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Compliance In Focus
Posted by John Lehmann on Wed, Jun 12, 2013

The Clinical Research Documentation Checklist

The Clinical Research Documentation ChecklistGood Clinical Practice is the cornerstone for conducting clinical studies. However, as clinical research professionals we should strive to take “good” to “great”. This requires having historical perspective and a firm understanding of GCP requirements, but it is equally important to know how to properly document authentic research observations.

Perhaps the best acronym for guiding researchers through proper documentation is “ALCOA”. Having its roots in the federal regulations governing good laboratory practice for non-clinical laboratory studies, or 21 CFR 58.130 (15), “ALCOA” remains the practice of FDA auditors and quality assurance professionals regarding clinical practices:

Attributable

  • It should be obvious who created a record, and when it was created
  • If a record was changed, it should be obvious who made the change, when the change was made, and why

Legible

  • The research record should be easily read

Contemporaneous

  • Study evidence/results should be recorded as they are observed
  • All signatures/initials should be attached to a date indicating when the signature was added to the document

Original

  • Study records should be originals, not photocopies

Accurate

  • Study records should have a high level of integrity and honesty to what was truly observed; give a full accounting of the research process
  • Study records should be thorough and correct; double check your work for unintentional errors

To guide you through your research documentation, download the checklist here.

When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

As research professionals, do you find this checklist helpful? Is there anything you would add to this list? As always, we’d love to hear your views!

Photo Credit:Maru es Maru

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Topics: Good Clinical Practice, ALCOA, 21 CFR 58.130 (15)

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