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