Exeter Clinical Trials Support Network Event 14, Wednesday 8th

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

The Team Core CTU Staff:

10:4 0 INTRODUCTION & NEWS UKCRC Informational Sites Operational Group Meeting Sarah Dean – CTU Deputy Director Tim Eames – ExeCTU Senior Analyst Programmer UK CRC registration update 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 11:0 0 Q&A followed by networking 11:1 5 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 12:3 End

Performance Metrics in Multicentre Clinical Trials consensus workshop Voting Data from 3 rounds of a delta survey using COMET initiative software http://www.comet-initiative.org/ 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!

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 80-100 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 http://beta.hra.nhs.uk

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 http://www.tmn.ac.uk/?page AM Slides 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 email [email protected] and we will send you instructions to upgrade.

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

GDPR timeline 6 Months Transition Period (Directive 95/46/EC) 1995 UK Data Protection Act 1998 (EU 2016/679) 27 April 2016 (EU 2016/679) 25 may 2018 16 Days

GDPR Data Controllers vs Data Processors Data Controllers 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. Data processors 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.

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)

Minimun Data required Why you do require the data? How did it happen? Mandatory Breach Report Collecting Data How to mitigate it? Identify what is personal data Right to be forgotten Time to delete personal data when required What is the impact? What’s newin GDPR 72 hours to report Patients (if required) Autorities Delete Data Show that you have a plan Why do you need to keep data? Why do you need to archive the data? Penalties (whichever is greater) Keep the data 20 Million Euros 4%annual global turnover

Government departments Lawfulness Some responsibilities Be able to demonstrate compliance about personal data General Practitioners Comply the rules about how to collet and use personal information Examples Data Controllers Register annualy with the Data Protection Commissioner if required Institutions and organisations Controllers vs Processors in GDPR Accuracy Fairness Data minimisation Transparency Storage limitation and Integrity Confidentiality of personal data Enable and contribute to compliance audit Payroll companies Notify data controllers about any data breach Data Processors Cloud Providers Examples Accountants Some responsibilities Market research companies Take reasonable steps to secure data Upon request, delete or return alla personal data to the controller Obtain written permission from the controller Inform the controller about noncompliances

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 ( 10484 )

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)

Screening/Recruitment Module Demo Mary Davis - Analyst Programmer 45 Initial Screening 25 Consent Visit 7 Baseline Visit 1st Follow Up Visit 7 Not Eligible 8 Declined 4 Lost 1 Pending 25 Eligible 24 Consented 1 Declined Consent

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 Durham n 95 Exeter n 162 Leeds n 226 Baseline Assessment Arranged n 592 Exeter n 228 Durham n 191 Leeds n 173 Pending Baseline n 41 Exete rn 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 Eligible/Randomised n 361 Exeter n 122 (*1) Durham n 125 Leeds n 114 (*35) Durham n 35 Leeds n 57

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

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?

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

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

ANY QUESTIONS? Email: [email protected] for general enquiries or [email protected] for IT/database support Telephone: 01392 722700 Website: https://www.exeter.ac.uk/ctu/