Monitoring Clinical Trials

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 clinical trial monitor is a temporary member of the site team. A good monitor will conduct scheduled visits, and the investigator and the site staff should provide sufficient time to answer questions and correct data in the CRF that has been transferred incorrectly from source documents. Common errors are omitting negative answers and signatures. The monitor will need space to work and should be provided with requested documentation, including medical records, for review. 

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. 

The investigator should prepare an informed consent form for every study to be performed at the institute and should obtain an approval by the IRB that covers the institute. GCP listed a dozen points to be covered by the informed consent (1C) form (see Table 23.6). The new GCP allows a reasonable amoimt of pa)unent to the patient, such as transport cost. Patients should allow clinical trial monitors, auditors, IRB members and inspectors from the regulatory authority to verify the source documents. This new requirement of obligatory written 1C is regarded as a... 

In an effort to layer CQA throughout all aspects of clinical trial monitoring, the following levels of personnel should be considered ... 

A work breakdown structure (WBS) can be thought of as an organizational chart of tasks and activities needed to achieve the project objectives. The project WBS can be arranged either by deliverables (e.g./ formulations/ clinical trials) or by resource (e.g./ formulation chemist/ clinical trial monitor). A common way of illustrating these different approaches is by analogy with the construction of a new house. One part of the construction WBS would include plumbing and might be sorted by either house level or by room. A second option would be to sort the construction... 

Clinical trial monitoring includes those activities that ensure that the study is being conducted according to the protocol. Monitoring permits an in-process assessment of the quality of the data being collected. The first alert to safety issues is often revealed during the process of monitoring the clinical trial. 

Monitoring clinical studies involves the act of overseeing the progress of a clinical trial. Monitors ensure that the study is conducted, recorded and... 

In case of use date extension an additional label should be affixed to the investigational medicinal product. This additional label should include the new use date and repeat the batch number. It may be superposed on the old use date, but, for quality control reasons, not on the original batch number. This operation may be performed on site by the clinical trial monitor(s) or the clinical trial site pharmacist, in accordance with specific and standard operating procedures and under contract if applicable. The operation should be checked by a second person. Documented evidence of this additional liability should be available in the trial documentation and in the batch records. 

Chester Yarns, Director, Clinical Trials Monitoring... 

Clinical trials monitoring, study implementation, data acquisition. 

Monitoring clinical studies involves the act of overseeing the progress of a clinical trial. Monitors ensure that the study is conducted, recorded and reported in accordance with the protocol. This is accomplished by the review of CRFs on-site for possible errors, inconsistencies, and omissions. The monitor identifies errors and discrepancies... 

The first extensively documented British case, in 1988, was that of Dr Uzair Siddiqui, a psychiatrist in the city of Durham (Anon. 1988). He was found by an astute pharmaceutical company clinical trial monitor to have invented some of the laboratory data for most of the patients purported to have taken part in the trial and to have invented one complete patient. The laboratories used for this... 

Two further cases will never be fully documented, because they involved doctors who died prematurely, one where the coroner recorded that the death was due to suicide, the other where the coroner reached an open verdict. In both cases the fraud discovered was multiple, and on a very extensive scale, where the doctor involved had gone to very great lengths to disguise the nature of his fraudulent activities and had thus hoodwinked clinical trial monitors and auditors, who had not detected anything amiss. Original patient records... 

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