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WorksheetsGCP- homework
Total questions: 20
Worksheet time: 14mins
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provide assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality or that subjects are protected.
Good Manufacturing Practice
Good Clinical Practice
ICH Guidelines
Belmont Report
Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection.
Ethnics
Beneficence
Respect for Persons
Justice
Which of the following is one historical event that's a foundation of GCP?
Henrietta Lacks
National Research Act
Declaration of Helsinki
Tuskegee Syphilis Study
Individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection.
Human Subjects
Beneficence
Respect for Persons
Justice
The following are example of which Principle
A) Must be IRB approved prior to beginning the trial.-
B) should be revised whenever important new information becomes available that may be relevant to the subject's participation.
C) must provide information in an understandable manner to the study subject.
D)more than just a signature on a form.
(a)
Which Principle is a necessary step(s) must be taken to ensure that a subject's records are kept private and confidential at all times. If a breach occurs, proper regulatory bodies must be informed.
Trial Participants
Confidentiality
Risks
Ethnics
What factor may affect the capacity to consent?
Cognitive impairment
Illness
Age
All of these above
Which of the following is NOT an ICH GCP requirement for clinical trial sites?
Adequately trained staff
Adequate facilities
Experienced staff
Study co-ordinator
Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the:
1. Protocol
2. Consent form updates
3. Subject recruitment procedures
4. Written informed consent form
1 and 4 only
1, 3 and 4 only
2 and only 3
All of them
According to ICH GCP which of the following documents should be reviewed by the IEC/IRB?
1. The Investigator's Brochure
2. The Investigator's CV
3. The subject compensation4
. Payment to the Investigator
All of them
2 and 3 only
1, 2 and 3 only
2 and 3 only
According to ICH GCP who should be responsible for the medical care of trial subjects at site?
(a)
The (a) is responsible for the ongoing safety evaluation of the investigational product.
For nonsignificant risk device, a sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects and terminate all investigations. Upon "Resumption of Terminated Studies", sponsor needs approval again from (a)
A quality assurance program should include:
Policies and procedures, training, audits, and corrective action plans
Training PIs to enter the study data into an EDC system
Testing CRCs on knowledge of GCP
Discipline for CRCs for protocol deviations
A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?
(a)
Which of the following roles has the ultimate responsibility for the quality and integrity of the data produced in a clinical trial?
Contract research organization
IRB/IEC
Investigator
Sponsor
What is the key document used when assessing "expectedness" of an adverse event or adverse drug reaction?
Informed Consent Form
Investigator Brochure
Study Protocol
Investigator Study File
All staff working on the trial must be qualified to do their job and have proper training. Qualifications should be apparent on one's CV and training should be tracked in the training log.
(a)
All guidelines and regulations must be followed when it comes to shipping and storing a product that will be given to human subjects is
(a)
When must a serious adverse event be reported by an Investigator to the Sponsor?
Immediately, in accordance with the protocol
Immediately, for all cases, regardless of the protocol
Within 7 calendar days for events related to the investigational product
Within 7 calendar days for all events, regardless of their relationship with the investigational product
