crf

complex CRF documentation, NCR book, folders and distribution

A case report form (or CRF) is a paper or electronic questionnaire(s) specifically used in clinical trial research. Today the trend is towards single leaf documentation, and the need or desire for carbonless pages has diminished.

carbon colour can originate, edit, adapt and implement artwork, manage and audit the revision process and then produce content, folders and packaging – then control the whole distribution and shipping worldwide as required by the trial.

The Case Report Form is the tool used by the sponsor of a clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The extent of a CRF can range from a handwritten one-time ‘snapshot’ of a patient’s physical condition to many hundreds of pages of electronically capturable data obtained over a period of time. (It can also include records of required check-up visits months after the patient’s treatment has stopped.) Usually contained in a bespoke binder or booklet the size and format can be tailored to suit the geographic market or demographic.  Production in multiple languages is often a pre-requisite.

The sponsor is normally responsible for designing the content of a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Good form design helps both the clinician and patient enter / record accurate information, and handwritten (fillable) forms have the advantage of speed, quick selection using tick box answers and the benefit of hard copy recording for audit management.