Site feasibility, selection and pre-study visits MCQs With Answer

Introduction:

This quiz set on Site feasibility, selection and pre-study visits is designed specifically for M.Pharm students studying Clinical Research (MPP 104T). It focuses on the practical and regulatory considerations required to evaluate and choose investigational sites, conduct pre-study visits, and ensure site readiness for clinical trials. Questions cover feasibility questionnaires, investigator qualifications, facility and equipment requirements, regulatory and ethics review, informed consent, source documentation, site staff training, and practical site activation steps. The aim is to deepen understanding of site assessment metrics, risk-based selection, and investigator responsibilities to prepare students for roles in clinical trial management and monitoring.

Q1. What is the primary objective of a site feasibility assessment?

• To negotiate the site budget and contract terms
• To verify the site’s ability to recruit, retain participants and comply with protocol requirements
• To install trial-specific equipment at the site
• To file the regulatory submission with the authority

Correct Answer: To verify the site’s ability to recruit, retain participants and comply with protocol requirements

Q2. Which document typically contains structured questions about a site’s past performance, facilities and staff during feasibility?

• Investigator’s Brochure (IB)
• Site Feasibility Questionnaire (SFQ)
• Clinical Study Report (CSR)
• Case Report Form (CRF)

Correct Answer: Site Feasibility Questionnaire (SFQ)

Q3. During a pre-study visit, which element is most critical to assess for ensuring data integrity?

• Availability of a hospital cafeteria
• Source data documentation practices and access to medical records
• Number of parking spaces for study staff
• Local weather forecast

Correct Answer: Source data documentation practices and access to medical records

Q4. Which qualification of the principal investigator is essential to verify during site selection?

• Their salary grade at the hospital
• Clinical trial experience and relevant therapeutic expertise
• Academic publications unrelated to the study disease
• Number of supervised nursing staff

Correct Answer: Clinical trial experience and relevant therapeutic expertise

Q5. What is the main purpose of the Site Initiation Visit (SIV) following a successful pre-study visit?

• To collect final signed consent forms from participants
• To train site staff on protocol, safety reporting and study procedures and activate the site
• To close the site at the end of the trial
• To audit the site’s financial records

Correct Answer: To train site staff on protocol, safety reporting and study procedures and activate the site

Q6. Which of the following is a key metric used during feasibility to estimate enrollment potential?

• Number of hospital beds only
• Average monthly number of eligible patients seen in the site’s clinic
• Number of administrative staff
• Distance from sponsor’s headquarters

Correct Answer: Average monthly number of eligible patients seen in the site’s clinic

Q7. What regulatory requirement must be confirmed at a site before initiating patient enrollment?

• That the site has completed at least ten prior trials
• That the Investigational Product (IP) temperature logbook is empty
• That ethics committee/IRB approval and any regulatory approvals are in place
• That the site director has published a review article

Correct Answer: That ethics committee/IRB approval and any regulatory approvals are in place

Q8. In feasibility assessment, which aspect of pharmacy capability is important for drug accountability?

• Proximity of pharmacy to a café
• Secure storage with temperature control and documented dispensing procedures
• Number of pharmacists on weekend duty only
• Availability of experimental refrigerators without logs

Correct Answer: Secure storage with temperature control and documented dispensing procedures

Q9. Which factor indicates a high risk for poor retention identified during pre-study visits?

• Short average travel time for patients
• Frequent study procedures with long clinic visits and limited clinic hours
• Availability of patient reminder systems
• Experienced study coordinators

Correct Answer: Frequent study procedures with long clinic visits and limited clinic hours

Q10. What is the role of site staff CVs and delegation logs in feasibility and pre-study preparation?

• To calculate the study budget
• To confirm staff qualifications, delegated responsibilities and training needs
• To advertise the site to potential participants
• To replace the informed consent form

Correct Answer: To confirm staff qualifications, delegated responsibilities and training needs

Q11. Which of the following best describes a site selection scorecard?

• A financial invoice from the site
• A standardized tool to rank sites based on objective feasibility criteria
• A list of all patients screened historically
• Protocol text annotated by the investigator

Correct Answer: A standardized tool to rank sites based on objective feasibility criteria

Q12. During the pre-study visit, why is delegation of authority and responsibility important to verify?

• Because it sets the site’s lunch schedule
• Because it ensures clear assignment of tasks related to consent, assessments and reporting, reducing protocol deviations
• Because it increases the number of enrolled patients automatically
• Because it reduces the need for monitoring visits

Correct Answer: Because it ensures clear assignment of tasks related to consent, assessments and reporting, reducing protocol deviations

Q13. Which item should be present in the Investigator Site File (ISF) at activation?

• Personal medical records of unrelated patients
• Regulatory approvals, signed protocol, investigator CV and delegation log
• Only the study budget
• Previous site selection scorecards for other sponsors

Correct Answer: Regulatory approvals, signed protocol, investigator CV and delegation log

Q14. What is the importance of assessing laboratory capabilities during feasibility?

• To ensure the lab has an attractive waiting room
• To confirm assay availability, turnaround time, sample handling, storage and accreditation
• To compare lab logos for brand alignment
• To ensure the lab has social media presence

Correct Answer: To confirm assay availability, turnaround time, sample handling, storage and accreditation

Q15. Which element is critical when evaluating a site’s ability to handle adverse event (AE) reporting?

• Whether the site publishes newsletters
• Presence of SOPs for AE reporting, trained staff and 24/7 contact mechanisms
• Availability of free parking for participants
• Distance from nearest pharmacy

Correct Answer: Presence of SOPs for AE reporting, trained staff and 24/7 contact mechanisms

Q16. What should a sponsor verify about the site’s consent process in a pre-study visit?

• That consent is obtained verbally without documentation
• That there are appropriate procedures, private space, and translated ICFs if needed and documentation of consent discussions
• That the site uses social media for consent
• That consent is signed by a staff member instead of the participant

Correct Answer: That there are appropriate procedures, private space, and translated ICFs if needed and documentation of consent discussions

Q17. Which practical consideration often causes delays between site selection and activation?

• Swift completion of ethics approval
• Contract negotiations, budget approval and timely ethics/regulatory approvals
• Excessive staff training availability
• Immediate shipment of investigational product

Correct Answer: Contract negotiations, budget approval and timely ethics/regulatory approvals

Q18. In risk-based site selection, which factor increases a site’s priority?

• Low patient volume and no prior trial experience
• High expected enrollment, strong data quality record and experienced coordinator
• Long distance from sponsor office only
• High staff turnover rates

Correct Answer: High expected enrollment, strong data quality record and experienced coordinator

Q19. What is an important contractual consideration identified during pre-study visits?

• Whether the PI prefers specific stationery
• Clear definitions of payment milestones, scope of work, IP handling and liability
• Only the color of the site logo
• Which monitor will bring snacks

Correct Answer: Clear definitions of payment milestones, scope of work, IP handling and liability

Q20. Which post-selection activity ensures continuous site readiness after activation?

• Never communicating with the site again
• Regular monitoring, training refreshers, ongoing data quality checks and communication about enrollment targets
• Only occasional social media posts
• Replacing the PI every month

Correct Answer: Regular monitoring, training refreshers, ongoing data quality checks and communication about enrollment targets

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