And although many may know this, the FDA added that the e CRF should be capable of recording metadata (e.g., data about the data identifying who entered or generated the data and when the data were entered or generated).
Also, changes to the data must not obscure the original entry, and must record who made the change, when, and why.
in the protocol or study specific source data agreement).
The requirement by EMA of ICH E6 of an independent contemporaneous investigator copy (ICIC) of the case report form (CRF) has led to numerous and passionate debates among the professional and industry associations.
The basic concept of the ICIC is still far from being consistently understood and implemented in the different geographies; regardless, ICIC has had a considerable impact and has brought about an extension of the concept of ALCOA, that source data should not only be attributable; legible; contemporaneous; original; and accurate, but also complete; consistent; enduring and available, when needed.
FDA perspective According to the FDA Guidance, source data include all findings, observations, or other activities in original and certified copies of original records, which are used by regulators to reconstruct and evaluate a clinical trial.
All interested parties need to review source data and ensure adequate protection of human clinical trial subjects and the quality and integrity of the clinical data.
Source data should be ALCOA and must meet the regulatory requirements for recordkeeping.