Good Clinical Practice fully solved graded A+ 2023/2024

Good Clinical PracticeICH GCP Concepts - correct answer Investigator - correct answer A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the Principal Investigator (PI) Sub-investigator - correct answer Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial related procedures and/or to make important trial related decisions. PI and Sub-I - correct answer Can both make important trial related decisions Both do critical trial-related procedures PI often are important busy people so a lot of work is deligated to SUB-Is Difference between roles - correct answer Sub-I is only responsible for their own actions while PI is responsible for everything that is being done at the site investigator - correct answer Must be qualified by education, training, and experienced. Thoroughly familiar with the appropriate use of investigational product. Should also be aware and comply with GCP requirements. Investigator Responsibilities - correct answer Demonstrate potential for- recruiting the required number of suitable subjects within the agreed recruitment period and have sufficient time to properly conduct and complete the trial with the agreed trial period. Have adequate number of qualified staff and adequate facilities and ensure that all persons assisting with trials are informed about the study Sponsor - correct answer An individual, company, institution, or organization which takes responsibility for the initiation, management, and or financing of a clinical trial. Sponsors can transfer any of all of their trial-related duties and functions to a CRO