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Compliance and Regulatory

Latest Compliance and Regulatory Resources

Waiving Informed Consent Under the Proposed Rule

Under the Proposed Rule, minimal risk trials may have the ability to waive informed consent. Explore the benefits and challenges of this rule.

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Q&A Part II: How Protocol Feasibility Assists in Promoting Compliance

In this Q&A, Dr. Wendy Tate answers attendee questions from her webinar “How Protocol Feasibility Assists in Promoting Compliance.”

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Q&A Part I: How Protocol Feasibility Assists in Promoting Compliance

In this Q&A, Dr. Wendy Tate answers attendee questions from her webinar “How Protocol Feasibility Assists in Promoting Compliance.”

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PRIM&R AER Conference: Collaborating to Advance Ethical Research

The 2019 PRIM&R AER Conference provided insights into the changing regulatory world, and reaffirmed the importance of technology as processes and regulations continue to evolve.

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How Protocol Feasibility Assists in Promoting Compliance

Wendy Tate, Director of Analytics at Forte, discusses adding a protocol feasibility committee to improve trial compliance and ethics through proper resource allocation and ensuring that the objectives can be met through proper accrual.

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The Beginner’s Guide to Implementing an Enterprise eRegulatory Management System

Many sites understand the benefits of moving from paper regulatory binders to an electronic system. But it’s also important to ensure your organization is implementing a system that will fit your regulatory workflows and set you up for long-term success.

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Performing Protocol Feasibility Assessments to Enhance Clinical Trials

Protocol Feasibilities are designed to help clinical research staff determine the possibility of conducting a study. Here’s how to seamlessly work an assessment in before accepting your next clinical trial.

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Unpacking the Benefits and Drawbacks to eConsent

With electronic processes dominating systems, electronic consent is starting to make its way onto the scene. Check out the benefits and drawbacks to the alternative consent process.

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Using Integrated CTMS and eReg Systems to Build New Clinical Research Efficiencies

Learn how an eRegulatory-CTMS integration can improve workflows and bring additional benefits to your institutional research operations.

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Informed Consent: When, Why and How It’s Obtained

Conducting informed consent is more than making sure your participants understand the protocol. Learn more about when, why and how it’s obtained continuously throughout a trial.

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