Avoid Audit Findings in Clinical Trials



Who did it?

Recorded data should be attributable to the individual who collected the data and attested to by the use of dated initials.

Such data ownership fixes responsibility and fosters data quality


Can you read it?

Is it Permanently recorded? NO pencils!

Recorded data should be legible.

It is not acceptable for written records to be obscured with scribbled cross-outs and obliterations.

Errors should be corrected by NEATLY crossing out the original entry with a single line – Use a ruler if possible

  • use of correction fluids is not permitted

  • original entry must still be visible corrections should be initialed and dated by the person making the change


Was it collected in “real time”?

Data should be recorded as soon as possible after an event is observed (e.g. measurement taken, information collected, symptoms noted etc.)


Is it the original document or a true copy of the original?

The data needs to be an original or a certified copy.

Certified copies are copies of original information that have been verified by a qualified individual (i.e., medical records department) who attests that the copies are accurate, complete, and having all of the same attributes and information as the original (and should, wherever possible, be the person making the copy from the original)


Is it accurate?

Accurate data is required to achieve study objectives and ensure that others can replicate the results.

Don’t Guess!

Don’t Assume!



adj total, not lacking

Entire – Exhaustive – Full – Whole – Unabridged – Unimpaired – Uncondensed - Unabbreviated


adj constant, regular

True – Steady – Dependable – Persistent – Undeviating – Logical – Rational


adj lasting

Permanent – Surviving - Abiding


adj ready for use

Accessible – Usable – Handy – Reachable – Obtainable – On Hand