Investigators

Essentials of Clinical Trial Budgets

This in-depth course provides practical knowledge on how to develop, negotiate, and implement a clinical trial budget from the perspective of the clinical site. It...

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QA/QI: Human Subjects Research

QA/QI programs are integral to the protection of the rights, safety, and welfare of human research subjects. This course provides foundational training on establishing or...

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Disaster Response and Research Reactivation

Natural or human-influenced disasters and emergencies require institutions to strategize and implement business continuity plans to resume research operations after the resolution or dissipation of...

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Noncompliance and the IACUC:
Basic Approaches for Success

The IACUC is charged with ensuring humane and judicious use of animals in research, teaching, and testing in a way that both meets the expectations...

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FDA IND Safety Reporting for Clinical Trial Investigations

IND safety reporting is a core function of clinical trials. Study sites and sponsors are responsible for reporting adverse events (AEs), serious adverse events (SAEs),...

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Aggregate Safety Assessment Planning and IND Safety Reporting

According to the U.S. Food and Drug Administration (FDA), IND safety reporting needs to be supported by ongoing systematic assessment of the product’s safety data...

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Drug Safety and Pharmacovigilance for Drugs, Biologics, and Devices

Drug safety and pharmacovigilance are key in developing drugs, biologics, and medical devices. This webinar defines drug safety concepts and terms while detailing the types...

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The Role of Data Managers in Clinical Trials

The webinar highlights the importance of clinical data managers during the conduct of a clinical trial and outlines the process of collecting, managing, analyzing, and...

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Sponsor-Patient Engagement: How Patients Shape Clinical Development

Sponsor-patient engagement can play a pivotal role in the development of safe, effective, and clinically relevant new medicines. Increasingly, clinical trial sponsors are integrating patient...

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Managing Risk by Contract – Sponsor Perspectives on Clinical Trial Agreements

Protracted clinical trial agreement (CTA) negotiations often delay the start of a study. Understanding each party’s motivation and expectations facilitates quicker issue resolution, thereby expediting...

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