The importance of quality assurance

1. The Importance of
Quality Assurance
“How Not to Lose a Study”

2. What is Quality Assurance in Clinical Research?
Quality assurance (QA): The systematic and
independent examination of all trial-related
activities and documents to determine
whether the evaluated activities were
appropriately conducted and that the data
were generated, recorded, analyzed, and
accurately reported according to protocol,
standard operating procedures (SOPs), and
good clinical practices (GCPs).

3. The Quality Challenge
The ongoing challenge in managing the quality of clinical data is to continually
monitor data collection procedures and data management practices at every
level of the study. This includes:
● Ensuring that data generated during the study reflect what is specified in the
protocol (case report form [CRF] vs. protocol)
● Comparing data in the CRF and data collected in source documents for
accuracy (CRF vs. source documents)

4. Standard Operating Procedures
Write a thorough manual of SOPs including:
- Informed Consent Process
- Protocol review procedure
- Handling of biological specimens
- GCP
- Data management
- Procedure for scientific misconduct
Make sure all site staff are trained on site SOPs

5. Components of a Quality Site
● Personnel roles and responsibilities
● Policies and procedures
● Study team training
● Quality assurance and auditing
● Document management, record keeping and reporting
● Corrective and preventive action plan

6. Personnel Roles and Responsibilities
● All study team members must be knowledgeable about:
- Regulations
- GCP Guidelines
- Site SOPs
● Each study team member should be delegated tasks based on their ability,
training, and licensure compared to protocol procedures
● Have a written plan for what is expected of each team member as well as a
completed Delegation of Authority Log (DAL) for each active study
● Ensure that site staff only carry out tasks that they are delegated on the DAL

7. Staff Training
● Make sure all study team members have up to date
training for every protocol they are delegated on
- This may include protocol training, EDC
training, or survey administration training, etc.
● Ensure that all site staff have completed GCP, IATA,
and NIH training
● All training should be documented and filed into
study regulatory binders
● Assess adequacy of training (knowledge testing)

8. Document Management and Record Keeping
● Site files and subject binders should be
handled properly and systematically
● Enforce a system of conventional
naming and filing
● Adequately train staff on archival
procedures
● Standardize methods of data collection
to ensure consistency
● Make sure all files are secured and
“double locked”

9. Corrective and Preventive Action
● Identify potential or real problems
and take action to prevent or correct
- Evaluate why the problem
occurred
● Develop a plan:
- Corrective action plan (CAP)
- Preventive plan
● Document the whole process

10. Regulatory Review
Make sure the following are filed and up to date:
● All protocol versions and approvals
● All IRB correspondence
● All participant original consents, signed and dated
● All Investigator Brochure Versions
● All versions of Form 1572
● CVs, licenses, and Financial Disclosure Forms for Investigators, signed and dated.
● All sponsor correspondence
● Lab certifications and normal ranges
● Delegation of Authority Log

11. Source Document Review
● Ensure that medical records contain:
- All lab reports
- X-ray or scan reports
- Progress notes
- Informed Consent process documentation
- Drug compliance notes
- All completed study procedures
● Make sure no information is missing or document why it is missing
● Ensure that all lab reports are reviewed and signed by PI

12. CRF and eCRF Review
● Ensure that CRF’s are complete, accurate, and up to date
● Review adverse events
- Make sure the investigator signs off on severity and causality
● Review concomitant medications
- Make sure start and stop dates are recorded
● Review study medications
- Make sure start and stop dates are recorded
Always make sure that the paper source matches what is on the EDC!