What is SharePoint? - University of Cape Town · What is SharePoint? ... Anglo American BHP...
Transcript of What is SharePoint? - University of Cape Town · What is SharePoint? ... Anglo American BHP...
Data Managers Forum
What is SharePoint?What is SharePoint?
Ashley Rustin - Senior eResearch Technical Specialist
UCT Clinical Research Centre Data Managers’ Forum
25 April 2016
Ashley Rustin - Senior Technical Specialist
Ashley Rustin - Senior Technical Specialist
Leveraging Microsoft SharePoint for Clinical Trial Management
eResearch Centre University of Cape Town
Agenda:
�Establishing Partnerships
�Clinical Trial Management (CTM)� Clinical Data Management Systems
� Research Data Storage & Management
�Using SharePoint in CTM� What is SharePoint?
� What value does it offer to CTM?
� Examples & Use cases
� Demos
eResearch Centre University of Cape Town
Establishing Partnerships
eResearch Centre University of Cape Town
Establishing Partnerships
• 2013 partnered with & Clinical Pharmacology to assist
with GCP requirements for the audit.
• 2014 partnered with the to establish
community of practise & centralised Clinical Data
Management Systems (CDMS), e.g. OpenClinica, RedCap &
OpenMRS for the UCT Clinical Trial Management community.
eResearch Centre University of Cape Town
Establishing Partnerships
• 2015 UCT eResearch joined as an institutional partner in the
Worldwide RedCap Consortium
• 2016 UCT eResearch joined the OpenMRS community
• 2015 & 2016 – establishing international partnerships with
other eResearch centres across the world.
eResearch Centre University of Cape Town
Research Data �Research Data Storage
�Research Data Management
eResearch Centre University of Cape Town
Research Data Storage
eResearch Centre University of Cape Town
Research Data Storage
eResearch Centre University of Cape Town
Research Data Storage
eResearch Centre University of Cape Town
Research Data �Research Data Storage
�Research Data Management
How secure is my Research Data?
eResearch Centre University of Cape Town
UCT Research Data Storage Benefits:
• Highly discounted for research – R240 per TB per month or R2880 per year
• Discount: R180 per TB per month for 3 years upfront (R6480 for 3 years).
• Data is replicated to University of the Free State data centre in
Bloemfontein
• Access your data from anywhere in the world
• Collect & store data from your instruments
directly to the central research data store.
• Contact: - [email protected]
eResearch Centre University of Cape Town
Research Data Management
http://www.digitalservices.lib.uct.ac.za/dls/rdm
eResearch Centre University of Cape Town
Clinical Trial Management(CTM)
eResearch Centre University of Cape Town
Clinical Trial Management Systems (CTMS)
eResearch Centre University of Cape Town
Clinical Trial Management Systems (CTMS)
CTMS Requirements:
• Budgeting & Tracking
• Manage Study
• Site Monitoring
• IP Inventory Management
• Document Management
• Reporting
eResearch Centre University of Cape Town
Clinical Data Management Systems (CDMS) at UCT – Open Source
eResearch Centre University of Cape Town
Regulatory Compliance - FDA 21 CFR Part 11
What is FDA 21 CFR Part 11?• 21 CFR Part 11 is a law that ensures companies implement good business
practices (GxP). Part 11 allows a company to implement computer systems
that will greatly increase the efficiency of individuals, reduce errors by
identifying risks, and increase overall productivity of the company.
• Part 11 allows any paper record to be replaced by an electronic record,
and allows any handwritten signature to be replaced with an electronic
signature.
eResearch Centre University of Cape Town
Regulatory Compliance - FDA 21 CFR Part 11
There are three primary areas of 21 CFR Part 11 compliance:
• 1. SOPs - There are about 10 SOPs needed to address the IT infrastructure. They address Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures.
• 2. System features - There are more than 40 industry standard features that are implemented to ensure the computer system is secure, contains audit trails for data values, and ensures the integrity of electronic signatures.
• 3. Computer System Validation - Every computer system must have documented evidence that the system does what is intended and that users of the system can detect when the system is not working as intended. Validation must follow the company's SOPs, and virtually all companies find the risk-based approach to computer system validation to be the most efficient and cost effective method of validation available.
eResearch Centre University of Cape Town
http://technet.uct.ac.za/training/SharePoint%202010/Videos/What%20is%20SharePoint%20SharePoint%202010%20Essential%20Training%20from%20lynda.com.mp4
eResearch Centre University of Cape Town
What is SharePoint?
SHAREPOINT EXAMPLE SITES:
International Sites:
AMD
Carlsberg
City of Philadelphia
Chrysler
Dell
Expedia
Ferrari
Fiat
State of Georgia, USA
Swiss Airlines
Kraft Foods
Pfizer
Philip Morris
Maersk Oil
Renault
Viacom
Volvo
UPS
US Treasury, etc.
South African Sites:
Anglo American
BHP Billiton
City of Cape Town
Checkers
CNA
Eskom
Monte casino
Mr Price
Murray and Roberts
MTN
Nampak
SAA
SA Reserve Bank
Spar
Sun International
Toyota SA
Vodacom, etc.
University Sites:
University of Johannesburg
University of Stellenbosch
University of the Western Cape
North West University
Washington University
Harvard Business School
University of Northampton
DePaul University
University of Wales
University of Florida
University of Colorado Denver
University of Kentucky
Utrecht University
University College London
Hospitals, etc.
EXAMPLES OF SHAREPOINT SITES
eResearch Centre University of Cape Town
eResearch Centre University of Cape Town
SharePoint Collaboration site components:
Microsoft SharePoint Components & Features: � Document Libraries
� Document Sets
� Lists
� Calendars
� Announcements
� Alerts & Notifications
� Team Discussions
� Team Task Lists
� Word, Excel & Visio Services
� Workflows
� Audit trails
� Document version tracking via check-in & check-out
� Co-authoring of documents
eResearch Centre University of Cape Town
SharePoint Collaboration site components:
Microsoft SharePoint Components in the context of Clinical Trials
Site Lists and Libraries:� Clinical Trial Protocols: This document library could host all the Clinical Trial
Protocol documents, including archived versions.
� Protocol Documents: This document library could host Protocol Documents including those automatically generated for each Clinical Trial Protocol through the workflow provided in the template via Document Sets: Objectives, Study Design, Project Plan, Subject Selection and Budget.
� Standard Operating Procedures: This document library could host all the source (Word format) and published SOPs (PDF format)
� CVs , Job Descriptions & Training Logs, etc. This document library could host all these source documents
Announcements: � You could use the announcements list to post NB messages on the home page of
the site.
eResearch Centre University of Cape Town
SharePoint Collaboration site components:
Microsoft SharePoint Components in the context of Clinical Trials
Shared Calendars:
� Use the calendar list to inform team members of upcoming events and activities.
� Can also be used for site visits /patient visits / scheduling
Issues:
� The issues list is used to track open issues related to the clinical trial protocol process.
Tasks Lists:
� The tasks list is used to track open tasks related to the clinical trial protocol process.
Document Discussions:
� This discussion board is used to hold newsgroup-style discussion on topics relevant to the client trial protocol team.
eResearch Centre University of Cape Town
Clinical Trial Management – A case study
UCT Clinical Pharmacology
Prof Karen Barnes
Lesley Workman
Jennifer Norman
eResearch Centre University of Cape Town
Document Management using SharePoint
eResearch Centre University of Cape Town
Document Management using SharePoint
eResearch Centre University of Cape Town
Document Management using SharePoint
UCT Faculty of Health Sciences Research Operations WorkshopeResearch Centre University of Cape Town
CTMS Components utilised
• Clinical Trial Management using OpenClinica
• Data Management – UCT Central Research data store
• Document Management using Microsoft SharePoint
� Calendars – site visits /patient visits / scheduling
� Audit trails
� Document version tracking via check-in & check-out
� Co-authoring of documents
� Announcements
� Alerts & Notifications
� Team Discussions
� Team Task Lists
• Data Analysis using Stata
eResearch Centre University of Cape Town
Other Examples
What is SharePoint?
What is SharePoint?
eResearch Centre University of Cape Town
Document Management using SharePoint
What is SharePoint?
eResearch Centre University of Cape Town
Clinical Trial Management Systems (CTMS)
CTMS Requirements: SharePoint caters for:
• Budgeting & Tracking
• Manage Study
• Site Monitoring
• IP Inventory Management
• Document Management
• Reporting
Demos
UCT Faculty of Health Sciences Research Operations WorkshopeResearch Centre University of Cape Town
Thank you for your time
Questions?
eResearch Centre University of Cape Town