Regulatory Guidance
Regulatory Guidance Quiz
Welcome to the Regulatory Guidance Quiz! This quiz is designed to enhance your knowledge of important regulatory documents and procedures in clinical trials. Learn about various aspects such as the structure of the documents, training requirements, and the roles of staff members.
- Test your understanding of protocols and ethical considerations.
- Ensure you're familiar with the necessary documentation processes.
- Enhance your compliance with regulatory standards.
Where are DMs regulatory documents housed?
In Florence
In the Wet-Ink regulatory binder
At corporate
In what section of Florence can you find the ICFs?
Section 2
Section 5
Section 6
Section 9
Once staff are trained on the original protocol they do not need to be retrained on the updated versions.
True
False
Staff can start working on the study before they are added to the DOA if the PI approves it.
True
False
What document tell you who does what tasks on a trial?
FDF/ financial disclosure form
DOA/ Delegation of authority log
1572
CV
What section of Florence is the IB located?
Section 5
Section 6
Section 1
Section 3
The entire site staff needs to be trained on the IB
True
False
Where should you look to identify whether or not all subjects need to be re-consented once a new IRB approved ICF is made available?
The ICF
The IRB approval letter
The IB
The filing cabinet on the 4th Floor
When reviewing Florence, the QA associate should ensure that each IB has a corresponding ___________ located in the site level critical docs folder (IB receipt)
When should there NOT be a Site Blinding Plan filed?
Double blinded studies
Single blinded studies
What should you use as a guide/reference when ensuring all study tasks are captured on the DM DOA?
The IB
1572
The sponsor provided template of the DOA
The protocol
When does an Investigator's CV expire?
1 year
2 years
3 years
4 years
When do staff CVs expire?
1 year
2 years
3 years
4 years
Where in Florence find/keep up with important Site communications with the Sponsor?
In section 1
Correspondence>emails
In section 5
With the protocols
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