Prospective Studies Sample Clauses
Prospective Studies. SAEs/NS-AEs (independently from causality and expectedness) that are subject to the reporting requirements in prospective studies are those that occur from the first dose of the Pfizer Product through and including 28 calendar days after the last administration of the Pfizer Product or the subject’s last Study visit (whichever is earlier), or longer if so specified in the Protocol. In addition, if the Principal Investigator becomes aware of an SAE occurring any time after the end of this zveřejněných Národním institutem pro výzkum rakoviny (National Cancer Institute, NCI) klasifikována jako porucha zraku 3. nebo 4. stupně. ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇ poruchy zraku 3. stupně symptomatická retinopatie s ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (▇▇▇▇▇ ▇▇▇ 20/40) nebo s postižením (omezená možnost vykonávat běžné denní činnosti a postarat se ▇▇▇ ▇ ▇▇▇▇). Poruchy zraku 4. stupně zahrnují oslepnutí (20/200 nebo horší) na postižené oko. 5.2. ▇▇▇▇▇▇▇ ohrožující zrak zahrnuje všechny výše uvedené poruchy zraku 2. stupně (kromě poruchy zorného pole) a rovněž následující poruchy zraku 2. stupně: odchlípení sítnice, otok sítnice, makulopatie, iritida, uveitida a abnormální výsledky vyšetření zorného pole. 6.
Prospective Studies. The prospective studies performed well against the quality check (see Figure 2- 2). All studies addressed a clearly focused issue with a standardised exposure across all participants. Studies often lacked information about how participants were recruited. However, self-report measures were widely used to minimise bias from experimenters. The identification and control of confounding factors was only deemed an issue for six studies that neglected to control for demographic factors such as gender or age and past symptom reporting. The follow up of participants was judged to be appropriate in 16 studies. Regarding the generalisability of the findings, it was often difficult to know if the results could be applied to the population being studied due to the insufficient information about how participants were recruited. In addition, similarly to the experimental studies, justification for sample size was limited with only one study providing an a priori sample size calculation.
a) Experimental studies
Prospective Studies. Figure 2-2 Quality assessment of experimental and prospective studies.