Risk Management Tool (this tool has been completed with data for illustrative purposes) Project area Risk identified Cause/Source Project Scope Scope is under estimated Poor collective planning and lack of adequate literature review Narrow consultation Poor spade work No clear plan or lack of formative research Complicated fund management solutions Private/partnership concept Site selection criteria Lack of research orientation Key stakeholder unaware of project & own role Poor consultation and engagement techniques Lack of coordination Additional components Project Schedule Uncertain recruitment rate; too slow or too fast Contracting delays Inefficient/Incompati ble systems Stakeholder buy in Ethics review decisions Duplication of efforts leading to conflict Probability 1 low high 3 4 Affected site Seriousness of impact 1 less – 10 threat Course of Action x.y,.z 5 6 Contingency Planning 5 5 5 3 3 3 4 4 3 3 7 8 8 8 7 7 Contingency Planning 2 3 And prevention mitigation 3 Prevention 4 9 7 7 5 9 Mitigation of impact 4 7 Transfer Project Managers of focal persons to deal with Transfer to Project Manager and MOH focal people Mitigation of impact Transfer Project Managers of focal persons to deal with Risk Plan 1. Avoidance: Course operation that eliminates exposure to the threat 2. Transfer: Move to someone else to handle more relevant. 3. Assumption: Recognise the risks but choose to take no course of action. 4. Prevention: Take course of action to reduce the probability of occurrence. 5. Mitigation of Impact: Strategy to reduce negative effects of the problem/ 6. Contingency Planning: Prepare contingency plans in advance to address the risk if it occurs – mainly high probability and threatening situations. Risk Management Tool (this tool has been completed with data for illustrative purposes) Facilities and equipment Need for data collection (both clinical and Community questioned. Incomplete orders Delay in installation Substandard/incom patible systems Resource Delay in recruitment Staff poaching & high turnover Fund Mismanagement Institutional Misaligned priorities Inadequate sponsor support Incapacity to deliver Lack of research orientation 4 10 Possible avoidance modifying our plans Poor planning Import Duty waivers and contract delays Poor consultation and configuration by sponsor Remote areas an attractive package Remote areas an attractive package Poor systems lack of capacity Poor monitoring Poor planning 5 5 7 3 Mitigation & prevention action Mitigation and preventive action 2 4 Mitigation of impact 3 Contingency planning 2 8 8 8 4 10 2 3 8 Corrective and preventive action Contingency Plan Poor recruitment Funds delays Bureaucracy 3 8 Mitigate impact training TA monthly support – use of short-term consultants Contingency planning Risk Plan 7. Avoidance: Course operation that eliminates exposure to the threat 8. Transfer: Move to someone else to handle more relevant. 9. Assumption: Recognise the risks out choose to take no course of action. 10. Prevention: Take course of action to reduce the probability of occurrence. 11. Mitigation of Impact: Strategy to reduce negative effects of the problem/ 12. Contingency Planning: Prepare contingency plans in advance to address the risk if it occurs – mainly high probability and threatening situations. Risk Management Tool (this tool has been completed with data for illustrative purposes) Project team Delayed decisions Bureaucratic structures of authority Government partners 2 2 2 6 6 6 Prevention – consultation of feedback Negative team dynamics. At least within 3-6 months of project Poor communication Unclear authority and accountability systems Ineffective leadership Poor recruitment Non-supportive structures Poor communication Lack of project charter Greed Incompatible work ethics Poor communication 3 8 Prevention through open frequent communication 3 7 7 Mitigation of impact: training and sponsor support 2 3 5, 5 9 Mitigation of impact Avoidance and prevention 4 9 Contingency: part time assistance Treatment errors Recruitment and funding delay Lack of expertise 3 6 Laboratory errors Lack of expertise 3 6 Inadequate drug procurement Lack of SOP’s 3 8 Delayed date collection Lack of experience 3 4 Political/Policy framework Poor policy analysis Change in political office bearers God Almighty 3 Cultural/historical barriers Lack of proper community entry 3 10 10 10 10 10 9 9 Mitigation of impact Refresher training 24 hour hot line Prevention Additional training QA/CC implementation Prevention Distributor consultancy and emergency service contracted Mitigation of impact Assistance from clinical monitors Avoidance team to familiarise themselves with all relevant policies Patent, copyrght issues Pharma and government relations 1 Ineffective leadership Personality clashes Consortium dynamics Lack of HR personnel Technical / Clinical External influences Natural disasters 5 8 Mitigate – (Contingency planning) Requests from Project Managers Contingency plan request from Project Manager Assumption Risk Management Tool (this tool has been completed with data for illustrative purposes) Risk Plan 13. Avoidance: Course operation that eliminates exposure to the threat 14. Transfer: Move to someone else to handle more relevant. 15. Assumption: Recognise the risks out choose to take no course of action. 16. Prevention: Take course of action to reduce the probability of occurrence. 17. Mitigation of Impact: Strategy to reduce negative effects of the problem/ 18. Contingency Planning: Prepare contingency plans in advance to address the risk if it occurs – mainly high probability and threatening situations.