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Source data in pharmacovigilance



  • anon
    05/12/2017 15:40
    When adverse events are initially received for instance by medical information / sales representatives frequently either a paper form or piece of paper is used to take down the initial AE and reporter details. It is understood that this constitutes source data. Now that tablets and smart phones are in general use, would it be acceptable to take a photograph of the paper material and send this photograph via email to pharmacovigilance operations in lieu of retaining the original. In some markets for instance postal services are less efficient. In such a way a copy of the original source has been taken, would it be considered that the record was preserved.?
  • RQA GPvP Committee
    20/03/2018 09:35
    Dear Anon There are a number of considerations/risk assessments needed when photographing initial source safety data for transferring to pharmacovigilance operations e.g. • How would you demonstrate/document that a copy of the original information had been verified as an exact (accurate and complete) copy having all of the same attributes and information as the original, what criteria would be used for the review of the photograph prior to stating/documenting the photo was certified and subsequently how that photograph would be managed when it was sent to pharmacovigilance operations • If photographing source information to an individual’s mobile phone/tablet how would you protect this information e.g. from hackers or ensure that the information was not maintained on the phone hard drive • What processes would need to be implemented for storing and archiving documents using electronic or optical media including how transferring the data to these media would be validated and documented • What back up strategy would be in place to prevent destruction and/or loss of data (and is it possible to generate hard copies through the retention period) Whichever option you take you would need to have a robust process in place which would also included archiving or destruction of the source data after a certified copy had been implemented. There are various guidance re source data, certified copies and validation of the process for this on the website e.g. CDISC (Clinical Data Interchange Standards Consortium) e-SDI Group publication 'CDISC Standards and electronic Source Data Within Clinical Trials', EMA Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (in consultation stage), ‘Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials’ and also the topic is covered in the RQA GCP Discussion forum (ICH E6 R2 Certified copies – applicability). Apologies for the late reply.
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