The person who has the overall responsibility for the technical conduct of the study as well as the interpretation, documentation and reporting of results.
Who is the Study Director?
100
This is when the study is initiated.
What is when the Study Director signed the protocol?
100
All individuals engaged in the conduct or responsible for a nonclinical study must have this.
What is the education, training, and experience or a combination thereof to perform their assigned functions?
100
Study Completion Date.
What is when the Study Director signs the final report?
100
A summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
What need to be included in the final report?
200
A person who initiates and supports by provision of financial or other resources of a nonclinical laboratory study.
Who is the Sponsor?
200
This is signed by the Study Director and included in the final report.
What is the GLP Compliance Statement?
200
QA assures that there weren't any of these and if there were, they are documented.
What are deviations to protocol and SOP?
200
Unplanned changes to the protocol for failure to follow the protocol are called this.
What are deviations?
200
These are not obscure the original entry, include a reason for the change and signed and dated by the person making the change.
What are changes or corrections to data ?
300
Appoints or replaces the Study Director when necessary.
Who is Test Facility Management?
300
The Study Director assures this.
What is that all applicable Good Laboratory Practice Standards are followed?
300
Is also required to approve the protocol according to GLP.
Who is the Sponsor?
300
How this will be controlled needs to be stated in the protocol.
What is bias?
300
Responsible for make sure there are sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
Who is Test Facility Management?
400
Must manintain copies of all GLP study protocols and a copy of the Master Schedule.
Who is Quality Assurance?
400
The Study Director must document these along with the corrective action taken.
What are unforseen circumstances?
400
Assures that only authorize personnel enter.
Who is the Archivist?
400
Corrections or changes to a final report need to be in this form.
What is an amendment by the Study Director?
400
Peggy Seymour
Who is the Archivist at NBRC?
500
A person who actually conducts a nonclinical GLP study.
What is that test facility?
500
These are the number of days that the Study Director has to get a signed final report, raw data and/or specimens archived?
What is zero?
500
Quality Assurance cannot be.
What is involved in the conduct of a GLP study?
500
Quality Assurance provides this to be included in the final report.
What is the Quality Assurance Statement?
500
Wet specimens, samples of test or control article/substances (reference substances) and specially prepared material need only be retained for this length of time.