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Biomedical PI

Focuses on key topics essential to the biomedical investigator’s role and responsibilities in conducting a clinical investigation of a product regulated by the U.S. Food and Drug Administration (FDA). This role-based course covers supervision, delegation, management, reports, and communication for investigators.

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About this Course


Reviews the important role of the biomedical investigator (also referred to as the clinical investigator or principal investigator [PI]) in a clinical investigation that complies with federal regulations and Good Clinical Practice (GCP) standards. This course is designed for individuals new to the investigator role or those seeking a focused, role-based course.

A fictional narrative of an investigator responding to an FDA Warning Letter and reflecting on his imperfect supervision and conduct is interspersed throughout the course. This narrative establishes context for the discussion of regulatory requirements and GCP standards. Further, the narrative combined with the course content provides practical information in the areas of supervision, delegation, management, informed consent, reports, and communication.

This course also provides supplemental tools available for download, including example standard operating procedures (SOPs), checklists, and templates.

This course was created by Cindy Gates, RN, JD, CIP, and peer reviewed by experts.

Language Availability: English

Suggested Audiences: Clinical Investigators, Biomedical Investigators, Sub-investigators, Investigators, Principal Investigators

Organizational Subscription Price: $500 per year/per site
Independent Learner Price: $99 per person


Course Content


Introduction: Biomedical PI Course New Content

Provides an overview of the course. Reviews the investigator’s important role in a clinical investigation and introduces regulatory responsibilities and adherence to GCP standards.

Recommended Use: Required
ID (Language): 19582 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Qualifications and Training of Research Staff New Content

Covers the investigator’s supervisory role of the clinical investigation. Provides procedures to ensure only qualified and trained research staff are delegated study-related duties. Gives example SOPs for communication and delegation.

Recommended Use: Required
ID (Language): 19583 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Implementing SOPs and Working with the IRB New Content

Discusses the rationale and importance of creating and using SOPs in research. Describes the requirements for IRB review, defines the process for obtaining initial IRB approval and maintaining that approval, and lists the communications that must occur between the investigator and the IRB during the trial.

Recommended Use: Required
ID (Language): 19584 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Complying with the Protocol New Content

Reviews the investigator’s responsibility for complying with the protocol and provides best practices for preventing deviations from the protocol. Discusses planned deviations made to protect subjects, while maintaining compliance with FDA regulations. Covers development of a corrective and preventive action (CAPA) plan including root cause analysis.

Recommended Use: Required
ID (Language): 19585 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Accounting for Investigational Products New Content

Explains the investigator’s responsibility for accounting for the investigational product in a clinical investigation according to U.S. FDA regulations and GCP standards. Focuses on strategies to improve investigational product accountability.

Recommended Use: Required
ID (Language): 19586 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Informed Consent New Content

Describes the investigator’s responsibility to obtain legally effective informed consent in a manner that is compliant with applicable regulations and ethical principles. Discusses re-consenting requirements and processes.

Recommended Use: Required
ID (Language): 19587 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Assessing and Reporting Adverse Events New Content

Discusses the investigator’s responsibility to assess subjects’ responses to the investigational product and report observations in compliance with the protocol, applicable regulations, and IRB requirements. Reviews the requirements for assessing and reporting adverse events according to federal regulations and GCP standards.

Recommended Use: Required
ID (Language): 19588 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Required Records and Reports New Content

Reviews the requirements for documentation of clinical investigations, including good documentation practices to ensure data accuracy and integrity, meet record retention requirements for data verification, and report financial interests to enhance transparency. Covers submitting reports, retaining records, and complying with proper documentation practices (such as for corrections).

Recommended Use: Required
ID (Language): 19589 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Research Misconduct New Content

Provides an overview of the issues surrounding different types of research misconduct, including strategies to prevent their occurrence. Provides examples of research misconduct and the potential consequences for different parties.

Recommended Use: Required
ID (Language): 19590 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami

Epilogue – Understanding the FDA Inspection Process New Content

Summarizes the course by reviewing the process of FDA regulatory investigations. Discusses the reasons for FDA inspections and specific actions that should take place or will take place before, during, and after the inspection.

Recommended Use: Required
ID (Language): 19591 (English)
Author(s): Cynthia Gates, RN, JD, CIP - University of Miami


FAQs


Who should take the Biomedical PI course?

This course is designed for individuals new to the investigator role or those seeking a focused, role-based course. It can be used for professional development of investigators to supplement their basic human subjects research and GCP training.

How does the Biomedical PI course fit in with other CITI Program courses like human subjects research training?

This course supplements the basic human subjects research and GCP courses by providing specific, role-based training for biomedical investigators. It is not meant to replace other CITI Program courses.

How long does it take to complete the Biomedical PI course?

This course consists of ten modules. Each module contains detailed content, images, supplemental materials (such as the interspersed narrative, helpful tips, and regulatory guidance), and a quiz. Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. However, modules are each designed to take about 30 to 45 minutes to complete, which means the entire Biomedical PI course could take about four to six hours to complete.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

How frequently should learners take the Biomedical PI course?

There is no uniform standard for how frequently biomedical PI training should occur. For a retraining (refresher) cycle, organizations should designate the frequency for their learner groups.

What are the standard recommendations for learner groups?

This course is designed to be completed in its entirety and sequentially.

A recommendation is to set all modules as “Required” for initial completion. This would help prepare learners to serve as biomedical investigators for clinical investigations.

What are the advantages of CITI Program’s Biomedical PI course?

This course provides role-specific, peer-reviewed training developed by an expert. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for biomedical PI training.