Health data basically consists/represent diagnosis, procedures and observations. It mainly focuses on observations such as Direct primary patient, Meta-observations, Context observations, Analysis observations etc., Hence, it is imperative for developed/updated SDTM and ADaM views (perhaps as operational data http://www.selleckchem.com/products/ganetespib-sta-9090.html model [ODM]), which will be required for submission readiness that will support clinical review and its analysis. It is important that we understand that CDISC data structures will eventually bridge the gap from the raw data to structured clinical trial views of the clinical data. The gap will be bridged as various sources of data collection to analysis and reporting through regulatory submission and electronic data archive are controlled using the SDTM, ADaM, ODM, laboratory data model, Protocol Representation, trial design model, Case Report Tabulation Data Definition Specification ?C (define.
xml), standard for exchange of nonclinical data and the clinical data acquisition standards harmonization. This is a continuous process and surely these developments will benefit the standardization between the health-care record and the clinical trial data. Footnotes Source of Support: Nil Conflict of Interest: None declared.
Although, Drug_discovery descriptions of childhood illnesses is found in ancient Egyptian, Greek and Roman texts; there is hardly any documentation of medical research in children prior to the 18th century. Edward Jenner’s smallpox vaccination experiment is, probably, the first documented study in the pediatric population.
Later, in the 19th century, when pediatric medicine became a recognized specialty, children in pediatric hospitals and orphanages became a ready source of for experimentation in children. The use of this highly vulnerable section for research studies hardly caused any flutter; given the prevalent norms regarding biomedical research. The real opposition came towards the end http://www.selleckchem.com/products/BIBW2992.html of the 19th century, when anti-vivisectionist movement began protesting against the use of animals and children in research activities and some felt the need for regulating research involving children. During the World War II, Nazi doctors conducted several experiments of dubious scientific basis. Children were a part of some of these experiments, which resulted in pain, misery, disability and death. The Nuremberg Code that was formulated after the Nazi doctors and officials were prosecuted, insisted upon ??voluntary consent by the prospective participant who had the legal capacity to do so??.[1,2] As children do not have this capacity, strict adherence to the Code would have disallowed any research in children. Since, most physicians chose to ignore the Code anyway, pediatric research continued without any regulation till 1960s.