Glossary

CRO

CRO (a Clinical Research Organization) normally refers to a body for accepting the consignment of aspects of the medical drug development business in medicine-related fields. It indicates corporations that can substitute for and support some of the business and other activities related to clinical testing (clinical trials) during the medical drug development stage, and clinical tests after sales of medical drugs when they are being developed by pharmaceutical companies.

CRA

CRA (Clinical Research Associate) normally refers to a clinical development monitor (or clinical trial monitor). It indicates a person who monitors whether a clinical test (or clinical trial) during the medical drug development stage is being performed in compliance with the Pharmaceutical Affairs Laws, other related regulations, and the clinical trial execution plan sheet.

SMO

SMO (Site Management Organization) normally refers to clinical trial facility support organizations. It indicates corporations that support the work of doctors, nurses, and people engaged in clinical trials at a medical organization, for clinical tests (clinical trials) during medical drug development by pharmaceutical companies.

CRC

CRC (Clinical Research Coordinator) normally refers to the clinical trial coordinator.” It indicates a person who coordinates between medical personnel (doctors), the clinical trial requesting body (pharmaceutical companies), and subjects (patients), for clinical tests (clinical trials) during the medical drug development stage. The CRC also performs selection, checks the appropriateness of subjects, and explains the clinical trial to the subjects.

Monitoring Activites

Monitoring is the central activity in the development of new drugs. A CRA (Clinical Development Monitor), the person in charge of development, visits a medical institution and formally explains the clinical trial contract, explains the clinical trial drug to the doctors, describes the clinical trial execution plan sheet, checks the compliance status, delivers the clinical trial drugs, requests cooperation with the clinical trial (integrates the clinical cases), secures the data trust level, and collects the data.

Quality Control (QC) Activities

Quality Control activities are the work of confirming that the monitoring is performed properly according to the clinical trial execution plan sheet and clinical trial standard business procedure sheet.

Consulting Activities

During the medical drug development stage, a pharmaceutical company that is requesting a clinical trial needs support in the creation of a development schedule and applying for approval of a new drug. Consulting activities are the work of individuals with a great deal of experience with clinical trial support who guide a company through these procedures.

Medical Write-ups

This term refers to the whole process of creating various applications and reports needed for clinical tests (clinical trials) and writing material for obtaining approval from the government at the stage of medical drug development. The documents must be provided by pharmaceutical companies who are requesting clinical trials.

Clinical Trial Standard Business Procedure Sheet

This is also called the SOP (Standard Operating Procedure). It is a procedure sheet systematically summing up the basic procedures required for developing medical drugs, in order to make sure the clinical trial is ethical and scientifically appropriate, as well as to secure the reliability of the test results. This procedure sheet is created on the basis of the comprehensive concept of GCP (Good Clinical Practices), and is created by pharmaceutical companies. (In Japan, the ministerial ordinances concerning execution standards for clinical tests of medical drugs and the ministerial ordinances concerning execution of clinical test of medical equipment (published in a document dated March 27, 1997), as well as operation notifications for these ordinances issued by the Ministry of Health, Labor and Welfare are referred to as Japan's GCP.)

Clinical Trial Execution Plan Sheet

The clinical trial execution plan sheet is also called a protocol. It is a plan sheet that contains items that must be obeyed by the medical institution (the execution organization) and the pharmaceutical company (the requesting party) when executing the clinical trial. According to the clinical trial standard work procedure sheet, the documents must be created by the pharmaceutical company that is requesting the clinical trial.

Clinical Trial Domestic Administration Business

If a foreign pharmaceutical company, which does not have any business base inside Japan, wants to apply for the execution of clinical trials and the approval for new drugs inside Japan, it has to obtain the services of a domestic management clinical trial staff that has a business base inside Japan. This kind of company executes this procedure.