approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. Additional Regulations or Policies N/A (MANDATORY LANGUAGE) [Optional: Insert any additional project, department, sponsor, institution, state or federal policies that apply] DEFINITIONS ARCHIVE: To place or store in an archive ARCHIVES: The documents or records relating to the activities of an organization; a place where historical records are kept ARCHIVIST: A person who has the job of collecting and storing the materials in an archive AUDITOR: An individual responsible for the systematic and independent examination of trial-related activities and documents to determine whether the trial-related activities being evaluated were conducted and the data were recorded, analyzed and accurately reported according to the protocol, the sponsor’s standard operating procedures, Good Clinical Practice, and the applicable regulatory requirement(s) GOOD CLINICAL PRACTICE: A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected INDEPENDENT ETHICS COMMITTEE (IEC): An independent body- i.e. a review board or a committee, whether institutional, regional, national, or supranational, constituted of medical professionals and non-medical members that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection INSTITUTIONAL REVIEW BOARD (IRB): An independent body- constituted of medical, scientific, and non-scientific members that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments
approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. Additional Regulations or Policies N/A (MANDATORY LANGUAGE) [Optional: Insert any additional project, department, sponsor, institution, state or federal policies that apply] DEFINITIONS ARCHIVE: To place or store in an archive ARCHIVES: The documents or records relating to the activities of an organization; a place where historical records are kept ARCHIVIST: A person who has the job of collecting and storing the materials in an archive AUDITOR: An individual responsible for the systematic and independent examination of trial-related activities and documents to determine whether the trial-related activities being evaluated were conducted and the data were recorded, analyzed and accurately reported according to the protocol, the sponsor’s standard operating procedures, Good Clinical Practice, and the applicable regulatory requirement(s) GOOD CLINICAL PRACTICE: A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected INDEPENDENT ETHICS COMMITTEE (IEC): An independent body- i.e. a review board or a committee, whether institutional, regional, national, or supranational, constituted of medical professionals and non-medical members that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection INSTITUTIONAL REVIEW BOARD (IRB): An independent body- constituted of medical, scientific, and non-scientific members that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments
Archiving.docx