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Thread: Electronic Patient Records

  1. #1
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    Electronic Patient Records

    Hiya

    I work in a clinical research within an NHS healthcare setting . We are changing our electronic patient record system and consideration is being given to how the source data which is contained within it can meet all the required standards.

    I want to ensure that we are future proofing this as much as possible and also to ensure we have considered all the applicable standards.

    Obviously GCP standards apply and some sponsors have expectations for us to meet the federal regs 21 CFR Part 11.

    Is anyone able to point out whether there are any other specific trial related standards that are out there that we ought to consider?

    Many thanks

  2. #2
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    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    FDA Guidance for Industry Electronic Source Documentation in Clinical Investigations draft guidance Dec 2010

  3. #3
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    paper and electronic medical notes source data discrepancy

    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.



    Quote Originally Posted by a123456 View Post
    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

  4. #4
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    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?

  5. #5
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    Sorry for the brief reply. The best thing is to follow your Monitoring SOPs regarding discrepancy resolution at site. ICH E6 is always a good place to start. The section on monitoring (5.18) says that (for instance) ... "Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained. ...data required by the protocol are reported accurately on the CRFs and are consistent with the source documents... Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialled by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented...... Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.."

    And section 4 says what the PIs responsibilities are (for instance):- ...The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports. ... Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained. ...Any change or correction to a CRF should be dated, initialled, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections (see 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections".
    The PI also has supervisory responsibilities for those he/she has delegated trial related duties to (i.e. those on the delegation of duties log) (for example see the FDA ten point plan for PIs - Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects Oct2009)
    The EMA (Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials 09June2010 effective 01Aug2010) states that the quality aspects of source documents (ALCOACCEA) are considered universal regardless of whether they are paper or electronic.

    The EMA previously mentioned guidance states that sites should have a source document agreement or locator, that states what is considered as source ... "The source data and their respective capture methods should be clearly defined prior to trial recruitment (i.e. in the protocol or study specific source data agreement).." The FDA (FDA Guidance for Industry Electronic Source Data in Clinical Investigations FINAL GUIDANCE Sep 2013) also say something similar with saying that there should be a list of source document originators.


    See other sections of the MHRA GCP Forum under records and delegation of responsibilities.
    There is lots of other information about monitoring in the MHRA GCP guide (2012) and the RQA website www.theRQA.com. Enjoy.

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