Clinical Site Audit Checklist Form
Complete this form to assess and document the readiness and compliance of a clinical site for clinical research activities.
General Site Readiness
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Site facilities are adequate and operational
1
2
3
4
Essential documents are available and up to date
5
6
7
8
Site staff are present and available
9
10
11
12
Staff Training and Qualifications
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Staff training records are available
13
14
15
16
Staff qualifications meet study requirements
17
18
19
20
Delegation of duties log is current
21
22
23
24
Investigational Product (IP) Management
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
IP storage is secure and temperature-monitored
25
26
27
28
IP accountability logs are maintained
29
30
31
32
IP dispensing procedures are followed
33
34
35
36
Participant Safety and Emergency Procedures
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Emergency equipment is available and functional
37
38
39
40
Adverse event reporting procedures are in place
41
42
43
44
Participant safety protocols are followed
45
46
47
48
Data Management and Confidentiality
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Source documents are complete and accessible
49
50
51
52
Data entry is accurate and timely
53
54
55
56
Confidentiality procedures are maintained
57
58
59
60
Regulatory and Ethics Compliance
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
IRB/ethics approvals are current
61
62
63
64
Essential regulatory documents are filed
65
66
67
68
Protocol deviations are documented
69
70
71
72
Site Equipment and Facility Assessment
*
Rows
Compliant
Partially Compliant
Non-Compliant
Not Applicable
Equipment calibration records are available
73
74
75
76
Facility cleanliness is maintained
77
78
79
80
Access controls are in place
81
82
83
84
Overall Site Readiness Rating
*
1
2
3
4
5
Key Findings or Observations
Recommended Actions or Follow-up
Submit Checklist
Should be Empty: