1. Exeter Clinical Trials Support Network
Event 14, Wednesday 8th Nov 2017

2. The Team Core CTU Staff:
Exeter CTU launched yesterday – nicked the slides

3. 10:40 11:00 11:15 12:30 INTRODUCTION & NEWS
UKCRC Informational Sites Operational Group Meeting
Tim Eames – ExeCTU Senior Analyst Programmer
Performance Metrics in Multicentre Clinical Trials consensus workshop
National Trial Managers Meeting
Shelley Rhodes - ExeCTU Senior Trial Manager
General Data Protection Regulation (GDPR)
Sofia Sanabria – ExeCTU Analyst programmer
11:00
Q&A followed by networking
11:15
WORKSHOP
How to improve Recruitment: communication with sites
Please bring example news letters for group discussion/workshop
Mary Davis - Analyst Programmer
Shelley Rhodes –ExeCTU Senior Trial Manager
12:30
End
Sarah Dean – CTU Deputy Director
UK CRC registration update

4. Performance Metrics in Multicentre Clinical Trials consensus workshop
Voting Data from 3 rounds of a delta survey using COMET initiative software
294 registered, 227 round 1, 251 round 2, 211 round 3
Meeting Chair: Prof Mike Clark, Dir MRC Methodology Hub
15 “consensus in” metrics were the focus of the consensus meeting
3 main areas: recruitment, retention, data quality
there were others, such as staffing, that did not make it in to the 15
7 Metrics were selected
Results to be published soon!

5. 2017 National Trial Managers Meeting
Similar attendance to last year - 122
Streamlined efficient trials - Shaun Treweek
SWAT 59: Offering financial incentives to potential trial participants to improve recruitment
SWAT 60: Mentioning scarcity of trial places in text (SMS) reminders
SWAT 61: Telephone reminders to people who do not respond to a postal invitation to join a trial
Update from the HRA – Chris Cannaby
amendments every day so increased team of 4 people to 40 people
40% of applications not correct
UK Policy for health and Social Care is out!
New website

6. 2017 National Trial Managers Meeting
NHS Digital – Gaynor Dalton, Data Access Request Service
Record level data i.e. identifiable or pseudo anonymised or anonymised
Anonymous aggregated data “counts” easier to get
Research without prior consent- Kerry Woolfall
Woolfall K, Firth L, Gamble C, Young B. How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials. BMC Medical Ethics 2013; 14 (45)
We have now posted the slides from the presentations and workshops at
You will need to be a Full member to access these slides. If you are an Affiliate member wishing to upgrade to Full member status, please and we will send you instructions to upgrade.

7. NHS General Data Protection Regulation Guidance
General Data Protection Regulation (GDPR) Sofia Sanabria – ExeCTU Analyst programmer
NHS General Data Protection Regulation Guidance

8. GDPR timeline

9. GDPR Data Controllers vs Data Processors
Means a person who (either alone or jointly or in common with other persons) determines the purposes for which and the manner in which any personal data are, or are to be processed.
In relation to personal data, means any person (other than an employee of the data controller) who processes the data on behalf of the data controller.

10. According to the Information Commissioner's Office (ICO)
The government has confirmed that the UK’s decision to leave the EU will not affect the commencement of the GDPR.
According to the Information Commissioner's Office (ICO)

13. Resource Links for GDPR
Ico. Information Commissioner's Office - Data Protection Reform
NHS General Data Protection Regulation Guidance
Ico. GDPR Data Controllers and Data Processors guidance
Information Governance GDPR University of Exeter
Bespoke training:
Information Governance Team
University of Exeter GDPR training:
You can register using Trent and searching for:
GDPR (General Data Protection Regulation) Overview ( )

14. WORKSHOP How to improve Recruitment: communication with sites
Mary Davis - Analyst Programmer Shelley Rhodes –ExeCTU Senior Trial Manager Anita Hill - Research Project & Data Manager (NIHR Exeter Clinical Research Facility)

15. Screening/Recruitment Module Demo
Mary Davis - Analyst Programmer

16. Example COBRA Identified from case note screening n = 7615
Exeter n = 2711
Durham n = 2409
Leeds n = 2495
Excluded by GP n = 1859
Exeter n=870
Durham n=663
Leeds n=326
Invited to participate n = 5752
Exeter n = 1841 (*12)
Durham n = 1742
Leeds n = 2169 (*600)
Declined/no response n = 4663
Exeter n=1437
Durham n=1456
Leeds n = 1770
Gave permission to contact n = 1089
Letter n= 925; Telephone n = 164
Exeter n = 404 (*1)
Letter=305; Phone=99
Durham n = 286
Letter=271; phone=15
Leeds n = 399 (*136)
Letter=349; phone=50
Excluded by telephone n = 483
Exeter n = 162
Durham n=95
Leeds n =226
Baseline Assessment Arranged n = 592
Exeter n = 228
Durham n = 191
Leeds n = 173
Pending Baseline n = 41
Exeter n = 8
Durham n=31
Leeds n =2
Baseline carried out n = 551
Exeter n = 220
Durham n = 160
Leeds n = 171
Ineligible/withdrew n = 190
Exeter n = 98
Durham n=35
Leeds n = 57
Eligible/Randomised n = 361
Exeter n = 122 (*1)
Durham n = 125
Leeds n = 114 (*35)

20. Exeter Clinical Research Facility
StartRight
A prospective study to assess utility of clinical features and biomarkers in classifying adult diabetes
Recruitment Target:
1800 NEWLY DIAGNOSED DIABETES PATIENTS
(identified in primary or secondary care)
Funded By: The National Institute for Health Research and Diabetes UK

21.
53 Sites: 44 Sites Recruiting & 9 Sites In Set Up

24. Workshop Questions Who are you communicating with?
What do they need to know?
What is the best way to tell them?
How can you check that they got the information?

25. Services offered: Automated randomisation Statistical design
Database management
Sample size calculation
Trial Oversight Committees
Funding application development
Trial Management
Central and Remote Monitoring
Assistance with costings
Protocol development
Analysis and Reporting
Case report forms
Quality Assurance

26. Request CTU support for your proposed clinical trial 3 months prior to any funding application deadline

27. ANY QUESTIONS?
for general enquiries
or for IT/database support
Telephone:
Website: