The IRB/IEC should have enough members who together can review the science, medicine and ethics; it is recommended to include at least five members, at least one whose main interest is outside medical science and at least one independent of the institution or site, and only members independent of the investigator and sponsor who took part in the review should vote or give an opinion. A membership and qualifications list should be kept. It should operate under documented procedures, keep activity records and minutes, comply with GCP and regulation, and decide at announced meetings with a quorum (with expedited review for minor changes where allowed); investigators and sponsors may provide information but not take part in decisions, and outside experts may be invited. Its procedures should cover composition and authority, meetings, initial and continuing review and its frequency, expedited review, no enrolment before documented approval, no protocol deviations or changes without prior approval except to remove immediate hazards or for logistical or administrative changes, prompt reporting by investigators of hazard-driven deviations, risk-increasing changes, SUSARs and adverse new information, and prompt written notice of its decisions, reasons and appeal procedures. It should keep all relevant records (procedures, membership and affiliations, submissions, minutes, correspondence) as regulations require and provide them, and its procedures and membership list, when asked.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.