Investigative site

Site characterization is defined as the process of collecting information from an investigation site in order to support the evaluation of a hazardous chemical-based incident... 

The first stage of the site characterization process is the customization of the generic plan developed as part of planning and preparation for responding to contamination threats. In general, the incident commander will develop the customized plan in conjunction with the site characterization team leader. The steps involved in the development of the plan include (1) perform an initial evaluation of information about the threat, (2) identify one or more investigation sites, (3) assess potential site hazards, (4) develop a sampling approach, and (5) assemble a site characterization team. 

There are several reasons why the data for total petroleum hydrocarbons do not provide ideal information for investigating sites and establishing target cleanup criteria. For example, use of the term total petroleum hydrocarbons suggests that the analytical method measures the combined concentration of all petroleum-derived hydrocarbons, thereby giving an accurate indication of site contamination. But this is not always the case. Furthermore, target cleanup levels based on total petroleum hydrocarbons concentrations implicitly assume (1) that the data are an accurate measurement of petroleum-derived hydrocarbon concentration, and (2) the data also indicate the level of risk associated with the contamination. These assumptions are not correct due to many factors, including the nonspecificity of some of the methods used and the complex nature of petroleum hydrocarbons and their interaction with the environment over time. 

The conventional methods of analysis for total petroleum hydrocarbons (Chapter 7) have been used widely to investigate sites that may be contaminated with petroleum hydrocarbon products (see also EPA 418.1) for the determination of petroleum hydrocarbons. The important advantage of this method is that excellent sample reproducibility can be obtained, but the disadvantages are that... 

Using this methodology via measurement of adsorption isotherms, Guiochon and coworkers investigated site-selectively the thermodynamics of TFAE [51] and 3CPP [54] on a tBuCQD-CSP under NP conditions using the pulse method [51], the inverse method with the equilibrium-dispersive model [51, 54], and frontal analysis [54]. 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

Normally, the study subject is informed both verbally and in the ICF that certain other individuals besides the investigator site staff wiU view his or her medical records. In clinical studies sponsored by pharmaceutical companies or institutions, the monitoring and quality assurance (QA) personnel from the sponsors and CROs, and inspectors from a regulatory agency wiU review the medical records of the study subject. 

Does the protocol make sense It is recommended that someone other than a physician read the protocol. In the case where there are many investigator sites, the individuals reading the protocol may be tired and overworked Also, laypersons such as those present on lECs will need to understand the document. 

The version number, date and page number (i.e. V of y pages) should be on each page. Without these features, new versions of the ICF can be mixed with old versions in the wrong page order in the bustle of the investigator site. 

The study drug should be stored in a secure facility free from pests and vermin, whether it is the hospital pharmacy or the consulting rooms at the investigator site. The environment where the study material is kept should be monitored and controlled for temperature and humidity. 

Experienced senior staff of the sponsor must always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in previous studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. Key questions will need to be answered relating to staff support and the present workload of the site. The competence of the staff to conduct any procedures, the maintenance, calibration and QC of any equipment to be used, and whether other clinical trials demand too much resource are aU questions that need answers. In addition, the facilities should be inspected to establish whether the site could store and securely archive the large amounts of documents and study drugs that will be present. The pharmacy may play a major role in the study and therefore the facility and the pharmacist should be visited. 

Remote data entry is the process by which data are entered into a laptop or personal computer rather than onto a paper CRE Normally, this process will take place at the investigator site. The computer screen provides a so-called electronic CRF (eCRF), which, like the paper CRF, will require a series of answers or parameters to be recorded. The system provides screen prompts and checks. These remind the investigator to complete responses and can immediately draw attention to any inconsistency between responses. Not all the data can be recorded directly into the eCRF and, as with the paper CRF, key elements will still need to be recorded in the study subject records. 

Laboratory safety data When the CRFs arrive at the data manager s office, questions will arise relating to laboratory safety data. Queries may occur at the investigator site and advice can be requested from the pharmaceutical physician associated with the clinical trial in the sponsor company. 

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

In a similar manner, QA departments and consultants paid for by the sponsor will conduct audits of investigator sites. Again, as with the clinical trial monitor, there may be some annoyance among the investigator and his staff that some person, who may not be a physician, should be appointed by the sponsor to review the clinical trial documentation at the site. 

Many investigator sites employ part- or fulltime nurses to support the clinical trials. Nurses should never be considered to be an extravagance, because without them, the onus of administration and QC is solely on the investigator. The clinical trial nurse can help the investigator in many ways, but two of the most important are ensuring that the CRT reflects what is present in the source documents, such as essential events of the medical history of the subject, and close liaison with the sponsor s monitor. 

Doping with small amounts of noble metals was often used to promote the photobehavior. However, the loealization of these metal nanoparticles within the Ti02 nanotubes was reeently shown to have an important role. Nishijima et investigated site-seleetive deposition of Pt nanoparticles on a titania nanotube (TNT). When Pt nanopartieles were deposited only inside the TNT, aetive sites on the TNT were not covered by Pt nanoparticles, resulting in an inerease in its photoeatalytic activity for oxidation of acetaldehyde. 

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