Data Collection & Management

Source data is the original recording of each item of data you collect during a study/trial. It is important to make clear to all study team members, study monitors (where applicable) and potential auditors which document is the source document, where it has come from and where it is stored.

The source data and their capture methods should be clearly defined prior to participant recruitment. This list should be prepared by the site and signed and dated by the Principal Investigator and should be filed in the ISF.

MCTC015 Template | Source document plan

A Case Report Form (CRF) is a data collection tool used to record all the protocol required information to be reported to the sponsor on each research/trial participant, the source data. 

MCTC004 Guidance | Data collection for research: Source documents and the Case Report Form

The Clinical Epidemiology and Biostatistics Unit (CEBU) has developed a variety of resources to assist with your research. As a specialised group focusing on biostatistics, epidemiological methods, and data management, they provide expertise and support to all researchers at the Melbourne Children’s campus. This includes a CRF Review Checklist on their SOPs and Template page.