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?:abstract
  • The COVID-19 virus diffusion is, nowadays, global and any clinical trial is potentially affected by the direct and indirect consequences of the COVID-19 during the pandemic. Any step, from protocol design to result\'s disclosure, needs to be revised to assess the impact of the COVID-19 on the study, evaluate the potential risks, and establish a mitigation plan. We have developed a series of recommendations, belonging to our experience in any aspect of clinical trials. We hope that the Risk and Mitigation actions for clinical trials during COVID-19 Pandemic (RiMiCOPa) will help all clinical trial professionals, patients, auditors, and assessors to ensure effective data management, statistics, and medical writing standards while conducting clinical trials in the pandemic.
is ?:annotates of
?:creator
?:doi
  • 10.1016/j.conctc.2020.100682
?:doi
?:journal
  • Contemp_Clin_Trials_Commun
?:license
  • no-cc
?:pdf_json_files
  • document_parses/pdf_json/54634573613a04258459e5063cb0d4a2d3bc18a9.json
?:pmc_json_files
  • document_parses/pmc_json/PMC7703225.xml.json
?:pmcid
?:pmid
?:pmid
  • 33283069.0
?:publication_isRelatedTo_Disease
is ?:relation_isRelatedTo_publication of
?:sha_id
?:source
  • Elsevier; Medline; PMC
?:title
  • Risk and mitigation actions for clinical trials during COVID-19 pandemic (RiMiCOPa)
?:type
?:year
  • 2020-11-30

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