Data Collection Standard Practice Guidelines

Traceable Case Report Forms crafted to connect each data point back to its origin, ensuring data integrity

What is this resource?

It is critical that data used for research purposes is collected in a manner which allows it to be traced back to its original source. Data collection instruments, which are often called Case Report Forms (CRFs), are frequently created in both paper and electronic format. In some cases, the data on the CRF is the original source of information; at other times the CRF is used to transcribe data collected from another source, such as a medical record or lab report.

Any revision to the data on a CRF, whether serving as a source document or not, should be clearly documented without destroying the underlying or original results. Case Report Forms must also be created in a manner that allows the data to be clearly linked to the appropriate research study, site, subject, and study event (time point) for successful management of the data.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research