M8L3 Data management for medical research

  • Data management objectives

    • Ensure integrity/confidentiality of research data

    • Facilitate data accessibility —> analysis + sharing

  • Challenges

    • Compliance with legal/ethical standards

    • Maintaining data security and patient privacy

    • Handling large volumes of data

  • Data management is central to the designing, conducting, and reporting of trials and critical for validity/reliability of results

  • MHRA GXP Data Integrity Guidance Document - GXP= good X practice (distribution, clinical, lab, manufacturing, pharmacovigilance)

  • Source data - original records/documentation of data

  • Metadata is ‘data about data’ - structured information that describes, explains, locates, or manages other data eg documenting context like creation date, creator, format, and usage rights for efficient cataloging, discovery, and retrieval of resources

  • Derived data - result of the data analysis

  • Research data lifecycle - all phases in the life of the data from generation/recording to processing, use, retention, archive, retrieval, and destruction

  • Data governance applies over the whole life cycle to provide assurance of data integrity

    • This is the arrangements to ensure data are recorded, processed, retained and used to ensure the record throughout the data lifecycle

  • Data integrity - degree to which data are complete, consistent, accurate, trustworthy, and reliable

  • Data should be ALCOA

    • A - attributable to the person generating it

    • L - legible and permanent

    • C - contemporaneous

    • O - original record or certified true copu

    • A - accurate

  • Data governance should ensure that data is complete, consistent, enduring, available

  • Legislative requirement - UK policy framework for health and social care research

    • Principle 14 - specific reference to transparent management of tissue/sample collection

    • Appendix 2: Laws - comprehensive list of regulations eg Medicines for Human Use (Clinical Trials) Regulations 2004, Human Tissue Act 2004, Data Protection Act 2018 (UK Implementation of GDPR)

  • Data management plan - structured tool outlining data handling during research which guides collection, processing, storage, and sharing of data