Is this course right for me?

This course is for you if you manage clinical trials and want to achieve better quality and inspection readiness of your trial. When you enrol in the course, you will be able to ask questions you have on the content and get your responses to the exercises reviewed by the instructor.

  • You want to understand the requirements of GCP with regards to oversight of vendors

  • You feel overwhelmed by the amount of work, resources and documentation required to demonstrate adequate oversight of a clinical trial and that seem to compete with budget and timelines priorities set by senior management

  • You are looking for ways to prioritise your work to focus on what really matters to the success of the trial

  • You are looking for practical advice (this course includes a case-study, an exercise workbook and a customisable oversight cheat sheet!)

  • You either work for a sponsor company or you work for a vendor and want to understand what the regulators require of sponsors so you can improve the quality of the service you provide

  • You are looking for a course that includes a test and a completion certificate

Course curriculum

  • 1

    Welcome to the Clinical Trials Oversight Course!

    • How to use this course?

    • Before we begin...

    • Case Study and Workbook to Download

    • Introduction - Meet the team

  • 2

    Module 1: why do we need oversight?

    • Why do we need oversight?
  • 3

    Module 2: establishing a risk-based oversight strategy

    • Establishing a risk-based oversight strategy

    • Copy of Case Study and Workbook to Download

  • 4

    Module 3: selecting and assessing vendors

    • Vendor selection and assessment
  • 5

    Module 4: developing the sponsor-vendor relationship and setting expectations

    • Developing the sponsor-vendor relationship and setting expectations
  • 6

    Module 5: overseeing start-up activities

    • Overseeing start-up activities

    • Oversight Cheat Sheet
  • 7

    Module 6: overseeing the study conduct

    • Overseeing the study conduct

    • Oversight Cheat Sheet

  • 8

    Module 7: measuring performance and managing issues

    • Measuring performance and managing issues
  • 9

    Module 8: documenting oversight

    • Documenting oversight
  • 10

    Completion

    • Congratulations!

    • Test

    • Before you go...

Course Developed by

Hello, I am Mallorie Mitchell-Dellac!

I am the owner of Good Clinical People Ltd. I am a Clinical Quality Expert with 20 years’ experience in GCP Quality/Compliance and Clinical Operations. I have worked for sponsor companies, CROs and Academic Research Organisations. I am passionate about fostering consistent compliant behaviours and giving GCP guidance to the clinical study teams I support. I hope you enjoy the GCP course and tips you find on this site!

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Access to education is really important to me, as is the quality of clinical research, which I have dedicated my career to. This is why I am making this course free for all.

FAQ

  • What is included in the course?

    The course contains a series of presentations covering all aspects of clinical trial oversight. I have developed a case study and a workbook that you can download to write your answers to the exercises. You also get your copy of the clinical trial oversight cheat sheet I have developed and that you can customise and use in your clinical trials. When you complete the course, you get a certificate that you will be able to file in your training records. And last, but not least, you get access to me as a clinical quality expert with over 20 years' experience in the clinical research industry.

  • Will I be able to ask questions on the content of the course or the exercises?

    Yes! When you enrol in the course, you will have access to me as your instructor. You can raise questions using the discussion mode in each module or email me any questions you have. If you want, I will also review your answers to the exercises. How cool is that?

  • Can I enrol now and complete the course at a later time?

    Absolutely! Once you enrol in the course, you can complete each module in your own time.

  • Is there a limit of time to complete the course?

    There isn't. Once you are enrolled in the course, you have lifetime access. That includes access to any updates I make to the course and any new download I release.

  • How much time does the course require?

    Each module requires less than 30 minutes of work each day.

Bonus material

This is not just theoretical training. The following is included in the course:

  • Case Study & Workbook

    Put the course lessons into practice with a real-life example and exercises in each module. The workbook allows you to capture your exercise notes.

  • Customisable oversight cheat sheet

    Download the clinical trials oversight cheat sheet. It contains suggestions on how to oversee very task delegated to a vendor from the beginning to the end of the trial. It can be customised for your clinical trials.

  • Access to the instructor

    Ask questions as you progress through the course using the discussion mode. Get your exercise workbook reviewed by the instructor.

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You can choose to make a single payment or pay the course over a 3 months period.