28 January, 2026
Author : Dr Vijaykumar Gawali

Topic : SOURCE NOTE WRITING & DOCUMENTATION PRACTICES

1 Definition

Source Documentation refers to all original clinical records and notes where trial-related information is first recorded. This includes OPD notes, inpatient charts, lab reports, imaging, ECGs, phone-call documentation, and progress notes written specifically for the trial.

Source documentation must follow the ALCOA+ principles:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• + Complete, Consistent, Enduring, Available

2 Purpose of Source Notes

• To document what was done during the visit
• To verify data entered into the CRF
• To ensure eligibility compliance
• To record AEs and SAEs
• To document informed consent discussions
• To support audits, inspections, and monitoring

3 CRC Responsibilities in Source Note Writing

3.1 Medical History Documentation

CRC ensures:

• Past medical history documented with supporting evidence
• Diagnosis confirmed with old medical records
• Inclusion/exclusion criteria addressed clearly
  Example:
  “Patient has no history of uncontrolled hypertension (BP records from last 3 months reviewed).”

3.2 Documenting Each Study Visit

A complete source note includes:

• Visit date
• Purpose of visit (Screening/Visit 1/Visit 2/etc.)
• Assessments performed
• Procedures (vitals, ECG, labs)
• IP dispensing &counseling
• Patient questions or issues
• AE/SAE documentation (if any)
• PI/Sub-PI signature

3.3 Telephonic Call Documentation

Every phone call related to the study must be documented.

Documentation must include:

• Date & time
• Caller and receiver
• Summary of discussion
• Action taken
• Signature

Example:
“20/02/2025 10:35 AM – Called patient to remind about Visit 3. Patient reports mild headache; advised to monitor. – CRC Signature”

3.4 Corrections & Amendments

Corrections must follow GCP:

• Single strike-through
• Initials and date
• Reason for correction (if needed)
• No use of white-out or erasing

4 Common Errors to Avoid

• Missing signatures
• Unclear handwriting
• Documentation after long delay
• Using unapproved abbreviations
• Missing visit dates/timings
• Not documenting abnormal results