Source data list
In clinical trials, the investigator must ensure that a list of source data is available with a description of where source data, etc. can be found.
The list of source data must be prepared before the trial is initiated. It must be signed and dated by the principal investigator or by a person whom the principal investigator has assigned this task. The list must be available in the Investigator’s Trial Master File (Investigator Site File (ISF)). The list of source data must also be stored by the sponsor.
Purpose of the list of source data
The purpose of the list of source data is to define the source data and location of the specific types of data for the individual site.
The list of source data is primarily intended as a tool for monitors, auditors and inspectors in their work of identifying and verifying trial data and that the trial is performed in keeping with the ICH GCP guidelines, current legislation and guidelines as well as the trial protocol.
What is source data?
Source data (source documents/records) are defined in ICH GCP and are generally original documents and data (including relevant metadata) or certified copies, regardless of the media used that contain records of clinical findings, observations or other clinical trial activities.
The following list includes examples of where source data may be stored:
- medical records
- laboratory reports
- diaries or other electronic tools for patient-reported outcomes
- dispensing logs
- ECG print-outs
- CRF (Case Report Forms)
- X-ray images
- radiological reports, etc.
The list of source data must be sufficiently detailed
To make it easy to locate data, the list of source data must 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.
Deviations from the list of source data
Deviations from the list of source data must be explained, for example if an electronic system is unavailable and it becomes necessary to write down notes on paper.
Updates to the list of source data
If the location of the source data changes, new source data is added, the principal investigator (PI) or other information changes, the list of source data must be updated accordingly.