GCP- homework

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.

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