GCP Quiz

**GCP Quiz** 1\) What does \'informed consent\' in GCP primarily ensure? A. Data accuracy B. Participant understanding C. Research publicity D. Funding transparency 2\) Which criteria must be met for a clinical trial to be considered ethical? A. Sponsor benefit B. Minimal documentation C. S...

**GCP Quiz** 1\) What does \'informed consent\' in GCP primarily ensure? A. Data accuracy B. Participant understanding C. Research publicity D. Funding transparency 2\) Which criteria must be met for a clinical trial to be considered ethical? A. Sponsor benefit B. Minimal documentation C. Scientific validity D. High financial reward 3\) Why is blinding used in clinical trials? A. To prevent bias\-- B. To reduce costs C. To simplify protocols D. To speed up trials 4\) What is the significance of the Declaration of Helsinki for clinical trials? A. Guides ethical principles\-- B. Specifies drug types C. Regulates data sharing D. Defines funding sources 5\) What is essential for the IRB/IEC when determining the composition of its members? A. All members must come from the same institution. B. Members must have a minimum of 10 years of experience. C. At least one member should be independent of the institution/trial site.\-- D. The composition must consist entirely of scientific members. 6\) Which responsibility does the IRB/IEC have regarding trial subjects and payments? A. To evaluate if the payment amounts could lead to undue influence. \-- B. To negotiate payment amounts with each trial subject individually. C. To ensure payments are only made upon trial completion. D. To decide the payment schedule without involving subjects. 7\) What role does the investigator have in the IRB/IEC meetings? A. The investigator can vote on trial-related matters. B. The investigator must prepare the meeting agenda. C. The investigator is responsible for determining the outcome of votes. D. The investigator may provide information but should not contribute to deliberations\-- 8\) What is a required minimum composition of members for the IRB/IEC? A. At least five members\-- B. At least seven members. C. At least ten members. D. At least three members. 9\) What is the purpose of inviting non-members with expertise to the IRB/IEC? A. To gain specific insights that enhance the review process\-- B. To increase the number of votes on trial matters. C. To reduce the time spent on decision-making. D. To provide additional financial support for the trial. 10\) What agreement must the investigator/institution give to conduct the trial? A. Compliance with financial regulations only B. Compliance with Good Clinical Practice and regulatory requirements \-- C. Compliance with ethical review guidelines only D. Compliance only with the trial sponsor\'s interests 11\) Which of the following is NOT a responsibility of the investigator as per the agreement with the sponsor? A. Conducting the trial in compliance with the protocol B. Providing financial support to subjects \-- C. Allowing monitoring and auditing D. Ensuring data is recorded and reported accurately 12\) What must the sponsor do regarding insurance or indemnification? A. Offer insurance only if there are no regulatory requirements B. Provide unlimited insurance to the investigator C. Indemnify the investigator for all trial-related claims D. Provide insurance except for claims relating to malpractice -- 13\) What is the primary role of the principal investigator in a clinical trial? A. To conduct the trial without any support team B. To manage external communications with regulatory bodies C. To lead the team of individuals at the trial site \-- D. To oversee the financial aspects of the trial 14\) What is the purpose of a protocol amendment in a clinical trial? A. To describe changes or clarifications to the original protocol \-- B. To clarify the roles of team members C. To outline the budgetary requirements for the trial D. To provide a summary of trial results to date 15\) What types of adverse drug reactions (ADRs) must the sponsor expedite reporting for? A. ADRs that were anticipated during the trial design. B. Serious and unexpected ADRs only. \-- C. All known ADRs. D. Mild ADRs with no significant impact.