Table 1 Comparison of key components between routine audit and screening audit
Item | Routine audit | Screening audit |
|---|---|---|
Target protocols | Active protocols approved by IRB | Active protocols approved by IRB |
Protocol Selection | 1–2 protocols per week upon the risk matter (i.e. Early phase study, protocols with vulnerable participants, etc.) | Every active protocols at the time when the screening audit conducted |
Initiation meeting with investigators | About 30 min | Not required |
Details of review | ||
1) Regulatory documentation (i.e., IRB/FDA approval letter, Contract, Protocol, etc.) | - Availability - Accuracy and completeness | - Availability |
2) Participant logs | - Availability - Accuracy and completeness | - Availability |
3) Investigator’s log and CV | - Availability - Qualification - Scope of the delegation | - Availability |
4) Consent process | - Availability of obtained ICF - Adequacy of consent process | - Availability of obtained ICF - Adequacy of consent process |
5) Protocol compliance | - Source documents and medical records verification | - Not required |
6) Case Report Forms | - Availability - Accuracy and completeness | - Availability |
7) Reports | - Safety issues detection and report - Compliance for report to sponsor/IRB/FDA | - Availability of documentation |
8) Pharmacy, laboratory, other facility maintenance | - Availability of quality control record - Facility check | - Availability of quality control record |
9) Specimen maintenance | - Availability of related record - Accuracy and completeness of maintenance log - Facility check | - Availability of documentation |
Closing meeting with investigators | About 30 min | Not required |
Reporting the audit findings | Inform the investigators of the findings Response of investigators is needed | Inform the investigators of the findings Response is not required |
Decision | Decision made by IRB in the convened meeting with audit findings and investigator’s response | Decision made by auditors with only audit findings |
Follow up measure | Follow up with investigator’s corrective action and preventive action | Recommend full routine audit or for-cause audit |