Good Clinical Practice (GCP) Questions and Answers | Latest Version | Rated A+

Good Clinical Practice (GCP) Questions and Answers | Latest Version | Rated A+ What should you do if a participant signs yesterday's date on the informed consent form after leaving the clinic? You should ask the participant to correct the date by crossing out yesterday's date, adding today's date, initialing the change, and dating the form correctly during their next visit. How can you prevent errors in informed consent dates in the future? To avoid such errors, keep a checklist handy for reviewing informed consent documents signed by study participants. Additionally, highlight the areas for initials, signature, and date on the consent form to ensure clarity during discussions. Always review the signed informed consent form before the participant leaves to confirm all sections are appropriately marked, signed, and dated. Keep a calendar nearby to verify today's date against the date provided by the participant on the form. True or False: Can a person with a court-appointed legal guardian or determined by a court to be legally incompetent sign an informed consent form? False. Individuals who are legally incompetent cannot sign an informed consent form, even if they have a court-appointed guardian. If a research participant is a minor (under 18), what is required before they can participate in the study? Before a minor can participate in a research study, both their parent or legal guardian must provide permission and the minor themselves must agree to participate. What happens when researchers obtain new information about the study medication? Participants will be promptly informed of any new findings that could affect them. They have the right to withdraw from the study without facing penalties or losing benefits. True or False: Due to incarceration, can prisoners have difficulty making voluntary decisions about participating in clinical trials? True. Incarceration can impair a prisoner's ability to make a fully voluntary decision about participating in clinical trials. To document that the research participant has voluntarily agreed to participate in the study, the research participant must: Sign