Data collection, storage and some ethics

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Data collection, storage and some ethics

• ASNEMGE, Young Investigators Meeting
• Interactive course
• Daisy Jonkers
• University Hospital Maastricht

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Contents

• Ethics
• Before data collection
• Data collection and storage

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Ethics and guidelines

• Humans
• Medical Ethics Committee
• check compliance with declaration of Helsinki
• with national/European guidelines
• In research proposal / manuscript -gt compliance
  with declaration
• Animals
• Animal experiment committees
• Respect for animals replacement
• reduction
• refinement

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Declaration of Helsinki (1964)

• Ethical principles for medical research
  involving humans subjects
• - importance of objectives must be in proportion
  to risk
• - scientific quality
• - concern for subject must always prevail over
  scientific interest
• - detailed information
• - written informed consent
• - right to withdraw
• - data confidentiality
• etc.

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Guidelines

• European guidelines
• clinical trials
• - registration required for all CT to be
  published
• -gt national registrations
• -gt www.ClinicalTrials.gov
• - reports during and after study on
  progression, safety, results
• studies with medication
• - Eudract-protocol number (http\\eudract.emea.eu
  .int)
• - Adverse events (when, where to be reported and
  by whom)
• - Good Clinical Practice
• National/local guidelines medical ethics
  committee

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GCP/ GLP

• Good Clinical practice (GCP)
• - guidelines for all studies with medication
• -gt to protect trial subjects
• -gt to obtain reliable results (accurate,
  complete, verifiable)
• - International guidelines
• FDA (www.fda.gov/oc/gcp/guidance.html)
• Europe (www.efpia.org/6_publ/document/clinical.p
  df)
• Good laboratory practice (GLP)
• - to ensure quality and reliability
• - work according to protocols and write down all
  deviations
• - www.oecd.org

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Guidelines to be expected for functional
foods European guidelines www.ich.org

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Before performing the study

• Study protocol
• Define outcome parameter
• Define best assay / method to measure
• Perform and validate method BEFORE start study
• Standardised procedures
• Contact statistician

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Standardised procedures

• Collection of biological samples - sample type
• - storage medium / conditions
• - in a standardised way
• Laboratory analyses - best assay for outcome
  parameter
• - perform/validate assay before start
• - work accurate
• - control conditions
• - limit inter-test variation
• - include controls
• Animals - one batch (animals, food)
• - housing conditions, stress
• Always include controls and work in a
  standardised way!!!

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Standardised procedures

• Clinical assessment - one person,
• - same equipment / procedure
• - calibration
• Questionnaires use validated questionnaires
• - open question when exploring new or unknown
  situation
• - closed question define response categories
• (uniform mode, distinctive, limit I dont
  know / other)
• - limit referral questions
• - clear formulation, layout, etc.

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Before start of study

• Standardised and validated procedures
• Flow-chart
• Pilot test-day in advance
• Consider the Ethics and guidelines

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Data collection

• Case-record form uniform registration
• all variables (in logical order)
• Stick to standardised procedures
• Handle all samples the same
• Work accurate / be complete
• Document every deviation!!!
• Do what you write and write what you do!

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Creating a data base I

• Spread-sheets such as excel
• -gt easy to import to statistics and graphic
  programs
• Discuss with statistician before start
• Enter data in a standardised way
• manual
• scanning
• connection with computerised system
• Code-book

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Creating a data base II

• Check, check, check (double entry, parallel
  files)
• Check for mistakes lowest-highest
• diagram of distribution
• etc.
• Archive / back up
• Data confidentiality

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• When all data are complete -gt code can be broken
• and then statistics...
• Be sure to use the right statistical test
• (go to see a statistician.)

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