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14 results
  1. Adverse Event Detection, Processing, and Reporting - Registries for Evaluating Patient Outcomes - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK208615
    ... 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 ...
  2. Annotated Bibliography of Animal Models Literature With Framework Mapping - Mechanistic Evidence in Evidence-Based ... 
    https://www.ncbi.nlm.nih.gov/books/NBK154591
    ... coordinating center, external data monitoring committee and outcome adjudication committee. This structure mimics the practice of multicenter RCTs. [ ...
  3. Results - Analgesics for Osteoarthritis - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK65650
    ... meloxicam and PUBs (ascertained by a blinded, external adjudication committee). Meloxicam 7.5 mg was associated with lower ...
  4. Results - Screening for Osteoporosis - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK45207
    ... despite appropriate care) applied by an independent, blinded adjudication committee. 205 Osteonecrosis was not evaluated or reported in ...
  5. 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
    resource.nlm.nih.gov/9918351277606676
    ... 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/ ...
  6. NLM Digital Collections - Cytomegalovirus in transplantation : developing drugs to treat or prevent disease 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2020
    resource.nlm.nih.gov/9918231202806676
    ... 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 ...
  7. NLM Digital Collections - Chronic hepatitis C virus infection : developing direct-acting antiviral drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
    resource.nlm.nih.gov/101719919
    ... specific to the population. Evaluation by an independent adjudication committee is encouraged to review all serious hepatic events, ...
  8. NLM Digital Collections - Recurrent herpes labialis : developing drugs for treatment and prevention 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
    resource.nlm.nih.gov/101719926
    ... and it would be difficult to have an adjudication committee to add further specificity. The same is expected ...
  9. NLM Digital Collections - Insulin degludec (Tresiba??, Novo Nordisk A/S) for the treatment of diabetes : effectiveness, ... 
    Publication: [Boston, MA] : Institute for Clinical and Economic Review, March 14, 2016
    resource.nlm.nih.gov/101679187
    ... also influence co- interventions and adherence. The central adjudication committees were masked to treatment assignment, but there could ...
  10. NLM Digital Collections - E17 general principles for planning and design of multiregional clinical trials 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
    resource.nlm.nih.gov/101734380
    ... is planned, a centralized assessment by a single adjudication committee should be considered. For endpoints based on laboratory ...