Unscheduled Visits. Estimated [NUMBER] unscheduled visits per site will be provided for at a rate of €[AMOUNT] per each unscheduled visit.
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 by Sponsor/Greenphire from Institution... Poplatok za začatie štúdie: Jednorazová nevratná platba za činnosti spojené so začatím štúdie bude inštitúcii splatná vo výške stanovenej v rozpočte po potvrdení súhlasu IRB / ES, úplnom vykonaní dohody a dokončení. akýchkoľvek požiadaviek na predštudovanie, ako sú špecifikované sponzorom alebo PPD Study Start-up Fee: A one-time non- refundable payment for Study start-up activities will be payable at the rate set forth in the budget to the Institution upon confirmation of IRB/EC approval, full execution of the Agreement, and completion of any pre-Study requirements as specified by Sponsor or PPD Skladovanie a archivácia záznamov: Inštitúcii sa bude platiť jednorazový poplatok za uloženie a archiváciu záznamov vo výške stanovenej v rozpočte na účely dosiahnutia súladu s touto dohodou. Inštitúcii bude tento poplatok zaplatený po vykonaní tejto dohody, potvrdení zasadnutia a schválenia IRB / EC a splnení požiadaviek pred štúdiou, ako ich špecifikuje sponzor alebo PPD. Record Storage and Archiving: A one-time record storage and archiving fee will be paid to the Institution at the rate set forth in the budget for purposes of compliance with this Agreement. Institution will be paid this fee upon execution of this Agreement, confirmation of IRB/EC meeting and approval, and completion of pre-Study requirements as specified by Sponsor or PPD. Poplatok za preskúmanie náboru: Jednorazová platba za aktivity spojené s kontrolou pred náborom bude inštitúcii splatná vo výške stanovenej v rozpočte po prijatí správnej a podrobnej faktúry od sponzora / Greenphire od inštitúcie. Chart Review Recruitment Fee: A one-time payment for pre-enrollment chart review activities will be payable to the Institution at the rate set forth in the budget upon receipt of correct and itemized invoice by Sponsor/Greenphire from Institution. Poplatky centrálnemu laboratóriu: Za náklady Centrálneho laboratória zodpovedá zadávateľ a zadávateľ bude tieto náklady hradiť nezávisle Central Laboratory Fees: Central Laboratory costs are the responsibility of the Sponsor and will be paid by the Sponsor apart from this od tejto zmluvy. Agreement.
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. 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 condition or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) In addition, all procedures for Visit 5 (Follow-up/Exit) should be completed (as possible). 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. 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. 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: Platby za ďalšie návštevy alebo postupy, ktoré nie sú plánované, sa budú uhrá- dzať od prípadu k prípadu na základe predchádzajú- ceho písomného povolenia od zadávateľa/CRO. Na úhradu povolených neplánovaných návštev xx xxxxx predložiť faktúry. Start-up Costs: Start up costs up to 60€ shall be paid following shipment of Investigational Product. Start-up fees are 50% refundable for failing to enroll an eligible subject into the study within six (6) month of initiation. This sum comprises all payments due in connection with the start up of the Study, including but not limited to: Administrative Start up, Regulatory preparation, Pharmacy set up fee, Storage fee, and Recruitment planning, etc… Počiatočné náklady: Po dodávke skúšaného produk- tu sa vyplatia počiatočné náklady do výšky 60€. 50 % počiatočnej platby je potrebné vrátiť v prípade, že do šiestich 6 mesiacov od začiatku skúšania sa do skúšania nezaradí žiadny subjekt, spĺňajúci podmien- ky. Táto suma zahŕňa všetky platby splatné v súvislosti so začiatkom skúšania, xxxxx: počiatoč- né administratívne náklady, náklady na prípravu podkladov pre kontrolné úrady, poplatky za zriadenie lekárne skúšania, poplatky za uchovávanie, plánova- nie náboru, atď. Ethics Committee Fees shall be reimbursed on receipt of an invoice. Poplatky etickým komisiám sa budú uhrádzať po prevzatí faktúry. PAYEE INFORMATION ÚDAJE PRÍJEMCU PLATIEB Payment under this Agreement shall be made payable to: Platby podľa tejto zmluvy majú byť splatné nasledu- júcemu príjemcovi platieb: Payee (Institution): / Príjemca platieb (inštitúcia) Ad- resa: Fakultna nemocnica s poliklinikou X. X. Xxxxxxxxxx Banska Bystrica Address: /: Xxxxxxxx X. Xxxxxxx 0, 000 00 Xxxxxx Xxxxxxxx, Xxxxxx Xxxxxxxx Payee Contact Name: /Meno kontaktnej osoby prí- jemcu platieb: na Telephone Number: /Telefónne xxxxx: na VAT Registration Number (if applicable): / IČ DPH Organisation Identification No.: 165549 Tax Identification No.: 2021095670 (ak sa vzťahuje): VAT ID: SK2021095670 DETAILS FOR PAYMENT BY BANK TRANSFER ÚDAJE PRE PLATBU BANKOVÝM XXXXX- DOM Account holder: /Majiteľ účtu: Fakultna nemocnica s poliklinikou F. D. Xxxxxxxx- xx Banska Bystrica Account No.: /Xxxxx účtu: XX00 0000 0000 0000 0000 0000 Bank: /N...
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 • Collect device deficiency information • Record changes in medical condition or concomitant medication • Perform a biomicroscopy • VA w/study lenses (OD, OS, logMAR distance) 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 IP or discontinuing from the study, the investigator must conduct Exit procedures according to Table 3–1 Schedule of Study Procedures and Assessments and Section 10.4.3, as possible.
Unscheduled Visits. Payment for unscheduled visits will be reimbursed in the amount of 56 EUROS to the Institution and in the amount of 168 EUROS to the Investigator. 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. pomerným spôsobom podľa počtu potvrdených absolvovaných návštev.
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.
