Document

About Bella

Release history
Version 2.00 is released on 2020-10-26
Benefits
Bella EDC is a software as a service application so no software installation is required and accessible anytime, anywhere.
Bella EDC is compliant with industry regulations such as GAMP5 and 21 CFR Part 11.
Bella EDC supports CDISC Standards to create a study easily, quickly, and efficiently. It also provides complete traceability and improved data quality.

Contact

System design & development
Hyeongwon Seo, PhD

Lead Software Engineer
Biostatistics and Data Management department
Epidemiology, Public Health, Impact, Clinical Development unit
International Vaccine Institute

Please contact hyeongwon.seo@ivi.int     for any technical difficulties and questions.

Abbreviations

Abbreviation Explanation
IVI International Vaccine Institute
CRF Case Report Form

Assumptions & Constraints

Assumptions
  • A.
  • B.
Constraints
  • A.
  • B.
  • C.

Requirements

For the best experience and compatibility, we highly recommend you installing the latest version of Google Chrome.

User roles & Permissions

User roles defined in Bella EDC are grouped based on organizations and represented as follows:

IVI: User Administrator, Study Creator (IVI Data Manager), Study Medical Monitor, Clinical Operations, Biostatistician, Quality Management, Clinical Research Lab

SITE: Principal Investigator, Sub Investigator, Site Coordinator, Site Data Encoder, Site Data Manager

CRO: CRA, Safety Specialist

OTHERS: Auditor, Guest, Coder

Roles
Responsible for creating and managing Study Creators accounts for a study and has read-only access to study data.
Performs study build activities (configure study parameters), has read-only access to the study data, manages user roles, requests study closure, exports entered raw e-CRF data in Excel format, generates PDF reports (based on entered e-CRF data and query status) and opens manual queries, reviews e-CRF data, reviews queries, requests and finalizes DB lock, downloads audit log report, and generates subject data in PDF format for archive.
Responsible for reviewing and confirming SAEs, has read-only access to the study data, opens manual queries.
Responsible for monitoring e-CRFs data, has read-only access to the study data, reviews source data, opens manual queries, performs SDV to verify whether the data entry is complete, downloads data audit log report.
Responsible for analysis of clinical data to ensure logic, consistency and protocol compliance, has read-only access to the study data, exports entered raw e-CRF data in Excel format, generates PDF reports (based on entered e-CRF data and query status), opens manual queries, and performs e-signature for DB lock.
Has read-only access to the study data, downloads audit log report, performs e-signature for DB lock.
Responsible for uploading immunogenicity lab data into EDC, performing e-signature.
Responsible for enrolling subjects into EDC, performs data entry on the e-CRFs, reads and responds to open queries, exports entered raw e-CRF data in Excel format, inactivates/reactivates subjects with e-signature & comments, confirms DB lock with e-signature & comments, submits SAE, and uploads SAE-related documents.
Responsible for enrolling subjects into EDC, performs data entry on the e-CRFs, reads and responds to open queries, exports entered raw e-CRF data in Excel format, inactivates/reactivates subjects with e-signature & comments, submits SAE, and uploads SAE-related documents.
Responsible for checking data quality, enrolls subjects into EDC, performs data entry on the e-CRFs, reads and responds to open queries, and inactivates/reactivates subjects with e-signature & comments.
Responsible for checking data quality, enrolls subjects into EDC, performs data entry on the e-CRFs, reads and responds to open queries.
Enrolls subjects into EDC; performs data entry on the e-CRFs, reads and responds to open queries.
Responsible for monitoring e-CRF data, reviews e-CRF, opens and closes manual queries, performs SDV to verify whether the data entry is complete. Has read-only access to the study data and verifies data when the review is complete.
Have read-only access to the study data; reviews and confirms SAE and CIOMS reports, opens and closes manual queries (SAE only).
Have read-only access to the study data including audit trails, downloads audit log report.
Read-only access to demo study only.
Responsible for coding all medical terms as per the approved Medical Dictionaries and following the appropriate coding conventions, opens manual queries.
Permissions

* UA User Administrator, SCR Study Creator, SMM Study Medical Monitor, CO Clinical Operations, BST Biostatistician, QM Quality Management, CLR Clinical Research Lab, PI Principal Investigator, SI Sub Investigator, SCD Site Coordinator, SDM Site Data Manager, SDE Site Data Encoder, CRA Clinical Research Associate, SS Safety Specialist, ADT Auditor, GST Guest, CDR Coder

Object Activities UA SCR SMM CO BST QM CRL PI SI SCD SDM SDE CRA SS ADT GST CDR
e-CRF Entry / Edit X X X X X
Inactivate / Reactivate X X
Export X X X X X
Review X X
SDV X X
Confirm / e-signature X X
Lab Upload X
Download X X X
Query Open X X X X X X X
Respond X X X X X
Close X X X X X X X
Review X X X X X X X X X
User Role assign X X X X X
PWD reset X X

How to sign-up/-in

How to sign-up
Press the button 'Sign Up' at the login page (Fig.1) to access the sign-up form.

Fig.1 - Sign In page
Fill out your email address, first name, last name, and organization name with several personalized questions.

Fig.2 - Registration form

When you successfully submit the data you entered, you will see the message and get an activation email.

Fig.3 - Successful message

How to build a study

Benefits
Bella EDC is compliant with industry regulations such as GAMP5 and FDA 21 CRF Part 11.
Bella EDC supports CDISC Standards to create a study easily, quickly, and efficiently. It also provides complete traceability and improved data quality.
2020 © International Vaccine Institute
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