| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 19.05.2014 10:38:01 |
| Modified: | 27.02.2018 10:51:37 |
| Advanced : | |
| Appears In: | Manage clinical study, CA_Clinical Affairs, Do / update clinical evaluation |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
- Clinical Marketing
Clinical Marketing- CA_Clinical Affairs
- CA_Clinical Affairs
«BusinessProcess» Appraisal of individual data sets
«BusinessProcess» Do clinical study forecast- «BusinessProcess» Manage clinical study
- Manage clinical study
«Activity» Create clinical investigator brochure- «Activity» Create final report
- «Activity» Generate list of deviations and constraints
- «Activity» Identify medical device for use in a clinical study only
- «Activity» Inform NCA about ending of clinical study
- «Activity» Introduce clinical staff
- «Activity» Perform clinical study site audit
- «Activity» Perform regular monitoring audit
- «Activity» Update monitoring report
«StartEvent» Authorization for clincical study achieved
«EndEvent» Clinical study finshed
«IntermediateEvent» Deviations closed by Clinical Investigator- «IntermediateEvent» Regular monitoring
«Gateway» Audit passed?- «BPMN2.0::Gateway» Create constraints
- «Gateway» Study in compliance with CIP ?
- «BusinessProcess» Perform clinical study based on CIP
- «BusinessProcess» Do AE surveillance
- «BusinessProcess» Do / update clinical evaluation
- «BusinessProcess» Apply for clinical validation
- «BusinessProcess» Prepare and apply for clinical study
- CAM_Clinical Application Management
- MC_Marketing & Communications
- PM_Product Management
- TW_Technical Writing
- «BusinessProcess» Manage compentencies CM
- «BusinessProcess» Manage tools and equipment CM
- «BusinessProcess» Plan resources and budget CM
- «BusinessProcess» Report CM
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox