Navegar por los elementos (2 total)

• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

  Etiquetas Institutional Review Board (IRB), NSPS 1, NSPS 2, R-Res&Pub, Research, Research Design
  Autor: FDA
  Tema: Research
  Tipo de elemento: Hipervínculo
  Fecha de actualización: 2021-05
  Descripción: Guidance for Sponsors, Clinical Investigators, and IRBs. Information for investigational new drugs (IND).
  Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA…

• Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop

  Etiquetas Ethics, Federal Research Partners, Informed Consent, Institutional Review Board (IRB), Patient Care, Prophylaxis, Public Health, R-Res&Pub, Therapeutics, Vaccine Study
  Autor: National Academies of Sciences, E. and Medicine
  Tema: Research
  Tipo de elemento: Publicación
  Fecha de actualización: 2017-10-31
  Descripción: During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to…