The documentation specifying PICOBOO is modular and hierarchical (Fig. 1). The Core Protocol describes study procedures that apply to all participants and aspects of the trial and is presented elsewhere [5]. Here, we present the booster vaccination substudy protocol (SSP), which details the outc...
that the outcome was the primary reason for the medical encounter, that the outcome occurred in the inpatient or ED setting, and that there was no documentation in the medical record that the child was diagnosed as having a vaccine-preventable disease (VPD) on the same day as the non–vacci...
Participants were enrolled between April 1 and May 15, 2002, after providing written informed consent. Healthy adult volunteers between the ages of 32 and 60 years were eligible to participate if they had a smallpox vaccination prior to 1971 and had a typical vaccinia scar or documentation of ...
Patient Consent for EVV Location Capture (Ohio) Inquiries for Potential Patients OASIS Improvement Indicators Medi-Span Mobile Medi-Span Download and Print Patient Chart Nursing Note Validations Prior Period Adjustments on Managed Care Earned Revenue Report Patient and Family Portal View Documentation Perm...
One other area over which the FDA exercises authority with respect to vaccines is requirements for labeling and documentation. Typically, when a vaccine is transmitted to the administrator who's going to administer it to patients, it has to be accompanied by two kinds of documentation. One of ...
Nudging measures to promote vaccination might be administrative by restricting the recruitment of unvaccinated individuals or socioeconomic by not offering free-of-charge medical services to non-vaccinated individuals as a risk allowance or requesting documentation of immunization on school entry [35, 37]...
A portion of this increased expense arises from the extensive documentation 938 | NOVEMBER 2006 | VOLUME 5 www.nature.com/reviews/drugdisc REVIEWS and auditing requirements demanded by GCP guidelines. Although this increased expense is accepted by produc- ers anticipating major markets for their ...
Where possible, participants visited their respective study clinic where nasal swabs were taken for RT-PCR, with documentation of medical history and medications taken. A protocol-defined COVID-19 case had to have virological confirmation (by RT-PCR) of SARS-CoV-2 and at least one of the ...
progressive disease (PD) suspected by the Investigator as pseudo-progression may continue treatment until confirmation of PD with repeat imaging at least 4 weeks later or at the next regularly scheduled imaging timepoint, but not to exceed 12 weeks from the initial documentation of pseudo-progression...
https://www.census.gov/programs-surveys/acs/technical-documentation/table-and-geography-changes/2018/1-year.html 33. American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys. Revised 2016. Accessed November 12, 2021. https...