Eligibility Process for Cohort 4 & 5 HRA Approval Studies (post CSP) RM&G Lead’s 09 March 2015 Louise Lambert: Non-commercial Research Initiatives Manager louise.a.lambert@nihr.ac.uk Delivering clinical research to make patients, and the NHS, better

Eligibility Process for Cohort 4 & 5 (post CSP) CRN Readiness (Eligibility) Process description (included in this slide set) Eligibility SOP updated Standard eligibility emails updated Eligibility Team have had the required training

Eligibility Process for Cohort 4 & 5 (post CSP) Main changes from Cohort 3 (Eligibility) Portfolio Application Forms (PAFs) will continue to be submitted to IRAS and CSP post 1 April. This has been agreed to ensure LCRNs have early visibility of studies. This will continue until the HRA and CRN are ready for this information to be received into CPMS. To ensure the CRN has early visibility of studies, please ensure that researchers applying for HRA Approval and seeking CRN Support are advised to submit their PAF before submitting their IRAS Form. To encourage the correct order of submission and to prevent reliance on another organisation (HRA) for applications to the CRN, the Eligibility Team will insist a PAF application is made prior to the eligibility review of the IRAS Form for a study. The Question Specific Guidance in IRAS for Project Filter Question 5 has been reworked in line with the new process. It includes additional information on the role of the CRN and emphasises the order of submission for studies applying for NIHR CRN Support (ie PAF, then other approvals). This guidance will be implemented with the upcoming IRAS release v5.3 on 04 April.

Eligibility Process for Cohort 4 & 5 (post CSP) Main changes from Cohort 3 (Eligibility) A new question (5c) has been added to the IRAS project filter for Devolved Administration led studies. ‘You have indicated that your study has sites located in England. For the research sites located in England, do you wish for the study to be considered for NIHR Clinical Research Network (CRN) Support and inclusion in the NIHR Clinical Research Network (CRN) Portfolio? Please see information button for further details’ This question only appears if Filter Q3 indicates that the study is led from Northern Ireland, Scotland or Wales AND if England is selected in Filter Q3a. For these studies Filter Q5a and 5b will be hidden. The question allows the HRA to identify those DA led studies which need to be sent to the Eligibility Team in the CRN. The ‘initial assessment’ notification from the HRA will be the trigger for the eligibility review. Please note a PAF submission is not required for DA-led studies. On receipt of a DA- led study, the Eligibility Team are proposing to send a request email to all LCRNs with the expectation that a LCRN will step forward to act as the Lead. It is expected that the Lead LCRN will have sites participating in the study.

Eligibility Process for Cohort 4 & 5 (post CSP) Main changes from Cohort 3 (Eligibility) The study sites listed in Part C of the IRAS Form for HRA Approval studies will continue to be available in ODP until the HRA and CRN are ready for this information to be received into CPMS.

Eligibility Process for Cohort 4 & 5 (post CSP) Process description (Includes Cohort 1-5 study types) PAF validation and eligibility A PAF will be submitted by the study team from IRAS to CSP On receipt, the Eligibility Team will validate and the assess the PAF for ‘potential eligibility’ The Eligibility Team will communicate the decision to the study team using a standard email adapted for the HRA Approval process (cc’ing the Lead RM&G Manager, Sponsor, Lead LCRN generic mailbox)

Eligibility Process for Cohort 4 & 5 (post CSP) Eligibility Decision (IRAS Form stage) The study team will complete an IRAS Form (single application e-submission) and upload all relevant documents. HRA performs the ‘Initial Assessment’. Once complete, an email notification is sent to the Eligibility Team. If the study does not require REC, the HRA do not send an ‘Initial Assessment’ notification. The Eligibility Team will be copied into the HRA Approval letter. The Eligibility Team login to the HRA Approval Portal and download the information necessary to perform an eligibility review (IRAS Form, protocol and grant award letters).

Eligibility Process for Cohort 4 & 5 (post CSP) Eligibility Decision (IRAS Form stage) cont… Missing documents that cannot be obtained from the HRA will be requested from the Lead LCRN An email is sent to the study team notifying them of the eligibility decision (cc’ing the Lead RM&G Manager, Sponsor, Lead LCRN generic mailbox). Once eligible, the Eligibility Team will ‘drop’ the IRAS Form xml file for the study into Google Forms to allow the sites listed in Part C of the IRAS Form to be visible in ODP.

Eligibility Process for Cohort 4 & 5 (post CSP) Study Record Management Eligibility Team send notification to Portfolio Research Officers who login to the HRA Approval Portal and download the information necessary to create a study record in CPMS. The Portfolio Research Officers will monitor the HRA Portal for the HRA Approval decision. Once received this information is used to change the status in the study record in CPMS. The status will appear as ‘HRA Approval received’