Sample Case Report Form - Global Clinical Trials Playbook - Appendix CELSEVIERGlobal Clinical Trials Playbook
Objectives The aim of this study was to elucidate the clinical data packages for the biosimilars approved in Japan. The details of clinical data packages and sample size for the regulatory approvals of biosimilars in Japan was reported. Methods We surveyed the clinical data packages and sample siz...
Met and spoke with patients in recruitment for clinical trials to discuss consent, study subject matter, risks, and more. Utilized ICH and local regulations as well as good clinical practices to keep patients fully informed throughout the entirety of trial proceedings. Ensured 100% compliance of c...
Reference Intervals for Clinical and Lab Medicine Tests for the Difference Between Two Linear Regression Slopes Tests for the Difference Between Two Linear Regression Intercepts Mendelian Randomization with a Binary Outcome Mendelian Randomization with a Continuous Outcome Acceptance Sampling Acceptance Sampling...
Qualitative and quantitative dermatoglyphic traits in patients with breast cancer: a prospective clinical study BMC Cancer, 7 (44) (2007) PubMed PMID: 17397524. Pubmed Central PMCID: 1831782 Google Scholar [9] R.L. Jantz Variation among European populations in summary finger ridge-count variable...
Clinical, anthropometric and body composition measurements All measurements were conducted in the morning, before lunch time. Clinical measurements indicative of vascular health namely systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were taken using an automated blood pressure...
The financial costs of conducting a clinical trial have increased, particularly in light of the current regulations and governance, so that it can take many months (46) to set up a study (Hackshaw et al, 2008). Having a small study, where acceptable, can therefore have clear benefits in ...
Vitamin D deficiency and insufficiency among US adults: prevalence, predictors and clinical implications. Br J Nutr. 2018;119:928–36. Article CAS PubMed Google Scholar Cancer Australia. Sunburn and sun protection. Cancer Australia; 2019. https://ncci.canceraustralia.gov.au/prevention/sun-...
(2017). The impact of hypomagnesemia on erectile dysfunction in elderly, non-diabetic, stage 3 and 4 chronic kidney disease patients: a prospective cross-sectional study. Clinical Interventions in Aging, 12, 437–444. https://doi.org/10.2147/CIA.S129377 Article Google Scholar Træen, B.,...
This study examined the prevalence of sexual aggression perpetration and victimization in a sample of 1,172 students (755 female, 417 male) from four unive