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Research Planning

Research Planning

Project Planning

Project Planning

Impact

Project Team and Management Plain English Summary Research Question / Aims / Objectives Research Plan Public Involvement Gantt Chart / Timelines Risk Register Project Exit Points Artificial Intelligence (AI)

Risk Register

What NIHR are looking for:

A description of the main hurdles to be overcome technically, clinically, and commercially
The steps to be taken to manage and mitigate these risks
A risk register that is maintained and updated during the timeline of the research

Details

Key risks/barriers to success should be identified and mitigated against. These risks should be considered when defining milestones (the go/no-go points for your project). A risk register should be produced and managed by the Project Manager and/or Principal Investigator (Lead). Individual risks may be assigned to a relevant team member who should take responsibility for monitoring and controlling that risk. Once a risk is identified, contingencies should be put in place to mitigate it.

Mitigating Against Risks/Barriers to Success

Risk Management:

A risk is an uncertain event(s) that will affect the achievement of the aims and deliverables
Risk consists of a combination of probability and perceived threat or opportunity occurring that will have an impact on project outcomes
Management of risk is a continual activity performed throughout the life of the project
Effective risk management gives confidence that the project will meet its objectives and is worth continuing
Risk should be identified, assessed and controlled
It is important to maintain a risk management policy/register reporting on risks regularly

The Risk Register should cover all aspects of the research/project plan

risk register

Case Study/Example

Example - Risk Based on Likelihood and Impact (PRINCE2 Probability Impact Grid)

Risks are scored from very low to very high for likelihood and impact. This can be used to judge if risk is low (green) or high (red)

likelihood

		Likelihood	Impact
very low	VL	0.1	0.05
low	L	0.3	0.1
medium	M	0.5	0.2
high	H	0.7	0.4
very high	VH	0.9	0.8

Example of Risks and Barriers

	Description
Technology	Technology not proven No recognised clinical need Concept not innovative All technical requirements not covered by the team Risk to the environment (waste production, not fitting net zero NHS)
Finance	Cost estimates not realistic Budget over-runs
Project Management	Resource issues/incorrect team build Loss of key personnel Organisational changes Uncontrolled changes to scope of project/project scope not set Lack of coordination between the project partners Project delays Incorrect innovation model Project time scales not achievable Milestones not realistic (go/no-go criteria)
Public Engagement	Mis-interpretation of facts Biased outcomes from group (group structure) Inadequate training of participants Product is not acceptable to public involvement group Stakeholders not available for reviews/testing
Development	Cannot automate production Cannot scale up Stability issues Incorrect evaluation/validation Equipment issues Product too complex for the proposed development Design issues Unclear user interface Required performance not met
Software	Does not work End users reject software Poor data for analysis Does not fit with NHS (other) systems Data storage issues Unclear user interface
Regulatory	Ethics approval delays Ethical issues with data sharing with a partner Regulatory change Changes to Medical Device Regulations Regulatory hurdles impact on the commercial uptake of the technology System approval, and accreditation issues Difficulties or delays in obtaining a Letter of No Objection from the MHRA
Clinical Study	No clear clinical outcomes Clinically ineffective The study will not provide enough clinical information to advance the project Safety/tolerability issues arise from the clinical study Failure to recruit patients Lower than predicted number of study participants Higher than predicted participant drop-out from the study Conflict over results between sites Adequate quantity and quality /robustness of clinical data not generated
IP&Commercialisation	Freedom to Operate issues Loss of IP Weak IP protection Inadequate outcome/impact measures Contracts cannot be made with key partners Not economically viable to NHS Cannot integrate into routine clinical pathway
Market	Commercial failure Technology change impacts project Market changes No incentive to change clinical practice Inadequate return on investment (ROI) Competing solutions Market slow to adopt Diversion of NHS resources to other urgent needs Health economic case and impact not clear
Adoption&Dissemination	Stakeholders/champions not engaged End users reject the product Product is not acceptable to NHS (cost, lack of evidence etc) Slow adoption/dissemination Product not adequately tested before implementation Does not fit NHS pathways

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