SoCRA Study Guide exam questions and answers already graded A+| Updated & Verified | 2024

IRB approval - the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) - a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - an investigational new drug application, aka a notice of claimed investigational exemption for a new drug. Independent Ethics Committee (IEC) - -A review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. -An independent body (or review board, committee, institution, regional or national or supranational) of constitutes (medical professionals and non-medical professionals), whose responsibility it is to ensure that the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator's facilities and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. Custom Device - -necessarily deviates from devices generally available to physicians -not fully available to physicians -not available in finished form for purchasing or dispensing-not offered through labeling/advertising commercially -intended for use by an individual patient and is made in a specific form for the patient Implant - A device that is placed into a surgically or