Study Start-Up
What’s the first document that the site is signing within the study?
Confidentiality Agreement
This must be submitted to the IRB at least annually or prior to expiration.
What is: a Continuing Review
What does ALCOA stand for?
What is: Attributable, Legible, Contemporaneous, Original, and Accurate.
What document was written as a response to the unethical experiments that were done in concentration camps and is also the first document that introduces the idea of informed consent of patients?
What is: the Nuremberg Code (1947)
What is the new ClinOps Training Initiative called?
What is PSI USA CRA Top Gun Academy
Arrange the following start-up events in the correct order:
-Distribution of Protocol Synopsis and Feasibility questionnaires
- Site Selection Visit
- CDA/CDU collection
-Review of completed feasibility questionnaires.
What is:
1. CDA/ CDU collection
2. Distribution of Protocol Synopsis and Feasibility Questionnaires
3. Review of completed feasibility questionnaires
4. Site selection visit
What is the main purpose of an IRB?
What is: to protect the rights and wellbeing of human subjects involved in research.
What 2 places can the TMF be stored?
What is: In PSI eTMF system or in a sponsor system (e.g. Veeva systems)
What does SUSAR stand for?
What is: Suspected Unexpected Serious Adverse Reaction.
Who is responsible for preparing essentials documents like the Protocol, Investigator's Brochure, and Case Report Form during a clinical trial?
Who is: the sponsor
Arrange the following start-up events in the correct order:
-Study Approval
-Site Selection
-Site Initiation Visit
-Initial Submission
What is:
1. Site Selection Visit
2. Initial Submission
3. Study Approval
4. Site Initiation Visit
How many years is an IEC/IRB required to retain records?
What is: at least 3 years.
During which project phases are TMF activities performed?
What are: Startup, Enrollment, Treatment/Follow-up, and Closure
Which document provides the primary ethical principles for conducting clinical trials involving humans?
A. Good Laboratory Practice
B. Declaration of Helsinki
C. International Council of Harmonization
D. Biological Weapons Convention
What is B: Declaration of Helsinki
Which research participants require additional consideration in obtaining informed consent? (list at least 4 categories)
What are vulnerable subjects:
-Individuals withing a hierarchical structure
-The elderly/ people in nursing homes
-Unemployed or impoverished individuals
-Individuals in emergency situations
-Ethnic minority groups
-Unhoused individuals
-Minors and those incapable of giving consent
-Pregnant women.
What is the difference between a Confidentiality Disclosure Agreement (CDA) and a Confidentiality Disclosure Undertaking (CDU)?
What is: The CDA is signed by both the site and PSI, and the CDU us signed only by the site.
According to ICH GCP, who should participate in the decision-making process and vote/ provide an opinion during IRB/IEC meetings?
What is: Only members independent of the investigator and sponsor.
What essential document is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug?
What is: Form FDA 1572
What does ICH stand for?
Bonus: What year was ICH established?
What is: International Council for Harmonization, established in 1990
What are the indications of a Serious Adverse Event (name at least 3)
What are:
-Results in death
-Is life-threatening
-Requires in-patient hospitalization or prolongation of existing hospitalization
-Results in persistent or significant disability or incapacity
-Is a congenital anomaly or birth defect
What happens during Site Initiation Visit? (List at least 5 activities)
1. Training of site team
2. Vendor system overview
3. ISF Review
4. Staff Authorization
5. Assessment of facilities, equipment, supplies
6. Enrollment Planning
7. Overview of procedures.
What are the requirements for an IEC/IRB membership?
What are:
-To have at least 5 members
-At least 1 member whose primary area of interest is in a non-scientific area
-At least 1 member who is independent of the institution/ trial site
Arrange the following TMF lifecycle events in the correct order:
-Final TMF check
-Ongoing TMF Maintenance
-Shipment to client
-TMF set-up
What is:
1. TMF set-up
2. Ongoing TMF maintenance
3. Final TMF check
4. Shipment to the client
What is the key distinction between an Adverse Event (AE) and an Adverse Drug Reaction (ADR)
A. The severity of the medical occurrence
B. Whether the event occurs during pre-approval or post-marketing phases
C. The causal relationship with the study treatment
What is C: the causal relationship with the study treatment.
During what phase (1,2,3,4) is a drug's safety tested by increasing the dose to establish which doses are safe and well tolerated?
What is: a Phase 1 trial.