Preparing & Submitting a Protocol Follow the step-by-step instructions below to successfully prepare and submit a protocol to the IRB. Instructions below include information about single IRBs, student ...

Protocol deviations have the potential to place participants at risk and can also undermine the scientific integrity of the study, thus jeopardizing the justification for the research. Examples of ...

In order to address the specific details and regulatory requirements present in a retrospective medical chart review, the UB IRB recently created a new Protocol template: the HRP-503R.

A BPR is a voluntary opportunity for PI's conducting human research to recieve quality improvement recommendations and an on-site, low pressure evaluation of how their projects and protocols are being ...

It is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures described in the protocol-related documents, such as the IRB-approved research protocol and informed ...

The Post Approval Monitoring (PAM) team within Research Regulatory Affairs aims to help ensure the well-being of humans and vertebrate animals involved in research. Authorization for researchers to ...

Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA. Study design should match the research question. ‘Non-inferiority’ hypotheses, for example, can test whether the ...

Research from all publishers Recent studies have advanced the state of protocol reverse engineering through the application of sophisticated deep learning models and embedding techniques.