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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


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.



• 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.


Research Data �Research Data Storage

�Research Data Management


Research Data Storage


Research Data �Research Data Storage

�Research Data Management

How secure is my Research Data?


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]


Research Data Management

http://www.digitalservices.lib.uct.ac.za/dls/rdm


Clinical Trial Management(CTM)


Clinical Trial Management Systems (CTMS)



CTMS Requirements:

• Budgeting & Tracking

• Manage Study

• Site Monitoring

• IP Inventory Management

• Document Management

• Reporting


Clinical Data Management Systems (CDMS) at UCT – Open Source


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.


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.


http://technet.uct.ac.za/training/SharePoint%202010/Videos/What%20is%20SharePoint%20SharePoint%202010%20Essential%20Training%20from%20lynda.com.mp4


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



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



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.



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.


Clinical Trial Management – A case study

UCT Clinical Pharmacology

Prof Karen Barnes

Lesley Workman

Jennifer Norman


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


Other Examples

What is SharePoint?


Document Management using SharePoint

What is SharePoint?



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?
