Prestudy visits

A prestudy visit is conducted after the initial investigator contact to assess if the investigator and staff are qualified to conduct the clinical study. 

After the prestudy visit is completed, a report is written documenting site observations and any pertinent discussions. Any unusual observations are also noted (e.g., outdated equipment). A follow-up letter is sent to the investigator stating the qualification status for participating in the clinical study. If the investigator is qualified, the letter will request a list of the following documents to be sent to the CRA before a clinical research study is started. 

At the time of the prestudy visit, and certainly before any study subjects are recruited, other activities will need to take place. The medical management will need to select the laboratories to be used, and organise QA auditors to check any software houses involved in the production of... 

Prestudy visits. The purpose of the prestudy visit is to evaluate the investigator s interest and ability to conduct the study to the required sponsor standards. Special attention is paid to the quality of the investigator s staff and facilities, as well as to the availability of the required patient population. In conducting the prestudy site evaluation visit, the sponsor s representative determines whether or not the investigator is qualified by training and experience to conduct the trial. 

Some objective measure of the availability of the correct patient population is important during a prestudy visit. This can often be best accomplished through a chart or hospital census review by the monitor. The time spent doing this aspect of a clinical trial will invariability result in better and more timely results in clinical programs. 

Assuming that the outcome of the prestudy visit(s) is successful, the sponsor s representative will need to develop and negotiate study contracts and secure essential documents. 

The study initiation visit is sometimes confused with the prestudy visit. The purpose of the study initiation meeting is to orientate the study staff to the requirements of the protocol. At the point of the study initiation visit, the study site should be fully ready to begin all aspects of the trial. The monitor must ensure that the study medication and materials are available at the site. In addition, all essential documentation must be completed and available. Key study documentation is shown in Table 3.4. 

Development of study reference manual and monitoring plan Site identification selection, recruitment Prestudy site visits... 

Identification and Selection of Clinical Investigators for Study Placement and Conducting Prestudy Evaluation Visits... 

To successfully identify and select clinical investigators, the sponsor s representatives need to identify internal and external sources for potential investigators define investigator selection criteria, protocol requirements, expected cost of the study, and investigator and facility qualifications interview potential investigators and, finally, schedule and conduct prestudy site evaluation visits. 

Prior to selection of a clinical study site, the sponsor/CRO must confirm and document, in the prestudy assessment visit report, that the investigator has access to a local ethics committee/ IRB. Local committees cannot be bypassed the only official exception to this requirement is in France, where, by regulation, a central committee may rule for all sites in a multicentre study. However, in the USA, it appears to be common practice for a central IRB to rule for the widely geographically separated areas in the country, and researchers may not inform the local IRB. 

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