CT: Clinical Study Implementation and Management

Examine the elements involved in implementing and monitoring a clinical study from the sponsor's point of view. Topics include finalizing the study materials; site selection; staffing and training; strategies for communicating with sites, regulators, and others; cost management; site initiation; enrollment options; data management set-up and testing; monitoring procedures and training; auditing; safety monitoring; reports; and the Data and Safety Monitoring Board (DSMB).

Other Credits: BRN: 16 CE hours.

Note: Prerequesites: Drug Development Process, Good Clinical Practices, and Human Subjects Protection/IRBS. Elective for Professional Certificate in Clinical Trials Design and Management.

Course Number: FPM-40229
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management

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4/8/2024 - 6/2/2024

$525

Online

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• SECTION ID:

  179630

• 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.

• INSTRUCTOR:
  

  Paredes Solis, Jenny, Senior Manager, Clinical Operations, PRA Health Sciences

  Jenny Paredes has been working in clinical research for over 20 years. She currently provides Clinical Consulting in Clinical Research for companies in Latin America and the USA.  She worked in the CRO environment for 14 years where she held various roles as CRA, LCRA, CTM/PM, Clinical Operations Manager and Country Lead. She has experience working on Phase I-IV studies in multiple therapeutic areas. Additionally, she has vast knowledge in Monitoring, Regulatory, and Quality, which she is passionate about. Jenny holds a B. A, M.A and Ph.D in Psychology from Atlantic University in Hawaii as well as an Associate’s Degree in Medical Health Science from Mount St Mary's College in Los Angeles CA. Some of her various hobbies include traveling, reading and going to the...Read More

• TEXTBOOKS:

  No textbook required.

• POLICIES:

• NOTE:

  Refund deadline: one week after enrollment or start date of section, whichever is later.

• DATE & LOCATION:

  4/8/2024 - 6/2/2024
  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.