CPCSEA guidelines overview MCQs With Answer

CPCSEA guidelines overview MCQs With Answer

Introduction: This set of multiple-choice questions is designed for M.Pharm students studying Quality Control & Quality Assurance, focusing on CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals) guidelines. The quiz highlights regulatory aims, ethical principles, Institutional Animal Ethics Committee (IAEC) responsibilities, animal house registration, and practical requirements such as the 3Rs, anesthesia, humane endpoints, record keeping and reporting. Answers are provided to reinforce learning and exam preparation. These questions go beyond definitions to test understanding of how CPCSEA rules shape protocol design, animal procurement, housing, personnel training and institutional oversight in pharmaceutical research.

Q1. What does CPCSEA stand for?

• Community for Control and Safety of Experimental Animals
• Committee for the Purpose of Control and Supervision of Experiments on Animals
• Council for Pharmaceutical and Clinical Studies on Experimental Animals
• Central Panel for Care and Standards of Experimental Animals

Correct Answer: Committee for the Purpose of Control and Supervision of Experiments on Animals

Q2. Under which act was the CPCSEA constituted?

• Indian Medical Research Act, 1970
• Prevention of Cruelty to Animals Act, 1960
• Animal Welfare and Research Act, 1984
• National Bioethics Act, 1995

Correct Answer: Prevention of Cruelty to Animals Act, 1960

Q3. What is the primary objective of CPCSEA guidelines?

• To promote animal use in all research to speed drug development
• To ensure humane care and ethical use of animals in scientific experiments
• To standardize clinical trials in humans
• To regulate import-export of laboratory chemicals

Correct Answer: To ensure humane care and ethical use of animals in scientific experiments

Q4. In the context of CPCSEA, the 3Rs principle stands for:

• Replacement, Repetition, Regulation
• Reduction, Refinement, Reanalysis
• Replacement, Reduction, Refinement
• Reproducibility, Replication, Refinement

Correct Answer: Replacement, Reduction, Refinement

Q5. Which institutional body must review and approve all animal experimentation protocols before studies begin?

• Institutional Human Ethics Committee (IHEC)
• Drug Controller General’s Office
• Institutional Animal Ethics Committee (IAEC)
• Medical Records Committee

Correct Answer: Institutional Animal Ethics Committee (IAEC)

Q6. Which of the following is NOT a responsibility of the IAEC under CPCSEA guidelines?

• Reviewing scientific merit and ethical justification of protocols
• Approving procedures for anesthesia and postoperative care
• Granting approval for human clinical trials
• Monitoring ongoing animal welfare and record keeping

Correct Answer: Granting approval for human clinical trials

Q7. Which feature is considered essential for the Chairperson of an IAEC according to CPCSEA principles?

• The Chairperson should be the head of the animal facility
• The Chairperson should preferably be non-affiliated or external to the institution
• The Chairperson must be a practicing clinician in the same department
• The Chairperson must be the principal investigator of the majority of protocols

Correct Answer: The Chairperson should preferably be non-affiliated or external to the institution

Q8. Before conducting experiments, an institutional animal house must:

• Obtain registration/recognition from CPCSEA
• Only notify CPCSEA after study completion
• Register with the Human Ethics Committee instead
• Only maintain internal records without external registration

Correct Answer: Obtain registration/recognition from CPCSEA

Q9. Which aspect of animal housing is specifically emphasized in CPCSEA guidelines to improve welfare?

• Maximum stocking density irrespective of species
• Complete isolation without environmental enrichment
• Provision of species-appropriate environmental enrichment and suitable microenvironment
• Removal of all bedding to simplify cleaning

Correct Answer: Provision of species-appropriate environmental enrichment and suitable microenvironment

Q10. For procedures expected to cause pain or distress, CPCSEA guidelines require:

• Omission of analgesia to avoid interfering with data collection
• Provision of appropriate anesthesia and postoperative analgesia unless scientifically justified and approved
• Use of pain without any documentation to speed up experiments
• Only observation without interventions

Correct Answer: Provision of appropriate anesthesia and postoperative analgesia unless scientifically justified and approved

Q11. What is meant by a ‘humane endpoint’ in CPCSEA context?

• The final date of the calendar year for reporting
• The earliest point at which an experimental animal’s pain or distress is terminated or minimized by ending the experiment
• The scheduled time for data collection regardless of animal condition
• The mandatory rest period between two experiments

Correct Answer: The earliest point at which an experimental animal’s pain or distress is terminated or minimized by ending the experiment

Q12. Which statement about euthanasia under CPCSEA guidance is correct?

• Euthanasia methods may be unstandardized if performed quickly
• Euthanasia must use scientifically recognized, humane methods performed by trained personnel
• Euthanasia is prohibited under all circumstances
• Euthanasia protocols need not be documented

Correct Answer: Euthanasia must use scientifically recognized, humane methods performed by trained personnel

Q13. Which of the following is NOT one of the 3Rs promoted by CPCSEA?

• Replacement
• Reduction
• Refinement
• Replication

Correct Answer: Replication

Q14. Which record-keeping practice is mandated by CPCSEA for institutions using animals?

• No records are necessary if animals appear healthy
• Maintain detailed records of animal acquisition, use, health, procedures and disposal
• Only financial records need to be kept
• Records can be verbal and informal

Correct Answer: Maintain detailed records of animal acquisition, use, health, procedures and disposal

Q15. From where should experimental animals ideally be procured according to CPCSEA guidelines?

• Any local market without documentation
• From CPCSEA-registered breeders or approved sources
• Brought in from the wild without permits
• Only from international suppliers without registration

Correct Answer: From CPCSEA-registered breeders or approved sources

Q16. When submitting an animal experiment protocol to the IAEC, investigators are expected to include:

• Only the experimental objective without methodological details
• A detailed scientific justification including statistical rationale for sample size
• A promise to decide sample size after data collection
• Only a budget breakdown

Correct Answer: A detailed scientific justification including statistical rationale for sample size

Q17. Which action can CPCSEA take to ensure compliance with its guidelines?

• Conduct inspections and recommend cancellation of registration or penal action for non-compliance
• Only provide verbal advice without any enforcement
• Delegate all enforcement to institutional students
• Allow indefinite non-compliance if research is important

Correct Answer: Conduct inspections and recommend cancellation of registration or penal action for non-compliance

Q18. CPCSEA requirements for personnel working with laboratory animals include:

• No specific training; hands-on learning is sufficient
• Mandatory training in animal handling, experimental techniques and welfare awareness
• Only a written exam with no practical training
• Training solely in administrative paperwork

Correct Answer: Mandatory training in animal handling, experimental techniques and welfare awareness

Q19. Withholding analgesics or anesthetics solely to obtain experimental data is:

• Permissible without oversight
• Allowed if the investigator signs a waiver
• Allowed only if scientifically justified and specifically approved by the IAEC
• Recommended as best practice

Correct Answer: Allowed only if scientifically justified and specifically approved by the IAEC

Q20. How should serious adverse events involving animals during a study be handled under CPCSEA guidance?

• Ignored to avoid paperwork
• Reported promptly to the IAEC and, where required, to the CPCSEA with documentation of action taken
• Reported only at the end of the study
• Discussed informally among student volunteers

Correct Answer: Reported promptly to the IAEC and, where required, to the CPCSEA with documentation of action taken

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