Investigator meetings and trial start-up activities MCQs With Answer

Introduction

Investigator meetings and trial start-up activities are critical phases in clinical research that ensure study readiness, regulatory compliance, and effective site performance. This blog presents focused MCQs with answers tailored for M.Pharm students studying Clinical Research (MPP 104T). The questions emphasize practical and regulatory aspects such as site selection, feasibility assessments, ethics and regulatory submissions, site initiation visits, training of study staff, essential documents, delegation of duties, and trial activation workflows. Working through these MCQs will deepen understanding of responsibilities, timelines, documentation requirements, and communication strategies necessary to launch and manage clinical trials successfully. Use these items to prepare for exams and real-world trial management.

Q1. What is the primary objective of an investigator meeting during trial start-up?

• To negotiate the clinical trial budget with the sponsor
• To provide scientific training and align site teams on protocol, responsibilities, and procedures
• To conduct final clinical examinations of enrolled subjects
• To perform a formal audit of the site by regulatory authorities

Correct Answer: To provide scientific training and align site teams on protocol, responsibilities, and procedures

Q2. Which document is essential to present at a site initiation visit to confirm site readiness?

• Investigator’s published research articles
• Signed protocol and informed consent form (approved by Ethics Committee/IRB)
• Site electricity usage report
• Copies of previous study participant records

Correct Answer: Signed protocol and informed consent form (approved by Ethics Committee/IRB)

Q3. During trial start-up, what is the purpose of a feasibility assessment?

• To test investigational product stability at the site
• To evaluate the site’s ability to recruit eligible participants and meet trial requirements
• To finalize the study publication plan
• To train monitor staff in data entry procedures

Correct Answer: To evaluate the site’s ability to recruit eligible participants and meet trial requirements

Q4. Which regulatory submission is generally required before patient enrollment can begin?

• Clinical trial insurance policy
• Ethics Committee/Institutional Review Board (IRB) approval
• Investigator’s curriculum vitae only
• Final study manuscript

Correct Answer: Ethics Committee/Institutional Review Board (IRB) approval

Q5. What is a key agenda item at an investigator meeting focused on safety?

• Discussion of site financial accounting
• Detailed review of adverse event (AE) and serious adverse event (SAE) reporting timelines and processes
• Selection of invitation menus for the meeting
• Planning social activities for site staff

Correct Answer: Detailed review of adverse event (AE) and serious adverse event (SAE) reporting timelines and processes

Q6. Which document records delegated trial responsibilities at a site?

• Patient screening log
• Delegation of Authority Log (Delegation Log)
• Monitoring visit summary
• Site financial contract

Correct Answer: Delegation of Authority Log (Delegation Log)

Q7. What is the role of the Site Initiation Visit (SIV)?

• To close out the study at a site
• To verify that the site has the necessary facilities, staff training, and documentation to start enrolling subjects
• To conduct laboratory assays for study samples
• To finalize the clinical study report

Correct Answer: To verify that the site has the necessary facilities, staff training, and documentation to start enrolling subjects

Q8. Which activity is NOT usually part of trial start-up?

• Contract and budget negotiation
• Regulatory and ethics submissions
• Writing the final study conclusion
• Site staff training and initiation visits

Correct Answer: Writing the final study conclusion

Q9. In investigator meetings, why is standardized training on the informed consent process important?

• To reduce variability in participant recruitment language and ensure ethical, compliant consent procedures
• To improve the speed of data entry in the eCRF
• To eliminate the need for ethics committee oversight
• To enable sites to write their own study protocols

Correct Answer: To reduce variability in participant recruitment language and ensure ethical, compliant consent procedures

Q10. Which of the following is a critical timeline tracked during trial start-up?

• Time to first site meal served
• Time from site selection to first patient enrolled (site activation to first patient in)
• Time spent on investigator vacation planning
• Duration of initial sponsor marketing campaign

Correct Answer: Time from site selection to first patient enrolled (site activation to first patient in)

Q11. What is the significance of the Site File/Investigator Site File (ISF) during start-up?

• It stores confidential participant financial details only
• It contains essential documents to demonstrate compliance and site readiness throughout the trial
• It is used to store sponsor marketing materials
• It is an optional record for small trials

Correct Answer: It contains essential documents to demonstrate compliance and site readiness throughout the trial

Q12. Which item should be completed before dispensing the investigational product at a site?

• Site staff birthday calendar
• Appropriate training and documentation, regulatory approvals, and drug accountability procedures in place
• Finalization of the study publication author list
• Monitoring plan signature by the sponsor only

Correct Answer: Appropriate training and documentation, regulatory approvals, and drug accountability procedures in place

Q13. What is a common objective for sponsors when holding investigator meetings across multiple regions?

• To recruit sponsors’ personal staff into sites
• To harmonize protocol interpretation, procedures, and data quality expectations across all sites
• To publish a joint press release
• To replace local ethical requirements with sponsor policies

Correct Answer: To harmonize protocol interpretation, procedures, and data quality expectations across all sites

Q14. Which document outlines monitoring frequency and procedures during a trial?

• Investigator meeting minutes
• Study Monitoring Plan (SMP)
• Delegation log
• Site enrollment flyer

Correct Answer: Study Monitoring Plan (SMP)

Q15. What should be reviewed with site laboratories during start-up or an investigator meeting?

• Local dining options for lab staff
• Sample collection, processing, storage, shipping procedures, and turnaround times aligned with the protocol
• Investigator’s academic career plan
• Lab historical salaries

Correct Answer: Sample collection, processing, storage, shipping procedures, and turnaround times aligned with the protocol

Q16. How does a well-conducted investigator meeting impact patient safety?

• It delays reporting of adverse events intentionally
• It ensures consistent understanding of safety reporting, inclusion/exclusion criteria, and protocol procedures which reduces risks to participants
• It allows sites to decide safety procedures independently
• It removes the need for ethics committee oversight

Correct Answer: It ensures consistent understanding of safety reporting, inclusion/exclusion criteria, and protocol procedures which reduces risks to participants

Q17. Which of the following is a critical contract-related activity during trial start-up?

• Signing a non-binding letter of appreciation
• Negotiating and executing clinical trial agreements that outline responsibilities, indemnity, and payment terms
• Planning the end-of-study celebration
• Creating the study social media plan

Correct Answer: Negotiating and executing clinical trial agreements that outline responsibilities, indemnity, and payment terms

Q18. What is the role of training provided at investigator meetings regarding protocol deviations?

• To encourage sites to ignore the protocol when convenient
• To explain detection, documentation, reporting procedures, and corrective actions for protocol deviations
• To teach sites how to amend the protocol independently
• To outline financial penalties for all deviations

Correct Answer: To explain detection, documentation, reporting procedures, and corrective actions for protocol deviations

Q19. Which element is important to confirm for investigational product (IP) management at site activation?

• IP branding and marketing strategy
• Secure storage conditions, accountability logs, and procedures for dispensing and return/destruction
• Investigator personal preference for shipment routes
• Trial results before dosing the first subject

Correct Answer: Secure storage conditions, accountability logs, and procedures for dispensing and return/destruction

Q20. What is an effective outcome measure for evaluating if an investigator meeting achieved its start-up objectives?

• Number of catering items consumed
• Reduction in site activation time, fewer protocol queries, and demonstrated staff competency on core procedures
• Number of social media posts about the meeting
• Number of slides presented by the sponsor

Correct Answer: Reduction in site activation time, fewer protocol queries, and demonstrated staff competency on core procedures

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