The PI Trainer: An Interactive Companion to The PI’s Guide to Conducting Clinical Research

To advance your career as a principal investigator (PI) — and conduct better, safer and more efficient clinical trials — you need to sharpen your skills and keep up with clinical trial conduct developments. The PI Trainer empowers you to do just that, whether you’re a veteran PI or an aspiring one.

This new visual, interactive online course — and companion to The PI’s Guide to Conducting Clinical Research — enables you to gain proficiency in all aspects of your role and expedite your career trajectory along with earning 3.0 continuing education units.

The PI Trainer will increase your expertise in evaluating the feasibility of a proposed protocol, obtaining IRB approval, budgeting and contracting, training and supervising staff, overseeing informed consent and enrollment, supervising site visits and medical procedures, managing monitor visits, reporting adverse events and handling regulatory inspections.

The course’s self-paced lessons reinforce knowledge and ensure material mastery with a post-course assessment, so you can:

• Implement the principles of good clinical practice (GCP)
• Understand and excel at your PI responsibilities
• Comply with the regulations applicable to clinical trials
• Appropriately protect human research subjects
• Understand trial phases
• Comprehend various types of trial designs
• Adhere to IRB review processes
• Abide by informed consent requirements
• Establish compliant study startup procedures
• Create and sustain robust recruitment and retention strategies
• Implement robust data management and monitoring
• Comply with adverse event reporting requirements
• Conduct successful study close-outs and reporting

The course consists of six individual modules that break the information in The PI’s Guide into easily absorbed segments:

• Module 1: Roles and responsibilities of the PI, trial staff, research institution, sponsor and IRB
• Module 2: The drug development process, GCP and ethical principles of human research
• Module 3: Informed consent, the history of human subject protection, pretrial elements and trial design
• Module 4: Study initiation, recruiting and retention, and managing monitor visits
• Module 5: Adverse events and safety monitoring, study closure, and managing inspections and audits
• Module 6: A 25-question multiple-choice test to assess mastery of the subject

Each module takes 20-30 minutes to complete. A certificate of completion is awarded to those who pass the post-course assessment, which may be submitted to the Association of Clinical Research Professionals (ACRP) for self-reported continuing education units toward maintenance of their professional certifications.*

To meet — and exceed — the increasing demands of the PI role, you must stay on top of all of the vital aspects and developments of the job. The PI Trainer will get you there.

*Successful completion of this program has been approved for a total of 3.00 self-reported contact hours of research-specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

Who Will Benefit

• Physicians and scientists interested in entering clinical research
• Sub-investigators and research nurses interested in moving up to PI status
• CRCs and CRAs who want a better understanding of the PI role