Electronic Patient Records

[ecsy911]

Hi,

I am pretty new to monitoring and so have a lot of questions about almost every process.

Our Trust has shifted now to electronic medical notes; however some patients in a trial would have some visits recorded on paper records, and some on both paper and electronic. Would both paper and electronic be considered source then? I came across a discrepancy today where data in the paper differed from that in the electronic. The paper record was entered by a nurse and signed off by PI, and the electronic notes was typed in by the PI himself. How should the team solve this?

Many thanks in advance.

Here are some useful references:_

European Medicines Agency (EMA) GCP Inspectors Working Group. Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials,(Final), 09 June 2010.
Clinical Data Interchange Standards Consortium (CDISC) e-SDI Group. CDISC Standards and electronic
Source Data within Clinical Trials, 20 November 2006.
Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry – Computerized Systems Used In Clinical Investigations, May 2007.
Food and Drug Administration. 21 Code of Federal Regulations Part 11 – Electronic Records, Electronic Signatures.
Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics
Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, December 2009.
Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) in support of Clinical Research Addressing Regulatory Considerations (Release 1.0), 2 April 2009. Electronic Health Records for Clinical Research (EHRCR) Working Group
FDA Guidance for Industry Electronic Source Documentation in Clinical Investigations draft guidance Dec 2010

[a123456]

The Principal Investigator is ultimately responsible for the quality of data recorded and forwarded from his/her clinical research team and research clinic. What do the institutions SOPs and/or working practices say? Should you put a CAPA in place to make sure that this does not recur elsewhere in the organisation?