GCP - Records Managers Association Guidance on the Scanning and Destruction of Paper Records 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 The introduction and use of etmf (electronic trial master files) presents opportunities for organisations to improve operational efficiencies, enable global accessibility to records, and enhance the integrity of records: but the digitisation of records has also introduced uncertainties, particularly in relation to the scanning and destruction of paper records for those organisations that scan paper records into a single source etmf. Whilst EudraLex Volume 10 guidance requires sponsors to ensure that essential TMF records are not destroyed prematurely, the digitisation of paper records for storage in an etmf may enable earlier destruction of the original paper record provided the electronic record remains readily available, complete and legible, and contains traceability of any changes. However, if an organisation plans to destroy the original paper record, it is vital that the scanning process employed is validated to ensure that electronic copy records are certified copies of the original. Because inspectors may need to request some original paper records for inspection, the current recommendation is to undertake a risk assessment in order to decide which documents do not need to be retained on paper, particularly focusing on whether or not the paper version could be obtained upon request (MHRA Good Clinical Practice Guide 10.5.5) The recently published DIA Framework for the Destruction of Paper provides a comprehensive assessment of the scanning and possible destruction of scanned paper copy records yet best practice remains open to interpretation. In this guidance document, GCP-RMA seeks to summarise the Framework into clear guidance that will help organisations develop scanning and destruction policies and procedures. This GCP-RMA guidance comprises decision flowcharts (figure 1 and figure 2) to help determine whether or not paper records need to be retained; this is supplemented by a flowchart for a validated scanning process (figure 3) for records that might be legitimately scanned and destroyed. Guidance on whether to Scan and Destroy The decision on whether or not to scan and destroy paper records largely depends on an organisation s approach to risk and how the organisation maintains its TMF. These guidelines recommend best practice and are NOT mandated by regulation or statute.
35 36 37 38 39 40 41 42 43 44 45 46 47 Traditionally, official TMFs have been maintained in paper format only. Whilst GCP-RMA sees no regulatory or legal justification for this, it is nonetheless a long established practice that inspectors widely accept. Emerging regulations combined with the increasing use of etmf technologies may shift this practice so that the retention of electronic records may be mandated in the future. Despite the rapid emergence of etmf, few organisations have yet fully embraced it. Most maintain a hybrid TMF comprising digital records and paper records, particularly paper records identified as requiring (wet-ink) signatures. The flowcharts below attempt to define pathways for each of the TMF options. It should be emphasised that the existence or anticipation of legal hold will impact on these pathways. However, each organisation should have a specified SOP to govern the legal hold process and so legal hold considerations are not reflected in these flowcharts. Figure 1 Figure 2
48 The Scanning Process 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 This guidance assumes that the organisation has established support for a scan and destroy approach, undertaken any necessary change management programme including associated training, and that the organisation has implemented all requisite policies and procedures to define and support that approach. Those policies and procedures should detail among others: the method(s) for preparing records for scanning; the checks to be undertaken to ensure accuracy, completeness and reliability of scanned records; the method and frequency of regular sampling checks on scanned records; escalation procedures to deal with any issues that arise particularly in relation to: accuracy, completeness, image quality (readability) and metadata accuracy. Consideration should be given to the employment of OCR (optical character recognition) technology in the scanning process to facilitate the search and ready retrieval of records. This is likely to be a separate process supplementary to the scanning process itself and necessitate the use of (an) additional programme(s) or software application(s). In any event, the scanning process and system(s) (including any OCR technology) employed in the scanning process should be validated and suitable records maintained to demonstrate that both the process and system(s) are properly validated. Validation and certification should be made by an individual with appropriate authority to undertake these checks. Regulations require that QC is carried out periodically. GCP-RMA recommends that each organisation adopts a risk-based approach and stipulates an acceptable period or frequency for QC in its TMF quality plan. Figure 3
73 74 75 76 77 78 79 80 81 a. GCP-RMA recommends that records are scanned in colour only if the colour elements are critical to the interpretation of the content of the record; if not, the record may be copied in black and white. b. Post scan adjustments to the image to increase legibility are acceptable, provided the limits of what may be undertaken are clearly specified in a formal procedure. It is not acceptable to use the scanning process to remove or add material to the image (for example, to remove the header a fax machine has added) or undertake physical cut and paste or correction fluid activities on the original paper records. c. Use lower case characters and avoid using special characters except hyphens and underscores in file names 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 References The numbers below refer to the numbers used in the scanning operation flowchart (figure 3) 1 Prepare Scanner FDA Industry Guidance Portable Document Format Specifications www.fda.gov/downloads/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsub missions/ucm163565.pdf Draft FDA Guidance for Industry Providing Regulatory Submissions in Electronic Format General Considerations http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm124751.pdf 2 PDF/A ISO-19005-1 Document management: Electronic document file format for long-term preservation Part 1: Use of PDF 1.4 (PDF/A-1) http://www.iso.org/iso/catalogue_detail?csnumber=38920 PDF/A A New Standard for Long-Term Archiving www.pdfa.org/2011/08/pdfa-a-new-standard-for-longterm-archiving 3 QC Scanned Image "BS 6498:2002 Guide to preparation of microfilm and other microforms that may be required as evidence" http://shop.bsigroup.com/en/productdetail/?pid=000000000000239896 Electronically." http://shop.bsigroup.com/en/productdetail/?pid=000000000030186227 FDA Draft Guidance: Electronic Source Documentation in Clinical Investigations http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf US National Archives and Records Administration Technical Guidelines for Digitizing Archival Materials for Electronic Access: Creation of Production Master Files Raster Images http://www.archives.gov/preservation/technical/guidelines.html 110 111 4 Process Validation 112 113 114 Electronically."
115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 FDA Portable Document Specifications www.fda.gov/downloads/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsub missions/ucm163179.pdf FDA Guidance for Industry Providing Regulatory Submissions in Electronic Format General Considerations www.fda.gov/downloads/regulatoryinformation/guidances/ucm124751.pdf United States. Food and Drug Administration. Guidance for Industry: Computerized Systems Used in Clinical Investigations www.fda.gov/ohrms/dockets/98fr/04d-0440-gdl0002.pdf 5 Systems Validation European Medicines Agency Q&A: Good Clinical Practice (GCP). Expectations of EU competent authorities on the use of electronic Trial Master Files www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000016.jsp&murl=menus /regulations/regulations.jsp&mid=wc0b01ac05800296c5&jsenabled=true FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations Guidance for Industry: Part 11; Electronic Records; Electronic Signatures- Scope and Application www.fda.gov/ohrms/dockets/98fr/04d-0440-gdl0002.pdf Electronically." http://shop.bsigroup.com/en/productdetail/?pid=000000000030186227 FDA Electronic records; electronic signatures Scope and Application, 21 CFR Part 11. http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf GAMP5. A Risk-Based Approach to Compliant GxP Computerized Systems. ISPE 2008. 6 Destruction Process European Medicines Agency. Q&A: Good Clinical Practice (GCP). Expectations of EU competent authorities on the use of electronic Trial Master Files (see 5 above) FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations Guidance for Industry: Part 11; Electronic Records; Electronic Signatures- Scope and Application (see 5 above) Electronically." (see 4 above) "BS EN15713:2009.Secure Destruction of Confidential Material; Code of Practice The Uniform Rules of Evidence (US 128 0060 00 to 0170 00) The DIA Framework for the Destruction of Paper can be found at www.diahome.org/en-us/news-and- Publications/Publications-and-Research/~/media/62E1D4ACE7974EB7A43577D74AD02C63.ashx Reference to these standards reflects best practice only. Adoption is not mandatory for (e)tmf.