FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical TrialsJames S. CohenJennifer S. GeetterMichael W. Ryan
SACHRP Comments on FDA draft guidance "Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers" The growing volume and the diversity of clinical research has led to related laws and regulations as well as the Institutional Review Board (IRB) approval ... A Cristia,A...
To our knowledge, the effectiveness of nirmatrelvir or molnupiravir against newer Omicron subvariants, particularly BQ.1.1 and XBB.1.5, has not been investigated. We conducted a large cohort study using the electronic medical records of Cleveland Clinic patients who received a diagnosis of COVID...
10-12 And despite a lack of FDA clearance for the use of these devices among individuals with known arrhythmias, individuals with AF are using wearables with pulse rate and ECG capabilities. The goal of this exploratory project was to characterize individuals with AF who used and sought care ...
When access is given via the institution’s electronic health record (EHR) system, the FDA’s newly released guidance, “Use of Electronic Health Record Data in Clinical Investigations,” may apply. The FDA guidance encourages the use of EHRs in most situations and provides four factors to ...
Evaluates a structured and rigorous informed consent procedure involving subjects with schizophrenia. Impact of the implementation of systematic informed c... Wirshing,Donna,A.,... - 《American Journal of Psychiatry》 被引量: 196发表: 1998年 The Use of Multimedia in the Informed Consent Process ...
To assess potential exposure of non-users to exhaled constituents from pod and cartridge electronic nicotine delivery systems (ENDS) products, an environmental clinical study was conducted with (n = 43) healthy adult smokers. Room air concentration
This article is based on a consensus conference, promoted and supported by the International Federation of Clinical Neurophysiology (IFCN), which took place in Siena (Italy) in October 2018. The meeting intended to update the ten-year-old safety guidelines for the application of transcranial magnet...
Informed consent was waived because data were deidentified and samples were obtained as part of routine clinical care. Deidentified WSIs and electronic health record (EHR) data were transferred to the Massachusetts Institute of Technology for processing and analyses and was exempt from institutional ...
Electronic cigarette use and uptake of cigarette smoking: a longitudinal examination of US college students. Addict Behav. 2017;67:66-72. doi:10.1016/j.addbeh.2016.12.009PubMedGoogle ScholarCrossref 20. US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on...