Good Clinical Practice Guide
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Thread: Retention of Trial Records

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    Retention of Trial Records

    This document provides further clarifications surrounding the retention of trial records and as such should be read in conjunction with the MHRA GCP guide, specifically sections 10.5 and 10.7.

    The main pieces of relevant legislation governing the retention of trial records is outlined in our clinical trial regulations (SI 2004/1031, plus its subsequent amendments), please refer to 31A (8) and principle 9 of Schedule 1, part 2:

    “The Sponsor and Chief Investigator shall ensure that the medical files and essential documents from the Trial Master File (TMF) are retained for at least 5 years after the conclusion of the trial”. (Please note that Sponsors should retain such documents for longer periods if the study is to be submitted as part of a marketing authorisation. The SI does not state in what format the documents should be retained).

    “All clinical information shall be recorded handled and stored in such a way that it can be accurately reported, interpreted and verified”

    Trials where the data are used to support a marketing authorisation have further requirements as per Directive 2003/63/EC. Here the documentation should be retained for at least 15 years after completion or discontinuation of the trial or for at least 2 years after the granting of the last marketing authorisation in the EC (when there are no pending or contemplated marketing applications in the EC) or for at least 2 years after formal discontinuation of clinical development of the investigational product.

    In addition Directive 2003/63/EC also requires the sponsor or other owner of the data to retain a specific set of documentation pertaining to the trial for as long as the product is authorised, and that the final report be retained for five years after the medicinal product is no longer authorised. This means that a reduced set of documents are required to be retained after the last marketing authorisation in the EC. These documents include: the protocol including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational product, the reference medicinal product and/or the placebo used; standard operating procedures; all written opinions on the protocol and procedures; the investigator’s brochure; case report forms on each trial subject; final report; audit certificate(s), if available.

    The TMF has to be capable of delivering its objectives which include not only the storage and protection of the electronic documents, but also the management of clinical trials and the easy retrieval of information. The TMF provides the basis for the audit by the sponsor’s independent auditor and for the inspection by the competent authority. In addition the media used to store essential documents are required to be traceable so that those documents remain complete and legible throughout the required period of retention and can be made available to the competent authorities upon request. Any alteration to records is required to be traceable. This also applies to when records are stored on electronic, magnetic, optical, or other non-indelible media. In such cases suitable controls should be implemented to ensure that these records cannot be altered without appropriate authorisation and the creation of an audit trail. When original records are transferred to other media, for the purpose of archiving, the system of transfer should be validated to ensure that information will not be lost or altered.

    Therefore electronic records are acceptable under the regulations, however the GCP Inspectorate has seen many issues with respect to electronic records, and therefore, the GCP Inspectorate suggests that the original paper documents (where applicable) are available for 5 years after the conclusion of the trial. If, after the 5 year period, we are presented with copies (in any medium) we would expect that the process for copying and storage would enable full verification that these data were complete, legible and verifiable as accurate copies of the originals. If we are not able to do this, we may wish to request the original documentation. Thus, the decision as to the destruction of the paper originals would need to be based upon the confidence that you have in your system to meet these requirements.

    Therefore, our advice would be to retain all original trial essential documents (including trial medical records) for at least 5 years after the completion of the trial. If, after that time, the documents are required by regulatory authorities (e.g. in support of applications for marketing authorisation) and original paper records were destroyed in favour of electronic copies, the electronic data would only be acceptable if they meet the conditions in the previous paragraph.

    From previous inspection experience a number of issues have been encountered with the use of electronic records relating to the ease of access and quality of the records contained in it. Some further guidance on the TMF and archiving can be found in Volume 10 Chapter 5: http://ec.europa.eu/health/documents/eudralex/vol-10/

    Retention of patient notes and scanning of patient notes are also expected to follow the guidance covered in section 10.5 and 10.7 of the MHRA GCP guide.

    This has been a very hot topic in GCP and there is extensive additional information in other areas of the GCP forum. Under the sticky notes for TMF there are numerous Q&As regarding electronic records, and within the Electronic Systems section in relation to electronic health records guidance. Also, there is extensive information on the MHRA’s position regarding eTMF and e-source data in the GCP guide under the TMF and investigator sections respectively.

    In addition there is EU guidance on electronic data: http://www.ema.europa.eu/docs/en_GB/...C500095754.pdf
    and TMFs: http://www.ema.europa.eu/docs/en_GB/...C500138893.pdf
    Last edited by MHRA Super Moderator; 1st Dec 2015 at 03:27 PM. Reason: update to clarify consistency with GCP guide

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