The visit

For companies that have fully implemented GCP into everyday working, initiation visits are required before the setting up of a clinical trial. These visits provide the ideal opportunity to assess the reliability, effectiveness, and, sometimes, honesty of the centres being considered to participate in a research programme.

To fully exploit the opportunity presented by these early visits and the planning of clinical research a certain approach is necessary from the company representative. Many company representatives (clinical research associates or medical research associates) involved in the initiation visits for clinical research are new graduates in their first professional post. They need to understand that, if they have the slightest concern that something is not right with the centre or the investigator, this should be communicated to the responsible person in the company. Many new graduates find this very difficult to put into practice, particularly if dealing with well-known or prestigious investigators or centres. Strong reassurance from their management on the importance of this issue is needed.

In helping clinical research staff to identify the "giveaway signs" conveyed during a study initiation visit, training and the sharing of experience are the keys to success.With encouragement, trial monitors will rapidly build up a bibliography of relevant quotes or situations or attitudes that may indicate a possible future problem.

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