Featured Articles

81. Regulatory And Ethical Considerations For eConsent In Research 12/14/2022

    Although it’s becoming more widespread, explore why there are currently no definitions for eConsent in the Human Subjects Protection– it’s a concept only described in guidance.

82. How Paper And Electronic Source Data Meet ALCOA-C Principles 10/24/2022

    According to the Food and Drug Administration (FDA), data should meet certain fundamental elements of quality. If these best practices for source documentation aren’t followed, there is no valid evidence the test article is safe and effective. 

83. Unpacking IRB Innovations For Decentralized Clinical Trials 10/24/2022

    This blog highlights how IRBs can simplify review of electronic patient reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) materials to streamline study startup without impacting the review quality.

84. How Centralized IBC Review Can Benefit Gene Therapy Research 10/14/2022

    Gene therapy research is beginning to boom in the clinical setting. This blog summarizes the growth, risks, and regulatory requirements for gene therapy research. 

85. Demonstrating The Impact Of The Longboat Portal On Recruitment Success 10/13/2022

    A top-30 pharmaceutical company was conducting two phase 3, multicentre, randomized, double-blind studies to evaluate the safety and efficacy of a treatment for a serious dermatological condition. So how did the sites involved manage such significant and prolonged engagement?

86. Patient Recruitment And Enrollment In Clinical Trials 10/13/2022

    This infographic outlines how the public learns about clinical trials, why they participate, and the enrollment challenges trials pose.

87. Beginner's Guide To 21 CFR Part 11 Compliance 9/21/2022

    Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. While Part 11 is widely known, this blog explains how it fits in with your research software.

88. What Does An Endpoint Adjudication Committee (EAC) Do? 9/21/2022

    This white paper discusses the EAC’s role in research, the basics of setting up an EAC, and regulatory context on why it is so important for the committee to be completely separate from study conduct.

89. Reporting To The IRB: Serious Adverse Events (SAEs) In Drug Studies 9/6/2022

    In 2009, the Food and Drug Administration (FDA) released a guidance document on adverse event (AE) reporting to IRBs. This blog examines what the regulations do and do not say about IRB reporting requirements, and addresses some of the undefined “gray areas.”

90. Grant Application Checklist 8/16/2022

    Use this list of common elements included in research grant applications and budgets to ensure you’ve considered all the necessary resources in your proposal.