Note: A study is generally considered as having commenced when the first person is consented into the study. However, different stakeholders may have a different interpretation; the funder may consider that a study has commenced when payments are first released.
There are many reasons why a study does not go ahead after it has received approvals; newly identified safety concerns, lack of funds and lack of staff, hypothesis proved or disproved elsewhere, or departure of Chief Investigator.
The date of first consented participant into the trial must take place within at least 12 months of receiving a favourable opinion from REC. If the study has not started within this timeframe the REC must be provided with a written explanation for the delay. Should a study not commence within 24 months the REC reserves the right to review its ethical opinion and, in the case of CTIMPs, may recommend to the MHRA that the CTA should be suspended or terminated.
If the research project is to be cancelled completely, notification should be made to Sponsor, REC, R & D and MHRA as relevant to let them know.
Remember even if only one person has signed to take part in the trial the study has started.
