Often clinical trials teams have country approval and Central Ethics Committee (CEC) approval but they have to wait for their Local Ethics Committee (LEC) approval as well. Some LECs are very organized and issue approvals shortly after regulatory and CEC approvals, however there are LECs, which tend to be slow due to increased workload or reduced recourses. It is common in such cases clinical trials teams and Sponsors to grow impatient and to be egger to start before LEC approval.
So if you are sitting in your office thinking, “Well, of course, LEC will approve it. We can start pre-screening patients for the study and randomize them after we receive approval.” – Please don’t do that! It is mandatory to have all required regulatory approvals before working on clinical trial. This could be not just major finding during inspections but could cause you serious troubles.
What could possible go wrong if you don’t wait for LEC approval?
- LEC rejects the study – This may not be common scenario but it happens.
- LEC request additional information or changes in ICF – This is not so unusual.
- LEC rejects the sub-study – It is possible LEC to reject sub-study if they have safety concerns.
- LEC have requested additional information or rejected the study, however you have been contacting potential patients. Your patients will be disappointed and frustrated by the missed opportunity for new treatment.
- You have potential patients, who are eligible and you have informed them that you are waiting for LEC approval before they can start treatment. By the time you receive approval, your patients may no longer be eligible for the study. This could cause them frustration and distrust in the treating team.
- Your team is pre-screening patients but not informing them about the study. There are a few eligible patients but by the time LEC approval is received they are no longer eligible. In this case you are wasting your resources on pre-screening activities on a clinical trial, which is not approved yet, instead of focusing on recruiting studies.
- LEC team has realized you have started pre-screening without their approval. This could trigger internal inspection and create internal conflict between the investigator and LEC.
In order to avoid unnecessary stress and conflicts, it is always better to wait for all approvals before preforming any work on a clinical trial.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 1 Sep 2015
