HRA Approval performance to September 2018

Transcription

1 16 May Mar- May- Mar- May- HRA Approval performance to September 2 Performance report data cut was taken on 1 October 2. Figure 1 provides a breakdown of the number and types of applications received for HRA Approval by month. There appears to be some suggestion that the number of non-rec applications are continuously increasing, with a 3% increase in average submissions in 2-2 when compared to that of 216-2, equating to about 15 studies more every month. It is counter balanced by a 1% decrease in REC-PR submissions. Figure 1 Types of Applications submitted for HRA Approval TOTAL REC, non- REC-PR REC,

2 Figure 2 shows the median timelines for Approval of different study types, splitting out the time period to REC decision and the remaining time to issue HRA Approval. The REC decision is defined as the date of the final REC output, which is either the date of the Favourable Opinion Letter or the date on the Further Information Favourable Opinion letter if there are no additional conditions, or the date the REC acknowledges that these conditions have been met. The start date is the date the application is valid for REC review (this does not necessarily mean that all documents for assessment are present), or for non-rec studies the date valid for assessment. An increase in timelines for all studies types in July 2, due to factors such as changes in GDPR, summer annual leave, and training days. Time to REC decision includes the time for the applicant to respond to provisional opinions. Figure 2: Monthly Median Timelines in calendar days for studies approved 1 Time from REC decision[non-rec from 9 application submission] to HRA Approval 8 Time to REC decision Figure 3: Mean time for full REC review (England) excluding time for applicant to respond. Mean time to complete full review % full reviews complete in 6 days Mar- May

3 Figures 4-7 show the 1st, medians and 3rd s for Studies Approved each month. Timelines are calendar days from application submission to HRA Approval, including time for applicant to respond. Figure4 Non-REC Studies Submission timelines 1st, median and 3rd Non-REC Studies 3rd Non-REC Studies Non-REC Studies 1st Figure 5 REC-PR Studies Submission timelines 1st, median and 3rd REC - PR Studies 3rd REC - PR Studies 4 2 REC - PR Studies 1st

4 Figure6 REC- Studies submission timelines 1st, median and 3rd rd 1st Figure7 REC-Non- Studies submission timelines 1st, median and 3rd Non- 3rd Non- Non- 1st

5 Figure 8 shows the percentage of valid REC applications with missing documents required for HRA Assessment only (SoA/SoE, Contract, Validated ICT, funding letter). Following the implementation of the verification tool in IRAS is April 2 and delivery of training to industry and academic researchers, we have seen a drop in incomplete initial submissions across all study type in the past couple of months. The rate for commercial (Full REC) studies has decreased from an average of ~4% to under 3% since April 2, similarly Non-REC has dropped form under 4% to under 3% in the since August 2. Incomplete applications cause delay in the review of applications. Despite a number of actions by HRA, a significant proportion of applicants fail to submit applications that are valid for both REC review and assessment. Figure 8: Document Submissions for HRA Approval Percentage line graph 45% 4% 35% Non commercial (NHS) 3% 25% 2% 15% 1% Non commercial (Academic) 5% % May' Percent missing Jun' Percent missing Jul' Percent missing Aug' Percent missing Sep' Percent missing

6 Figure 9 shows a breakdown of studies, where assessment has been undertaken, but the study cannot be issued HRA Approval due to a variety of causes. Studies may have more than one cause attributed to them. Figure 9 Assessment undertaken - breakdown of causes prohibiting HRA Approval No. of Studies identifying with status No. of studies only awaiting one cause Amendments submitted to the HRA Figure 1: Mean time to Amendment Categorisation Mean Time to issue categorisation Mar - May - Figure 11: Median time taken to assess amendments requiring HRA assessment Median Time to Assess (Working Days) Mar - May Figure 12: Mean time for REC review (England) of substantial amendments Mean time to review substantial amendments % substantial amendments completed in 35 days Mar - May