Electronic informed consent (eConsent) represents a major improvement in the overall participant consenting process in clinical trials for investigation sites, sponsors, and IRB/IECs. eConsent offers researchers numerous benefits, including the capability to mitigate regulatory risk, improve study participants’ comprehension, and provide a more efficient way of collecting consent, therefore saving time and money.
You may already know too well the challenges of a paper-based informed consent process, but did you know that informed consent is one of the most cited deficiencies by regulatory authorities? Paper-based informed consent increases your risk for delayed approvals, fines, litigation, and even trial failure.
With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study life cycle, data managers will deal with data from many sources — such as MRI scans, ECGs, lab data, as well as eCOA — all of which are equally important.