Jennifer Lawyer
Comment Now! Enhancing the Diversity of ...

6/25/2019

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The Food and Drug Administration (FDA) released a draft guidance “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs”. It is the position of the FDA to enroll subjects who are the target audience for the investigational product once approved. Certain populations are underrepresented in clinical trials, even though they are part of the target audience. The draft guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).

Jennifer Lawyer
Introducing the DIGR-ACT® Solution! Part 5

6/20/2019

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What does ‘A’ stand for?

Don't waste time on root cause analysis, at least not if you won’t use the results! Proper root cause analysis takes effort and resources, and you need to use the output to determine actions to try to stop the issue recurring. This is the ‘A’ step of the DIGR-ACT® solution. Having dug into the issue, you now need to ‘Act’ on what you found.

Jennifer Lawyer
ICH Releases E8 “General Considerations for ...

6/11/2019

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Clinical trials have become increasingly complex since the ICH E8 guideline on “General Considerations for Clinical Trials” was finalized in 1997. The draft revision is in Step 2b and available for public comment, and there are some interesting changes to note. Specifically, there is a greater emphasis on patient centricity, design of trials with quality in mind, and risk management. The overlying theme is fit-for-purpose quality as an essential consideration for study design. The revision is part of the Good Clinical Practice (GCP) Renovation initiative. Previously, the ICH E6 GCP R2 addendum was finalized in 2016.

Jennifer Lawyer
Introducing the DIGR-ACT® Solution! Part 4

6/04/2019

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What does ‘R’ stand for?

We're all in a rush, and we want to fix issues quickly. But often, by assuming too much, we might reach the wrong conclusion. The cause that we used root cause analysis tools to discover is actually incorrect. Once we have the (wrong) cause(s), we may rush off and take action to fix it. But if it's the wrong cause, it is wasted effort and you rushed - only to go slow. Like if your taxi doesn't show, you might decide never to use that company again because they are unreliable - when the real problem was that you gave them the wrong pick-up address.

Jennifer Lawyer
Highlights from the Critical Thinking Webinar!

5/29/2019

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Did you miss the free live webinar on “Critical Thinking and Clinical Research – A Better Way”? Some key highlights of the training were:

  • What is critical thinking? To learn more about the seven critical thinking skills and how they relate to clinical research, sign up to view the recorded webinar here. DIGR-ACT® was built to support all of these.

  • Root Cause Analysis: There are many tools to find root cause, but they often lead down the wrong path, yielding inconsistent and ineffective results. For example, asking 5 Whys can result in different root cause depending on how the questions are asked, and what about other relevant questions such as who, what, where, when, and how?

Clinical Research

Comment Now! Enhancing the Diversity of Clinical Trial Populations (Draft Guidance)

6/25/2019

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The Food and Drug Administration (FDA) released a draft guidance “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs”. It is the position of the FDA to enroll subjects who are the target audience for the investigational product once approved. Certain populations are underrepresented in clinical trials, even though they are part of the target audience. The draft guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).

Introducing the DIGR-ACT® Solution! Part 5

6/20/2019

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What does ‘A’ stand for?

Don't waste time on root cause analysis, at least not if you won’t use the results! Proper root cause analysis takes effort and resources, and you need to use the output to determine actions to try to stop the issue recurring. This is the ‘A’ step of the DIGR-ACT® solution. Having dug into the issue, you now need to ‘Act’ on what you found.

June NC East/RTP SoCRA Meeting, Workforce Gaps Post RBM: It is Time to “DIG” in!

5/30/2019

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Clinical Research Professionals of North Carolina (a chapter of SoCRA also referred to as NC East or the RTP chapter)

Locations: For more information, click here.

Date: June 3, 2019

Time: 6:00 – 7:00 EDT

Topic: Workforce Gaps Post RBM: It is Time to “DIG” in!

Description:

Highlights from the Critical Thinking Webinar!

5/29/2019

-

Did you miss the free live webinar on “Critical Thinking and Clinical Research – A Better Way”? Some key highlights of the training were:

  • What is critical thinking? To learn more about the seven critical thinking skills and how they relate to clinical research, sign up to view the recorded webinar here. DIGR-ACT® was built to support all of these.

  • Root Cause Analysis: There are many tools to find root cause, but they often lead down the wrong path, yielding inconsistent and ineffective results. For example, asking 5 Whys can result in different root cause depending on how the questions are asked, and what about other relevant questions such as who, what, where, when, and how?

The Importance of Public Speaking in Clinical Research

5/21/2019

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Effective Public speaking is integral to clinical research education/ communication. It impacts every aspect of study conduct.

  • The investigator educates the study patient on trial participation (via the informed consent) with an avid description of risks, benefits and patient responsibilities

  • The Clinical Research Associate (CRA) presents protocol procedural information to the study coordinators (SC) at the site initiation visit (SIV) to ensure accurate completion

  • The clinical trial manager (CTM) trains CRA staff on protocol endpoints to ensure credible data review/collection practices during monitoring visits