Examples of Study Sponsor in a sentence
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of seriousness and/or causality.
The Investigator should provide the Study Sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device.
An assessment of causality will also be performed by Study Sponsor utilizing the same definitions, as shown below: Causality Related An AE classified as related may be either definitely related or possibly related where a direct cause and effect relationship with the medical device or study procedure has not been demonstrated, but there is a reasonable possibility that the AE was caused by the medical device or study procedure.
The Study Sponsor will notify the Investigator of any AEs that are upgraded from non-serious to serious or from unrelated to related.
The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved.
If the Sponsor payment information changes during the Study, Sponsor is responsible for informing Payee, with ongoing payments not to be unreasonable withheld.
For performance of the Study Sponsor will compensate the Institution for each enrolled Subject treated in accordance with the Protocol, on a pro-rata basis, see Table below.
Site monitors are appointed by the Study Sponsor and are independent of study site staff.
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.
Agreements made by the Study Sponsor with the Investigator/Institution and any other parties involved in the clinical study will be provided in writing as part of the protocol or as a separate agreement.