IRB receives multiple hits for insufficient SOPs, failure to ensure compliance.(Cooper Hospital University Medical Center, standard operating procedures)(Brief Article)

Cooper Hospital University Medical Center, Camden, NJ, New Jersey District

A February 2000 inspection of Cooper Hospital University Medical Center's IRB offered both good news and bad for the institution.

The good news was that, as stated in the EIR: "[the 2000] inspection revealed that some corrections were made to operations of this IRB since the last inspection..."in July 1996, which resulted in an untitled letter from CDER.

The bad news was that: "other deficiencies were observed..."

Conducted by New Jersey district investigator Judith Jones, the audit examined records from four clinical studies.

In one study, Jones discovered a mass of confusion over which version of protocol had been used and approved. She found correspondence from the IRB chairman to the principal investigator that stated: "it is …