The driving document of a study that is written by the test facility that clearly indicates the objectives and all methods used for a conduct of a study.
What is a protocol?
100
Before use, these things should be adequately inspected, cleaned and maintained, there should be an SOP outlining its use, and all records of calibration maintained.
What is equipment?
100
These must be labelled with: identity, expiry date, lot number, initials and date and stored accordingly. And should not be used when expired.
What are reagents/solutions?
100
The place where a specific phase of a multisite study is being conducted
What is a test site?
100
This regulation apples to computer system security and validation as its key focus
What is 21CFRpart11
200
For a non-clinical laboratory study, the scientist with appropriate education and experience that represents the single point of control for the study
Who is the Study Director?
200
an independant group which is responsible for monitoring each study to assure Management that it follows the regulations.
Who are QA?
200
This person is responsible for performing a correction on a data entry
Who recorded the original entry?
200
The driving document of a study that a TEST SITE will write that outlines the responsibilities, and procedures to follow for a given phase of a pre-clinical protocol.
What is a workplan?
200
a system which may exist where the electronic record must be saved and authenticated manually (by hand on hardcopy)
What is a hybrid system (excel or word) for example?
300
Procedures written that allow you to conduct an activity in a standardized way. A must have for all activities and equipment at Caprion.
What are SOPs?
300
This place is used to retain records in a secure manner with restricted access and temperature/humidity control to prevent deterioration.
What is an ARCHIVES room/area?
300
These regulations must also be followed once the drug progresses into CLINICAL (Human) trials
What are GCP (Good Clinical Practices) and/or GMP (Good Manufacturing Practices)?
300
The person identified as responsible for a SPECIFIC PHASE of a GLP multisite study.
Who is a PI (Principal Investigator)
300
A security parameter that will protect unauthorized access into an electronic data system and should never be shared
What is a password?
400
any food additive, drug, biological product that is dosed to an animal for the purposes of a preclinical study evaluation
What is a Test Article
400
Must be signed by the study director before any data is collected in a pre-clinical study.
What is a protocol (test facility) and/or workplan (test site)?
400
This role will sign the final report and is responsible to make sure that all of the GLP regulations were followed during the study
Who is the PI (test site) and/or Study Director (test facility)
400
In a multisite study there must be effective communication with this person to assure adequate oversite. Therefore the PI must advise this person all deviations, QA findings, and issues that may have arose during the study conduct.
Who is the Study Director?
400
A computer entry that will detail who, when, what and the reason for a change in electronic data
What is an audit trail?
500
Any laboratory worksheets, records, memo, notes or exact copies thereof that are the result of original observations and are necessary for the reconstruction of a study
What is Raw Data?
500
Documents that show that the personnel have the adequate experience and education to perform their tasks in a GLP study.
What are training records or files?
500
The person or persons who is responsible to assign a Study Director (Test facility) or PI (Test site), and will assure there is a QAU, and adequate resources available to perform a GLP study?
Who is Management?
500
The main facility where the tox study is being conducted.
What is a test facility?
500
The process of testing a IT system before it is placed into use, may include IQ, OQ, PQ and other deliverables