GLP Refresher Training 2019

Which of the following are key roles required by the Principles of GLP?

• Test Facility Management

• Quality Management

• Archivist

• A and C

• A, B and C

Which of the following is the responsibility of the Test Facility Management?

• Ensure SOPs/WKIs are established and followed

• Ensure that study plans/amendments and SOPs/WKIs are avaiable to study personnel

• Ensure maintenance of records for qualification and training of staff

• Ensure the maintenance of a master schedule

• A, C and D

Which of the following is the responsibility of the Study Personnel?

• Record data promptly, accurately and completely

• Know the Principles of GLP applicanle to their work at the facility

• A and B

• Maintain copies of all approved study plans, SOPs/WKIs

• Verify that the study plan is GLP compliant

Study plan amendment means:

• A new Version of the Study Plan

• A modification to the Study after the study was requested by the sponsor

• a modification to the study plan after the study plan is signed by SD

For each particular study report, a statement of GLP compliance is provided by:

• Quality Assurance

• Study Director

• Test Facility Management

Who is the single point of study contgrol during a multi-site study?

• Principal Investigator

• Test Facility Management

• Study Director

Which of the following requirements are true for Standard Operating Procedures to comply with GLP?

• Approved by TFM

• Periodically reviewed

• Immediate accessible

• Describing the validation, operation, maintenance, security, change control and back-up of computerized systems

• All of the above

Study completion date means:

• the last date on which data is collected from the study

• the date SD signs the final report

• the date the archiving is completed

Which one is the latest OECD GLP document published?

• Management, Characterisation and Use of Test Items

• Application of GLP Principles to Computerised Systems

What is the definition of a test item?

• An article used to provide a basis for comparison for the study

• An agent that is the subject of a study

• Any biological, chemical or physical system or a combination there of used in a study

• None of the above