nCRC: National Clinical Research Organization

Presented on 1 May 2018 at Siriraj Hospital

Bandit Thinkhamrop, Ph.D. (Statistics)

And nCRC Developers

Data Management and Statistical Analysis Center (DAMASAC)

Faculty of Public Health, Khon Kaen University

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Overview nCRC

• Customizable, scalable and reliable online research tools

• DIY and comply with essential international standard

• Enhance research literacy regarding project management, data management and statistical reasoning among clinical researchers

• nCRC being an open platform to promote sustainable development of clinical research tools

• nCRC leaves no clinical researcher behind

• Give less, Get more: minimum efforts to get a free and a high quality online clinical research tools

• Available both versions: Community or Enterprise; Online (cloud computing) or Offline independent

• Interface for different category of viewers: Investigators, Committees, Sponsors, Monitors, Auditors, Participants

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Core characteristics

• nCRC being a Platform as a Service (PaaS)• Users can create forms, Modules, or Projects as if developers create a software

• Research projects combine essential modules

• Modules: user-created using EzModule and EzWidget

• Case report form (CRF): user-created using EzForm

• nCRC being a Software as a Service (SaaS)• Forms, Modules, and Projects were created by either nCRC Core Team or other developers and

achieved them for public use

• Each of these can be viewed as a software being achieved at an App Store

• Users can apply for an account at nCRC and then “get” those “App” for free

• nCRC being a national asset of Thailand• Archived at the Digital Government Agency (DGA) at the Prime Minister's Office

• DGA responsible for Software Building Integration and Deployment

• Any software developers can contribute to this initiative

There are tools to render

a mobile application from

any of these.

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Development Platform

• Collaborative development at GitLab Continuous Integration (GitLab CI), a platform developed by MIT, USA

• Based on Yii 2 Framework

• Main languages: PHP 7.0, Python, JScript, NodeJS, Electron, npm5.4, Node 8.4, and R statistical package

• OS: Ubuntu 16.04 LTS

• Web Server: Apache II

• Database Server: MySQL 5.7 or MariaDB 10.03

• Monitoring system• Use Mackerel via Line Application

• Use Yii debug & monitoring system

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Development setup

• 1st version of nCRC complies with GCP principle and 21 CFR Part 11

• Project’s details will be based on 23 items of the International Clinical Trials

Registry Platform (ICTRP), might automatically imported from the Thai

Clinical Trials Registration (TCTR) or the ICTRP WHO database

• Project’s initial setup begins with a pre-defined Templates which were based

on the study design specified in ICTRP or did so independently. Then the

project creator can modify it by getting additional widgets, CRFs, or

modules from the one being shared by others or from a self-created one

ICTRP at http://apps.who.int/iris/bitstream/10665/76705/1/9789241504294_eng.pdf?ua=1

WHO Search Portal at http://apps.who.int/trialsearch

TCTR at http://www.clinicaltrials.in.th

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Project templates to be used as a starter kit

• One project, 1 URL (https://yourproject.work.ncrc.in.th)

• Project templates:• Randomized controlled trial (RCT)

• Other type of experimental studies

• Prospective cohort study

• Disease registry

• Retrospective cohort study involving chart review

• Other type of cohort study

• Case-control study

• Cross-sectional study with multiple occasions survey

• Cross-sectional study with a single occasion survey

• Cross-sectional study serving as a poll or a quick short and simple survey involving only one data collection form

• User-created research template (Shared or self-customized template)

• Each project could be very simple comprising only a data collection form or highly sophisticated comprising several working Modules and several study sites

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Modules to be developed so that any Project creators can add to their Projects

• System modules• EzForm: Create data collection forms to add into either a Project or Module• EzModule: Combine forms according to a workflow

• Core modules• 1. My Workbench: Main working space once login to a Project website • 2. DESS: Data Entry System Settings• 3. DMS: Data Management System

• Recommended modules• 4. PMS: Project Management System• 5. PSS: Project System Settings • 6. MMS: Member Management System• 7. ECMS: Ethical Clearance Management System

• Optional modules• 8. PRS: Project Resource Management• 9. TMFMS: Trial Master Files Management System • 10. TMMS: Timeline & Milestone Management System • 11. Randomization System• 12. IAS: Interim Analysis System• 13. EzCalendar• 14. EzMap• 15. Manuscript Writing Supporting System• 16.+ …….. To be added

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Architecture

• EzForm allows users to create any data input as a case report form (CRF)

• EzModule combines several CRFs that designed to have the same target to a pre-specified workflow and format to form a so-

called “Module”

• One Module can contain 1-30 CRFs

• An example of a “pre-specified” Module is the “My Workbench” which was formatted based on type of study design

• Each module, such as the My Workbench contains some initial CRFs for research data collection where users can remove or

add more the CRFs. The Project Creator can add this Module to his/her Project. Many other modules can also added to the

Project. After that the creators can modified them to suite the Project requirements.

• Project generator combines any types of forms or Modules to an initial, pre-specified working environment- the Project

Templates

• Thus “Project” can be viewed as a module of Modules

• The Project Templates can be expanded to any types of research design or even self-customized to suite personal need

• This architecture allows nCRC to be flexible and scalable to ensure long-term development and sustainability

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CRFs -> Modules -> Project

EzForm

Create CRFs

EzModule

Create ModulesProject

Creator

First Created: Version 1.0

Version 1.0

Tested

Approved

Kickoff

Conduct

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Project Cloning: Generate a new project using a shared, existing project

Clone without data - for training purpose

- for adding new centers

Clone with data- for testing purpose

- for demo purpose

- for back-up purpose

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Project Cloning for Multi-center study

• Project Cloning according to the assigned roles and responsibilitiesNot available/ Not clone

Clone without data [Click to clone]

Clone with data [Click to clone]

First Created: Version 1.0

Version 1.0

1st Cloning: Site A

A: Version 1.0

2nd Cloning: : Site B

B: Version 1.0

Project revision tracking

• Under revision

• Submitted for approval

• Under reviewing process

• Approved

• Kickoff

Project revision tracking

• Under revision

• Submitted for approval

• Under reviewing process

• Approved

• Kickoff

Center A Center B

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Get Started

Enter to work via https://www.ncrc.in.th1

or

Click Create New Project

Create New Project from scratch 12

Project Setup Wizard: Step 1 13

Project Setup Wizard: Step 2 14

Project Setup Wizard: Step 3 15

Project Setup Wizard: Step 4 16

Project Setup Wizard: Step 5 17

Project Setup Wizard: Step 6 18

Open activity

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My Workbench >> Open Activity>>Open Visit for each subject

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Modules in brief 21

EzForm 22

EzForm23

EzForm: Types of question item (variable)

1. Text Input

2. Numeric Input

3. Phone Number

4. E-Mail Input

5. CID Input (Special)

6. Masked Input

7. Dropdown List

8. Radio Box (Multiple choice)

9. Single Checkbox (Boolean)

10. Checkbox (Multiple-item

Response)

11. Date Time (Time Stamp)

12. Date (Calendar)

13. Time

14. Text Area Input

15. HTML Editor

16. Target (Form Master)

17. Component

18. Hospital List

19. ICD 10

20. ICD 9 CM

21. File Upload

22. GIS Map

23. Province Amphur Tumbol

24. Drawing Pad

25. Rating Scale

26. Grid (Input within a table)

27. Data Table

28. Reference Field

29. Auto Number

30. Audio Recorder

31. Question Text

32. Heading Text

33. Line Spacing

34. SNOMED-CT

Google Form’s question types

1 - Text type

2 -Paragraph type

3 - Multiple Choice type

4 - Checkboxes type

5 - Choose From a List type

6 - Scale type

7 - Grid type

8 - Time type

9 - Date type

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EzForm 25

EzModule 26

EzModule 27

EzModule 28

Open Activity

1. My Workbench 29

1. My Workbench

Electronic Data Capture

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1. My Workbench

TMF user interface

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1. My WorkbenchTMF User interface

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1. My Workbench

Member management system

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1. My Workbench

Member management system

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1. My WorkbenchMember management system

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1. My WorkbenchEthic clearance management sysytem

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1. My Workbench

Corrective and preventive action (CAPA)

37

1. My WorkbenchCorrective and preventive action (CAPA)

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1. My WorkbenchSubject Management System

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1. My Workbench

Financial Management System

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1. My Workbench

Financial Management System

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1. My Workbench

Financial Management System

Generate invoice

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1. My Workbench

Financial Management System

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nCRC website

URL:

https://www.ncrc.in.th\

Facebook Fanpage: ncrcthailand

Email: ncrcthailand@gmail.com

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