Pharmacovigilance in clinical trialsMay 27, 2014 2014-05-27 16:50
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.
The sponsor must at the appointed time communicate any unexpected or serious or adverse drug reaction to all relatable institutions and investigators, the IEC/IRB, and the local regulatory body by sending regular developments and safety information. These reports should abide by the formats and rules of applicable regulatory authorities.
Local regulations should lay down the time frames required for reporting both serious and unexpected adverse events and expected. Reporting periods should be short; for example, in the case of serious and unexpected adverse events, the report should be filed within 24 hours at the latest.
Reports from clinical studies should be sent or treated separately from expected or unexpected events relatable to drugs already available in the market.