GOOD DOCUMENTATION PRACTICE (GDP)

Transcription

1 GOOD DOCUMENTATION PRACTICE (GDP) a partner in Good Research Practice Hilde De Boeck, Philippe Gillet, Jan Jacobs, hdeboek@itg.be, pgillet@itg.be, jacobs@itg.be January,

2 GOOD DOCUMENTATION PRACTICE GOALS What is Good Documentation Practice [GDP]? How to use/handle: Notebooks Raw data / collected data -Metadata Electronic records Version control 2

3 What is GDP? DEFINITIONS Standards by which documents are created and maintained Concise Legible Accurate Traceable Basic Good Documentation Practices When entries are made in records, these should be made directly in spaces provided for such entries, directly after performing the activities, and should identify the person making the entry. Corrections to entries should be dated and signed and leave the original entry still legible. ICH Q7A, Documentation & Records (6.1), 8/01 ICH : International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 3

4 Legal framework for GDP ICH Good Clinical Practice (GCP) 4.9 Records and Reports 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, initialed, 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 (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 changesor 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 investigator/institution should maintain the trial documents as specified in Essential Documents for the Conduct of a Clinical Trial (see 8.) and as required by the applicable regulatory requirement(s). The investigator/institution should take measures to prevent accidental or premature destruction of these documents. 4

5 What is GDP? DOCUMENT LIFE CYCLE 5

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7 What is GDP? WHY? Objective proof that something happened What is not documented is not done! Legal framework for GDP Be aware: Type of research Regulatory requirements 7

8 What is GDP? WHAT does it apply to: DOCUMENTS + RECORDS Laboratory notebooks Logbooks SOPs Job Aids Reports Result Forms Labels Training records Purchase orders both paper and electronic!! 8

9 What is GDP? GDP GOALS TO CREATE Complete, contemporaneous, legible, accurate and traceable records TO GUARANTEE Quality of Research activities Credibility of the data & results RECONSTRUCT THE STUDY FROM THE RECORDS RETAINED! NEVER RELY ON YOUR MEMORY. OR THAT OF YOUR COLLEAGUE!!! 9

10 GDP summary Concise Legible Accurate - Traceable Simple statement Hard Task 10

11 BASIC GDP RULES EXERCISE! 11

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13 BASIC GDP RULES 13

14 BASIC GDP RULES - ENTRIES Use Indelible Ink No: pencil, corrector (tip-ex), fountain pen, Don t scrunch data 14

15 BASIC GDP RULES BLANK SPACES When might an entry in a form be not applicable? General rule: No Blank Spaces! Why is it left empty? Why is no entry required? Sign and date the explanation! Test N Temp. 1 NVT ph 2 NVT NA 3 NVT 4 NVT 15

16 BASIC GDP RULES IDENTICAL ENTRIES WHAT WITH IDENTICAL ENTRIES? Can or } be used? Test N Temp. ph C

17 BASIC GDP RULES DATE/TIME/ DATE: dd-mm(m)-yyyy(or another standard format!) GOOD: 05/07/2008 or 15-JUL-2008 or BAD: 5/7/8 or or TIME: 15u30 (or another standard format!) (know what date/time format your electronic systems use!) ROUNDING NUMBERS: Only when required in the result of a calculation 0,1,2,3,4 => down ( => 88.2) 5,6,7,8,9 => up ( => 88.3) UNLESS: other rules are applicable (justification to be given) 17

18 BASIC GDP RULES CORRECTIONS Correction of Entry Errors Single strike-through Add the correction Clarify the correction (if needed): clerical error, not clear, calculation error, see data on p, entered on wrong line, Add signature & date Important! The original value remains visible/readable Signature & date on the day of the correction (!) No use of corrector (TIPP-EX) Changes to the conclusion of a document require a new review / approval by supervisor (= all parties that signed the original document) 18 18

19 BASIC GDP RULES CORRECTIONS Correction examples ERZOR ERROR WE 16/07/ =5 6 CE 16/07/

20 BASIC GDP RULES MISCELLANEOUS ABBREVIATIONS: Official: SI-values + abbreviation list of the ITM Others: full wording + abbr. between brackets Examples: C; Key Performance Indicator (KPI) ATTACHMENTS: All: signed & dated + Page x of y or the attachment contains x pages (unless the print-out comes from a validated system) Referral to attachments is required (numbers) Unstable documents (thermal paper): COPY! Print-outs from lab equipment: signed & dated s: signed & dated + page x of y 20

21 BASIC GDP RULES MISCELLANEOUS WHAT TO DO WITH LOST DATA? DOCUMENTED EVALUATION IS REQUIRED 21

22 BASIC GDP RULES MISCELLANEOUS NOT ALLOWED: Unofficial documents (notes; scrap paper; codes, passwords; info on methods;..)»procedures POST-IT S Using the (electronic) signature or log-in of another person 22

23 BASIC GDP RULES DOC. APPROVAL Approval of documents ALL original documents are to be (electronically) signed by the author + the required supervisor / persons Signature(paraph) + date on: at least first page (+ p x/y) Signatures List of signatures, paraphsand initials Electronic signature: personal ID + password Initials are only to be used if they are unique All documents are to be dated on the day they were signed no backdating 23 23

24 BASIC GDP RULES EXAMPLES 24

25 GDP PRACTICAL ASPECTS How to make concise Make them easy to use Make them standardized Make sure to tell the complete story beginning middle end How to make -legible - Can everybody read what is written? 25

26 GDP PRACTICAL ASPECTS How to make Accurate Record data as soon as possible Review critical documents by appropriate person Transcription => verification (document!) How to make -Traceable Sign : who did it Date : when done 26

27 GDP PRACTICAL ASPECTS HOW TO HANDLE LABORATORY NOTEBOOKS RAW DATA (= SOURCE DATA) ELECTRONIC RECORDS & SIGNATURES 27

28 USING (LAB) NOTEBOOKS Who uses notebooks? What do they look like? What is noted down in the notebook? What is NOT noted down in the notebook? 28

29 (ITM) (LAB) NOTEBOOKS - GENERAL GOAL: Uniform way of noting down How& when work was performed Critical raw data Guarantee traceability + clarity of the raw data Comply with the GLP, GCP, requirements Demonstrate the quality of the performed test / research LAY-OUT: Individually numbered (1051-> ) Bound and hard case (robust) Numbered pages (=> no pages can be removed!) 29

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32 NOTEBOOKS - GENERAL Distribution and reconciliation by the quality responsible Traceability of the books before and after archiving ARE and always REMAIN ITM-property Confidentiality! Patient names, coding, privacy, IP / Patents / Value: scientific -$ 32

33 (ITM) (LAB) NOTEBOOKS USAGE MUSTbe used for: Raw data not recorded elsewhere (procedures; automated validated system); Critical experiments; Critical calculations; Formulating hypotheses, tests, CANbe used for: Meeting minutes for official meetings (if no official report is kept of the meeting: MUST); General information; Training records; CANNOTbe used for: Notes not related to the quality system 33

34 NOTEBOOKS -USAGE GDP rules apply Readability traceability! No loose pages documents/post-it s Attachments are to be glued into the notebook OR reference is to be made to a separate map (This map is archived together with the corresponding lab notebook) Sign and data all entries of source data! => between 2 notes and every new working day 34

35 Laboratory vs. Training Notebook Use: - ITM staff - Mandatory (experimental data, routine analysis, critical calculations..) - Registered - ITM property - Externals (students,..) - Training purpose, general notes, - Registration not necessary - Can be taken home 35

36 GDP PRACTICAL ASPECTS HOW TO HANDLE LABORATORY NOTEBOOKS RAW DATA (= SOURCE DATA) ELECTRONIC RECORDS & SIGNATURES 36

37 RAW DATA RAW DATA = SOURCE DATA EXAMPLES?? Raw data means all original records and documents(or verified copies thereof) which are the result of original observations and activities 37

38 RAW DATA Examples Compl. CRF Compl. Questionnaires Lab results Forms Signed documents ID labels (bottles/samples/ ) 38

39 RAW DATA General GDP requirements RAW DATA is Noted down when acquired To be signed & dated Clear and readable (understandable to a third party) To be noted down in (Electronic) (laboratory) notebook, (Electronic) forms Validated electronic systems Quality documents (validation reports, as described in procedures) 39

40 META DATA Definition: Data providing information about one or more aspects of the data Such as: Means of creation Purpose of the data Inter-relationships Standards used Time and date Creator In a broader sense, methods and parameter settings 40

41 META DATA 41

42 Rawdata meta data cluster Site: Centre of HOPE Parasite density (/µl) Plasmodium falciparum Leica DM1750M 1000x Study QuinAmal 14-AUG Lab. tech. Dieudonnée Giemsa lot XXX exp XXX Baseline visit Pt Buffered water lot XXX exp XXX Loss of a data element may invalidate the cluster of data! 42

43 BASIC GDP RULES AUDIT REMARKS Documentation Deficiencies Common Deficiencies: Back-dating Documentation Prior to Performance Documentation (long) After Performance DOCUMENTATION SHOULD BE CONTEMPORANEOUS!! 43

44 BASIC GDP RULES AUDIT REMARKS Common Deficiencies Signing for Someone Else where one person authorizes another to sign a document on his or her behalf, the second person must sign his or her own name (not the name of the first person) along with some notation that, in doing so, he or she is acting in the capacity, or on behalf, of the first person. ~ Delegation log Signing for verifying or witnessing one did not witness or check. 44

45 BASIC GDP RULES AUDIT REMARKS Common Deficiencies Correcting Someone Else's Errors Only obvious errors, but should be avoided whenever possible Question of authorization?! Nurse correcting clinical data entries? Clinical judgment of data managers? Query, don t modify! Which documents? 45

46 BASIC GDP RULES AUDIT REMARKS Common Deficiencies Scrap Paper or Non-official Forms Raw data! When entry is first made or saved by computer 46

47 GDP PRACTICAL ASPECTS HOW TO HANDLE LABORATORY NOTEBOOKS RAW DATA (= SOURCE DATA) ELECTRONIC RECORDS & SIGNATURES 47

48 What does an electronic record look like? Random combination of computer data Text Illustrations Data Sound Other information Digital view ABC On computer system Created Modified Maintained Stored Reproduced Distributed

49 EXAMPLE: ELECTRONIC NOTEBOOK, COLLECTION FORM 49

50 ELECTRONIC RECORD MGMT Who uses electronic systems / electronic signatures? What happens if we opt for electronic systems? Nearly ALL forms, systems, records, data, can be (automatically) entered in electronic systems. How to document changes in e-systems? Or review of data and approvals? 50

51 ELECTRONIC RECORD MGMT So, how do you assure GDP in electronic systems? Several aspects of control : Security Archiving Audit Trails Copy Controls Device Checks Change Control Document Control Computer Systems Validation Sequencing Controls 51

52 EXAMPLE: ELECTRONIC LAB NOTEBOOKS Access the actual work status of all group members Search on the experiments of all of the scientists in your laboratory Protect Intellectual Property Electronically Save time by streamlining the notebook signature process 52

53 ELECTRONIC RECORD MGMT Electronic record = Paper record Electronic signature = Hand-written signature 53

54 ELECTRONIC RECORD MGMT Electronic records Audit trail & traceability 54

55 Audit trail & traceability Changes Who? What? When? Audit trail records unchangeable Keep original value Date and time by computer Only new audit trail records generated 55

56 Audit trails and security of data Audit trail maybe used g g g g Must meet the GxP rules Allowed on paper Labo-book Electronically: security settings / users defined / Use of audit trails if operators can execute actions on critical records 4 Create 4 Change 4 Delete 56

57 Electronic audit trail example 57

58 VERSION CONTROL 58

59 What is version control? Revision or version control is an aspect of documentation control wherein changes to documents are identified by incrementing an associated number or letter code, termed the "revision level", or simply "revision". 59

60 Version control Why? Unique identification of your version Which one was approved? Which is the last/final one? Which one are we/site currently using? Maintain each final version (paper& save as ) 60

61 Version control ESSENTIAL documents! Study protocols & amendments Informed Consent Forms Data collection tools (Questionnaires, Source Documents, CRF s, ) Procedures References to versions! Approvals Data analyses 61

62 Version control Decimals ( ) can be used: to indicate minor changes to a document, or when a certain document is in the draft and review process could be used in conjunction with the indication DRAFTVERSION Integers: ( ) can be used: To indicate final versions or major changes Used at the finalization after the reviewing, drafting process Used for submitted versions to e.g. EC UZA / local HA + Version date! + Revision history Revision Changes with respect to the previous version Correction of typing error: catalogue number and IFU number Version based on version 2.0 of RDT for travellers SD Malaria Ag Pf/Pan POCT, Cat. No. 05FK63 on labquality website dated 07/10/

63 Version control example First Draft Version 0,1 Second Draft Version 0,2 Final Version Version 1.0 approved and signed First Review Version 1.1 Protocol, method revision! First Revision - Final Version 2.0 approved and signed 63

64 Version control Multiple reviewers? (Initials, track changes, ) Electronic version mgmt? 64

65 THANK YOU QUESTIONS - DISCUSSION 65