| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 23.02.2014 09:04:47 |
| Modified: | 27.02.2018 10:50:59 |
| Advanced : | |
| Appears In: | 7.2.1 Ermittlung der Anforderungen bezüglich des Produkts, CA_Clinical Affairs, Do / update clinical evaluation, Prepare and apply for clinical study, 7.2.1 Determination of requirements related to the product, 7.3.2 Design and development inputs |
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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
- «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
- Prepare and apply for clinical study
«Activity» Apply for clinicial study- «Activity» Create CRF
- «Activity» Create clinical investigation plan (CIP)
- «Activity» Create ethic commission votum application file
- «Activity» Create patient consense form
- «Activity» Define and proof of evidence of clincial investigator qualification and clinical investigation site
- «Activity» Define primary and secondary clinical endpoints
- «Activity» Define study design
- «Activity» Determine actual benefit risk consideration
- «Activity» Evaluate potential safety risks
- «Activity» Get ethic commission votum
- «Activity» Implement data monitoring committee
- «Activity» Implement monitor
- «Activity» Provide contract between sponsor and monitor
- «Activity» Provide contract between sponsor and principal investigator
- «Activity» Provide patient insurance
- «Activity» Substantiate need to perform the clinical study
«EndEvent» Attempt for clinical study abandoned
«StartEvent» Generate new clinical data- «EndEvent» Preparation for execution of clinical study finished
«Gateway» Clinical study accepted by ethics commission?- «Gateway» Clinical study approved
- «Gateway» High safety risks concerning the product?
- 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