Quality Management Summary Report (Safety)

Site: to be filled later

Reporting Period: January – August 2022

QM Coordinator (Signature) Date

Principal Investigator (Signature) Date

 Table of Contents

1 STAFF PARTICIPATION IN QM REVIEWS.........................................................................

2 SUBJECT/PARTICIPANT DATA REVIEW...........................................................................
2.1 Summary of Review Process.........................................................................................
2.2 Results of Review: General Issues, Trend Analysis, Corrective Actions.......................
3 STUDY-WIDE REVIEW........................................................................................................
3.1 Essential Documents Review........................................................................................
3.1.1 Summary of Review Process..................................................................................
3.1.2 Results of Review: General Issues, Trend Analysis, Corrective Action.................
3.2 Other Study-wide Processes and Materials...................................................................
3.2.1 Summary of Review Process..................................................................................
3.2.2 Results of Review: General Issues, Trend Analysis, Corrective Action.................
4 OUTSTANDING ITEMS FROM PRIOR QM REPORTS.......................................................
5 CLINICAL QUALITY MANAGEMENT PLAN EVALUATION FOR ADEQUACY....................
6 SUMMARY AND CONCLUSION..........................................................................................
ATTACHMENT 1: RESULTS OF SUBJECT/PARTICIPANT DATA REVIEW (SAMPLE)...........
ATTACHMENT 2: RESULTS OF ESSENTIAL DOCUMENTS REVIEW (SAMPLE)...................
ATTACHMENT 3: RESULTS OF OTHER STUDY-WIDE PROCESS AND MATERIALS
REVIEW (SAMPLE).....................................................................................................................
1 SAFETY AND HEALTH COMMITTEE

2 LOST TIME INJURY

3 NUMBER OF ACCIDENT RECORDED

No
. Type Of Accident Total Percentage
1 Property Damage 41 29%
2 Road Accident 21 15%
3 Occupational Accident 14 10%
4 Property Damage (Fire) 12 9%
5 Occupational Health 12 9%
6 Occupational Accident ( Needle Prick) 11 8%
7 Electrical Supply Disruption 10 7%
8 Water Supply Disruption 4 3%
9 Property Damage (Ambulance) 4 3%
10 Line Disruption / Operation 3 2%
11 Others 3 2%
12 Fighting 2 1%
13 Health Disorder 2 1%
14 Leakage 0 0%
15 Near Miss Incident 0 0%
16 Disaster 0 0%
Occupational Accident ( Malfunction of
0 0%
17 work equipment)
18 Information Security 0 0%
JUMLAH 139 100%
4 OVERALL ACCIDENT & ACCIDENT REPORT

5 SUMMARY OF NEEDLE PRICK

6 SUMMARY OF WORKPLACE INSPECTION

7 SHE PROGRAM

8 ENVIRONMENTAL PERFORMANCE