Source Documentation
Source Documentation refers to the original records and files that contain information about patients in clinical trials. These could be hospital records, lab results, or patient charts that show what actually happened during a study. Think of it as the 'proof' behind all the data that goes into clinical trial reports. Clinical research professionals need to review these documents to make sure the trial data is accurate and trustworthy. This process is essential for ensuring that new medicines and treatments are safe and effective before they reach the public.
Examples in Resumes
Conducted quality checks of Source Documentation for Phase III clinical trials
Managed Source Documentation verification process across 15 research sites
Trained site staff on proper Source Document maintenance and filing procedures
Performed Source Documentation review and data verification for 200+ patient records
Typical job title: "Clinical Research Associates"
Also try searching for:
Where to Find Clinical Research Associates
Professional Organizations
Job Boards
Online Communities
Example Interview Questions
Senior Level Questions
Q: How would you handle a situation where source documentation at a site is consistently incomplete?
Expected Answer: A senior professional should discuss developing corrective action plans, providing site training, implementing quality control measures, and possibly escalating to study management if needed. They should also mention documentation of these efforts.
Q: What strategies would you implement to improve source documentation quality across multiple sites?
Expected Answer: Should discuss standardizing procedures, creating templates, conducting regular training sessions, performing periodic audits, and maintaining open communication channels with site staff.
Mid Level Questions
Q: What are the key elements you look for when reviewing source documentation?
Expected Answer: Should mention checking for completeness, accuracy, consistency with protocol requirements, proper signatures and dates, and clear documentation of any protocol deviations or adverse events.
Q: How do you ensure source documentation meets regulatory requirements?
Expected Answer: Should discuss following Good Clinical Practice (GCP) guidelines, maintaining audit trails, ensuring proper corrections are made, and verifying all required elements are present.
Junior Level Questions
Q: What is source documentation and why is it important?
Expected Answer: Should explain that these are original patient records that prove clinical trial data is accurate and describe their role in ensuring data quality and patient safety.
Q: What are common problems you might find in source documentation?
Expected Answer: Should mention missing dates, illegible entries, unsigned documents, incomplete information, and inconsistencies between source documents and case report forms.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of medical records
- Knowledge of documentation requirements
- Ability to identify missing information
- Understanding of confidentiality rules
Mid (2-5 years)
- Detailed source document review
- Query resolution
- Site staff training
- Quality control procedures
Senior (5+ years)
- Process improvement
- Risk management
- Audit preparation and response
- Team leadership and training
Red Flags to Watch For
- Unfamiliarity with Good Clinical Practice (GCP) guidelines
- Poor attention to detail
- Lack of understanding about patient confidentiality
- No experience with clinical research documentation
- Unable to explain basic verification processes
Related Terms
Need more hiring wisdom? Check these out...
The Ultimate Guide to Hiring PHP Developers in 2024: Beyond the Technical Checklist
Speak Their Language: How Localized Job Descriptions Unlock Regional Talent
Sourcing Strategies That Actually Work: A Modern Recruiter's Guide
