www.cineca.it 1 © CINECA 2012 CINECA web based platform In supporting of Ethics Committee activities July 2013
Www.cineca.it 1 © CINECA 2012 CINECA web based platform In supporting of Ethics Committee activities July 2013.
Dec 28, 2015
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www.cineca.it 1© CINECA 2012
CINECA web based platformIn supporting of Ethics Committee
activities
July 2013
www.cineca.it 2
Ethics Committees platformThe project
Establish a monitoring and evaluation system to ensure quality and achievement of the IRB to improve research processes and operations.
The aim is to provide Ethics committees with a web based platform for the integrated management of IRB activities, supporting harmonization, optimization and transparency of procedures and improving the efficiency of the process.
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Ethics committees Needs (1)
• to employ administrative tools for organizing meetings and secure storing of minutes, resolutions and results
• to support networking of members involved in the IRB process (sponsors, investigators, IRB members, IRB secretariat, ..) by offering data collection and data sharing directly form one sources
• to create one centralized registry for each Ethics Committee containign all the information and all the documents related to clinical research
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• to support harmonization and standardization of procedures, improve transparency and efficiency of monitoring and evaluation of clinical research
• to employ tools for scientific and economic monitoring of studies (study follow-up, results and publications, SAE, amendments, study costs and payments, …)
• to use tools and indicators for the analysis and planning of activities at local level and at central level (Ethics Committee, Hospital, Region …) in an integrated and transversal way
Ethics committees Needs (2)
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Platform Users
• Sponsors
• Ethics Committees Secretariat
• Ethics Committees members
• Principal Investigator
• Directors of Hospitals and Health Units
• Pharmacies
• Local competent authorities
• …
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Platform modules
The platform is composed of several integrated web modules, offering all functionalities to manage the entire IRB process.
Core modules
Registry of all clinical studies
Workflow management system
Meetings organization
Scientific monitoring
Additional modules
Administrative and economic monitoring
Pharmacy activities management
EC Public Web Portal
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Platform schema
Workflow management system
Centralized Registry of all clinical studies
Mee
tings
or
gani
zatio
n
Adm
inis
trat
ive
and
econ
omic
m
onito
ring
Sci
entif
ic
mon
itorin
gEC
Secretariat
EC members
Directors of Hospitals
and Health Units
Investigators
Research Units
EC Public Web Portal
Sponsors
Local competentauthorities
Pha
rmac
y m
anag
emen
t
Pharmacy
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Workflow management system and Registry of all clinical studies
The main aim of the platform is to create an unique centralized registry of all ECs
clinical studies recording all informations and documents of each studies:• Interventional studies• Observational studies• Studies involving drugs• Studies involving medical devices• Biological studies• ….
The Registry is constantly updated by the workflow management system, that manages and monitors the entire process from initial application submission to ECs review and approval, and from first patient enrollment to the publication of results.
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Meetings Organization Module
• Electronic Calendar of meetings• Invitations for members and external experts (via
mail, sms, etc)• Automatic agenda and minutes of meetings using
information available on registered clinical studies• Ethics Committees members access to reports and
comments, or to confirm their participation to meetings, etc
• Meetings attendance registry
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Scientific Monitoring Module
This module includes all functionalities for collection and management of all necessary information necessary for monitoring the progress of a clinical study, from Ethics Committee approval to study closure and publication of results.
In particular, the platform manages the following
information:• Study Follow-up (accrual, annual report, study
closure)• Study amendments, with relative Ethics Committee
review process management • Serious Adverse Events (SAE)• Study results and publications
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Data analysis and Reporting tools
The platform offers advanced tools for data analysis and quick information retrieval.
Information entered in the platform are integrated to allow global monitoring of research activities.
For example– OLAP Reporting– Predefined reports – Studies progress report– Information dashboards– …
Availability of information will be based on user roles and profiles.
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Example of predefined reports
Some reports are already be setted up in the platform
For example, studies distribution for:• status (to be approved, open, closed, etc)• type of study • sponsor• therapeutic area and pathology• participating sites• …
And reports on study progress monitoring , such as:• time for EC review and approval• patients enrollment (enrolled patients vs. expected
patients, enrolment progress)• actual duration vs. expected duration• …
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Service delivery model for Ethics Committees
The proposed service is offered as SaaS (Software-as-a-Service), a cloud model service where software is delivered via the Internet to remove all burdens of hardware and software implementation and maintenance from users. Main advantages:• enhanced flexibility in updating the service (e.g new regulations) and its standards and dictionaries (e.g. ICD IX e MedDRA).• Networks of users can easily be extended to new participants• high reliability, availability, security and integrity of information, constant and transparent technological maintenance and evolution (Data Center: Cineca)
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Information Security
•High level of security and confidentiality of information is granted by the use of AXMR® (“Advanced eXtended Multicenter Research”) developed by Cineca coupled with http e SSL protocols and password protected access, thus ensuring data transmission on a secure and encrypted channel.
•The IT infrastructure, its applications and data are hosted at the Cineca Data Center to grant daily backup and disaster recovery
• The quality management system is certified ISO 9001:2000 and the information security management system is certified ISO 27001:2005
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Cineca platform supporting
Makerere SHS IRB processes
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Cineca platform for Makerere SHS IRB
Cineca will use the Italian model for Ethics Committee for the SHS IRB.
The system will include the following modules:• Registry of all clinical studies• Workflow management system • Meetings organization • Scientific monitoring (study follow up, annual reports, SAE,
amendments, results and publications)
In the phase I of the project, Cineca will provide a system where the Secretariat will enter the application information, organize meetings and IRB post approval reporting.
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Makerere SHS IRB Platform Demo
Enter a new study
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Home page – Study registry
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Enter a new study
Click here to enter a new study
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Identification data of the study
At first it is necessary to enter data identification of the study: study code, title and type of the study. Once the form has been filled in, click on “Proceed” botton to save the data.
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Home page of the study - Study details
Study summary information table: It helps to identify the study and is available in each form of the registry
The form Details of the proposed research contains informations about:-Performance site(s)-Collaborating Institutions-Funding-Details of study population - Proposed inclusione criteria
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Details of the proposed research (1)
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Details of the proposed research (2)
www.cineca.it 24Click Save to proceed with data entry
Details of the proposed research (3)
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Study details – Research Team
Click on “Details of Research Team” to fill in this form
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Click Save to continue
Details of Research Team
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Study details - Documentation
Click on “Study documentation” to upload the documentation.
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Study documentation – add a new document (1)
Choose the type of document you are uploading
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Study documentation – add a new document (2)
Upload a file
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Study documentation – List of documents included
It is possible to download, modify and delete documents
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Send data to central database to check the documents by the IRB Secretariat (1)
Click here to send study data to the central database
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Send data to central database to check the documents by the IRB Secretariat (2)
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Check documentation for the next meetings by IRB
Secretariat
Makerere SHS IRB Platform Demo
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Home Page – List of new studies to be checked
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List of studies to be check by IRB Administrator
Click here to view study data alredy entered
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Check study data – Access to study forms
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Check study data – IRB Administrator review checklist
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Click here to view or update the checklist
Check study data – IRB Administrator review checklist
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IRB Administrator review checklist (1)
If data are complete, the system will show a new field at the bottom of the form, which ask to state the type of review
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IRB Administrator review checklist (2)
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When the IRB Administrator review is filled in and sent, it is possible to Schedule and prepare IRB meeting
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Schedule and prepare IRB meeting by the Secretariat
Makerere SHS IRB Platform Demo
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Home Page – Meeting calendar
Calendar of current month
Click here to “Add a New meeting” to enter a new meeting
Scheduled meeting to be prepared
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Insert a new meeting
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Home page of the IRB meeting
Data summary of the meeting
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Select studies /amendments to be reviewed by IRB
Check from the lists new studies and suspended studies (major changes required), renewal reviewa and amendments.
It’s also possible to select a relator for each study
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Home page of the IRB meeting
Click here to invite IRB members
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IRB members invited (summon)
Tick members and investigators that should be invited to the meeting
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Home page of IRB meeting
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Planning agenda - Preview
The Agenda is partially pre-filled.
Is available on the platform a web editor that allow you to modify the agenda
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Home page of the IRB meeting
Meeting agenda is ready and complete. To download it click on PDF icon
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Home page of IRB meeting
Send summon and agenda to IRB members
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Confirm the completeness of data
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Prepare IRB minute after meeting (1)
Makerere SHS IRB Platform Demo
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IRB meeting calendar
Click on the meeting to enter IRB opinion and prepare the minute
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Click on Minute
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Prepare minute of the meeting (1)
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Prepare minute of the meeting (2)
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Prepare minute of the meeting (3)
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Prepare minute of the meeting (3)
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IRB Decision
Makerere SHS IRB Platform Demo
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IRB Decision (2)
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IRB Decision (3)
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IRB deliberation/decision form
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IRB Decision (2)
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Study Approval letter The study Approval letter will be available pre-filled and can be modify as a word document.
When the letter is complete, it is possible to save it and even print it in pdf format.
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Complete IRB minute after meeting (2)
Makerere SHS IRB Platform Demo
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Prepare minute of the meeting (3)
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Prepare minute of the meeting (4)
It is possible to check the minute and use editor to modify the text
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Here you can find the Minute of the meeting in PDF format
Prepare minute of the meeting (5)
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Renewal of the study after IRB approval
Makerere SHS IRB Platform Demo
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Home Page – Access to studies reviewed by IRB
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List of approved studies
Choose the study, clicking on pencil icon
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Renewal
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Renewal
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Renewal (1)
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Renewal (2)
you can upload a file
you can upload a file
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Renewal (3)
you can upload a file
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Renewal
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Renewal documentation (1)
you can upload a file
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Renewal
Click here to send the renewal request. New forms will be dispayed after sending.
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Renewal
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Renewal – IRB Administrator review checklist (1)
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Renewal – IRB Administrator review checklist (2)
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Renewal
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Renewal - Decision
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Once the previous Renewal has been completed, a new Renewal section is
available
New Renewal
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SAE and Amendments
SAE and AMENDMENTS sections
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SAE - Serious adverse event reporting (1)
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SAE - Serious adverse event reporting (2)
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SAE - Serious adverse event reporting (3)
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To add other SAE click on “Add a new form”
SAE - Serious adverse event reporting (4)
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Amendments
In this section you can ask for amendments
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Amendments - Request of a new amendment (1)
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Amendments - Request of a new amendment (3)
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Amendments - Request of a new amendment (3)
If you need to change information, click on “Study data”
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Amendments - Update study data (2)
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Amendments - Update study data (3)
Click on the pencil to modify data
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Amendments - Update study data (4)
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Amendments - Update study data (5)
An exclamation mark will be shown beside the forms that have been modified
At the and of revisions you can send data to central database for IRB amendment opinion
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Amendments IRB Administrator Review (1)
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if data are incomplete you can ask for an integration
Amendments IRB Administrator Review (2)
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Amendments IRB Administrator Review (3)
if data are incomplete you can ask for an integration
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Amendments – IRB opinion (1)
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Amendments – IRB opinion (2)
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Final Report
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Final Report
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Final Report
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