Requirements for a monitor

The monitor must:

  • work according to standard operating procedures (SOPs)
  • in particular, (s)he must visit the investigator prior to, during and after the completion of the clinical trial in order to check whether the trial protocol has been adhered to and to verify that all data are reported and recorded accurately
  • examine whether the trial site has adequate space, facilities, equipment and personnel
  • compare the entries in the case report forms with the original medical reports and inform the investigator about any errors and/or omissions;
  • check whether the supporting staff involved in the clinical trail has been adequately informed about the particulars of the conduct of the clinical trial and whether they follow the specific instructions
  • check whether the storage, distribution and return of the study drug, as well as the documentation about its provision to the test subjects, is safe and appropriate
  • forward a written report to the sponsor about every monitoring visit or any contact that may be relevant to the clinical trial.