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StatX
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2014-06-18
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Source Data Validation

Detail

Source Data Validataion (SDV)

Document

  • Documentation of Informed Consent
  • Adverse event source documentation
  • study termination source document

Case Report Form v/s Source Documents

  • CRF not intended to replace Source Documents
  • Source data items to be recorded directly into the CRF must be documented

    • CRF REVIEW

      • Performing an overall review of each CRF for: internal consistency, completeness, ogic & legibility
      • Without reference to the corresponding source documentation
    • SDV

      • Verifying CRF data against information in supporting source documents held at the site
      • electronic records are the same as for paper records
      • Monitors may perform SDV by viewing computer screens

IMPORTANCE OF SDV

  • required to provide confidence in any data reported
  • protects study staff and sponsors from accusations of fraud, misconduct

SOURCE DOCUMENT VERIFICATION

  • Refers to data being verifiable from source documents
  • Unclear with regard to process of SDV, frequency & extent
  • Process to ensure that source data reported by an investigator be:

    • complete
    • accounted
    • follows a logical sequence of events
    • support entries in CRF
  • WHEN IT STARTED

    • Preferable undertaken before data are retrieved from investigator site
    • Soon after first subject is enrolled
    • Data forwarded to data management thus valid & accurate
  • WHAT TO CHECK Defined in sponsors’ SOPs
  • Documenting SDV

    • CRFs that were checked
    • The data items checked for each CRF
    • The types of source data/ documents examined
    • Nature & frequency of any errors/problems
    • Corrective action taken
  • Methods of SDV

    • Direct Access

      • Preferred choice
      • Investigators excluded who do not allow direct access
    • INDIRECT ACCESS

      • Time consuming
      • Ensures subject confidentiality
  • Common problems encountered during SDV

    • Missing , scant data
    • High error rate

SOURCE DATA

  • information in original records & certified copies of original records
  • Information of clinical findings, observations; or other activities in a clinical trial
  • Necessary for the reconstruction & evaluation of the trial
  • SOURCE DATA EXAMPLES Demographic data: DOB, gender, age, race, height, weight

SOURCE DOCUMENT

  • ACCORDING TO ICH E6: 1.52 Source Documents ARE Original documents, data, and records
  • ICH E6: 8.3.13 Source documents are one of the “Essential Documents”

    • document existence of patients
    • substantiate integrity of trial data collected
  • IND Regulations 21 CFR 312

    • Investigator record keeping and record retention
    • Case Histories- must be adequate and accurate
  • IND Regulations 21 CFR 11 Electronic Records
  • IMPORTANCE OF good source documents

    • Decrease generation of data queries
    • Record all events that transpired while subject was in the study
    • Include statements describing informed consent process & copy of ICF given to subjects
    • Site specific, protocol specific
  • Source Document Template

    • Speed data collection process
    • Guide the investigator to collect all required study data
    • Should allow for additional comments for unplanned/ unexpected situations
    • Help diminish mistakes
  • SOURCE DOCUMENT EXAMPLES

    • Physician Progress Notes
    • Nurse’s Notes
    • Diagnostic Test Reports
    • Medication Records
    • Laboratory Reports
    • Participant Diaries
    • Informed Consent Forms
  • Source Document Agreement

    • Agreement between investigator & sponsor
    • Made at or prior to study initiation
    • Type of documents/documentation to be
    • done for each data item is defined
    • Place of filing of each document is defined
    • CRF, if source for any data, is also defined
  • Custody & Archiving of Source Documents

    • Should be retained until at least 2 years after the last approval of a marketing application
    • measures to prevent accidental or premature destruction

From:https://www.mindomo.com/zh/mindmap/source-data-validation-sdv-7de3cc980ff449d08809279e1ccec109

所属话题:CRF,  SDV,  DM,  数据管理

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