Glossary¶

Document requestor

People who can request source documents

Document submitter

People who will redact and submit the Source data to the Document requestor. This happens using the mobile app.

GCP

Good Clinical Practice (GCP).

More information can be found on the National Institute for Health Research website.

GDPR

General Data Protection Regulation (GDPR).

More information can be found on the Information Commissioner’s Office website.

Personally Identifiable Information (PII)

Sensitive information that can must be redacted prior to upload.

Source data

Traditionally paper documents that are the first place where information is recorded. These may later be transcribed onto electronic platforms like an eCRF.

Source Data Verification (SDV)

Also known as monitoring. The process of checking source data against other records of that data for anomalies. Some examples of anomalies that a monitor may find could be transcription errors, missing data points, protocol deviations or potentially fraudulent data.

Workflow

Organisational unit. Intended to request source data from specific sites.