Terminology to Know and Understand

RDC Onsite uses many terms that are common in the clinical studies and clinical trials industry. However, some of the terms have a different meaning from the standard. It is important to understand the differences. This section clarifies the use of certain terms in the RDC Onsite application and documentation.

Case Report Form (CRF)

A case report form (CRF) is a paper or electronic record associated with a patient in a clinical study. Its purpose is to facilitate accurate collection of clinical data.

Strictly speaking, a CRF has no data. It is a blank form. Once you enter and save data into the form, it is an entered CRF or a document. However, in both the clinical trials industry and in this user guide, CRF can refer to either an empty CRF or an entered CRF. For clarity in a potentially ambiguous context, this user guide uses terms such as entered CRF, document, and empty CRF.

Many companies refer to eCRFs when using an electronic data capture system. In this user guide, all CRFs are electronic CRFs, unless the term paper CRF is used explicitly.

Page

A page refers to an RDC Onsite application page. RDC Onsite, like all applications or sites on the World Wide Web, is made up of pages.

Many companies refer to a CRF as a page. In some cases, this user guide refers to multi-page CRFs and pages within a CRF.

Casebook

A casebook refers to the definition of visits expected, and the CRFs expected at each visit. A patient casebook is one instance of the casebook, either with or without data entered. Some companies refer to an entire casebook as a CRF.

A casebook is a collection of phases, patients, visits, and CRFs within a study.

Discrepancy

A discrepancy is any data that falls outside of an expected range of values or is otherwise flagged during the edit check process as an error. Some examples of a discrepancy are an invalid date or an age greater than the maximum age for the study.

RDC Onsite checks the data and raises discrepancies (an electronic query) at various times in the data entry process. For example, suppose the age range for the patients in your clinical trial is 20 to 40 years old. If you enter 50 for the age of a patient, RDC Onsite immediately displays a message that the value is out of range. Because RDC Onsite verifies certain data against a set of values, you can immediately correct errors or discrepancies during the data entry process.