Transcript Dias nummer 1

Graduate School of Life Sciences
Sikring af data
- erfaringer fra UCPH LIFE/SCIENCE
Lars Holm Rasmussen, PhD
The Graduate School of Life Sciences
Det Natur- og Biovidenskabelige Fakultet
Københavns Universitet
Singapore Statement on Research Integrity
1. Integrity: Researchers should take responsibility for the
trustworthiness of their research.
4. Research Records: Researchers should keep clear,
accurate records of all research in ways that will allow
verification and replication of their work by others.
5. Research Findings: Researchers should share data and
findings openly and promptly, as soon as they have had an
opportunity to establish priority and ownership claims.
Source: http://www.singaporestatement.org/
Model of ISO 9000 Quality Management System
Continual improvement of the quality management system
Interested
parties
Interested
parties
Management
Responsibility
Resource
Management
Requirements
Input
Value-adding activities
Measurement
Analysis and
Improvement
Product
Realization
Product
Satisfaction
Output
Information flow
from ISO 9004:2000
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Graduate School of Life Sciences
The research process
- points of awareness
Graduate School of Life Sciences
Source: http://speakyssb.blogspot.com/2009_11_01_archive.html
Source: http://speakyssb.blogspot.com/2009_11_01_archive.html
Research without documentation is just anecdotes
hence
high quality research requires documentation
What is high quality research irt. documentation?
 Meeting required expectations from:
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Scientific journals.
Local standards.
Ethical guidelines.
Vancouver rules.
Personal standards.
Client standards.
Society.
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Quality assurance is fundamental!
Should be commen sense as most modern research involves:
Large amounts of data.
Many scientists and complex organizations.
Advanced and complex analytical methods.
Our data will be the fundament for decision making and future
research.
Graduate School of Life Sciences
QA manual and other documentation
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Quality manual.
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Basic documentation (equipment etc).
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Organization plan (who is responsible for what?).
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Description of methods and procedures (papers, SOP’s etc).
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Records (lab notes, raw data, split samples etc).
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Overview of material.
Reference: Prichard & Barwick (2008) Quality Assurance in Analytical Chemistry. Wiley.
Formal acceptance of scientific results
ISO 9000 series
• Development/implementation/improving the
effectiveness of a quality management system.
• Meeting customers requirements.
• Do not cover technical aspects. Very general.
ISO 17025 (and 15189 for medical laboratories)
• Competence of testing and calibration of laboratories.
• Includes ISO 9001.
• Valid measurements.
• Cover technical aspects. Very specific.
Good Laboratory Practise (GLP)
• Legal requirement for regulatory work (e.g. medicine).
• Organization of work to produce reliable results (Fitness
for Purpose).
• Focus on documentation and independent QA audit.
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Formal acceptance of scientific results
ISO 9000 series
• Development/implementation/improving the
effectiveness of a quality management system.
• Meeting customers requirements.
• Do not cover technical aspects. Very general.
ISO 17025 (and 15189 for medical laboratories)
• Competence of testing and calibration of laboratories.
• Includes ISO 9001.
• Valid measurements.
• Cover technical aspects. Very specific.
Good Laboratory Practise (GLP)
• Legal requirement for regulatory work (e.g. medicine).
• Organization of work to produce reliable results (Fitness
for Purpose).
• Focus on documentation and independent QA audit.
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ISO 9000 Quality Management System
Documentation requirements
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General description of the organization
Quality manual
Control of documents
Control of records
The 10 Commandments - GLP Principles
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Test facility organization and personnel
Quality Assurance (QA) program
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
Standard Operating Procedures (SOP’s)
Performance of the study
Reporting of study results
Storage and retention of records and materials
Content: © Springer-Verlag, Berlin Heidelberg 2010
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GLP
Storage and Retention of Records and Materials - 1
What to retain in archives:
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The study plan, raw data, samples
Inspection data and master schedules
Qualification, training experience, job description
Maintenance and calibration data
Validation data
SOPs
Environmental, health & safety
monitoring records
Content: © Springer-Verlag, Berlin Heidelberg 2010
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GLP
Storage and Retention of Records and Materials - 2
Retention period to be defined
If any study material is disposed of before expiry the reason to
be justified and documented
Index of materials retained in the archives
Controlled access to the archives
In case that the laboratory goes out of business the archives
are transferred to the relevant sponsor(s)
Content: © Springer-Verlag, Berlin Heidelberg 2010
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Graduate School of Life Sciences
Handling and Keeping of Scientific Data
- an example from Science
Scientific community, Science
Data and materials availability
All data necessary to understand, assess, and extend the
conclusions of the manuscript must be available to any
reader of Science. All computer codes involved in the
creation or analysis of data must also be available to any
reader of Science. After publication, all reasonable requests
for data and materials must be fulfilled. Any restrictions on
the availability of data, codes, or materials, including fees
and original data obtained from other sources (Materials
Transfer Agreements), must be disclosed to the editors
upon submission. If there are any MTAs pertaining to data
or materials produced in this research, or that you have
agreed to in conducting the research that restrict you from
providing data or materials, please describe these and send
the editor of your manuscript a copy of these specific MTAs.
Fossils or other rare specimens must be deposited in a
public museum or repository and available for research.
Source: http://www.sciencemag.org/site/feature/contribinfo/prep/gen_info.xhtml#dataavail
Scientific community, Science – con’t
Science supports the efforts of databases that aggregate published data
for the use of the scientific community. Therefore, appropriate data
sets (including microarray data, protein or DNA sequences, atomic
coordinates or electron microscopy maps for macromolecular
structures, and climate data) must be deposited in an approved
database, and an accession number or a specific access address
must be included in the published paper. We encourage compliance
with MIBBI guidelines (Minimum Information for Biological and
Biomedical Investigations).
Details include but are not limited to:
Molecular structure data. … Approved databases are the Worldwide Protein Data Bank,
Macromolecular Structure Database…
DNA and protein sequences. Approved databases are GenBank or other members of the International
Nucleotide Sequence Database Collaboration and SWISS-PROT.
Microarray data. Data should be presented in MIAME-compliant standard format. Approved databases
are Gene Expression Omnibus and ArrayExpress.
Climate data. Data should be archived in the NOAA climate repository or other public databases.
Large data sets with no appropriate approved repository must be housed as supporting online
material at Science, or only when this is not possible, on an archived institutional Web site,
provided a copy of the data is held in escrow at Science to ensure availability to readers.
Source: http://www.sciencemag.org/site/feature/contribinfo/prep/gen_info.xhtml#dataavail
Graduate School of Life Sciences
How can we improve data handling
- discussion points
Points for discussion
• Should we have a detailed UCPH QA policy?
• Data storage – who is responsible?
• Electronic notebook systems – an solution?
Source: http://www.blitzconditioning.com/yinyang-test/