OMEVAC
From EpiHandy
NOTE! The information on this page is outdated and only remains as a historical document.
Please go to http://www.openxdata.org/Main/OMEVAC
With OMEVAC we aim to improve quality and cost-effectiveness of vaccine trial sites and epidemiological studies through transfer of technology
OMEVAC consortium has extensive experience in conducting clinical trials, mobile data collection, managing, publishing and protecting research data and developing software suitable for the context and challenges found in low-income countries.
New 4 year international and interdisciplinary research and development project funded by Norwegian Research Council. Approx 1.5mill USD (10mill NOK).
Develop a complete secure electronic system for data collection and management in vaccine trials,
Handle data from source to publication using mobile devices
Comply to international standards and regulations of clinical trials – i.e.FDA 21 CRF Part 11, GCP and other EU regulation on electronic records and electronic signatures for usage in Clinical Trials.
Key elements:
- Audit Trails
- Electronic Signatures
- Security and storage of data (field/record encryption)
- Handling of eSourceDocuments (eCRF’s)
Adherance on standards in clinical trials data management.
Open source project leveraging EpiHandy, JavaROSA, OpenClinica and other opensource solutions