I am a lead RRDN for a study

What is the responsibility of the Lead RRDN when delivering PRIDES?

Early Contact and Engagement

Each RRDN should have a main contact (e.g. PRIDES Lead) to support study sponsors enquiring about PRIDES and how Health Informatics can be used to optimise recruitment to their study. Lead RRDNs are asked to work with Study Chief Investigators (CI) to set up the research study or clinical trial locally or nationally. As part of these discussions the Lead RRDN should help the CI decide how best to identify and recruit patients into their study. This may include the use of a Health Informatic (HI) to help identify and engage potentially eligible patients. This process can be used for commercial studies by agreement.

The aim is for the Lead RRDN to work with the CI as early in the research process as possible and preferably with ring fenced study team funding. The RRDN agrees with the study team how the digital solution or HI will be shared locally. They also agree that this can be shared nationally and that the study team will signpost other RRDNs to the Lead RRDN website.

Health Informatic Development

Each RRDN will have slightly different processes for developing HIs. For example some regions may have RRDN Core Team staff who lead on developments with clinical assistance from Clinical Specialty Leads, whereas other regions may devolve this activity to partner GPs who receive RSI or sessional funding. Regardless of who develops the HI it is important that any development includes 3 main steps:

• Adhere to the study protocol

• Include clinical input and review

• Quality assure through local GP practice testing

For more guidance please visit the PRIDES RRDN Guidance and SOPs. 

Sharing Digital Solutions and HIs

Each RRDN should ideally have a dedicated website for sharing Health Informatics for the study they lead on. RRDNs should decide on structure, content and access for their websites but should be mindful for obtaining permissions from study teams to share HIs and other study documents on open access sites. For more guidance please visit the managing Local PRIDES website page . 

Once an HI has been developed the Lead RRDN uploads this and any supporting documents to their website for sharing. 

Lead RRDNs will complete the PRIDES New Health Informatic Form so details of new study HIs can be added to the National PRIDES Website Search Directory. 

Lead RRDN Responsibilities Summarised

The Lead RRDN will:

• Have a named member of RRDN team or Clinical/IT team who study sponsors, local GP sites and the RDN Coordinating team can liaise with.

• Have a member the RRDN team take responsibility for their local Primary Care/PRIDES website.

• Have a generic contact email for the national PRIDES website.

• Contact the Coordinating Centre and PRIDES Hub to inform them about each new Lead RRDN Study HI so it can be added to to the search directory. 

• Share Lead RRDN HIs and any supporting documents vis local PRIDES website and/or GP System Sharing Groups. Share and HIs developed by other RRDNs taking part in a study.

• Work with the study Chief Investigators and study team to develop an HI; agreeing how the HI will be shared locally and nationally.

• Have an engaged clinician (or clinical orientated IT lead) to feed into the process of designing Health Informatics with the study team.

• Update the HI work on the Lead RRDN website if there is a change required due to a protocol change (it is not their responsibility to notify other RRDNs of this).

• Support the supporting RRDN teams if there are any issues with their HI that require trouble shooting.

• Engage in evaluation by asking for feedback from primary care sites and study teams.

• Use this process  for commercial studies by agreement.

Working with GP Practice sites

Has your RRDN and/or the Study Team created a user guide sheet for the GP Practices delivering the study?

We expect the Lead RRDN to create a user guide to explain how to download and share the IT solutions for other RRDN practices and as an assurance for study team to explain how the solution has been written.