We have recently had a site where the investigators routinely "dictated" their assessments/results of trial patient's visit via a dictaphone during the visit rather than making notes themselves, and the study nurses were afterwards typing out what the PI had dictated to file this typed page into the source data of the patient (signed and dated by the investigator obviously) as "the source".
Following a recent audit, we had a finding defined because the original tapes from the dictaphone had not been kept and as such - according to the auditor - the original source data had been destroyed.
Anyone have experience with similar cases? Would the recommendation be to treat the tapes as other source "documents" in terms of review/storage or would the typed document, signed & dated by the investigator, be considered as sufficient "original" source by the regulators?
Any feedback possible from regualtor point of view in this particular case?