Direct Data Entry

Monitoring and Source Document Verification

It is a requirement for Health Canada regulated clinical trials that a study is 'monitored' and that the study monitors perform Source Document Verification (SDV) in order to verify that the data contained in the study database is a true and accurate representation of the participant's medical record.

ICH GCP states:

The purposes of trial monitoring are to verify that:

(a)  The rights and well-being of human subjects are protected.

(b) The reported trial data are accurate, complete, and verifiable from source documents.

It defines Source Documents as "original documents, data and records". Generally, source documents are considered to be the first place a piece of data is recorded. 

Direct Data Entry and Electronic Source Documents

Clinical trials data may originate from many different sources, such as patient charts, paper lab reports and electronic medical records. All of these sources can be considered source documents. However, under some circumstances, data may be derived directly from a study participant. For example, a patient diary or a pain score that is communicated to a study coordinator verbally. This data may be written down by the patient, or by the coordinator, and when this happens these documents are the source documents. However, data may also be entered straight into the REDCap study database, either by the participant, or the coordinator. We refer to this as 'direct entry' and when this happens REDCap is considered to be an electronic source document.

While direct entry of data into REDCap is acceptable, we recommend that study teams document what constitutes source documents for each item of data collected in the study database. This information can be added to a manual of operations but, since it can vary from site to site within the same study, it may be better for each site to create a "Source Data Guide". If there are paper versions of data collection forms it may be simplest to annotate a copy of the paper forms.

The US Food and Drug Administration has published guidance on this matter that could be a useful reference.

Direct Entry and Audit Trails

When performing source document verification the study monitor may review audit trail (log) information for selected data values. This information should be consistent with their expectations for the study. In particular, they will expect the timestamp associated with a piece of data to be consistent with any protocol requirements. For example, if a pain score is collected from a participant and entered directly into REDCap by a study coordinator, then the timestamp should be consistent with the date and time of the participant's study visit and any data entry windows specified in the study protocol.

If the timestamp for direct entered data is not consistent with protocol requirements then it is possible that REDCap is NOT the source document for that data or there has been a protocol violation. 

This page provides more information about the way REDCap applies timestamps to audit/log records.