The consent process in clinical trials – more formally designated the Informed Consent process – is a key element in getting participants involved. Without a signed Informed Consent Form (ICF) the participant is not able to be enrolled in the trial.

Traditionally, this has been a paper form, which is why eConsent has become a big thing in the industry over the last few years – especially since Covid – with the arrival of many tech solutions providers who want to make the sign-up process easier.

But the key element of the phrase might actually be the word ‘process’, rather than the word ‘consent.’

Comprehensive information about the study and what participating will involve needs to be conveyed to the patient, in language they can understand, in order for them to make an informed decision about taking part.

And this shouldn’t be a one-off procedure, more an ongoing reaffirmation of consent as the trial progresses.