Documents
Protocol
Below, you will find the HVS Mitral Tricuspid Valve Database Protocol, which can be customized and submitted to the ethics committee of your institution.
Data collection
The data of the HVS Mitral Tricuspid Valve Database is collected via an online CRF (accessible via Castor EDC). To facilitate the data collection, the paper case report form (CRF) can be downloaded below which can be used in the clinic/OR. Afterwards, the data can be transmitted to the online database. The data dictionary contains an in-depth description of all variables included in the database.
Joint Data Registry Agreement (JDRA)
To join the HVS Mitral Tricuspid Valve database, each center must sign the Joint Data Registry Agreement (JDRA).
Informed Consent
This informed consent template is designed to assist institutions in obtaining informed consent from participants in the database. You can customize it to align with the specific requirements of your local institutional context.
Project Application Form
Centers can propose a project that enrolls a specific patient group within mitral and/or tricuspid valve disease. This project application form should be completed and submitted to the Scientific Committee for approval. Please send the document to mitralvalvedatbase@heartvalvesociety.org.
Castor EDC Handbook
The Castor EDC Handbook is designed for participating centers to guide them though data entry process and navigation in the HVS Mitral Tricuspid Valve Database in Castor EDC.
Other documents and agreements
For manuals pertaining to Castor EDC and other requirements, please reach out to mitralvalvedatabase@heartvalvesociety.org.