio
n, whichever is later.
***No Textbook Required***
6/26/2023 - 9/16/2023
extensioncanvas.ucsd.edu
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
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9/25/2023 - 12/16/2023
$645
Online
-
-
-
CLASS TYPE:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Mikyas, Yeshi
Dr. Yeshi Mikyas has 23 years experience in different areas of clinical trial conduct (academic and industry setting), with 16 years specifically in Medical Writing. She earned her BSc in Biology and PhD in Molecular Biology and Medical Pharmacology from UCLA. Her Medical Writing experience includes the preparation of regulatory and safety documents, and journal articles, reviews, abstracts, and presentations. Yeshi is currently the Senior Director, Medical Writing at Pfizer overseeing the preparation of regulatory documents for submission and disclosure. She has been involved with the UCSD Extension Medical Writing program since 2015, and has led the Regulatory Writing Capstone since its first offering in 2017. She is passionate about empowering and encouraging ...Read More
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-
-
NOTE:
***STUDENTS MAY ENROLL ANYTIME IN QUARTER, until OCTOBER 2, 2023. Students must complete course by DECEMBER 16, 2023, regardless of date of enrollment***
Refund deadline: one week after enrollment or start date of section, whichever is later.
9/25/2023 - 12/16/2023
extensioncanvas.ucsd.edu
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or unexhealthcare@ucsd.edu for information about when this course will be offered again.