Clinical site

Batches should be tailor-made for the proposed trial, and should be labelled with information as appropriate regarding the product, sponsor, investigator, subject and trial, together with the statement For clinical trial use only . In addition, where the medicine will be used outside ofthe clinical site, the statement Keep out of reach of children should be added. There should be full accountability for the distribution, storage and fate of the drug product at both the manufacture and trial sites. 

Figure 23.1 Components of the integrated system from the perspective of the clinical site, the data management group, and project management. The function of each of these components is built around complementary capabilities of others in the system to allow timely communications, tasking, and management. (Copyright 2001-6, Health Decisions, Inc.) See color plate.

A major complaint of clinical sites is the difficulty and time required for data entry (when they have to enter the data through a keyboard) and the effort required to resolve queries, which are often returned weeks or even months after a patient visit. Machine-read data, whether collected by optical mark read or SmartPen , ensure that data are both entered and validated, with queries returned, in a matter of minutes after they are recorded. Coupled with a quick feedback loop, this system ensures that query rates are typically about one-tenth those for web-based EDC systems and even lower for paper-and-hand entry systems. This system also highlights recurring problems and areas of potential improvement that may impair study timeliness and quality. 

Terrin ML, Forman S, Fick S, Clarke E, Gross R, Gerstenblith G, et al. Facsimile copy (fax) transmission data entry direct from clinical sites in the CHF team study. Controlled Clin Trials 1999 20 2S-91S. 

Figure 23.1 Components of the integrated system from the perspective of the clinical site, the data management group, and project management. For full caption see page 564.

There are other trial design concepts for you to be aware of. A clinical trial can be carried out at a single site or it can be a multi-center trial. In a single-site trial all of the patients are seen at the same clinical site, and in a multi-center trial several clinical sites are used. Multi-center trials are needed sometimes to eliminate site-specific bias or because there are more patients required than a single site can enroll. 

A query or data clarification form (DCF) for that data point is sent to the clinical site. 

The clinical data management group updates the database or CRF based on the response from the clinical site. 

Laboratory data may consist of many different collections of tests, such as ECG laboratory tests, microbiologic laboratory tests, and other therapeutic-indication-specific clinical lab tests. However, laboratory data traditionally consist of results from urinalysis, hematology, and blood chemistry tests. Traditional laboratory data can come from what are called local laboratories, which are labs at the clinical site, or from central laboratories where the clinical sites send their samples for analysis. Often when the laboratory data come from a central laboratory, there is no physical CRF page for the data and they are loaded into the clinical data management system directly from an electronic file. Local laboratory data may be represented with a CRF page such as this ... 

The new GCP, however, also stipulates requirements when clinical sites give the above activities on contract to contractors. By this means the trial-related offices can be established... 

There is, however, a possibility that an increased risk of breast cancer might be associated with the state of infertility itself and not with the agents administered to treat it. In a retrospective study of data on 12 193 women evaluated for infertility between 1965 and 1988 at five clinical sites, 292were identified and followed up to the end of 1999. The standardized incidence ratios for in situ and invasive breast cancers in these women were compared with the breast cancer risks in a cohort from the general population (62). Infertile patients as a group had a significantly higher risk of breast cancer (RR = 1.29, 95%CI... 

It is recommended that the regulatory status be reviewed by examining the most recent inspection reports on the facilities from which all data were derived for inclusion in the application. This includes manufacturing, non-clinical laboratories, and clinical sites. 

In addition, inspections of clinical sites during the clinical investigation phase have risen and therefore the numbers of FDA-483s and warning letter for these issues have also increased. This means that compliance issues in relation to clinical trial activities could also delay the reviewer s final... 

Ensure consistency between the submission and what the investigator will find in the facilities, including nonclinical laboratory test sites, clinical sites, and manufacturing sites. 

PRIMARY REVIEW Inspections (Manufacnring Sites, Clinical Sites)... 

Category 4 vendors are sole-source API manufactures. First-time clinical trial supply manufacturers, offshore single pivotal trial clinical sites, and... 

Principal investigator—The individual responsible for conducting the study at the clinical site and selecting additional investigators when needed. The investigator must adhere to the clinical protocol and comply with inclusion and exclusion criteria. Clinical QA must ensure that monitors know how to identify principal investigator noncompliance. 

Clinical site personnel—These individuals are responsible for the conduct of the study within the context of the daily clinical environment. Clinical QA must ensure that it is aware of such study medication requirements as appropriate storage and security as well as the importance of maintaining the privacy of study subjects and adequate records. 

Clinical sites 22 sites in France, Belgium and Holland. 

Auckland Allergy Clinic Site http //www.allergyclinic.co.nz... 

For each clinical study, there should be statements that the study was conducted in compliance with the informed consent regulations and either the IRB regulations or the Declaration of Helsinki. If any obligations for the conduct of the study were transferred to a CRO, the name and address of the CRO and the obligations transferred should be listed in the NDA. The clinical sites audited or monitored by the sponsor should be identified, either as part of the report for the study or as a separate list. 

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