- ... monitoring board (DSMB), data monitoring committee (DMC), or adjudication committee may be established with the primary role of ... for sites, registry personnel, the DSMB, DMC, or adjudication committee if one exists, and the sponsoring organization. Documentation ...
- ... coordinating center, external data monitoring committee and outcome adjudication committee. This structure mimics the practice of multicenter RCTs. [ ...
- ... meloxicam and PUBs (ascertained by a blinded, external adjudication committee). Meloxicam 7.5 mg was associated with lower ...
- ... despite appropriate care) applied by an independent, blinded adjudication committee. 205 Osteonecrosis was not evaluated or reported in ...
- NLM Digital Collections - Technical specifications for submitting clinical trial data sets for treatment of ...Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022... Ratio Index BDS Basic Data Structure CAC Cardiac Adjudication Committee CDISC Clinical Data Interchange Standards Consortium CK-18 ... Fibrosis FDA Food and Drug Administration HAC Hepatic Adjudication Committee 3 Available at https://www.fda.gov/industry/ ...
- NLM Digital Collections - Cytomegalovirus in transplantation : developing drugs to treat or prevent diseasePublication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2020... should be confirmed by an independent, blinded, clinical adjudication committee. FDA recommends that the secondary endpoints in CMV ... invasive 14 CMV disease (as determined by an adjudication committee) was reported with valganciclovir 15 than with oral ...
- ... biopsies may be needed; and for others, formal adjudication by a committee may be required. Generally, registries that are undertaken ...
- NLM Digital Collections - E17 general principles for planning and design of multiregional clinical trialsPublication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018... is planned, a centralized assessment by a single adjudication committee should be considered. For endpoints based on laboratory or imaging assessments, it is generally recommended that a centralized laboratory or centralized adjudication of imaging be used. If multiple laboratories are ...
- NLM Digital Collections - Chronic hepatitis C virus infection : developing direct-acting antiviral drugs for treatmentPublication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017... specific to the population. Evaluation by an independent adjudication committee is encouraged to review all serious hepatic events, ...
- NLM Digital Collections - Recurrent herpes labialis : developing drugs for treatment and preventionPublication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017... and it would be difficult to have an adjudication committee to add further specificity. The same is expected ...
468 results