Clinical competencies

Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent. 

Why did Dr. P carefully choose the psychiatrist that she sent Laura to see How might Laura s insurance options affect the choice of psychiatrist Dr. P thought the critical importance of the therapeutic relationship extended to the psychiatrist-patient relationship as well. She chose a psychiatrist who had excellent interpersonal skills, as well as clinical competence. Fortunately, Dr. S could be partially paid by Laura s health insurance. If not. Dr. P would have had a dilemma. Should she ask the parents to pay out of pocket because the therapeutic relationship was so critical Or should she pick another physician on Laura s list of providers and hope for the best ... 

Provide evidence-based, clinically competent care. 

A person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qualifications and competence in accordance with local laws and regulations as evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and the provision of, medical or dental care must always be the responsibility of a clinically competent person legally allowed to practise medicine or dentistry. 

Working at all times within clinical competence and professional code of conduct... 

To become a speech therapist in the United States, one needs to obtain a master s degree in the field. In many other countries, a bachelor s degree is accepted. Basic course work includes topics in child development, linguistics, psychology, physics and acoustics, physiolog y, anatomy, and neurology. Other qualifications vary by state. Many states require speech therapists to complete a minimum of four hundred hours of clinical experience, a thirty-six-week clinical fellowship, and the speech therapy Praxis exam to earn a clinical competence certificate (C.G.C.). 

The books in the NVMS help you prepare for National Boasds-and the Clinical Competency Test and are excellent resources for problem-based learning. 

Anion exchange resins are basic polymers with a high affinity for anions. Because different anions compete for binding to them, they can be used to sequester anions. Clinically used anion exchange resins such as cholestyramine are used to sequester bile acids in the intestine, thereby preventing their reabsorption. As a consequence, the absorption of exogenous cholesterol is decreased. The accompanying increase in low density lipoprotein (LDL)-receptors leads to the removal of LDL from the blood and, thereby, to a reduction of LDL cholesterol. This effect underlies the use of cholestyramine in the treatment of hyperlipidaemia. 

In contrast to macrolides, the targets of (3-lactams, the penicillin binding proteins (PBPs) require several mutations in order to become resistant while simultaneously maintaining their viable function as cell wall transpeptidases/transglycosidases. Thus, in order to achieve clinically relevant resistance Streptococcus pneumoniae uses a unique strategy to rapidly accumulate several point mutations. Due to its natural competence for transformation during respiratory tract... 

Most of the PKIs currently in clinical trials are small molecules that compete for the ATP-binding site [3,5]. They prevent the phosphate donor ATP to bind to the protein kinase, and hence the target protein will not become phosphorylated and the perturbed signalling can be terminated. 

Erlotinib (Tarceva ) competes with ATP in the HER1/EGFR ATP-binding pocket. It is used in the clinic in locally advanced or metastatic non-small cell lung cancer after failure of at least one chemotherapy regime [1, 3, 5]. 

Before a clinical trial can commence, it is necessary to submit a Clinical Trial Application (CTA) to the Competent Authority of each Member State, where it is... 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

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. 

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

Before initiating a clinical investigation, the manufacturer (or his/her authorised representative) must prepare a statement containing the information outlined in Figure 10.2, and notify the relevant Competent Authorities of the proposed study. The manufacturer must also keep available for inspection by the Competent Authorities the information outlined in Figure 10.3. Unlike for clinical trials, a standard application form has not been developed. Instead, appropriate application forms are... 

Figure 10.3 Information relating to clinical investigations that must be maintained available to Competent Authorities for inspection.

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