GCPs

GCp/kl the Graetz group Gz. and h/Cppu the Stanton group, St — Nu/(RePr)... 

If the liquid is heated almost to the wall temperature Tw (that is when GCp/kl is very small) then, on equating the heat gained by the liquid to that transferred from the pipe ... 

When (GCp/kl) < 10, the outlet temperature closely approaches that of the wall and equation 9.84 applies. These equations have been obtained with tubes about 10 mm to 40 mm in diameter, and the length of unheated tube preceding the heated section is important. The equations are not entirely consistent since for very small values of AT the constants in equations 9.81 and 9.85 would be expected to be the same. It is important to note, when using these equations for design purposes, that the error may be as much as 25 per cent for turbulent flow and greater for streamline conditions. 

Clinical trials must be conducted in accordance with the principles of Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is twofold ... 

A harmonised guidance document on GCP has been developed by the ICH (ICH E6). The core principles of GCP, as agreed in the guidance document, are outlined in Table 5.2. 

These principles of GCP have been incorporated into regulations that govern the initiation and conduct of clinical trials. The process for undertaking clinical trials in the EU and the US shall now be examined. 

Directive 2005/28/EC, which lays down the principles and detailed guidelines for GCP as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products... 

Name and description of the investigational product(s). A summary of findings from non-clinical sfudies and from clinioal trials that is relevant to the trial. Summary of the known and potential risks and benefits, if any, to human subjects. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). Description of the population to be studied. References to literature and data that are relevant to the trial, and that provide background for the trial... 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

The Competent Authorities are obliged to appoint Inspectors for checking that all activities associated with clinical trials are conducted in compliance with the regulations. The inspectors can inspect any sites concerned with the clinical trial, particularly the trial site (GCP), the manufacturing site of the investigational medicinal product (GMP), any laboratory used for analyses in the clinical trial (GLP), and/or the sponsor s premises. 

The relevant regulations governing the conduct of clinical trials in the U S are shown in Table 5.4. As they also reflect the principles of GCP, they are quite similar in requirements to those of the E U. However, because they apply to a single jurisdiction, they are framed to provide more prescriptive detail than can be found in the equivalent EU directives. Similarly, they are supported by the ICH- and FDA-specific guidelines. As most of the practices are the same as discussed in the previous section, the chapter will now just examine some of the aspects that are unique to the US regulations. 

A Form 1572 is used for investigators to summarise their educational qualifications and experience, and to make a required formal declaration as to their commitment to conduct the study according to the protocol, GCP and the regulations. The sponsor should also collect financial disclosure information from the investigators at this stage, although formal declarations on Form 3455 are not required until the submission of a marketing authorisation application. 

GMP = good manufacturing practice GCP = good clinical practice. 

Epithelial neutrophil activating protein-78 (ENA-78) Granulocyte chemotactic protein-2 (GCP-2) Neutrophil activating protein-2 (NAP-2) Interleukin-8 (IL-8)... 

The E6 (or GCPs) discusses the overall standards for implementing a clinical trial. Anyone who works on a clinical trial needs to understand this document. Of particular interest to the statistical programmer are the following parts of E6. The italics have been added for emphasis. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

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