Week 2

Question 1

ICH-GCP

Answer 1

International Conference of Harmonization fo Good Clinical Practice Guidelines
Leaders in the clinical research industry from around the world come together to agree on best practices and patient safety in clinical trial

Question 2

IRB

Answer 2

Enforces ICH-GCP guidelines and protecting the rights and welfare of human research subjects in their assigned study

Question 3

Inclusion Criteria

Answer 3

characteristics that the prospective subjects must have if they are to be included in the study

Question 4

Exclusion Criteria

Answer 4

those characteristics that disqualify prospective subjects from participating in the study

Question 5

Subject Screening

Answer 5

Informal Consent Process

Inclusion and Exclusion Criteria review for potential enrollment

Question 6

Screening Failure

Answer 6

If a potential subject declines to sign the Informed Consent Form
Inclusion and Exclusion Criteria are not met

Question 7

When should the site report to the IRB?

Answer 7

Anytime there has been an occurrence that risks the safety of human subjects and/or there are unexpected results on the subject from the clinical trial

Question 8

Protocol Violation

Answer 8

a deviation from the IRB approved protocol that may

• reduce the completeness, accuracy and reliability of study data
• Contradict or invalidate the Informed Consent
• Impact the subject’s safety, rights or well-being

Question 9

Protocol Deviation

Answer 9

a deviation from the IRB approved protocol that:

• Has no significant consequence to the subject or protocol integrity and is considered minor
• A frequently accepted delineation is that a deviation does not expose the subject to increased risk, whereas a violation does

Question 10

Source Documents

Answer 10

Records about each subject that will hold all trial related data about the subject and all trial related interactions ever had with the subject
-source documents are most important

Question 11

How to Handle Protocol Deviation

Answer 11

1. Query the site for more information via email or inside of the EDC to confirm the deviation
2. Notify the site in writing
3. Notify your study lead or study team by documenting as an observation in CTMS( and document in MVR)
4. Train site staff on proper study procedure according to protocol
5. Report to the IRB (if necessary)

Question 12

Source Document

Answer 12

The platform hosting information collected directly from the subject

Question 13

Source Data

Answer 13

Study related information collected directly from the subject