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Improving Clinical Trial Patient’s ...

04/09/2024

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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.

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FDA Issues Updated Draft Guidance on Use of ...

04/02/2024

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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006.  The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.

Amanda Dzengeleski
FDA Issues Warning Letter for Clinical ...

01/03/2024

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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.

Amanda Dzengeleski
FDA Releases New Draft Guidance on Confirmatory ...

09/27/2023

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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.

Jennifer Lawyer
FDA Releases 3 New Draft Guidances Regarding ...

09/13/2023

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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.

ICH Releases E8 “General Considerations for Clinical Trials” Draft Revision for Public Comment

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.

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.

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

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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?

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