Question 1:

I would like to know if there is anywhere that FDA has published ALCOA (Attributable-Legible-Contemporaneous-Original-Accurate) as guidance for GCP recordkeeping.

I have [redacted] for many years after hearing Dr. Lepay and Stan Woollen using it. However, the only place I have seen it written is in the GLP compliance program. Is there anyplace it is written down for GCPs? A PowerPoint presentation, anywhere.

Answer 1:

I put "attributable legible contemporaneous original accurate" into FDA's search engine and found the following:

"ALCOA" appears in the new draft of the Computerized Systems in Clinical Trials guidance (that issued in September 2004) . Here's a link . [Look in the "Background" section.]

"ALCOA" appears in Section 8.3.1 of the Final Guidance "Good Clinical Practice" issued for veterinary medicine (VICH GL9), and adopted by CVM in May 2001.

"ALCOA" also appears in an old presentation that Stan gave while he was at DSI that includes the ALCOA list: 12-05-2001

You might want to run the same search so you can see all of the references in which the phrase appears.

The terms also appear in an external document that our office (the Good Clinical Practice Program) had a major role in developing and drafting--specifically, the World Health Organization's "Handbook for Good Clinical Research Practice"--but which has NOT, to date, been adopted by the agency as "official" FDA guidance. The most recent draft of the "Handbook" is posted on WHO's website: . The handbook identifies the principles of good clinical practice and tries to apply the principles by describing the roles and responsibilities of the various parties who conduct, oversee, or participate in clinical research studies, and provides advice, in a Q & A format, for implementing each of the principles. Under the discussion of Principle #11 (which has to do with records and data), there is a question about data quality, and "ALCOA" appears in the answer. We expect the final version of the handbook to be posted soon on WHO's website.

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