Electronic Data Capture (EDC) Systems and Part 11 Compliance

Transcription

1 Electronic Data Capture (EDC) Systems and Part 11 Compliance Office of New Animal Drug Evaluation Center for Veterinary Medicine Society of Quality Assurance Gaylord Hotel, Washington DC March 28, 2017 Presenters: Ana Lazo, BS, RQAP GLP: Quality Assurance Study Reviewer Stefanie Cook, BS, RQAP GLP: Quality Assurance Study Reviewer

2 Copies of Raw Data submitted to CVM Two different types of raw data are submitted to CVM Manual (hand written) Data Collection Electronic Data Capture 2

3 Manual raw data submitted to CVM Manual data are collected via hand writing with indelible ink on paper and copies of manual raw data should be submitted to CVM as scanned copies in PDF format Examples: animal receipt records, test article accountability logs, analytical standard and QC preparations, paper data capture forms All copies of raw data submitted with critical studies should ensure any change is clearly denoted, legible, and attributable 3

4 Electronic Data Capture (EDC) systems The use of Electronic Data Capture (EDC) systems is on the rise CVM can only accept certain file types to meet our record retention requirements Require that copies of electronic data be submitted in nonproprietary Extensible Markup Language (XML), SAS XPORT (XPT) format, or possibly Portable Document Format (PDF) in order to secure longevity of the data Include audit trails from these systems CVM continues to work with EDC vendors and learn more about the capabilities of their systems to meet our file submission requirements 4

5 Types of Electronic Data Different types of electronic data Static data: data that cannot be altered or changed once recorded Collected via an automated data collection system or instrument e.g., hematology, data loggers, EKG Results may be printed or an electronic file of the raw data maybe available For systems that only permit printing of the data, copies of the raw data are submitted as PDFs For systems that permit exporting data in an electronic file, the raw data are submitted in PDF format and the in XML to permit electronic analysis and manipulation 5

6 Types of Electronic Data Different types of electronic data, cont. Dynamic data: e data that allows interaction between the user and the record content Collected via an electronic data capture system Results are electronic and the electronic file of the data should be available Copies of the raw data are electronic, i.e., XML, XPT or PDF, e.g., chromatograms, ECG charts 6

7 Types of Electronic Data Both static and dynamic data can be collected in a study. How these various types of data are used in a study should be clearly described. A description of how the data integrity is maintained when information is converted to a format different from that used for original capture should be provided. 7

8 Examples of Data Movement: Collection to Submission 8

9 CVM Review of Electronic Data Ultimate goal: The raw data should be reflected accurately in the final study report and CVM must be able to assure the veracity and integrity of the submitted data, both manual and electronic. 9

10 CVM Review of Electronic Data We must be able to navigate data files in order to locate data that correlates with protocol required activities, time points, treatments, etc. We need the actual electronic data points, not line listings 10

11 Electronic Data: How can you help us? Include in the final study report Names of data acquisition systems used and the data collected by each system A statement indicating the system(s) and/or equipment were validated and/or calibrated as appropriate Clearly identify data collected manually vs. electronically Identify data collected manually and later transcribed for review and the QC procedures used to verify the accuracy of the transcription * We will continue to work on where we want to be by identifying what crucial data needs to be submitted and what would be the best way to get it. 11

12 21 CFR Part 11 Awareness Electronic data capture systems are required to be compliant with Part 11 when the data collected from those systems are used in lieu of paper records or submitted to FDA Increased use of EDCs causing us to remind sponsors of their obligations under Part 11 (Electronic Records; Electronic Signatures) Agency has two GFIs on this topic Part 11, Electronic Records; Electronic Signatures Scope and Application 2003 Computerized Systems Used in Clinical Investigations 2007 Have begun asking sponsor whether the EDC systems used in their studies are Part 11 compliant 12

13 21 CFR Part 11 Scope Sec. 11.1(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. 13

14 21 CFR Part 11 Scope Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations ( 11.1). 14

15 21 CFR Part 11 Awareness For GLP Studies: Your GLP compliance statements imply compliance with Part 11 Any systems that are not Part 11 compliant must be included as an exception to the GLP compliance statements Additionally, describe the vulnerabilities of the system(s) and how you have ensured that the system is adequate for its use For Clinical Studies: You should describe the Part 11 compliance status of all systems used in your study Can be included in the FSR As with GLP studies, describe vulnerabilities of non compliant systems and how you have ensured that the system is adequate for its use 15

16 21 CFR Part 11 Awareness Note that for both GLP and clinical studies we request: A description as to the Part 11 compliance of the data collection systems used during the study Another description as to the Part 11 compliance of the electronic files (XML, XPT, PDF) submitted to CVM 16

17 21 CFR Part 11 Awareness In these descriptions, for both GLP and GCP studies: We recommend describing the Part 11 compliance status for all electronic data capture in your submission Ensure that all EDC systems used are accounted for, both those used during the study and those used to prepare the data for submission to CVM Ensure that your descriptions includes the Part 11 compliance status of all electronic data you have submitted regardless of whether it was required by the predicate rule Ensure that your submission includes a description regarding the controls in place after export of your data from the controlled electronic environment in preparation for submission to CVM 17

18 21 CFR Part 11 Points to Consider Compliance must be maintained throughout the data lifecycle and should be considered during your validation process. Be sure that you are thinking of the following: Data collection Changes to the data Submission to CVM Archival 18

19 21 CFR Part 11 Points to Consider Ensure that your electronically recorded data retains all of the same attributes that are required of paper data. Retain these throughout the data lifecycle. ALCOA Attributable, Legible, Contemporaneous, Original and Accurate How do you maintain originality and all of the attributes of originality in an electronic world? Is data contemporaneously recorded if several data points are locked at once? How do you ensure all of these attributes are available for submission to CVM? 19

20 Questions? 20

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