CONSENT IS KEY
This document must be reviewed and signed by a participant before any study-related procedures can begin.
What is the informed consent form (ICF)?
When a monitor finds a discrepancy in the data, they issue one of these to request clarification.
What is a data query?
According to GCP guidelines, this document must be maintained for every individual involved in the trial to document their identity, role, and signature for audit purposes.
What is the Delegation of Authority Log (or Signature Log)?
This specialty involves surgical procedures on the heart and major blood vessels.
What is cardiothoracic surgery?
The University of Colorado Anschutz Medical Campus is one of the few academic medical centers in the U.S. with two hospitals ranked nationally by U.S. News & World Report. Name both hospitals.
What are UCHealth University of Colorado Hospital and Children’s Hospital Colorado?
True or False: You can obtain informed consent after performing screening labs if the participant verbally agreed.
What is False?
This acronym refers to the form used to collect data from each study participant, often entered into an electronic data capture system.
What is a Case Report Form (CRF)?
GCP requires that this type of event be reported promptly to the sponsor and IRB/IEC, especially if it’s unexpected and related to the investigational product.
What is a Serious Adverse Event (SAE)?
Before entering the sterile field, all surgical team members must perform this specific type of hand and arm cleansing.
What is a surgical scrub?
The University of Colorado School of Medicine began in this city in 1883 with just two students and two professors.
What is Boulder, Colorado?
When enrolling a participant who does not speak English, this version of the consent form must be used.
What is a translated, IRB-approved version of the informed consent form?
OR
What is a short form?
This is the official record where clinical trial data is first recorded.
What is the source document?
This international guideline outlines ethical and scientific quality standards for designing, conducting, and reporting clinical trials involving human subjects.
What is ICH E6 (Good Clinical Practice)?
This person assists the surgeon by passing instruments and maintaining the sterile field.
What is a scrub tech (or surgical technologist)?
In 1955, this U.S. President was treated for a heart attack at what is now the University of Colorado Anschutz Medical Campus, then known as Fitzsimons Army Hospital.
Who is Dwight D. Eisenhower?
This person is ultimately responsible for ensuring that informed consent is obtained correctly.
Who is the Principal Investigator (PI)?
This term describes the process of checking data for accuracy, completeness, and consistency within the EDC system.
What is data validation?
ICH E6(R2) encourages this type of monitoring strategy, which uses centralized data review and analytics to complement or reduce on-site visits.
What is risk-based monitoring (RBM)?
Before the first incision, the surgical team performs this safety protocol to confirm the patient, procedure, and site.
What is a surgical time-out (or Universal Protocol)?
This groundbreaking organ transplant was first performed by Dr. Thomas Starzl at the University of Colorado.
What is the liver transplant?
To comply with this FDA regulation, an electronic consent system must include secure user authentication, audit trails, and system validation.
What is 21 CFR Part 11?
To maintain compliance, this feature of an EDC system must track all changes made to data entries, including who made the change and when.
What is an audit trail?
This guideline, while not officially adopted by the FDA, will go into effect on July 23, 2025 and provides recommendations for the future conduct of clinical trials.
What is ICH E6(R3) Good Clinical Practice (GCP)?
This type of randomized trial design is commonly used in surgical research to compare a new surgical technique to the current standard of care.
What is a non-inferiority trial?
The Anschutz Medical Campus is home to these six health-related schools.
What are medicine, dental medicine, pharmacy, nursing, public health, and the graduate school?