Introduction
Source data is defined in International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) GCP (1.51) as all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data should be accurate, legible, contemporaneous, original, attributable, complete and consistent.
Source data is documented in source documents which may be both electronic and on paper. The
Following list gives examples of source documents where source data may be located:
• medical records
• laboratory reports
• subject diaries
• nurses’ notes
• dispensing logs
• electrocardiogram (ECG) print-outs
• case report forms (CRF)
• X-ray images
• Radiological reports, etc.
Purpose of identifying source data location
Verification of source data is a considerable part of the work of monitors, auditors and inspectors.
During GCP inspections, it is frequently seen that data are recorded in multiple locations at a site.
It is therefore essential to the possibility of reconstructing the clinical trial that it is clear, where the
original record is documented. The identification list of where source data is documented is primarily
intended as a tool for monitors, auditors and inspectors in their work of verifying that the trial is
performed in keeping with the ICH GCP guidelines, current legislation and guidelines as well as the trial
protocol.
Requirements for source data
According to ICH GCP (6.4.9), the protocol should identify any data to be recorded directly into the CRFs
that are considered to be source data.
According to the recently published reflection paper on expectations for electronic source data and data
transcribed to electronic data collection tools in clinical trials, a detailed diagram and description of the
transmission of electronic data should be provided in the protocol. The source data and their respective
capture methods should be clearly defined prior to subject recruitment (i.e. in the protocol or in a trial
specific source data agreement). The sponsor should describe which data will be transferred, the origin
and destination of the data, the parties with access to the transferred data, the timing of the transfer and
any actions that may be triggered by real-time review of those data.
It is the expectation of the GCP Inspectors’ Working Group that investigators are aware about the
location of the source data and consistent in recording them. The intended location should be clearly
defined prior to subject recruitment. One way of achieving this is to generate a source data location list.
This list should be prepared by the site and should be signed and dated by the principal investigator or by
a person whom the principal investigator has assigned this task. The list should be filed in the
investigator’s trial master file.
As the location of source data could vary from one investigator site to another, it could be appropriate to
make the list site specific.
The list of source data must be sufficiently detailed
In order to facilitate location of data, the list of source data should be sufficiently detailed. It is often not
enough to write ’medical record’, as the medical record is often a collective name covering different
document types and locations. This may make it necessary to write: ‘patient record – dispensing and
administration chart’, ‘medical record – continuation’, ‘medical record – nurses notes’, etc.
