Unscheduled Visits. An Unscheduled Visit is defined as a Study Subjects visit which is not expressly set forth in the Protocol, but is otherwise required for the Study. Unscheduled Visits will be reimbursed in the amount set forth in the budget table below upon receipt of a correct and itemized invoice. Revízia záznamov, poplatok za nábor: Príjemcovi platieb bude vyplatená suma za snahu študijného koordinátora týkajúca sa výkonu detailnej revízie pacientskych záznamov. Príjemcovi platieb bude vyplatená suma vo výške podľa rozpočtu a na základe doručenia správnej faktúry s rozpisom položiek. Chart Review Recruitment Fee: Payee will receive payment for study coordinator efforts related to performing a thorough review of patient charts. Payee will be reimbursed at the rate set forth in the budget and will be paid upon the receipt of a correct and itemized invoice by PPD. Non-IMP: zadávateľ môže podľa vlastného uváženia priamo alebo prostredníctvom PPD preplatiť hlavnému skúšajúcemu obstaranie non- IMP pre klinické skúšanie. Po ukončení klinického skúšania alebo predčasnom ukončení klinického skúšania má zadávateľ právo rozhodnúť, či zvyšné non-INP budú zadávateľovi vrátené alebo nie. Platby sa uskutočnia po prijatí nesporných faktúr a podpornej dokumentácie. Non-IMP: Sponsor, at its reasonable discretion, directly or through PPD, may reimburse Investigator for procuring non-IMP for the Study. Upon completion of the Study or early termination of the Study, Sponsor shall have the right to decide whether any remaining non-IMP is returned to Sponsor or not. Payments will be made upon receipt of undisputed invoices and supporting documentation. Zabezpečenie vybavenia: Zdravotníckemu zariadeniu môže byť poskytnuté vybavenie na použitie v klinickom skúšaní v súlade s Protokolom. Pokaľ to bude vyžadovať zadávateľ a/alebo PPD bude toto vybavenie po ukončení klinického skúšania vrátené zdravotníckym zariadením. Equipment Allocation: Equipment may be provided to the Institution for use, in accordance with the Protocol, for this Study. If requested by PPD and/or Sponsor, such equipment shall be returned by the Institution at the completion of the Study. Etická komisia: Odmenu etickej komisii hradí PPD nezávisle od tejto zmluvy. Ethics Committee: The Ethics Committee fee will be paid by PPD apart from this Agreement.
Unscheduled Visits. Estimated [NUMBER] unscheduled visits per site will be provided for at a rate of €[AMOUNT] per each unscheduled visit.
Unscheduled Visits. In the case of unscheduled visits with bargaining unit members, the union representative shall give notice upon arrival in accordance with local procedures.
Unscheduled Visits. An Unscheduled Visit means a subject visit which is not expressly set forth in the Protocol, but is related to an adverse event experienced during the Study or otherwise required for the Study as directed by the Investigator. Unscheduled Visits will be reimbursed in accordance with the rates set forth in the Budget. 9.
Unscheduled Visits. Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject requires an Unscheduled Visit, he/she must be advised to return to the office wearing the study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must conduct the following procedures: • Collect AE and Device Deficiency information • Assess and record changes in medical health or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) In addition, refer to Table 1-1 Unscheduled Visit for required procedures. The Investigator may perform additional procedures for proper diagnosis and treatment of the subject. The Investigator must document this information in the subject’s case history source documents. If during an Unscheduled Visit the subject is discontinuing the study lenses or discontinuing from the study, the Investigator must conduct Exit procedures according to Table 1-1: Schedule of Study Procedures and Assessments, as possible.
Unscheduled Visits. Payment for unscheduled visits will be reimbursed in the amount of EUROS to the Institution. To be eligible for reimbursement for unscheduled visits, completed CRF pages must be submitted to IQVIA along with any additional information which may be requested by IQVIA to appropriately document the unscheduled visit.
Unscheduled Visits. If a subject visit occurs between any regularly scheduled visit and the visit is conducted by study personnel, this visit must be documented as an Unscheduled Visit. If the subject seeks medical attention outside the clinic (for example, at an Emergency Room) or at the clinic but is seen by nonstudy personnel, the investigator is to capture adverse event-related information on the Adverse Event form upon becoming aware. During all unscheduled visits, the investigator must conduct the following procedures: • Collect Adverse Event information • Record changes in medical condition or concomitant medication • Collect device deficiency information • Biomicroscopy The investigator may perform additional procedures for proper diagnosis and treatment of the subject according to Table 3-1 or at their discretion. The investigator must document this information in the subject’s case history source documents. If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the study, the investigator must conduct Exit procedures according to Table 3-1 Schedule of Study Procedures and Assessments, as possible.
Unscheduled Visits. An Unscheduled Visit means a subject visit which is not expressly set forth in the Protocol, but is related to an adverse event experienced during the Study or otherwise required for the Study as directed by the Investigator. Unscheduled Visits will be reimbursed in accordance with the rates set forth in the Budget. 10. Neplánované návštěvy. Neplánovaná návštěva znamená návštěvu subjektu, která není výslovně stanovena protokolem, ale souvisí s nežádoucí příhodou, ke které došlo během studie nebo která byla jinak ve studii vyžadována podle rozhodnutí zkoušejícího. Náhrada za neplánované návštěvy bude proplácena v souladu se sazbami stanovenými v rozpočtu.
Unscheduled Visits. For additional visits or procedures that are unscheduled, payment shall be made on a case-by-case basis, upon prior written authorization from Sponsor / CRO. Invoices for authorized unscheduled visits must be provided for reimbursement. Neplánované návštevy: Pri ďalších návštevách alebo vyšetreniach, ktoré sú neplánované, sa platba vykoná od prípadu k prípadu, na základe predchádzajúceho písomného súhlasu zadávateľa / CRO. Faktúry za povolené neplánované návštevy musia byť poskytnuté na úhradu.
Unscheduled Visits. C. NEPLÁNOVANÉ NÁVŠTĚVY: CRO will pay INSTITUTION for unscheduled visits required by the PROTOCOL and performed at said visit as documented by completed and submitted CRF pages and any additional information that CRO and/or SPONSOR may request to appropriately document the procedures performed. Once the completed CRF and any additional information which may be requested by CRO and/or SPONSOR to appropriately document the procedures performed for the unscheduled visit have been received and accepted by CRO and/or SPONSOR, payment for the unscheduled visit will be included in the scheduled payment. CRO bude platit POSKYTOVATELI za neplánované návštěvy podle postupů vyžadovaných PROTOKOLEM a provedených při takové návštěvě, jak bude zdokumentováno na vyplněných a předložených stránkách CRF a jakýchkoliv dodatečných informacích, které může CRO a/nebo ZADAVATEL vyžadovat pro náležitou dokumentaci provedených postupů. Jakmile budou vyplněné formuláře CRF a jakékoliv dodatečné informace, které může CRO a/nebo ZADAVATEL vyžadovat pro náležitou dokumentaci provedených postupů při neplánované návštěvě, obdrženy a přijaty CRO a/nebo ZADAVATELEM, bude platba za neplánované návštěvy zahrnuta do plánované čtvrtletní platby.
