SQA Startup 5 — Questions and Answers
Question 1: Which scenario at study startup would trigger a formal protocol amendment rather than a minor administrative correction?
- Correcting a typographical error in the Study Director's name
- Changing the dose levels or duration of treatment (Correct answer)
- Fixing a formatting error in the table of contents
- Updating the document version number
Correct answer: Changing the dose levels or duration of treatment
Changes that affect the scientific conduct of the study, such as dose levels or duration, require a formal signed protocol amendment.
Question 2: In GLP, what is the required outcome if a test article mixture is prepared at study startup and homogeneity cannot be confirmed?
- Use the mixture and note the uncertainty in the report
- Do not use the mixture until homogeneity is analytically confirmed (Correct answer)
- Allow the sponsor to waive the homogeneity requirement
- Archive the mixture and prepare a new batch without testing
Correct answer: Do not use the mixture until homogeneity is analytically confirmed
Homogeneity of test article mixtures must be analytically verified before administration to ensure dose accuracy and data validity.
Question 3: A QA inspector discovers that the study protocol was signed after the first day of dosing. Which GLP principle has been violated?
- Data archiving requirements
- The requirement that the protocol be signed before study-specific procedures begin (Correct answer)
- Sponsor confidentiality rules
- Animal welfare regulations only
Correct answer: The requirement that the protocol be signed before study-specific procedures begin
GLP mandates that the Study Director sign the protocol before study-specific procedures commence; signing after dosing begins is a serious GLP violation.
Question 4: Which of the following best describes a 'startup meeting' in the context of a GLP study?
- A meeting held after the final report is delivered
- A pre-study meeting to align all personnel on protocol requirements, roles, and responsibilities (Correct answer)
- A regulatory inspection kickoff
- An annual review of archived studies
Correct answer: A pre-study meeting to align all personnel on protocol requirements, roles, and responsibilities
A startup meeting ensures all study personnel understand their roles, the protocol, and GLP expectations before work begins.
Question 5: Under GLP, if the sponsor requests that certain startup documentation remain confidential, what obligation does the test facility still have?
- Destroy the documents after sponsor review
- Maintain all required GLP records and make them available to regulatory inspectors (Correct answer)
- Transfer all documentation to the sponsor's site
- Exempt confidential documents from archiving
Correct answer: Maintain all required GLP records and make them available to regulatory inspectors
Regardless of confidentiality agreements, all GLP-required records must be retained and made available to regulatory authorities upon request.
Question 6: When verifying test article storage conditions at study startup, which parameter is LEAST likely to be included in GLP documentation?
- Storage temperature range
- Stability data supporting storage conditions
- The sponsor's marketing claims for the test article (Correct answer)
- Expiration or re-analysis date
Correct answer: The sponsor's marketing claims for the test article
Marketing claims are commercial information and are not GLP documentation requirements; temperature, stability, and expiry are all required.
Question 7: Which GLP record created at study startup provides a direct link between the study protocol and individual raw data entries throughout the study?
- The QA audit certificate
- The specimen label and unique sample identification system (Correct answer)
- The archiving checklist
- The sponsor's contract
Correct answer: The specimen label and unique sample identification system
A specimen labeling and unique sample identification system established at startup allows each data point to be traced back to the correct protocol and subject.
SQA Startup 5
Which scenario at study startup would trigger a formal protocol amendment rather than a minor administrative correction?