Regulatory Guidance

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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.

15 Questions4 MinutesCreated by ThinkingGuide321

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

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

Regulatory Guidance

Regulatory Guidance Quiz

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