GCP - Records Managers Association

G C P - R e c o r d s M a n a g e r s A s s o c i a t i o n

Guidance on the Scanning and Destruction of Guidance on the Scanning and Destruction of Guidance on the Scanning and Destruction of

Guidance on the Scanning and Destruction of Paper Records Paper Records Paper Records Paper Records

The introduction and use of eTMF (electronic trial master files) presents opportunities for 1

organisations to improve operational efficiencies, enable global accessibility to records, and enhance 2

the integrity of records: but the digitisation of records has also introduced uncertainties, particularly in 3

relation to the scanning and destruction of paper records for those organisations that scan paper 4

records into a single source eTMF.

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Whilst EudraLex Volume 10 guidance requires sponsors to ensure that essential TMF records are not 7

destroyed prematurely, the digitisation of paper records for storage in an eTMF may enable earlier 8

destruction of the original paper record provided the electronic record remains readily available, 9

complete and legible, and contains traceability of any changes. However, if an organisation plans to 10

destroy the original paper record, it is vital that the scanning process employed is validated to ensure 11

that electronic copy records are “certified copies” of the original.

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Because inspectors may need to request some original paper records for inspection, the current 14

recommendation is “ to undertake a risk assessment in order to decide which documents do not need 15

to be retained on paper, particularly focusing on whether or not the paper version could be obtained 16

upon request ” (MHRA Good Clinical Practice Guide 10.5.5) 17

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The recently published DIA “Framework for the Destruction of Paper” ^† provides a comprehensive 19

assessment of the scanning and possible destruction of scanned paper copy records yet best practice 20

remains open to interpretation. In this guidance document, GCP-RMA seeks to summarise the 21

“Framework” into clear guidance that will help organisations develop scanning and destruction 22

policies and procedures.

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This GCP-RMA guidance comprises decision flowcharts ( figure 1 and figure 2 ) to help determine 25

whether or not paper records need to be retained; this is supplemented by a flowchart for a validated 26

scanning process ( figure 3 ) for records that might be legitimately scanned and destroyed.

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Guidance on whether to Scan and Destroy Guidance on whether to Scan and Destroy Guidance on whether to Scan and Destroy Guidance on whether to Scan and Destroy 30

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The decision on whether or not to scan and destroy paper records largely depends on an 32

organisation’s approach to risk and how the organisation maintains its TMF. These guidelines 33

recommend best practice and are NOT mandated by regulation or statute.

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Traditionally, official TMFs have been maintained in paper format only. Whilst GCP-RMA sees no 35

regulatory or legal justification for this, it is nonetheless a long established practice that inspectors 36

widely accept. Emerging regulations combined with the increasing use of eTMF technologies may 37

shift this practice so that the retention of electronic records may be mandated in the future.

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Despite the rapid emergence of eTMF, few organisations have yet fully embraced it. Most maintain a 40

hybrid TMF comprising digital records and paper records, particularly paper records identified as 41

requiring (wet-ink) signatures.

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The flowcharts below attempt to define pathways for each of the TMF options. It should be 44

emphasised that the existence or anticipation of “legal hold” will impact on these pathways. However, 45

each organisation should have a specified SOP to govern the “legal hold” process and so “legal hold”

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considerations are not reflected in these flowcharts.

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Figure 1

Figure 2

The Scanning Process The Scanning Process The Scanning Process The Scanning Process 48

This guidance assumes that the organisation has established support for a scan and destroy 49

approach, undertaken any necessary change management programme including associated training, 50

and that the organisation has implemented all requisite policies and procedures to define and support 51

that approach. Those policies and procedures should detail among others:

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­ the method(s) for preparing records for scanning;

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­ the checks to be undertaken to ensure accuracy, completeness and reliability of scanned records;

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­ the method and frequency of regular sampling checks on scanned records;

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­ escalation procedures to deal with any issues that arise particularly in relation to:

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­ accuracy, 57

­ completeness, 58

­ image quality (readability) and 59

­ metadata accuracy.

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Consideration should be given to the employment of OCR (optical character recognition) technology 62

in the scanning process to facilitate the search and ready retrieval of records. This is likely to be a 63

separate process supplementary to the scanning process itself and necessitate the use of (an) 64

additional programme(s) or software application(s).

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In any event, the scanning process and system(s) (including any OCR technology) employed in the 67

scanning process should be validated and suitable records maintained to demonstrate that both the 68

process and system(s) are properly validated. Validation and certification should be made by an 69

individual with appropriate authority to undertake these checks. Regulations require that QC is carried 70

out “periodically”. GCP-RMA recommends that each organisation adopts a risk-based approach and 71

stipulates an acceptable period or frequency for QC in its TMF quality plan.

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Figure 3

a. GCP-RMA recommends that records are scanned in colour only if the colour elements are critical to the

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interpretation of the content of the record; if not, the record may be copied in black and white.

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b. Post scan adjustments to the image to increase legibility are acceptable, provided the limits of what may be

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undertaken are clearly specified in a formal procedure. It is not acceptable to use the scanning process to

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remove or add material to the image (for example, to remove the header a fax machine has added) or

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undertake physical “cut and paste” or “correction fluid” activities on the original paper records.

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c. Use lower case characters and avoid using special characters except hyphens and underscores in file names

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References References References References

The numbers below refer to the numbers used in the scanning operation flowchart (figure 3)

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1 1 1

1 Prepare Scanner Prepare Scanner Prepare Scanner Prepare Scanner

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­ FDA Industry Guidance – Portable Document Format Specifications

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www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSub 87

missions/UCM163565.pdf 88

­ Draft FDA Guidance for Industry – Providing Regulatory Submissions in Electronic Format — General

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Considerations

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124751.pdf 90

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2222 PDF/A PDF/A PDF/A PDF/A

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­ “ISO-19005-1 Document management: Electronic document file format for long-term preservation Part 1: Use

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of PDF 1.4 (PDF/A-1) http://www.iso.org/iso/catalogue_detail?csnumber=38920 95

­ “PDF/A – A New Standard for Long-Term Archiving” www.pdfa.org/2011/08/pdfa-a-new-standard-for-long- 96

term-archiving 97

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3333 QC QC QC QC Scanned Image Scanned Image Scanned Image Scanned Image

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­ "BS 6498:2002 Guide to preparation of microfilm and other microforms that may be required as evidence"

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http://shop.bsigroup.com/en/ProductDetail/?pid=000000000000239896 102

­ "BIP 0008. Code of Practice on Legal Admissibility and Evidential Weight of Information Stored

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Electronically." http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030186227 104

­ FDA Draft Guidance: Electronic Source Documentation in Clinical Investigations

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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf

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­ US National Archives and Records Administration Technical Guidelines for Digitizing Archival Materials for

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Electronic Access: Creation of Production Master Files – Raster Images

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http://www.archives.gov/preservation/technical/guidelines.html 109

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4444 Process Validation Process Validation Process Validation Process Validation

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­ "BIP 0008. Code of Practice on Legal Admissibility and Evidential Weight of Information Stored

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Electronically."

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­ FDA Portable Document Specifications

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www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSub

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missions/UCM163179.pdf

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­ FDA Guidance for Industry Providing Regulatory Submissions in Electronic Format —General Considerations

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www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124751.pdf 119

­ United States. Food and Drug Administration. Guidance for Industry: Computerized Systems Used in Clinical

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Investigations www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf 121

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5555 Systems Validation Systems Validation Systems Validation Systems Validation

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­ European Medicines Agency Q&A: Good Clinical Practice (GCP). Expectations of EU competent authorities

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on the use of electronic Trial Master Files

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www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000016.jsp&murl=menus 127

/regulations/regulations.jsp&mid=WC0b01ac05800296c5&jsenabled=true 128

­ FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations Guidance for Industry: Part

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11; Electronic Records; Electronic Signatures- Scope and Application

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www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf 131

­ "BIP 0008. Code of Practice on Legal Admissibility and Evidential Weight of Information Stored

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Electronically." http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030186227 133

­ FDA Electronic records; electronic signatures – Scope and Application, 21 CFR Part 11.

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http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf 135

­ GAMP5. A Risk-Based Approach to Compliant GxP Computerized Systems. ISPE 2008.

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6666 D D D Destruction Process estruction Process estruction Process estruction Process

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­ European Medicines Agency. Q&A: Good Clinical Practice (GCP). Expectations of EU competent authorities

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on the use of electronic Trial Master Files (see 5 above) 141

­ FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations Guidance for Industry: Part

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11; Electronic Records; Electronic Signatures- Scope and Application (see 5 above) 143

­ "BIP 0008. Code of Practice on Legal Admissibility and Evidential Weight of Information Stored

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Electronically." (see 4 above) 145

­ "BS EN15713:2009.Secure Destruction of Confidential Material; Code of Practice

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­ The Uniform Rules of Evidence (US 128‐0060‐00 to 0170‐00)

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† 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.