CPI CPI Clinical Site Operations & Investigational Product

Question 1

What is the primary purpose of a site initiation visit (SIV) conducted before a clinical trial begins?

Accepted Answer

To train site staff on the protocol, procedures, and regulatory requirements

Answer

To enroll the first cohort of participants

Answer

To audit the site's financial records

Answer

To submit the initial IND application

Question 2

Which document serves as the definitive record of staff authorized to perform specific tasks on a clinical trial site?

Accepted Answer

Site Delegation Log (Delegation of Authority Log)

Answer

Protocol Synopsis

Answer

Site Feasibility Questionnaire

Answer

Master File Index

Question 3

What is the required action when a site staff member who has delegated study responsibilities leaves the institution?

Accepted Answer

Update the delegation log, retrain a replacement, and notify the sponsor/CRO

Answer

Simply reassign tasks verbally to available staff

Answer

Pause the study until a replacement is hired

Answer

File an amendment with the FDA

Question 4

What does 'source document' refer to in clinical trial terminology?

Accepted Answer

The original record where study data are first captured, such as medical charts or lab printouts

Answer

The final version of the Case Report Form submitted to the sponsor

Answer

The IRB-approved protocol

Answer

The participant's billing record

Question 5

According to GCP guidelines, how must corrections be made to a paper Case Report Form (CRF)?

Accepted Answer

Draw a single line through the error, write the correct value, date, and initial the change

Answer

Use correction fluid (white-out) to cover the error and rewrite

Answer

Shred the page and create a new CRF page

Answer

Simply erase the incorrect value and write the correct one

Question 6

What is the primary purpose of a monitoring visit conducted by a sponsor's Clinical Research Associate (CRA)?

Accepted Answer

To verify data accuracy, protocol compliance, and participant safety at the site

Answer

To collect payments owed to site staff

Answer

To conduct interim statistical analysis

Answer

To review the site's operational budget