Pharmacovigilance in clinical trials


Good Clinical Practices sets the principles for drug safety information and news on adverse drug reactions, describing that the clinical study’s sponsor is answerable for the enduring safety evaluation of the novel drugs being explored. Along with this, the Good Clinical Practices must quickly inform all relevant clinicians/ethics committees and the applicable regulatory authority of outcomes that may negatively involve the safety of human volunteers in the trial. This is either because they influence the conduct of the study or may amend the approval verdict by the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) to continue the trial. Continue reading