The purpose of this Standard Operating Procedure (SOP) is to describe the standard procedures to be followed when designing and developing CRFs for use within a Clinical Trial. The CRF is a data capturing tool used in all Clinical Trials to record eligibility of a subject and to capture the required data as defined by the trial protocol for each individual trial subject during the course of his/her participation in a trial. CRFs may be printed or electronic documents The design of the CRF and its completion have a direct impact on the quality of the Clinical Trial data. It is subject to quality assurance and control during monitoring for GCP compliance on behalf of the Sponsor by the KHP CTO (or other organization from time to time), as well as during audits and inspections by the MHRA and REC.
The CRF will be designed in an appropriate format in order to collect only trial data as set out in the protocol for planned analyses. A well-designed CRF will ensure that no essential data is missed and that data queries are kept to a minimum as well as aiding data management, statistical analysis and reporting.
This SOP will ensure that CRF design enables trials sponsored or co-sponsored by the Partner Organisations comply with the regulations encompassed in the UK and European Law.
SI 2006/1928 Part 2 Conditions and Principles which apply to all
Clinical Trials: “9. All clinical information shall
be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected”