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