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Clinical!
Random Stuff
OECD Consensus Documents
Computer Systems
Science!
100
A substance that does not contain active ingredients and is made to look and taste exactly like the actual drug being studied.
What is Placebo?
100
This document is a compilation of information to helps in the assessment of workload and for the tracking of studies at a test facility.
What is Master Schedule? See slide.
100
According to Consensus Document Compliance of Laboratory Suppliers with GLP Principles, it is the responsibility of _________ to ensure that all manufactured reference items meet the GLP requirements for identity, composition, purity and stability for each batch of material.
What is Test Facility Management?
100
Process that ensures that given software is suitable for its intended purpose.
What is Computer System Validation (CSV)? See Slide.
100
Laboratory animal(s) that is incapable of vomiting?
What is rodent? See slide.
200
Small number of subjects, usually healthy volunteers are involved in this Phase of the clinical trials.
What is Phase I?
200
True or False Question : As per OECD regulations Corrective Action Preventive Action (CAPA) is not a Regulatory requirement.
True.
200
According to OECD Consensus Document 4 on Principles of GLP and Compliance Monitoring, the Test Facility Management should also ensure that “for a multi-site study that clear lines” of communication exist between the _______, _______, _______, and ________.
Who is Study Director, Principal Investigator, the Quality Assurance Programme, and study personnel?
200
________ is the physical component of the computerised system.
What is Hardware?
200
A blood protein produced in response to and counteracting a specific antigen.
What is antibody?
300
Type of Clinical Trial Design where neither subject nor researcher/medical investigator knows which therapy is administered.
What is Double Blinding Clinical Trial?
300
True or False Question: FDA and OECD requires GLPs to be applied to validation trials conducted to confirm the analytical methods used to determine the concentration of test article in animal tissues and drug dosage forms.
False. See slide.
300
According to GLP consensus document 4 on Quality Assurance and GLP, it is ________’s responsibility to ensure that any areas of non-compliance with the GLP Principles are identified in the final report.
What is Study Director?
300
According to OECD GLP ________ should be responsible for ensuring that computerised systems are suitable for their intended purposes.
Who is SD and TFM?
300
An injection under the skin, directly under Epidermis and Dermis layers.
What is subcutaneous injection? (see slide)
400
True or False Question: There are separate regulations to cover pre-clinical work (GLP) and to cover clinical work (GCPs) but no guidance is available to cover analysis of clinical samples in GLP laboratory.
False. See Slide.
400
System(s) on our site that complies with electronic signature requirement.
What is Trackwise?
400
Consensus document 10 The Application of the Principles of GLP to Computerized Systems discusses this procedure that addresses the measures to be taken in the event of partial or total failure of a computerised system.
What is Disaster Recovery?
400
This document is needed when a change may affect the computerised system’s validation status.
What is a Change Control? See Slide.
400
Analysis used in Charles River to assess the learning and memory abilities of the rat.
What are Water Maze Test and Passive Avoidance?
500
Hypothetical situation: Nooshin, being an exemplary auditor, decided to interview a technician on a specific technique. During the interview she has noted that although SOP for this technique exists the technician gives more detail than what is specified in the SOP. The tech also references the training manual for those details. Should Nooshin flag? If so, what should the finding be?
No. (see slide)
500
Data that describes the attributes of other data, e.g. structure, data elements, inter-relationships and other characteristics of electronic records.
What is metadata?
500
This test, also performed in Charles River, is used in toxicological screening for compounds that cause genetic damage. It is also an OECD guideline for testing of chemicals.
What is micronucleus test?