If a mistake is made on a CRF, the error should be crossed out, and these two elements should be written above the error.
What are the initials and date
100
The PI or designee must notify the Director of the Protocol Office within this period of time of learning of a planned audit.
What is 48 hours
100
Children greater than 6 years of age and under 18 must provide this to participate in a research study.
What is assent
100
The agency responsible for enforcing drug and food laws regarding the research, manufacture, and safety of drugs and foods.
What is the FDA
100
In the 2015 Women’s World Cup Final, the U.S. beat this team to take home the gold medal.
Who is Japan
200
This principle states that research must maximize benefits and minimize harms.
What is the Principle of Beneficence
200
At our institution, this group will help you prep for audits and monitoring visits.
Who is QC (Quality Control)
200
The informed consent document must include a statement that indicates participating in research is ____________.
What is voluntary
200
This document created in 1964 forms the basis of ethical considerations in clinical research.
What is the Declaration of Helsinki
200
This main attraction inside the Galleria Mall was built in 1970.
What is the ice skating rink
300
When outside interests unduly influence professional judgment.
What is Conflict of Interest
300
During a monitoring visit, the monitor will verify the case report forms against this type of document.
What is a source document
300
The process of providing all relevant information about the trial's purpose, risks, benefits, alternatives, and procedures to a potential participant.
What is the informed consent process
300
A ___________ trial is designed to answer specific questions about and evaluate the effectiveness of a new treatment or a new way of using a standard treatment.
What is treatment
300
This movie recently became the third highest grossing film of all time.
What is Star Wars: The Force Awakens
400
ICH stands for this.
What is the International Conference on Harmonization
400
The time frame for reporting unanticipated problems involving risks to subjects/others to the IRB.
What is 5 business days
400
This person’s signature is required by FDA regulations to be on the consent form.
Who is the subject or Legally Authorized Representative (LAR)
400
This clinical trial phase studies the safety and effectiveness of an agent or intervention, and evaluates how it affects the human body.
What is Phase 2
400
In 1965, this Texas stadium was nicknamed the “8th Wonder of the World”
What is the Houston Astrodome
500
A rule of ethics regarding biomedical and behavioral research involving human subjects in the United States.
What is the common rule
500
This internal committee determines the type and number of studies to audit every year.
Who is CROC
500
When consenting non-English speaking patients, these three signatures must be found on the full consent form.
Who are the investigator, witness and translator
500
In a COG protocol, the schedule of assessments is always located in this numbered section.
What is Section 7
500
He was the last guest on the David Letterman show.