Featured Articles

  1. Preventing Protocol Deviations With Simulation-Based Training 2/22/2022

    Protocol deviations can have a devastating impact on the quality and integrity of key study data and potentially affect patient safety. Taking the right approach when training investigators, research coordinators and other key staff can be critical to avoiding protocol deviations.

  2. The Fallacy Of Footnotes Within Clinical Protocols 1/24/2022

    Discover how including footnotes is a common practice and one that contributes more to non-compliance than just about any other facet of the protocol.

  3. SIVs: Identify Skill Gaps Before Retraining 1/24/2022

    Discover how a focus on evaluating protocol-specific training already conducted at a research site could hold a key to better focusing site initiation visits (SIVs) on critical factors and reducing the amount of time spent on these meetings.

  4. Maximizing Site Enrollment With Better Protocol Comprehension 12/20/2021

    Sponsors and CROs trying to improve enrollment often overlook the most essential stakeholder in the process — the investigative sites. Get several strategies for improving existing and developing protocols.

  5. Behavior Should Drive Clinical Trial Training, Not Test Scores 12/3/2021

    Applying analytics that focus heavily on measuring changes to research staff behavior during training can be a strong predictor of performance during an active clinical trial, leading to better protocol and GCP compliance. Learn how training is important to ensure that researchers conduct clinical trials in accordance with the research protocols.

  6. Prepare For The PhRMA Code On Interactions Revisions 12/1/2021

    The PhRMA Code is a voluntary code of ethics, relating to interactions pharmaceutical companies have with U.S. healthcare professionals. This code provides a collection of detailed rules, as well as broader principles, that have yet to be compiled into a comparable industry or government document.

  7. 101 Things That Could Go Wrong If You Don't Get Your Clinical Study Training Right 10/27/2021

    Although it can be tricky to acquire proper clinical site training, inadequate planning for a research study’s training needs will create unnecessary, avoidable costs down the road. Let’s take a look at a not-so-uncommon scenario.

  8. Diversity In Clinical Research: Improving Clinical Trial Representation With High-Quality Training 10/27/2021

    Over the last several years, the pharma industry has become increasingly focused on issues of diversity. This has been reflected in regulatory guidelines and in the clinical trial recruitment phase of new drug research and development. However, relatively little attention has gone to diversity within the clinical research workforce, which many industry insiders have suggested can significantly enhance study population diversity.

  9. Stop The SIV Madness 10/5/2021

    In this post, Beth Harper advocates having CRAs conduct site training at site initiation visits (SIVs). 

  10. Simulation-Based Training For Better Decisions 10/5/2021

    Learning through simulation has historically been reserved for industries where even the smallest errors have major consequences. Clinical research is late to the party, only now realizing that the consequences of poorly trained staff, ranging from protocol deviations to site failures, can be avoided.