I am a lead LCRN for a study

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

Early Contact and Engagement

Each LCRN 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 LCRNs 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 LCRN 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 LCRN to work with the CI as early in the research process as possible and preferably with ring fenced study team funding. The LCRN 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 LCRNs to the Lead LCRN website.

Health Informatic Development

Each LCRN will have slightly different processes for developing HIs. For example some regions may have LCRN 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 LCRN Guidance and SOPs.

Sharing Digital Solutions and HIs

Each LCRN should ideally have a dedicated website for sharing Health Informatics for the study they lead on. LCRNs 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 LCRN uploads this and any supporting documents to their website for sharing.

Lead LCRNs 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 LCRN Responsibilities Summarised

The Lead LCRN will:

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

• Have a member the LCRN 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 LCRN Study HI so it can be added to to the search directory.

• Share Lead LCRN HIs and any supporting documents vis local PRIDES website and/or GP System Sharing Groups. Share and HIs developed by other LCRNs 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 LCRN website if there is a change required due to a protocol change (it is not their responsibility to notify other LCRNs of this).

• Support the supporting LCRN 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 LCRN and/or the Study Team created a user guide sheet for the GP Practices delivering the study?

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