Non compliance
A process for sites for identifying, documenting and reporting non-compliance during a clinical trial
Publication Version
2.0
Publication Code
QA03
The investigator/institution should conduct a trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given favourable opinion by the ethics committee. This procedure therefore describes the process for identifying, documenting and reporting non-compliance during a clinical trial.