The difference between sponsors and Contract Research Organizations (CRO’s) is explained. Some of the many functions of a CRO focus on acquisition and preparation of data before it is submitted to regulatory agencies.
The role of Clinical Research Associates (CRA’s) during events such as protocol deviations, adverse events, and Serious Adverse Events (SAE’s) is discussed. While CRA’s do not report these events, they are responsible for ensuring that the investigator successfully communicates to the Institutional Review Board (IRB).
Clinical Trial Educators may be a new option for Contract Research Organizations (CRO’s) which will help improve recruitment for their sites. It is possible that as the larger CRO’s begin to make use of Clinical Trial Educators, other CRO’s will follow suit.
Operating a research site does not require extravagant software. There are simple, low budget options that protect and are compliant with patient privacy regulations.
Most Sponsors currently do not require a Principal Investigator (PI) to be board certified. However, Sponsors could easily become more selective, and work only with board certified physicians, during the current period of low research study supply.
The frequency of standard of care studies appears to have increased recently. While these studies may not pay as much as other types of studies, they also require less attention.