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 (cf. Danish executive order no. 695 of 12 June 2013 on good clinical practice in clinical trials of medicinal products in humans – also known as the executive order on GCP).
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.
Purpose of the list of source data
The purpose of the list of source data, which should be kept at each individual site, is to make it possible to identify where the staff records specific types of data. The list of source data 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.
What is source data?
The executive order on GCP defines source data as any 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 may be both electronic and on paper. The following list includes examples of where source data may be stored:
- medical records
- laboratory reports
- dispensing logs
- ECG print-outs
- Case Report Forms (CRF)
- 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
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.