Certified Clinical Research Coordinator (CCRC) Practice Exam

True or False: It is a regulatory requirement to have source documents for every data item collected on case report forms.

1. True

2. False

3. Only if the data is critical

4. Only for certain trials

The correct answer is: False

In clinical research, the concept of source documents is integral to ensuring the integrity and reliability of data collected during a trial. Source documents serve as the original records that validate the data recorded on case report forms (CRFs). While it is essential to have source documents for verification of certain critical data items, regulatory requirements do not mandate that every single data item collected necessitates a source document. The regulatory framework allows for some flexibility, acknowledging that not all pieces of data require comprehensive documentation beyond what is recorded on CRFs. Source documents are most critical for information that pertains to patient safety, efficacy endpoints, or any other data deemed essential for the study's compliance and accuracy. Thus, while it is important to have source documents for critical data, this does not apply universally to all data items collected. This understanding clarifies why the correct answer indicates that it is not a regulatory requirement to have source documents for every single data item, supporting the notion that while source documents are vital, their necessity varies based on the type of data being collected.