Automated data reconciliation of the clinical and safety databases Thesis

Automated data reconciliation of the clinical and safety databases - Thesis Example It saves time, and more importantly, gets rid of possible discrepancies between databases. Whenever discrepancies are possible, it necessitates extra quality assurance steps for resolving mismatches (Zhengwu Lu, & Lu, Zhengwu, 2009). Serious Adverse Event, SAE, and Adverse Event, AE, reconciliation compares specific data between two databases; a clinical database and a safety database. A clinical database defined as s closed system while a safety database as an open system. A clinical database can review data for only a short time period that is lasting of the trial, hence defined as closed. A safety database on the other hand, is an open system due to its continuous reception of new SAEs or updates of SAEs that already exist concerning any clinical trials even when they are locked (Van et al 2012). Data management performs the task of SAE and AE reconciliation. Two departments are normally involved, the pharmacovigilance and drug safety, and clinical data science. During the data reconciliation, SAE is collected in the safety database and in the clinical database. Data cleaning takes place according to the specifications of data validation (Dwivedi & IGI Global, 2009). SAE reconciliation is performed continually between first patient first visit, FPFV, and last patient last visit, LPLV. The reason for such timely performances provides data that is reliable and trustworthy, that is of greatly useful in decision-making processes on a drug’s safety profile and successive trial design. It also ensures consistency in reporting to health authorities regarding individual Safety reports, New Drug Application, and the annual Investigational New Drug Update (Trasi, 1994). The skill set accessible in the data management section, many additional things can be done. The interior talents of the section are not fully utilized. It is not fulfilling for persons and the organization. The prospects and the demands are there.

Wooden Bats versus Metal Bats in Baseball Essay

Wooden Bats versus Metal Bats in Baseball - Essay Example Wooden bats are heavier than metal bats because they are solid, and that is why they require more effort to sway than aluminum bats. They also have a smaller sweet spot due to which the hit remains within range, i.e., the hitting zone is small. In other words, the weight of wooden bats is concentrated far from hands, or in other words, the center of gravity lies in the barrel. Thus, the swing weight is higher, which keeps the ball within range and means that the ball will not go much farther. Metal bats are hollow from within. A metal bat is lighter because of a larger sweet spot (Zumerchik 52), and the weight is concentrated very close to the hands, which will make the hit swing much higher as the swing weight is lower. A ball thrown at a higher or faster pace will also go farther. Wooden bats are safer than metal bats because the exit speed of the ball is much slower in case of wooden bats. Thus, the ball comes off with slow speed, which is good as it reduces the danger of injury if the ball hits another player or pitcher. Also, there is no chance that the bat will get tossed away from the hands of the player. This is why major league baseball authorities endorse the use of wooden bats, considering the hit power of the professional players. Metal bats, as they are lighter, can easily get tossed away to injure another player. Also, the larger sweet spot in case of metal bats causes larger exit speed of the ball, i.e., the ball will jump off faster, which could injure anybody within the hitting zone very seriously. There have been many unfortunate events in the past, in which players or spectators got injured due to this issue, as the Associated Press states, â€Å"A New Jersey teenager left brain-damaged after being struck by a line drive while playing in a youth baseball game will receive $14.5 million to settle his lawsuit against the bat.