Wendy Fisher Consulting

Where are we now?

• HRA in planning phase

• Posts advertised and staff being appointed

• Setting up programs of work to deliver HRA approval

What does this mean for you?

You can think differently

Imagine a world where you don’t have to chase paperwork Now think what you could do instead

Exercise 1

• In your groups – think outside of the jar – what could you do to make sure research was effectively delivered?

• 10 mins

Grants Training Partners PPI

Could you spend more

time bringing grants and

commercial income into

your organisation

Could you help your research

teams to be up to speed with current

practice

Could you work more closely with

your colleagues in imaging and

pharmacy

Could you finally really

focus on participant

input

Support

Could you be creative about

delivering research

Getting the project into a fit state for it to be approved and delivered

Assessment and Approval

Can you deliver and stay compliant

Organising the set up working with your support departments

You haven’t finished until the project is closed and the evidence is in practice

Sponsor

Feasibility

HRA

Readiness

Delivery

Delivering Research

Getting Ready

Intelligence

Skills

Facilitation

Partners

Delivery Ready to go – using evidence

Making things happen – being proactive

See support departments as partners in research

What skills will your team need

Understanding your research teams and the drivers of your organisation

Pharmacy Single Technical Review • A single technical review

• Summary sheet completed and held centrally

• Local resource review based upon technical review provided

• Piloted in UCL Partners

• Currently being scaled up across 18 Experimental Cancer Medicine Centres (ECMCs)

Practicalities

• Projects to enter process via IRAS handled by Application Managers

• Reviewers identified – may not be running the study themselves

• Aims to reduce duplication in the system

• One point of contact for Sponsor

• Local queries via Application Managers and Pharmacy Reviewer

Preparing for a single Technical Pharmacy review • Can you help your Pharmacists to work regionally in

preparation for a single technical review?

• Adopting the process in a geographical region will be the first step in scaling up to a national process

• However! It should be the process HRA are proposing not a regionally devised one – that will just be more work for everyone.

• The HRA process has been tried and tested and is still having iterations during the ECMC project to make sure it’s fit for purpose.

Medical Exposure

• The HRA are planning an overhaul of the guidance and process for the review of medical exposures

• The aim again is to reduce duplication of effort

• The biggest issues for medical exposure reviewers is the lack of accurate information from applicants and poor communication with R&D.

Sponsor

R&D

R&D

ME/R&D

Ensure all imaging information is accurately documented in the protocol and application

Understand how Medical Exposure works and why, what are their legal responsibilities?

Train applicants in recognising exposures that are standard of care or research

Work together on setting up research, communicate with each other

How can we help our colleagues in Medical Exposure?

What skills will I need?

In your group think about what your team

should look like

Skills to consider

On Click Animated Version

Questions? More Information?

Wendy Fisher

WFC and

Research

Applications Ltd.