- Course introduction (00:00:08)
- Additional resources (00:00:05)
- Research Continuity During COVID-19 (00:00:49)
- Speakers (00:00:41)
Clinical Trials During COVID-19
$49.00
This video lecture discusses the impact of COVID-19 on clinical trials, potential pathways and modifications needed to run a successful trial and how new technologies can assist in moving forward.
Description
Why take this course
This course addresses the impact of the COVID-19 on clinical trials. What are the potential modifications, the key regulatory guidance and how to use technology to guarantee continuity.
What I will learn
In this course, we discuss the struggles of conducting a clinical trial during the COVID-19 pandemic, getting know the key guidance released by Competent Authorities.
Skills I will gain
- You will find out how to do a risk assessment of your trial, considering the participants safety
- You will gain insight on the regulatory guidance created by EMA, MHRA and FDA especially for trials during this pandemic
- You will learn how to use technology to your advantage (remote monitoring, enrollment, informed consent)
TOPICS
- Impact On Clinical Trials (00:00:25)
- Major Disruption (00:00:50)
- EMA: Who They Are (00:00:48)
- EMA Regulatory Guidance (00:01:18)
- MHRA: Who They Are (00:00:58)
- MHRA Regulatory Guidance (00:02:46)
- FDA: Who They Are (00:00:51)
- FDA Regulatory Guidance (00:01:52)
- Regulatory guidance summarized – pt. 1 (00:00:43)
- Regulatory guidance summarized – pt. 2 (00:00:35)
- Trial Assessment (00:00:39)
- Tiered Approach (00:00:31)
- If continued enrollment or engagement is required (00:01:00)
- If the trial will be halted (00:00:31)
- In Any Scenario (00:00:20)
- Thinking in and outside the box – pt. 1 (00:00:51)
- Thinking in and outside the box – pt. 2 (00:00:39)
- Assessing tools and suppliers (00:01:06)
- How Meditrial Fits In (00:01:20)
- What meditrial is doing in the COVID-19 fight – pt. 1 (00:00:59)
- What meditrial is doing in the COVID-19 fight – pt. 2 (00:01:18)
Additional information
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1 review for Clinical Trials During COVID-19
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Sara (verified owner) –
Very useful!