ICR Anniversary Conference. Electronic Remote Data Capture (erdc) Paul Mason Head of Programming CRUK Clinical Trials Unit University of Birmingham

Transcription

1 ICR Anniversary Conference Electronic Remote Data Capture (erdc) Paul Mason Head of Programming CRUK Clinical Trials Unit University of Birmingham

2 This Session What is erdc and why use it? Paul Mason The CRCTU experience Paul Mason The NHS experience Rachel Hornabrook The CRO experience Vivienne Miller The perfect erdc Paul Mason

3 What is erdc First seriously proposed in late 90 s Data acquisition using computer based system Centrally located within the sponsor organisation edc, erdc, ecrf??? Laptops are edc Websites are erdc

4 What is the motivation for erdc Speed of data acquisition Quality of data Mobility Standardisation Single point of communication

5 Difficulties At CTU Design must be right first time Resources At Centre Access to PC s / Internet Skills / Training Time Incomplete records Regulation

6 Key Criteria System must be fast, simple and work on NHS computers Focus on the needs of the users Focus on data collection, data validation and discrepancy management 1 to 1 training Responsive to requirement changes

7 The CRCTU Experience part 1 Simple systems are good! Soft validation is good! Patient management Usernames and passwords All problems can be overcome with effort

8 The CRCTU experience part 2 Data attained more quickly Data is cleaner than paper based Paperwork is still being handled at the centre, but. Less paperwork being handled by the Trial Coordinator Centre set up is more intensive and harder work for the Trial Coordinator and Centre staff More work for centre staff Being cautious pays no dividends

9 So, what s gone wrong? Over engineered systems NHS resources Clinical management IT / Informatics PC s Systems integration Support

10 Rachel Hornabrook Neurology Research Sister & Clinical Research Facility Manager University Hospital Birmingham NHS Foundation Trust (UHBFT)

11 Objectives for this session To share the challenges I had with implementing and learning to use the two types of RDC I have used: laptop & web based

12 Laptop EDC Original Source : Charles Jaffe, AstraZeneca My source: Jane Bentley and Vivienne Miller, i3 Research February

13 Laptop EDC Advantages Neat / Small Transportable to clinic (in theory) Less paperwork (in theory) Instant data availability Quicker query resolution Faster database lock

14 Laptop EDC Disadvantages (for me) One off training provided Managing the set up of the project on site left to study nurse. Unable to get immediate help when inputting data Less personal contact with CRA Phone line kept crashing Yet another username and password I had to try an remember. Support centre abroad so times for help may not coincide with when the patient is seen.

15 Laptop EDC IT Support / Logistics challenges Needs up front planning Connectivity issues Other security issues Location of connectivity points Wireless technology security

16 Web based RDC Advantages Use PC already present in the office. No need to set up a new secure phone line Instant data availability Quicker query resolution Faster database lock Remote CRA monitoring

17 Web based EDC IT Support / Logistics challenges Specifications of the PC..Who knows? How do you find out? Broadband width that was available wasn t big enough. Firewall problems into and out of NHS sites Difficulty getting into the training package let alone the ecrf because of logging in difficulties. Support centres abroad so times for help may not coincide with when the patient is seen.

18 Web based RDC Disadvantages CRA needs to have access to your PC when monitoring, so preventing you from doing any other PC based work. Work sheets for information required for ecrf needed to be created to avoid missing required information. Use of quota time kicking in every 5 mins Unable to leave CRA to log in as have to use own NHS log in codes to get an external site before then logging into the ecrf.

19 Any type of RDC My Wish list for the future A stand alone training version that does not require. logging onto i.e. disk or downloads onto desktop. Site specific materials - Training Manuals showing Step-by-Step screen flow and study specific orientation. Individual face to face training conducted by CRAs. The ability to change the passwords to personal ones or more user friendly versions.

20 EDC from the CRO perspective Vivienne Miller i3 Research

21 Objectives Pharma/CRO perspective of challenges Solutions being used Future electronic integration

22 Challenges identified Site Assessment Training Management of ecrf accounts Timely completion of ecrf at site Timing of ecrf updates following protocol amendments Safety Reporting Integration of other electronic data systems eg IVRS/IWRS and central lab reports ecrf benefits only the sponsor/cro.

23 Site Assessment When should this be done Who should be completing the assessment How can challenges be addressed

24 Training What type of training (method of delivery)? When?

25 ecrf account management One person = one account Confidential usernames and passwords Training completed before account details provided Audit trail and compliance with regulatory requirements

26 ecrf completion Study specific information to be recorded in source Timely completion of ecrf Streamlined process

27 ecrf updates ecrf could be updated during the course of the study protocol amendment ecrf enhancement or correction

28 Safety management EDC can be used for SAE reporting Benefits avoids duplication of data already added to ecrf - only specific SAE details need to be added to ecrf - Pharmaco-vigilance can request clarification directly through ecrf Disadvantages Paper back up still need for server downtimes etc

29 Integration of other electronic data bases IVRS/IWRS Drug supply and accountability Central lab data

30 The Perfect erdc study? System navigation should be intuitive All data entries should be accepted; validations should be warnings Data query process should be simple and well defined Data discrepancy reports should be available to the whole team Training should be face to face and one to one IT and connectivity assessments should be completed by IT personnel All systems should be SSL256 encrypted and use strong passwords Training databases should be available for practice Usernames and passwords should be changeable Laminated lists of all data needed in source should be provided for each visit. Helpdesks and support should be available 24/7

31 a possible future? We have the knowledge, We have the technology What is holding EDC back?