What is source documentation and why is it important?
Maintaining accurate source documentation is the cornerstone of good clinical practice. Its purpose is to provide a comprehensive narrative of subject participation in a clinical trial from the date informed consent is obtained through to the end of the subject’s participation. Source documentation utilizes information from the subject’s medical record including assessments, tests, procedures and other relevant medical history. Good source documentation allows an independent observer to recreate a subject’s participation in a clinical trial and to account for the use of any investigational product or device.
In accordance with FDA regulations, good source documentation should be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA).
The FDA has issued guidelines for source documentation contained in electronic medical records (EMR) in the Code of Federal Regulations (CFR) Title 21, Part 11. 21 CFR Part 11 addresses the need for controls, audit trails, electronic signatures, and software documentation for processing electronic data in the EMR. Click here for additional information on the FDA’s EMR source documentation policy.
21 CFR Part 11 Compliance
The Weill Cornell Physician Organization (WCPO) utilizes EpicCare (EPIC) as its shared ambulatory EMR system. NewYork-Presbyterian flow sheets, assessments, progress notes, and medication administration records are maintained by the Eclipsys Clinical Information System (Eclipsys). EPIC and Eclipsys are 21 CFR part 11 compliant. Please click on the links provided for documentation on EPIC and Eclipsys.
External Monitoring of Source Documentation in the EMR
External monitor access to view source documentation is not currently available in EPIC and Eclipsys. Therefore, investigators and study teams should maintain research charts for each study subject. Research charts contain original source documents including but not limited to, the signed ICF, eligibility checklist and original ECG tracings. Printed copies of the EMR for all relevant study visits are also included within research charts. All printed copies must be certified.
If desired by a third-party, WCM/NYP medical record documentation can be accessed using the EPIC “Release of Information (ROI)” function. The ROI allows for medical data transfer of specific research subject and date ranges. An ROI PDF report can only be generated though an encrypted, secured computer created by an assigned WCM study team member. These reports are produced prior to scheduled monitoring visits, audits, or third party viewings. WCM medical records also include outpatient clinic notes, laboratory results, radiology reports or pathology procedures at WCM/NYP. For more information on EPIC policies visit here.
External monitors may also conduct a “spot check” of a subject’s EMR. In this situation, the monitor would be permitted to view selected subject records on a secure WCM computer to confirm the research chart is a true representation of the EMR.
The study team member may log in to the EMR using his/her CWID and password and must be present at all times while the EMR is viewed by an external party. Coordinators are responsible for ensuring records that are not pertinent to the subject’s participation on the clinical trial are not viewed. Monitors are expected to conduct the full source verification by reviewing the research chart.
To certify copies printed from the EMR, a study team member can sign a Global Note to File stating:
- He/she understands his/her assigned responsibility to provide an accurate, complete, and true copy of the electronic medical record for each subject.
- Attest that he/she will print complete and accurate source documentation for each study visit and file such documents within the research chart.
Certify to the best of his/her knowledge, each page of the printed medical record is an accurate reflection of the electronic medical record as of the date and time stamped at the bottom of every page.