Clinical Trial Collaborative: Principal Investigator Online Course
-
Register
- Non-member - Free!
- Member - Free!
Already registered?
Log in now.
An online, 12-module course focused on basic PI competencies designed by SIO alongside CRO experts and interventional oncology Principal Investigators (PIs) who understand the complexities of completing a successful multicenter clinical trial.
Learners who complete the course and pass the quiz will earn an SIO certificate of completion identifying them as a qualified PI.
The certificate of completion will be valid for up to three years with an option to retest to maintain the certificate.
Key:
Complete
Next
Failed
Available
Locked
Module 1: Introducing Principal Investigators to Clinical Research Basics
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to research sponsor models and basic role and responsibilities of the Principal Investigator.
Module 2: The Research Enterprise
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to the research enterprise and site requirements for successful clinical trials.
Module 3: Who & How
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to those members on the research team, their role and delegation of authority concept.
Module 4: Enrollment Goals and Strategies
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to the basics of enrollment goal setting for clinical trials and the strategies to meet those goals.
Module 5: Overview of Clinical Trial Budgets and Contracts
Begin self-paced component package.
Begin self-paced component package.
Learners will receive an overview of the budget process and contracting with clinical trials.
Module 6: Requirements of a Principal Investigator
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to the basics for serving in the role of Principal Investigator, as well as the role responsibilities and regulatory expectations.
Module 7: Informed Consent
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to the basics of an informed consent process and the requirements needed as well as provide an overview of the Informed Consent Form.
Module 8: Essential Study Documents
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to the sponsors trial master file TMF) and the Principal Investigators site file (ISF).
Module 9: Data Management Practices
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to the definition of adverse events, adverse drug reactions and serious adverse events, as well as related processes.
Module 11: Deviations
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to basics of deviations, types of deviations and the regulatory requirements with deviations.
Module 12: Preparing for an FDA Inspection
Begin self-paced component package.
Begin self-paced component package.
Learners will be introduced to preparations needed for an FDA inspection, the experience of the inspection and post inspection follow up and actions.
Final PI Quiz
45 Questions | 2 attempts | 35/45 points to pass
45 Questions | 2 attempts | 35/45 points to pass
