Trust the Process
What the Stat?!
You can dance if you want to (Safety Dance)
You Down with GCP?
Cornucopia
100
This study phase involves relatively small studies and has a goal to explore therapeutic efficacy. Answer Choices: Non-Clinical Studies, Phase I, Phase II, Phase III, Phase IV
What is Phase II?
100
This type of trial comparison is typically used in Phase I and II studies and explores the pharmacodynamics of an Investigational Product (IP) rather than comparing the IP to another product. Answer Choices: Superiority, Equivalence/Non-Inferiority, Dose-Response Relationship
What is a Dose-Response Relationship comparison?
100
This is the amount of time a sponsor has to submit their completed safety report of a serious adverse event (SAE) to the regulatory authorities. Answer Choices: 7 calendar days, 15 calendar days, immediately, within 24 hours
What is 15 calendar days?
100
<<< Daily Double >>> According to the Declaration of Helsinki and GCP, this is necessary to obtain before conducting any study activities with a subject.
What is written informed consent? Daily Double: Who is ultimately responsible for the informed consent?
100
This person is responsible for IP accountability at the site. Answer Choices: Pharmacist, Investigator, Coordinator, Monitor
Who is the Investigator?
200
<<< Daily Double >>> This study phase represents the first time an investigational product is administered in humans. Answer Choices: Non-Clinical Studies, Phase I, Phase II, Phase III, Phase IV
What is Phase I? Daily Double: This objective of Phase I studies is represented by the "Ph" for "Phil" in the study phases mnemonic: Phil Explores Confirmed Uses for the Phases of Clinical Trials.
200
The main characteristic of this study design is that each subject acts as his/her own control. Answer Choices: Parallel Group Design, Crossover Design, Factorial Design, Group Sequential Design
What is a Crossover Design?
200
The submission clock for the sponsor starts for expedited reporting of serious advents at this time. Answer Choices: Within 24 hours of knowledge; Within 7 days of knowledge; As soon as the sponsor becomes aware of the event; When the event occurs
What is "as soon as the sponsor becomes aware of the event"?
200
According to the principles of ICH GCP, this is the most important consideration when conducting a clinical trial. Answer choices: Protecting the rights, safety, and well-being of trial subjects; Following the proper regulations and guidelines; Having proper recruiting/retention practices
What is "protecting the rights, safety and well-being of trial subjects"?
200
The responsibility for trial conduct at a study site ultimately lies with this person or entity. Answer choices: Sponsor, IRB, Investigator, Monitor
Who is the Investigator?
300
This method to reduce bias produces treatment groups with similar prognostic factors and ensures there is an even distribution across study arms. Answer Choices: Blinding, Randomization, Compliance
What is Randomization.
300
Excluding subjects from the data analysis based on your knowledge of their study outcome is an example of this type of study bias. Answer Choices: Operational, Statistical, Design, Compliance
What is Statistical bias? (Note- Design and Compliance options are "distractors")
300
<<< Scenario Question >>>
What is Day 8?
300
These items regarding your subject population are important for both the trial planning and trial execution. Failure to meet expectations of these can affect the duration of the trial and have financial implications. Answer Choices (select all that apply): recruitment predictions, actual recruitment, subject retention
What are: (all of the above) recruitment predictions, actual recruitment, and subject retention.
300
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval in this instance. Answer Choices: changes that impact the immediate health/well-being of the subject; changes involve the ICF only; the sponsor tells the investigator to implement the changes immediately
What is "when the changes impact the immediate health/well-being of the subject"?
400
A clinical trial in THIS drug development phase is recruiting patients in the targeted demographic for the IP to confirm therapeutic efficacy. Information collected through this trial will later be used for the marketing application and product labeling. Answer Choices: Non-Clinical Studies, Phase I, Phase II, Phase III, Phase IV
What is phase III?
400
This type of Analysis Set includes all randomized subjects, whether or not they received investigational product or completed the study without major deviations/violations. Answer Choices: Intention-to-Treat , Per-Protocol Analysis , Interim Analysis
What is an Intention-to-Treat (ITT)? (Note- Interim Analysis was a distractor)
400
A coordinator knows that if the investigator deems an adverse event to be ______ related to the IP, it meets the minimum criteria to be considered an adverse drug reaction. Answer Choices: Possibly, Probably, Definitely
What is: Possibly related
400
At the final study visit, the CRC discovers a subject has not been taking the IP correctly. The pill counts throughout the study appeared to show the subject in compliance. The CRC knows he/she should take this action first in order to begin to resolve the issue. Answer choices: report the noncompliance to the sponsor; document the noncompliance in the CRF; chastise the subject for their noncompliance; have the subject re-enroll in the study and disregard all previous data for that subject
What is "document the available information regarding the noncompliance in the CRF".
400
An Investigator wanting to ensure protocol compliance prior to the start of the study will do this. (Name 2)
What is: review and understand the protocol, identify procedures that differ from SOPs, thoroughly train their study staff and document it, ensure they have well-designed study specific forms for documentation.
500
A coordinator knows the trial protocol will contain these key elements (Name at least 2).
What are: the I/E criteria, visit schedule, investigator assessments of safety and efficacy, patient assessments of safety and efficacy, IP requirements (such as randomization/pt compliance).
500
This randomization type is the simplest method, allowing for all subjects to have an equal chance of receiving treatment but leading to potential issues in equality across the comparison groups. Answer Choices: Unrestricted, Block, Central, Stratified, Dynamic
What is Unrestricted randomization?
500
This document is the main guide/resource that is used to determine if an adverse event qualifies as expected or unexpected. Answer Choices: Protocol, Informed Consent Form (ICF), Confidentiality Agreement, Investigator's Brochure
What is the Investigator's Brochure?
500
<<< Daily Double >>> A subject who speaks Spanish as a first language comes to the site for screening with her bilingual daughter. The CRC only has ICFs written in English available. The CRC's next action is do this. Answer Choices: use the daughter as a translator; find a non-biased translator; request a spanish language ICF from the sponsor; document the subject as a screen failure
What is: request a Spanish language ICF from the sponsor to provide for the subject. Daily Double: When the subject returns for screening after the spanish language ICF is available, what else will the CRC need to do to complete the informed consent process?
500
During the informed consent process, the coordinator knows the ICF will need to be signed by ______________ and ___________.
Who are: the subject and the person obtaining the consent
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