Source Document Worksheets
Our source document worksheets are an excellent tool to avoid inadequate documentation and minimize protocol deviations at the site
It is hard to overestimate the importance of good documentation practice for a clinical research trial. Therefore, it is necessary to ensure that the study results are built on the foundation of accurate, adequate, and valid data. The most crucial purpose of source documentation in clinical research is to reconstruct the trial as it happened at the site and form a solid basis for the data to be entered into a CRF which eventually gets presented in a clinical study report.
Integrity Research assists in implementing fair procedures to ensure high data quality and data integrity. We develop source document worksheets to ensure complete documentation for each subject visit. Accurately designed sheets are created according to the protocol and CRFs, and they are not just check boxes.
Our worksheets are the detailed guidelines considering the protocol requirements and procedures. They serve as a guide for the Principal Investigator and Clinical Research Coordinators and help to ensure that all the procedures are completed in the right order. In addition, they remind the site staff to prepare the subject for the next visit.
Integrity Research worksheet is an excellent tool to avoid inadequate documentation and to minimize protocol deviations at the site. Moreover, we update source document worksheets throughout the course of the study in case a protocol amendment is issued. Thus, our sites get the most reliable tool for good documentation practice to ensure high data quality.
Source Document Worksheets designed for your study
Complete documentation for each subject visit
Avoid inadequate documentation and protocol deviations
Ensure high data quality and data integrity
Contact Us to Learn More
Please contact us to learn more about how we may be of assistance. We create source document worksheets (SDW) for Sponsors, networks of research sites or independent clinical research centers which need SDW for a particular study.