Device Registry

Please read this consent carefully

Informed Consent

Southern Implants would like to formally record and collect data on your dental implant treatment. The data collected will involve the review and reporting of your dental and medical history associated with your dental treatment. This includes recording of your surgery, restoration and monthly and/or yearly contact from the treating clinician/Southern Implants.

The only known risk associated with recording your data is confidentiality. The personal information recorded from your treatment includes full name, date of birth, gender, email address and contact number. The personal identifiable information that might be collected about you will solely be used for research or operational purposes, such as:

    1. to send you an email with a link to a questionnaire that you have to complete or
    2. to send you a text message to your personal mobile number with a link to a questionnaire you have to complete.
Informed Consent continued (click to expand)

The collection and processing of your information is done using a software solution called SMART-TRIAL. All data in SMART-TRIAL is collected, transferred, and stored encrypted in databases, that are hosted on ISO certified servers, that are managed by SMART-TRIAL within the European Union (Ireland and the Netherlands). Click here for more details on the security of SMART-TRIAL. Southern Implants entered a contractual agreement with SMART-TRIAL which clarifies how SMART-TRIAL complies with regulatory requirements for processing of your information according to applicable regulations, such as the EU GDPR.

The data collected may be shared with regulatory agencies, ethics committees and medical professions, to ensure monitoring and compliance with medical devices regulations. If the data is shared, it will be anonymized i.e., your identifiable personal information will be omitted from the data reports and presented in accordance with the relevant protection of personal information acts.

The permission to collect your dental surgery and restoration data will not end unless you cancel it. You may cancel it by sending a written notice to your treating clinician or Southern Implants. Information collected before you withdraw may still be used. You can request access to your data or information on how your data is being processed by contacting Southern Implants.

Southern Implants Research Contact Details:

Contact person(s):   Tamsin Cracknell or Kirosha Ramdan
Email address:          research@southernimplants.com
Contact number:     +27 12 667 1708

There is no direct benefit to you, either than the predetermined dental treatment discussed with the treating clinician. However, other people may benefit from the data collected from your treatment. Your alternative to participating, is to not participate. There is no cost for you to participate and you will not be paid to participate in the on-going data collection.

Your decision to participate is voluntary. You will not be penalized or lose predetermined clinical treatment if you decide to not participate.

The clinician or Southern Implants may terminate your on-going participation without your consent for any reason, including if it is in your best interest and if you do not consent to any changes associated with the data collection.

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