FDA Warns Against Well-Intentioned Backdating

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You may have the best motive and intent in the world when you backdate a clinical trial document. You may also still have a problem with the U.S. Food and Drug Administration (FDA).

Example: A subject signs the wrong informed consent form (ICF) during a screening visit. The study coordinator later realizes that a signed copy of the correct form is not among the subject’s source materials, and asks the subject to fax him a signed copy of the correct ICF signature page. A fax of the ICF signature page dated November 15 is filed in the subject’s source; however, the fax header shows that the fax actually arrived several days later and yet the study coordinator’s signature is also dated November 15.

When a visiting clinical research associate asks about the discrepancy, the study coordinator explains that he did not really sign the ICF on November 15, but thought he should backdate the fax copy to the same date that the subject signed. Eventually, the study coordinator is able to get both his and the patient’s signature on an original copy of the correct ICF with the same date.

Should the study coordinator have not signed off on the fax copy and, instead, documented the situation in the source and reported the discrepancy to the institutional review board?

The FDA’s short answer? Yes.

“Back dating is considered a serious violation that could be considered falsifying the document,” says Doreen M. Kezer, MSN, Senior Policy Analyst, Office of Good Clinical Practice, Office of the Commissioner at the FDA.

Further, Kezer recommends that study staff who obtain informed consent be trained and reminded of the need to check all aspects of the informed consent form for accuracy when they are signing the forms, to reduce the occurrence of errors.

To further explore core document management issues of workflow, change, and signature management in clinical research, see A Case Study in Redefining Regulatory Binder Management from the April issue of Clinical Researcher.

Author: Michael Causey