PI Accountability & Oversight
This individual is ultimately responsible for how a clinical trial is conducted at a study site.
Who is the Principal Investigator?
This document lists study staff, roles, and tasks assigned by the PI.
What is the Delegation Log?
According to ICH-GCP, this principle requires that the rights, safety, and well-being of trial subjects take precedence over the interests of science and society.
What is the principle of subject protection?
This document describes the objectives, design, and methodology of a clinical trial.
What is the protocol?
These are original records where clinical trial data are first recorded.
What are source documents?
This signed document shows that the Principal Investigator agrees to follow the study requirements and procedures.
What is the protocol signature page?
These are documents providing evidence of a staff member’s education, experience, and training to perform their clinical trial duties.
What are qualifications and training records?
This is the process by which a participant voluntarily confirms their willingness to take part in a clinical trial after being informed of all relevant aspects of the study.
What is informed consent?
This term refers to the study drug or product being tested in a clinical trial.
What is the Investigational Medicinal Product (IMP)?
This system is used to record clinical trial data electronically for sponsor review.
What is an electronic Case Report Form (eCRF)?
This refers to the Principal Investigator checking that trial activities are being carried out correctly and in line with study requirements.
What is PI oversight?
This training ensures study staff understand study-specific procedures and requirements before performing tasks.
What is protocol training?
This process ensures that participants are promptly informed of any new information that may affect their willingness to continue in the trial.
What is re-consenting (or ongoing informed consent)?
This document is regularly updated and provides investigators with safety, dosing, and risk information based on accumulated data for the investigational product.
What is the Investigator's Brochure?
This principle ensures data is accurate, complete, and verifiable from source documents.
What is data integrity (or ALCOA principles)?
This refers to conducting a clinical trial in line with the agreed study plan and approved procedures.
What is protocol adherence?
This is a qualified physician designated by the Principal Investigator to perform protocol-required clinical assessments and trial-related medical procedures.
Who is a sub-investigator?
These are any untoward medical occurrences in trial participants, with serious ones including events such as death, life-threatening conditions, or hospitalisation.
What are adverse events (AEs) and serious adverse events (SAEs)?
These records track receipt, storage, dispensing, and return of the investigational product.
What are drug accountability records?
These are untoward medical occurrences in a clinical trial that result in death, are life-threatening, require hospitalisation, or cause significant disability.
What are serious adverse events (SAEs)?
This concept means that, even if tasks are assigned to others, the Principal Investigator remains responsible for the outcome of those tasks.
What is investigator accountability?
This training provides an understanding of international ethical and scientific quality standards for conducting clinical trials.
What is GCP training?
These are medications taken by a subject alongside the investigational product that must be recorded to assess potential interactions and ensure subject safety.
What are concomitant medications?
This product is used in a clinical trial as a reference to compare against the investigational product to evaluate its efficacy and safety.
What is a comparator product?
These documents collectively permit evaluation of trial conduct and data quality.
What are essential documents (or Trial Master File/eTMF documents)?