SSDataProtection object

No

No

Confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a volunteer's identity.

The confidentiality of records that could identify volunteers should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements.

The monitors, auditors, the Ethics committee, Turkey Pharmaceuticals and Medical Device Agency and the other relevant health authorities will have direct access to the original medical records of the volunteer, but such information will be kept confidential.

Pursuant to the applicable regulation requirements, the records directly identifying the volunteer will be kept confidential, they will not publicly disclosed and the identity of the volunteer will be still kept confidential even if results of the trial are published (Guideline for Good Clinical Practice 2014).

Medical device clinical trials including observational medical device studies shall be registered into a public database with due regard for the rules of privacy of personal data (Regulation On Medical Device Clinical Trials 2014).