The DVT - India registry protocol does not require the transmission of unique subject identifiers to the registry. However, as the participating physicians will be consulting at multiple sites and maintaining a local register for enrolled subjects across various clinics is difficult and cumbersome, the registry will capture subject identifiers for the convenience of the physicians. These subject identifiers (First Name, Middle Name, Last Name and Date of Birth) will be visible only to the treating physician and his/her study coordinators. The sponsor, the Scientific Advisory Committee and Admin will not be able to view the same. Thus, a high degree of subject confidentiality shall be ensured by the study design.

Depending on the type of diagnosis, subject contact may not be required to gather data for this study. However, if subject contact is necessary, it will be unobtrusive and limited to a brief interview either during a regularly scheduled clinic visit or via telephone.

While the sponsor, Ranbaxy Ortholands, will have access to the names of physicians participating in this project, they will not have to access individual hospital, physician, or subject outcome data or to subject identities.

Physicians should inform their hospital’s ethics committee of their intention to participate in this registry. As dictated by hospital policy, it may be necessary to submit documentation for approval to participate.

Subjects will not undergo any interventions as part of this study. However, depending on the requirements of individual hospital ethics review committees, informed consent may be required for study subjects, based on the right of subjects to approve of the use of their confidential medical data in a research study. Typically, this may involve identifying potential study subjects while hospitalized and obtaining their consent for post-discharge contact. Some ethics committees may allow subjects to be contacted by telephone or letter following hospital discharge without receiving prior consent.

This protocol will not capture any hospital-specific confidential data. All confidential electronic data will be protected by a password and all paper copies of data and reports will be stored in a secure facility.

Any requests for registry specific data from nonparticipating physicians and other third parties will be forwarded to the Scientific Advisory Committee for due consideration and action.

Specific security checks include the following:

• BioQuest Solutions will act as a coordinating center and as also the agency responsible for the design and management of the website (Admin). It will not have any access to physician - specific data.  No subject identifiers will be accessible to the company. Also the usernames and passwords of participating physicians will not be visible to the company.
• Site names and addresses will be available to BioQuest. These will be used only for administrative purposes – to send trend reports, reminders etc. All subjects will be identified for the purposes of data analysis and management by unique, computer generated codes, which will also be visible to the treating physicians.
• Where required by the hospital ethics committee, all study subjects will be informed that information about them is being entered into the DVT - India registry database. Subjects will be told that they are free to refuse answering follow-up questions without affecting their medical care. They are told that all study findings will be handled in strictest confidence.
• Individual hospitals have the right to require local ethics committee review of this research. Thus, investigators are responsible for notifying their local hospital research ethics review committee of their intention to enroll subjects and, where required, obtaining all required permissions prior to enrolling subjects.