Final FDA guide calls for clinical holds if researchers fail to file SAEs, but finances, record-keeping faults not listed.(Misconduct, Food and Drug Administration)

FDA has issued a final guidance for clinical holds resulting from investigator misconduct, stating that the agency can hold up a trial before an enforcement action if it finds a failure by researchers to report serious or life-threatening adverse events or serious protocol violations, but not record-keeping or financial disclosure errors.

First issued as a proposal in October 2002, and announced as final in the Sept. 3 "Federal Register", the document is entitled: "Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct."

In the proposal, FDA included failure to file financial disclosure forms as a criteria for holds, but that was removed from the final on grounds the agency …