Enabling a data management system to support the good laboratory practice Masterthesis Status Report Miriam Ney (13.01.

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1 Enabling a data management system to support the good laboratory practice Masterthesis Status Report Miriam Ney ( ) Folie 1 Statusreport Masterthesis > Miriam Ney >

2 Overview Description of Task Approach to Complete Task Phase 1: Requirements Analysis Phase 2: Implementation Phase 3: Testing and Evaluation Folie 2

Description of Task: Enabling a data management system to support the good laboratory practice Data management system: DataFinder Open Source Project developed by DLR Data management and workflow

3 Description of Task: Enabling a data management system to support the good laboratory practice Data management system: DataFinder Open Source Project developed by DLR Data management and workflow management Heterogenous data store concept Meta Data handling Good laboratory practice (GLP) Scientific conduct Regulatories from DFG, OECD, Universities, Part of GLP: Laboratory Notebook Folie 3

workflow management Heterogenous data store concept Meta Data handling Good laboratory practice

Plan: Organizing the Master Thesis Requirements analysis (November, December) What is the good laboratory practice? How does a scientific workflow look like? What do other implementation have?

4 Plan: Organizing the Master Thesis Requirements analysis (November, December) What is the good laboratory practice? How does a scientific workflow look like? What do other implementation have? What is part of a laboratory notebook? Implementation Feature 1: Origin of Data (January, February) Feature 2: Evidentially Archiving (February) Feature 3: Signing digitally (March) Testing the Implementation (April) NANO in GBK Writing the thesis (concurrently) Folie 4

Implementation Feature 1: Origin of Data (January, February) Feature 2: Evidentially Archiving (February) Feature

5 Requirements analysis What is the good laboratory practice? The principles of Good Laboratory Practice (GLP) have been developed to promote the quality and validity of test data used for determining the safety of chemicals and chemicals products. OECD Principles on Good Laboratory Practice (as revised in 1997) [The recommendations] are designed to provide a framework for the deliberations and measures which each institution will have to conduct for itself according to its constitution and its mission Deutsche Forschungsgemeinschaft: Sicherung guter wissenschaftlicher Praxis (Safeguarding good scientific practice) 1998 (p.50). Folie 5

6 Requirements analysis How does a scientific workflow look like? Folie 6

7 Requirements analysis What do other implementations have? Folie 7

8 Requirements analysis: What is part of a laboratory notebook? Das Laborbuch ist ein Tagebuch des experimentierenden Naturwissenschaftlers (The laboratory notebook is the diary of the experimenting scientist) (Schreiben und Publizieren in den Naturwissenschaften Von Hans F. Ebel,Claus Bliefert,Walter Greulich; chapter page 16) Paper based Immediate documentation Protocol style Short notes Attesting authentication Genuineness Authenticity in general Integrity Chain of events Electronically based Durability Collaboration Versioning Rights management Variety of dataformats Searchability Device integration Individual Sorting Infrastructure Environmental specialisation Availability Complexity Folie 8

den Naturwissenschaften Von Hans F. Ebel,Claus Bliefert,Walter Greulich; chapter 1.

9 Implementation Feature 1: Origin of Data Provenance Integration Provenance (lat. pro venire = to come from): origin of data, source Motivation: Requirements: Integrity Chain of events Genuineness TODO: Provenance Model Provenance System adjusting noblivious Integration into DataFinder Folie 9

10 Implementation Feature 1: Origin of Data Provenance Integration Model Folie 10

11 Implementation Feature 2: Evidentially Archiving Motivation: Recommendation 7: Primary data as the basis for publications shall be securely stored for ten years in a durable form in the institution of their origin. Deutsche Forschungsgemeinschaft: Sicherung guter wissenschaftlicher Praxis (Safeguarding good scientific practice) 1998 (p.55). TODO: Requirements analysis: BeLab project results Developing concept: DataStore integration in DataFinder of WS-Secure Folie 11

Deutsche Forschungsgemeinschaft: Sicherung guter wissenschaftlicher Praxis (Safeguarding good scientific practice)

12 Implementation Feature 3: Signing digitally Motivation: Requirements: Authenticity in general Attesting authentication TODO: Developing concept: Authentification methods Saving methods of signatures Integration into DataFinder Signing of data as MetaData Folie 12

TODO: Developing concept: Authentification methods Saving methods

13 Testing the Implementation NANO: Gasdynamisch initiierte Partikelerzeugung TODO: Adjusting DataFinder for test data (datamodel) Testing the system with the data Folie 13

14 Fragen? Stand # Kontakt: Miriam Ney DLR Simulations- und Softwaretechnik, Berlin Miriam.Ney@dlr.de Folie 14

Enabling a data management system to support the good laboratory practice Master Thesis Final Report Miriam Ney (09.06.2011)

Enabling a data management system to support the good laboratory practice Master Thesis Final Report Miriam Ney (09.06.2011) Overview Description of Task Phase 1: Requirements Analysis Good Laboratory