|
IRB / IEC
As an IRB or member of an IRB your primary mission
is to protect the rights and welfare of human test subjects
before and during their participation in a biomedical research,
device or procedural study. We realize that you must work to
ensure that risks are minimized and that proper disclosure to
study participants is made in a timely manner. We help you stay
in compliance with Federal regulations [21 CFR §56.109(f)
and 45 CFR §46.109(e)] that require continuing review of
research and provide a context to manage adverse event reports,
interim progress reports, research change reports, protocol
deviation reports and annual review reports. Continuing review
is mandated by the FDA
in accordance with the guidance. At SelecTrials, we realize
the importance of complete compliance with the law and patient
safety must be a core component of any clinical trial. We hope
that you find this module of our online Clinical Trials Management
Solution a beneficial process improvement tool. The bottom line
is that it must help you do your job better.
|
