SDV

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