Clinical studies data source

Wireless pH measurement systems have been used in clinical studies. Unlike a standalone pH electrode, a power source, control electronics, and a signal transmitter have to be incorporated into a wireless system. Watanabe et al. [138] have reported a wireless pH sensor to record salivary pH continuously. The sensor system transmits pH data via a telemetry system for about 19 hours with a 3V lithium battery (190mAh). The error of transmitted pH data was less than 0.15 pH in the range of pH 5.0 to 9.0. 

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... 

An important body of evidence from descriptive, clinical, and genetic sources finds that bipolar disorder is a separate entity from unipolar disorder (i.e., genetically the two variants breed true see also the section Mechanism of Action earlier in this chapter). When we pooled data from several studies that investigated bipolar or unipolar disorders, lithium was more effective than placebo in preventing relapse in bipolar, as well as unipolar, disorders ( Table 10-11 and Table 10-12). 

The Study Population Results section often comes at the beginning of the Results section in the clinical study report and tells the reviewer about the disposition of the subjects in the study. The ITT population is typically used for these descriptions. Much of the information may be presented in tabular form in in-text tables to make the regulatory reviewers task as easy as possible. All data that are reported in a clinical study report need to be verifiable against original source tables provided in the overall submission, and so each in-text table indicates where the source data relevant to the entries in the table are located. 

It may be possible to undertake a meta-analysis if data are available from a number of similar studies (i.e., asking the same question in the same type of patients and in the same or similar clinical settings). Meta-analyses can explore sources of variability in the results of clinical studies, increase confidence in the data and conclusions, and signal when no further studies are necessary. For guidelines on conduct of meta-analyses of RCTs, see the Quality of Reporting of Meta-analyses (QUORUM) statement at http //www.consort-statement.org/QUOROM.pdf (accessed April 22, 2004). 

The aim of this chapter is to describe the general framework for conducting good clinical practices (GCP)-compliant clinical research. As it is difficult to cover this broad topic in such a short chapter, the authors will focus on those areas that are most discussed, most problematic and most critical to achieving a GCP-compliant clinical study. Thus, there is particular emphasis on ethical issues, source data verification and data integrity, monitoring and safety review, and study medication/device management. 

Maintain study subject clinical notes, that is source documents, separately from the CRFs. The source documents must support the data entered into CRFs and must clearly indicate participation in a clinical study. If the study subject is referred by another physician, the investigator must ensure that sufficient evidence is available in the clinical notes to support the eligibility of the study subject... 

The PI is responsible for maintaining records associated with the clinical study. These include case histories designed to record all observations or other pertinent data on each enrolled subject, independent of whether the subject received active treatment. Data for each trial subject is normally recorded on a case report form provided by the sponsor. The sponsor may also require study data to be recorded in a source document (patient chart). It is the responsibility of the PI to assure that the forms are filled out with the correct information and according to guidelines established by the sponsor. 

All the important and relevant costs and consequences for each program or treatment alternative should be identified. The costs and consequences identified must be relevant to the study perspective(s) and measured in suitable terms using the appropriate physical units. Costs should include direct, indirect, and intangible costs. Consequences should include the positive and negative clinical and humanistic outcomes associated with the program or treatment alternative. All these costs and consequences must be valued credibly, with the data sources clearly identified. 

Data from both human and animal exposures are frequently used in the risk assessment of chemical exposures [12]. Most toxicity data are obtained from animal studies. Human data sources are often not recognized, and internationally there is a lack of systematic experimental and clinical (human) observational data. Available data are often of poor comparability and frequently include inadequate follow-up. A number of institutions and services have the ability to collect human health data, and these include poisons information centres, clinical toxicology centres, pre- and post-natal surveillance programs, occupational health services and hospital out-patient services. 

Data sources (1) Mousa AR, Elhag KM, Khogali M, Marafie AA. The nature of human brucellosis in Kuwait Study of 379 cases. Rev Infect Dis. 1988 10 (1) 211-217. (2) Buchanan TM, Faber LC, Feldman RA. Brucellosis in the United States, 1960-1972 An abattoir-associated disease, I Clinical features and therapy. Medicine (Baltimore). 1974 53(6) 403 413. (3) Gotuzzo E, Alarcon GS, Bocanegra TS, et al. Articular involvement in human brucellosis A retrospective analysis of 304 cases. Semin Arthritis Rheum. 1982 12 (2) 245-255. 

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