1 © CINECA 2012 CINECA web based platform In supporting of Ethics Committee activities July 2013

2 Ethics Committees platform The 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.

3 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

4 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)

5 Platform Users Sponsors Ethics Committees Secretariat Ethics Committees members Principal Investigator Directors of Hospitals and Health Units Pharmacies Local competent authorities …

6 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

7 Platform schema Workflow management system Centralized Registry of all clinical studies Meetings organization Administrative and economic monitoring Scientific monitoring EC Secretariat EC members Directors of Hospitals and Health Units Investigators Research Units EC Public Web Portal Sponsors Local competent authorities Pharmacy management Pharmacy

8 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.

9 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

10 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

11 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.

12 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 …

13 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)

14 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

15 Cineca platform supporting Makerere SHS IRB processes

16 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.

17 Makerere SHS IRB Platform Demo Enter a new study

18 Home page – Study registry

19 Enter a new study Click here to enter a new study

20 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.

21 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

22 Details of the proposed research (1)

23 Details of the proposed research (2)

24 Click Save to proceed with data entry Details of the proposed research (3)

25 Study details – Research Team Click on “Details of Research Team” to fill in this form

26 Click Save to continue Details of Research Team

27 Study details - Documentation Click on “Study documentation” to upload the documentation.

28 Study documentation – add a new document (1) Choose the type of document you are uploading

29 Study documentation – add a new document (2) Upload a file

30 Study documentation – List of documents included It is possible to download, modify and delete documents

31 Send data to central database to check the documents by the IRB Secretariat (1) Click here to send study data to the central database

32 Send data to central database to check the documents by the IRB Secretariat (2)

33 Check documentation for the next meetings by IRB Secretariat Makerere SHS IRB Platform Demo

34 Home Page – List of new studies to be checked

35 List of studies to be check by IRB Administrator Click here to view study data alredy entered

36 Check study data – Access to study forms

37 Check study data – IRB Administrator review checklist

38 Click here to view or update the checklist Check study data – IRB Administrator review checklist

39 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

40 IRB Administrator review checklist (2)

41 When the IRB Administrator review is filled in and sent, it is possible to Schedule and prepare IRB meeting

42 Schedule and prepare IRB meeting by the Secretariat Makerere SHS IRB Platform Demo

43 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

44 Insert a new meeting

45 Home page of the IRB meeting Data summary of the meeting

46 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

47 Home page of the IRB meeting Click here to invite IRB members

48 IRB members invited (summon) Tick members and investigators that should be invited to the meeting

49 Home page of IRB meeting

50 Planning agenda - Preview The Agenda is partially pre- filled. Is available on the platform a web editor that allow you to modify the agenda

51 Home page of the IRB meeting Meeting agenda is ready and complete. To download it click on PDF icon

52 Home page of IRB meeting Send summon and agenda to IRB members

53 Confirm the completeness of data

54 Prepare IRB minute after meeting (1) Makerere SHS IRB Platform Demo

55 IRB meeting calendar Click on the meeting to enter IRB opinion and prepare the minute

56 Click on Minute

57 Prepare minute of the meeting (1)

58 Prepare minute of the meeting (2)

59 Prepare minute of the meeting (3)

60 Prepare minute of the meeting (3)

61 IRB Decision Makerere SHS IRB Platform Demo

62 IRB Decision (2)

63 IRB Decision (3)

64 IRB deliberation/decision form

65 IRB Decision (2)

66 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.

67 Complete IRB minute after meeting (2) Makerere SHS IRB Platform Demo

68 Prepare minute of the meeting (3)

69 Prepare minute of the meeting (4) It is possible to check the minute and use editor to modify the text

70 Here you can find the Minute of the meeting in PDF format Prepare minute of the meeting (5)

71 Renewal of the study after IRB approval Makerere SHS IRB Platform Demo

72 Home Page – Access to studies reviewed by IRB

73 List of approved studies Choose the study, clicking on pencil icon

74 Renewal

75 Renewal

76 Renewal (1)

77 Renewal (2) you can upload a file

78 Renewal (3) you can upload a file

79 Renewal

80 Renewal documentation (1) you can upload a file

81 Renewal Click here to send the renewal request. New forms will be dispayed after sending.

82 Renewal

83 Renewal – IRB Administrator review checklist (1)

84 Renewal – IRB Administrator review checklist (2)

85 Renewal

86 Renewal - Decision

87 Once the previous Renewal has been completed, a new Renewal section is available New Renewal

88 SAE and Amendments SAE and AMENDMENTS sections

89 SAE - Serious adverse event reporting (1)

90 SAE - Serious adverse event reporting (2)

91 SAE - Serious adverse event reporting (3)

92 To add other SAE click on “Add a new form” SAE - Serious adverse event reporting (4)

93 Amendments In this section you can ask for amendments

94 Amendments - Request of a new amendment (1)

95 Amendments - Request of a new amendment (3)

96 Amendments - Request of a new amendment (3) If you need to change information, click on “Study data”

97 Amendments - Update study data (2)

98 Amendments - Update study data (3) Click on the pencil to modify data

99 Amendments - Update study data (4)

100 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

101 Amendments IRB Administrator Review (1)

102 if data are incomplete you can ask for an integration Amendments IRB Administrator Review (2)

103 Amendments IRB Administrator Review (3) if data are incomplete you can ask for an integration

104 Amendments – IRB opinion (1)

105 Amendments – IRB opinion (2)

106 Final Report

107 Final Report

108 Final Report