Knowledge Center

How to use the Knowledge Center

Ready to broaden your skillset? This is your one-stop location for training and professional development resources. You will find all the resources you need to become a linical research professional, keep up-to-date or simply to get better at what you do.

  • FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond

    This activity explains how U.S. public health policy has influenced and shaped the Food and Drug Administration (FDA) protections that Americans have come to expect, provides an overview of FDA’s Center for Drug Evaluation and Research, or CDER’s, role in the regulation of new drug development, marketed drugs, quality testing, and post-market surveillance, and identifies new directions for the human drug regulatory process in the United States.

    Click here for course information: http://fdadrugregulations.e-paga.com

  • Questions about TMF Reference Model?

    Do you have questions about the Trial Master File Reference Model? The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. The Model is not intended to be taken and used “off-the-shelf” but can be adapted to an electronic or paper TMF, and does not endorse, nor require, any specific technology for application. DIA members and industry members are under no obligation to adopt the TMF Reference Model.

  • GCP Training Mutual Recognition

    The TransCelerate Site Qualification and Training (SQT) Initiative has developed a mutual recognition program for ICH E6 Good Clinical Practice (GCP) Training, targeted to investigator site personnel. TransCelerate Member Companies have developed guidelines to give innovative drug companies the comfort necessary to accept and rely on Member Companies’ and Training Provider’s investigator site personnel ICH GCP training meeting identified Minimum Criteria.

  • eLearnings by ACRP

    ACRP has several eLearnings available for the clinical research professional. You can choose from many categories including:

    Clinical Research Essentials
    - Fundamentals of Clinical Research
    - Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety
    - Theory to Practice: Operationalize Your Clinical Study Protocol
    - The Drug Development Process: Improving Trial Feasibility and Exploring Your Growth Potential

  • Transfer of Obligations between Sponsor and CRO

    It's always difficult as a Sponsor to delegate specific tasks to a CRO. However, when looking at it from an overall point of view, it is always good to review to obligations under 21 CFR Part 312 and ICH GCP E6 when transferring responsibilities. Below are some regulatory guidance to consider:

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