Clinical Protocols laboratory assessments

The medical records of the volunteers who received cholinesterase-reactivating chemicals consisted of the test protocol, physicians orders, nursing notes (Including clinical observations), a checklist of symptoms, and laboratory and performance test results. The reports of physicians examinations and physical findings were generally not Included. Volunteers were identified by number. The Committee on Toxicology s assessment was based on records and summaries provided by the Department of the Army and NRC staff. The procedures were described fully in Volume 1. In most cases, the analysis was based on summaries of drug administrations prepared by a consultant to the Panel. 

Cynthia approaches the cardiologists in her clinic with an idea that she could start a heart failure clinic to provide additional education and monitoring for these patients. While the physicians would oversee the clinic, she could conduct monthly educational seminars about heart failure for patients, order and assess laboratory tests, and order medications and adjust dosages under physician-approved protocols. 

The procedure protocol should be written according to specific guidelines, such as those from the National Committee for Clinical Laboratory Standards (NCCLS). The laboratory procedure is one of the most important aids during orientation and trainmg of new personnel along with continuing assessment for trained personnel. 

Setting up clinical studies is a lengthy process, as there are many documents to prepare [e.g. protocols and case report forms (CRFs)], study facilities to be assessed (e.g. study sites, CROs, clinical laboratories, phase I units), regulatory review to be considered and negotiations and agreements with study sites (e.g. contracts, finances, confidentiality, indemnity, insurance) to be undertaken. In addition, as will be dealt with in subsequent sections, ethical aspects of the study must be considered (e.g. ethics committee and IRB review and informed consent requirements), and study medications/devices must be organized. 

Visit dates. All visit dates should be recorded in the medical file. Interim visit dates recorded in the medical file, but not in the CRF, should be noted by the monitor in case they signify occurrence of AEs or protocol violations. The final visit date should be so indicated, for example study finished or withdrew from study AEs. All AEs noted in the medical file during the time period specified by the protocol must be recorded in the CRF. The monitor must also carefully check other documents (e.g. diary cards, quality of life forms) for sources of information about AEs. Occurrence of out-of-range laboratory values, which are considered to be clinically significant by the investigator, must be reported and assessed as AEs... 

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