30 09 2020

Announcements

Study Intensity Tool Training for Vaccination Studies

The Study Intensity Tool provides a standardised and structured approach to assessing individual and multiple study workload, assessing staffing levels and accurately planning resources during study set-up.

Study Intensity Tool; Become more resilient to workforce challenges

Introduction

The Study Intensity Tool is a research specific workforce planning tool which originated in the general clinical research centres of the USA. With permission it has been adapted and developed for use in the UK by the UKCRF Network’s Intensity Theme Group.

The Tool was developed in response to the need to quantify clinical activity initially within the CRFs, however its generic applicability across the research setting allows it to be used in other research settings and for both adult and paediatric studies. It can be used individually or collectively within an organisation as a means of predictive workforce planning.

The Intensity Tool has already been used widely across the UK to support COVID priority research, and we are pleased to announce that the Network has been working with the NIHR Clinical Research Network (CRN) to further promote the use of the tool for COVID vaccination studies. The Study Intensity Theme Group have therefore created some specialised training videos and example tools to support this important research.


On this page you will learn:

  • How the Study Intensity Tool works
  • The main benefits of using the Tool
  • How to access our new Study Intensity Tool training for vaccination studies
  • How to access our Study Intensity Tool beginner training webinars

How Does the Study Intensity Tool work?

The tool operates using Microsoft Excel and provides a calculation of whole time equivalent (WTE), giving an overall study intensity calculated from the WTE. This can be broken down for core groups including nursing, imaging, laboratory, and human performance staff as required.

The multidisciplinary section can be adapted as appropriate, for example clinical trial assistant, medical staff. Each core group has a separate study intensity score.

Within the tool itself standard procedures are represented as time defined tasks. Definitions of each activity are available in the tool for immediate reference and ease of use.

The tool provides flexibility to alter some time parameters or to add in study specific procedures and allocate timings to these, therefore allowing the user to customise the tool to the study.

Study Intensity Tool Screenshot

Tool Validation

An annual validation exercise is undertaken by the group using a standardised study protocol to validate the current version. This also ensures that any changes in practice, for example study administration or care delivery, are addressed.

What are the benefits of the tool?

  • Assesses how many staff are required to run multiple studies
  • Assesses the feasibility of undertaking particular studies
  • Can be used as an education tool for researchers to demonstrate the actual resources required to conduct a trial
  • Provides support when reporting activity to fund holders
  • It can be used as a “living” tool that adapts to the changing research environment

Feedback

During our 2019-20 follow-up survey we asked users what they liked about the Study Intensity Tool and received the following feedback:

  • “Allows for a reasonably simple way to calculate nursing intensity”
  • “Seeing multidisciplinary information all in one place”
  • “Helps you to think and identify ALL tasks that need doing on a visit”
  • “It works for all studies and covers all possibilities”
  • “Really informs our capacity and evidences both staffing requirements and costing”

Study Intensity Tool Training

Use of webinar software has allowed the Network to provide training to a larger and wider audience with a total of 229 UK and Ireland research staff attending training in 2019-20.

Results from our 2019-20 survey showed that 93% reported that the online training successfully taught them how to use the tool and that they had plans to implement it within their work area.

The Intensity Theme Group currently offers two types of training:

 

1. Study Intensity Tool Training for Vaccination Studies

The Group have recorded a training video showing a demonstration of the tool using one of the national vaccination study protocols, as well a video introduction to the tool for new users.

You will need to register for the training in order to gain access to these videos. You can do this by completing the form at the bottom of our UKCRF Portal page, and selecting “Yes” when asked if you want to register for the training.

If you already have access to the Portal you can email [email protected].

 

2. Study Intensity Tool Beginner Training

We have also restarted our monthly webinars to train beginners on how to use the Study Intensity Tool using a validated Study Protocol for training purposes. Due to the pandemic the webinar has been pre-recorded and questions asked during the session will be emailed to the Intensity Group afterwards. Training is applicable to both adults and paediatrics, and registration links can be found on our training page.

How to Download the Tool

The Study Intensity Tool can be downloaded from the UKCRF Portal. If you are not a member of the portal, please complete the request form at the bottom of the page. The request form also includes an option to register for our Study Intensity Tool training for vaccination studies.

Intensity Theme Group Members

Current Members:

Acknowledgments:

  • Nikki Harwood (Manchester)
  • Carol Chapman, (Southampton)
  • Josephine Studham (Exeter)
  • Jo Plumb (Birmingham)
  • Roberto Cayado-Lopez, (Cambridge)
  • Ruth O’Connor (Dublin)
  • Elizabeth McDowell (Edinburgh)
  • Dickon Jackson (Edinburgh)
  • Sharon Cameron (Edinburgh)
  • Susan Macfarlane (Dundee)