The International conference on harmonization-Good clinical practice (ICH-GCP) was introduced in the clinical research studies in response to several violations of human rights preceding the 1996 institution of the ICH… read more →
Abstract The good clinical practice (GCP) related laws, regulations, guidance and standard operating procedures (SOP), are derived products of the 1964 World medical association’s Declaration of Helsinki (ASCO. 2008). The… read more →
The development of a good clinical research database is the epitome of valid scientific data collection and management. Good scientific data starts with an unbiased state of mind or a… read more →
The importance of biomarkers/genetic markers cannot be overstated. Biomarkers are one of the most integral part of clinical research and science. In a nutshell, biomarkers are the objective physical or… read more →
The reality and unfortunate idealism is that there is no perfect systematic and legal loopholes reformation in the patient’s health information privacy globally. Health information privacy is a very important… read more →
Conducting clinical research studies, and selecting appropriate subjects within the inclusion criteria is the key to a successful ethical scientific study (Dombey, Markel, & Derenzo, 2012). In any clinical trial,… read more →
In discussing risks and benefits, the institutional review board (IRB) often discusses what makes incentives coercive or non-coercive. However, evaluating whether or not an incentive is coercive is a case… read more →
The main objective of risk management and minimization assessment is tailored in protecting subject’s well-being, welfare and privacy, in clinical studies. Thus, it is important to understand that investigational medicinal… read more →
The purpose of any scientific research is to make predictions, hypothesize, ask questions and derive a deductive answer to a given question. Preclinical studies in animal employ pharmacokinetics, pharmacodynamics and… read more →
Living things including humans are wounded deeply from birth, a chasm naked eyes may not see, but it is subject to the extrinsic factor’s temerity to become apparent. An exposure… read more →
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