End of trial reporting: who is responsible?

End of trial (i.e. the last visit of the last patient – LPLV) needs to be reported to HIRUZ CTU. HIRUZ CTU, when contacted by the investigator with regard to the end of trial, will report the end of trial to the EC and FAMHP.

Do I need to prepare a final report?

Within a year after the end of trial (i.e. the last visit of the last patient) a final study report has to be submitted to the EC and FAMHP, either as a report/summary or as a publication. HIRUZ CTU will contact the investigator with regard to the final report preparation.

Who is the Sponsor of a clinical trial?

A person, company, institution or organisation that takes the responsibility to start, coordinate and/or finance a clinical trial. The Sponsor is the owner of the study results and has the (free) publication rights. The Sponsor is also responsible for the financial management of the clinical tria...