CLINICAL INVESTIGATOR DOES NOT KNOW WHO IS ENROLLED IN STUDIES
The investigator in two clinical trials of the same device told the FDA he did not know how to access study data and did not know which patients were enrolled, according to a recent warning letter.
Randall Wolf of the University of Cincinnati Medical Center served as principal investigator for one of the studies for a while, but he failed to review and sign completed case report forms (CRFs) as required by the study protocol, and told the agency's investigators that he did not have access to the electronic CRF database, according to the Sept. 28 warning letter, which was posted to the agency's website last month.
The warning letter quoted Wolf as reading a statement to the FDA investigators saying, "I am not, nor ever have been involved with any data collection or entry in any study. If my life depended on it, I could not access data. I do not know how. I do not know which patients are enrolled in the current FDA study." Wolf gave the FDA investigators a signed copy of this statement, the warning letter said.