Pre-study visit

Pre-study visits The purpose of the pre-study visit is to evaluate the investigator s interest and ability to conduct the study to the required sponsor... 

Some objective measure of the availability of the correct patient population is important during a pre-study visit. The sponsor s representative can often best accomplish this through a chart or hospital census review. 

Assuming that the outcome of the pre-study 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 pre-study visit. The purpose of the study initiation visit is to orient the study staff (subinvestigators, study coordinators, etc.) 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. 

Prior to selection of a clinical study site, the sponsor/CRO must confirm and document, in the pre-study assessment visit report, that the investigator has access to a local ethics committee/IRB. Local committees cannot be bypassed the only... 

The frequency of monitoring visits should be agreed to between the CRO and the sponsor. However, a pre- and post-study visit as well as a... 

In conducting studies to determine temporal decay rates, sampled areas should be identified so that the same areas are not re-sampled pre-application and post-application. Likewise, if deposition coupons (e.g. a-cellulose filter paper or cotton gauze patches backed with aluminum foil) are placed on the floor during application of the pesticide formulation to estimate initial deposition rates, care should be exercised to avoid sampling in the areas covered by the coupons during subsequent monitoring visits. 

It is no longer sufficient for the pharmaceutical physician of a pharmaceutical company to meet a potential investigator in a restaurant and, with a handshake, discuss and agree on any future involvement by the investigator. Experienced senior staff of the sponsor should always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in pre vious studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. 

On the other hand, SO2 also combines in the atmosphere with ammonia to form sulfates—fine particulates (PM2 5)— which have been shown in several studies to contribute significantly to pre-mature mortality. Thus, even if acid rain has only a marginal environmental impact, reductions in SO2 emissions have additional (and potentially much larger) health benefits, through reduced pre-mature mortahty. EPA (2003) estimates that the human health benefits of the Acid Rain Program will be roughly 50 billion annually, due to decreased mortahty, fewer hospital admissions and fewer emergency room visits, by the year 2010. 

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