Common use of Unmasking of the Study Treatment Clause in Contracts

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study. If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study. If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device study product should not be disclosed during the studystudy (See Section 9.4). If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the studystudy (See Section 9.4 for details on the masking procedure). If the treatment code needs to be broken in the interest of subject safety, the Investigator investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (iei.e., medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the studystudy (see Section 9.4). If the treatment code needs to be broken in the interest of subject safety, the Investigator investigator is encouraged to contact an appropriate Study Sponsor study sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (iei.e., medical emergency), the code may be broken prior to contact with the Study Sponsorstudy sponsor. The Study Sponsor study sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor study sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study. study (see Section 9.2) If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, medical emergency), the code may be broken prior to contact with the Study study Sponsor. The Study study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study study Sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study. If In the event of a medical emergency where the knowledge of subject treatment is required, individual investigator(s) will have the ability to unmask the treatment code needs to be broken in the interest of subject safetyassignment for a specific subject. If time allows, the Investigator is encouraged to contact an appropriate Study Sponsor study sponsor representative should be contacted prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, medical emergency), the code may be broken prior to contact with the Study Sponsorunmasking. The Study Sponsor study sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor study sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the studystudy (refer to Section 9.4). If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study. If the treatment code needs to be broken in the interest of subject safety, the Investigator investigator is encouraged to contact an appropriate Study Sponsor study sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, i.e. medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.

Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the studystudy (see Section 9.4). If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (iei.e., medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting requirements.