Question

According to Good Clinical Practice, where should the master randomization list be kept?

1) Investigator's files
2) Sponsor's files
3) Both investigator's and sponsor's files
4) Cannot be determined

Answer 1

According to Good Clinical Practice (GCP), the master randomization list should be kept in both the investigator's and sponsor's files. This ensures transparency and accountability in clinical trials.

Step-by-step explanation:

According to Good Clinical Practice (GCP), the master randomization list should be kept in both the investigator's and sponsor's files. GCP is a set of international quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. The master randomization list is a critical component in the randomization process, ensuring that treatment assignments are randomly allocated to participants in a clinical trial. By keeping the master randomization list in both the investigator's and sponsor's files, it ensures transparency and accountability in the trial.