Common use of PER SUBJECT FEE Clause in Contracts

PER SUBJECT FEE. 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. For screen failure Subjects the Institution will be paid the same fee as the Screening visit fee. For Subjects who are withdrawn before the end of the Study, compensation will be provided on a pro-rata basis on completion of assessments and visits as follows from the specification below. Compensation will be given for extra (unscheduled) visits that occur as a result of adverse events that occur during the Study. The compensation will be according to table below. No financial compensation will be given for Subjects, who, within Principal Investigator’s control, are incorrectly included according to the inclusion and/or exclusion criteria or “lost to follow-up”. Payments for Subject visits will be made as follows: Screening NOK Visit 1 NOK Visit 3 NOK Visit x NOK Unscheduled visit NOK SAE NOK Payments for protocol procedures that are not included in the per visit payment will be made as follows: Procedure X NOK Procedure Y NOK National Coordinator fee [If applicable:] As Dr. [PI] is the National Coordinator for the Study, there will be a fee of NOK [X] for contact with EC regarding initial and amendment applications for the Study. The National Coordinator will also have contact with EC regarding safety issues during the Study, and be the support for the conduct of the Study. Sponsor will pay NOK [5.444] for extra work in relation to any Protocol amendments that require any EC submissions during the Study. Such submissions include i.e. review and input to amendment, submission to EC and implementation of the amendment. The Public Patient Travel Reimbursement “Pasientreiser” (xxxxx://xxxxxxxxxxxxx.xx/), within its limitations should, as the first instance, be used for reimbursement of Subjects’ travel expenses. Compensation will be paid by Sponsor for any reasonable expenses not covered by Pasientreiser when travelling by e.g. public transport (taxi, ferry, train, plane etc.) or by own car (reimbursement rates as defined in “Xxxxxxxxxx.xx”) or when hotel accommodation and refund of expenses for accompanying persons is needed. Sponsor will cover costs incurred by the Subjects, as described above, upon receipt of proper invoice from the Institution. The Payee shall invoice Sponsor based on documentation obtained by the Institution from the Subjects. The invoice to Sponsor must be blinded in regards to the Subjects’ personal information, but the invoice must contain Subject number and which visits to be refunded. The Payee is responsible for reporting remuneration to Norwegian authorities. Payee will forward these costs to Sponsor as pass-through costs, without revealing Subject identity. If any taxes apply, payee will add these to invoices, to be paid by Sponsor. Sponsor shall be entitled to inspect any further documentation supporting study subject costs, as deemed necessary by Sponsor.

Appears in 2 contracts

Samples: Clinical Trial Agreement, Clinical Trial Agreement

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PER SUBJECT FEE. 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. For screen failure Subjects the Institution will be paid the same fee as the Screening visit fee. For Subjects who are withdrawn before the end of the Study, compensation will be provided on a pro-rata basis on completion of assessments and visits as follows from the specification below. Compensation will be given for extra (unscheduled) visits that occur as a result of adverse events that occur during the Study. The compensation will be according to table below. No financial compensation will be given for Subjects, who, within Principal Investigator’s control, are incorrectly included according to the inclusion and/or exclusion criteria or “lost to follow-up”. Payments for Subject visits will be made as follows: Screening NOK Visit 1 NOK Visit 3 NOK Visit x NOK Unscheduled visit NOK SAE NOK Payments for protocol procedures that are not included in the per visit payment will be made as follows: Procedure X NOK Procedure Y NOK National Coordinator fee [If applicable:] (if applicable) As Dr. [PI] dr. [PI] is the National Coordinator for the Study, there will be a fee of NOK [X] X for contact with EC regarding initial and amendment applications for the Study. The National Coordinator will also have contact with EC regarding safety issues during the Study, and be the support for the conduct of the Study. Sponsor will pay NOK [5.444] for extra work in relation to any Protocol amendments that require any EC submissions during the Study. Such submissions include i.e. review and input to amendment, submission to EC and implementation of the amendment. The Public Patient Travel Reimbursement “Pasientreiser” (xxxxx://xxxxxxxxxxxxx.xx/), within its limitations should, as the first instance, be used for reimbursement of Subjects’ travel expenses. Compensation will be paid by Sponsor for any reasonable expenses not covered by Pasientreiser when travelling by e.g. public transport (taxi, ferry, train, plane etc.) or by own car (reimbursement rates as defined in “Xxxxxxxxxx.xx”) or when hotel accommodation and refund of expenses for accompanying persons is needed. Sponsor will cover costs incurred by the Subjects, as described above, upon receipt of proper invoice from the Institution. The Payee shall invoice Sponsor based on documentation obtained by the Institution from the Subjects. The invoice to Sponsor must be blinded in regards to the Subjects’ personal information, but the invoice must contain Subject number and which visits to be refunded. The Payee is responsible for reporting remuneration to Norwegian authorities. Payee will forward these costs to Sponsor as pass-through costs, without revealing Subject identity. If any taxes apply, payee will add these to invoices, to be paid by Sponsor. Sponsor shall be entitled to inspect any further documentation supporting study subject costs, as deemed necessary by Sponsor.

Appears in 1 contract

Samples: Clinical Study Agreement

PER SUBJECT FEE. 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. For screen failure Subjects the Institution will be paid the same fee as the Screening visit fee. For Subjects who are withdrawn before the end of the Study, compensation will be provided on a pro-rata basis on completion of assessments and visits as follows from the specification below. Compensation will be given for extra (unscheduled) visits that occur as a result of adverse events that occur during the Study. The compensation will be according to table below. No financial compensation will be given for Subjects, who, within Principal Investigator’s control, are incorrectly included according to the inclusion and/or exclusion criteria or “lost to follow-up”. Payments for Subject visits will be made as follows: Screening NOK Visit 1 NOK Visit 3 NOK Visit x NOK Unscheduled visit NOK SAE NOK Payments for protocol procedures that are not included in the per visit payment will be made as follows: Procedure X NOK Procedure Y NOK National Coordinator Informed Consent form (“ICF”) Review fee [If applicable:] As Dr. [PI] is will review the National Coordinator for the StudyICF, there will be a fee of NOK [X] for contact with EC regarding initial and amendment applications for the Study. The National Coordinator will also have contact with EC regarding safety issues during the Study, and be the support for the conduct of the Studythis additional support. Sponsor will pay NOK [5.444] 6.650 for extra work in relation to any Protocol amendments ICF review that require any EC submissions are required by PI during the Study. Such submissions include i.e. review and input to amendment, submission to EC and implementation of the amendment. The Public Patient Travel Reimbursement “Pasientreiser” (xxxxx://xxxxxxxxxxxxx.xx/), within its limitations should, as the first instance, be used for reimbursement of Subjects’ travel expenses. Compensation will be paid by Sponsor for any reasonable expenses not covered by Pasientreiser when travelling by e.g. public transport (taxi, ferry, train, plane etc.) or by own car (reimbursement rates as defined in “Xxxxxxxxxx.xx”) or when hotel accommodation and refund of expenses for accompanying persons is needed. Sponsor will cover costs incurred by the Subjects, as described above, upon receipt of proper invoice from the Institution. The Payee shall invoice Sponsor based on documentation obtained by the Institution from the Subjects. The invoice to Sponsor must be blinded in regards to the Subjects’ personal information, but the invoice must contain Subject number and which visits to be refunded. The Payee is responsible for reporting remuneration to Norwegian authorities. Payee will forward these costs to Sponsor as pass-through costs, without revealing Subject identity. If any taxes apply, payee will add these to invoices, to be paid by Sponsor. Sponsor shall be entitled to inspect any further documentation supporting study subject costs, as deemed necessary by Sponsor.

Appears in 1 contract

Samples: Clinical Trial Agreement

PER SUBJECT FEE. For performance of the Study Investigation Sponsor will compensate the Institution for each enrolled Subject treated in accordance with the Protocol, on a pro-rata basis, see Table below. For screen failure Subjects the Institution will be paid the same fee as the Screening visit fee. For Subjects who are withdrawn before the end of the StudyInvestigation, compensation will be provided on a pro-rata basis on completion of assessments and visits as follows from the specification below. For screen failures Subjects (Subjects withdrawn prior to enrollment), the screening visit(s) performed will be paid for. Compensation will be given for extra (unscheduled) visits that occur as a result of adverse events that occur during the StudyInvestigation. The compensation will be according to table below. No financial compensation will be given for Subjects, who, within Principal Investigator’s control, are incorrectly included according to the inclusion and/or exclusion criteria or “lost to follow-up”. Payments for Subject visits will be made as follows: Screening NOK Visit 1 NOK Visit 3 NOK Visit x NOK Unscheduled visit NOK SAE NOK Payments for protocol procedures that are not included in the per visit payment will be made as follows: Procedure X NOK Procedure Y NOK National Coordinator fee [If applicable:] (if applicable) As Dr. [PI] dr. [PI] is the National Coordinator for the StudyInvestigation, there will be a fee of NOK [X] [XX XXX] for contact with EC regarding initial and amendment applications for the StudyInvestigation. The National Coordinator will also have contact with EC regarding safety issues during the StudyInvestigation, and be the support for the conduct of the StudyInvestigation. Sponsor will pay NOK [5.444] X for extra work in relation to any Protocol amendments that require any EC submissions during the StudyInvestigation. Such submissions include i.e. review and input to amendment, submission to EC and implementation of the amendment. The Public Patient Travel Reimbursement “Pasientreiser” (xxxxx://xxxxxxxxxxxxx.xx/), within its limitations should, as the first instance, be used for reimbursement of Subjects’ travel expenses. Compensation will be paid by Sponsor for any reasonable expenses not covered by Pasientreiser when travelling by e.g. public transport (taxi, ferry, train, plane etc.) or by own car (reimbursement rates as defined in “Xxxxxxxxxx.xx”) or when hotel accommodation and refund of expenses for accompanying persons is needed. Sponsor will cover costs incurred by the Subjects, as described above, upon receipt of proper invoice from the Institution. The Payee shall invoice Sponsor based on documentation obtained by the Institution from the Subjects. The invoice to Sponsor must be blinded in regards to the Subjects’ personal information, but the invoice must contain Subject number and which visits to be refunded. The Payee is responsible for reporting remuneration to Norwegian authorities. Payee will forward these costs to Sponsor as pass-through costs, without revealing Subject identity. If any taxes apply, payee will add these to invoices, to be paid by Sponsor. Sponsor shall be entitled to inspect any further documentation supporting study subject costs, as deemed necessary by Sponsor.

Appears in 1 contract

Samples: Clinical Investigation Agreement

PER SUBJECT FEE. 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. For screen failure Subjects the Institution will be paid the same fee as the Screening visit fee. For Subjects who are withdrawn before the end of the Study, compensation will be provided on a pro-rata basis on completion of assessments and visits as follows from the specification below. Compensation will be given for extra (unscheduled) visits that occur as a result of adverse events that occur during the Study. The compensation will be according to table below. No financial compensation will be given for Subjects, who, within Principal Investigator’s control, are incorrectly included according to the inclusion and/or exclusion criteria or “lost to follow-up”. Payments for Subject visits will be made as follows: Screening NOK Visit 1 NOK Visit 3 NOK Visit x NOK Unscheduled visit NOK SAE NOK Payments for protocol procedures that are not included in the per visit payment will be made as follows: Procedure X NOK Procedure Y NOK National Coordinator fee [If applicable:] (if applicable) As Dr. [PI] [PI] is the National Coordinator for the Study, there will be a fee of NOK [X] X for contact with EC regarding initial and amendment applications for the Study. The National Coordinator will also have contact with EC regarding safety issues during the Study, and be the support for the conduct of the Study. Sponsor will pay NOK [5.444] for extra work in relation to any Protocol amendments that require any EC submissions during the Study. Such submissions include i.e. review and input to amendment, submission to EC and implementation of the amendment. The Public Patient Travel Reimbursement “Pasientreiser” (xxxxx://xxxxxxxxxxxxx.xx/), within its limitations should, as the first instance, be used for reimbursement of Subjects’ travel expenses. Compensation will be paid by Sponsor for any reasonable expenses not covered by Pasientreiser when travelling by e.g. public transport (taxi, ferry, train, plane etc.) or by own car (reimbursement rates as defined in “Xxxxxxxxxx.xx”) or when hotel accommodation and refund of expenses for accompanying persons is needed. Sponsor will cover costs incurred by the Subjects, as described above, upon receipt of proper invoice from the Institution. The Payee shall invoice Sponsor based on documentation obtained by the Institution from the Subjects. The invoice to Sponsor must be blinded in regards to the Subjects’ personal information, but the invoice must contain Subject number and which visits to be refunded. The Payee is responsible for reporting remuneration to Norwegian authorities. Payee will forward these costs to Sponsor as pass-through costs, without revealing Subject identity. If any taxes apply, payee will add these to invoices, to be paid by Sponsor. Sponsor shall be entitled to inspect any further documentation supporting study subject costs, as deemed necessary by Sponsor.

Appears in 1 contract

Samples: Clinical Study Agreement

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PER SUBJECT FEE. For performance of the Study Investigation Sponsor will compensate the Institution for each enrolled Subject treated in accordance with the Protocol, on a pro-rata basis, see Table below. For screen failure Subjects the Institution will be paid the same fee as the Screening visit fee. For Subjects who are withdrawn before the end of the StudyInvestigation, compensation will be provided on a pro-rata basis on completion of assessments and visits as follows from the specification below. For screen failures Subjects (Subjects withdrawn prior to enrollment), the screening visit(s) performed will be paid for. Compensation will be given for extra (unscheduled) visits that occur as a result of adverse events that occur during the StudyInvestigation. The compensation will be according to table below. No financial compensation will be given for Subjects, who, within Principal Investigator’s control, are incorrectly included according to the inclusion and/or exclusion criteria or “lost to follow-up”. Payments for Subject visits will be made as follows: Screening NOK Visit 1 NOK Visit 3 NOK Visit x NOK Unscheduled visit NOK SAE NOK Payments for protocol procedures that are not included in the per visit payment will be made as follows: Procedure X NOK Procedure Y NOK National Coordinator fee [If applicable:] (if applicable) As Dr. [PI] dr. [PI] is the National Coordinator for the StudyInvestigation, there will be a fee of NOK [X] [XX XXX] for contact with EC regarding initial and amendment applications for the StudyInvestigation. The National Coordinator will also have contact with EC regarding safety issues during the StudyInvestigation, and be the support for the conduct of the StudyInvestigation. Sponsor will pay NOK [5.444] for extra work in relation to any Protocol amendments that require any EC submissions during the StudyInvestigation. Such submissions include i.e. review and input to amendment, submission to EC and implementation of the amendment. The Public Patient Travel Reimbursement “Pasientreiser” (xxxxx://xxxxxxxxxxxxx.xx/), within its limitations should, as the first instance, be used for reimbursement of Subjects’ travel expenses. Compensation will be paid by Sponsor for any reasonable expenses not covered by Pasientreiser when travelling by e.g. public transport (taxi, ferry, train, plane etc.) or by own car (reimbursement rates as defined in “Xxxxxxxxxx.xx”) or when hotel accommodation and refund of expenses for accompanying persons is needed. Sponsor will cover costs incurred by the Subjects, as described above, upon receipt of proper invoice from the Institution. The Payee shall invoice Sponsor based on documentation obtained by the Institution from the Subjects. The invoice to Sponsor must be blinded in regards to the Subjects’ personal information, but the invoice must contain Subject number and which visits to be refunded. The Payee is responsible for reporting remuneration to Norwegian authorities. Payee will forward these costs to Sponsor as pass-through costs, without revealing Subject identity. If any taxes apply, payee will add these to invoices, to be paid by Sponsor. Sponsor shall be entitled to inspect any further documentation supporting study subject costs, as deemed necessary by Sponsor.

Appears in 1 contract

Samples: Clinical Investigation Agreement

PER SUBJECT FEE. 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. For screen failure Subjects the Institution will be paid the same fee as the Screening visit fee. For or Subjects who are withdrawn before the end of the Study, compensation will be provided on a pro-rata basis on completion of assessments and visits as follows from the specification belowin the agreed budget. For screen failures Subjects (Subjects withdrawn prior to enrollment), the screening visit(s) performed will be paid for. Compensation will be given for extra (unscheduled) visits that occur as a result of adverse events that occur during the Study. The compensation will be according to table belowthe actual time spent by Study site staff, the examinations done and assessments made to treat and document the adverse event. No financial compensation will be given for Subjects, who, within Principal Investigator’s control, are incorrectly included according to the inclusion and/or exclusion criteria or “lost to follow-up”. Payments for Subject visits will be made as follows: Screening NOK Visit 1 NOK Visit 3 NOK Visit x NOK Unscheduled visit NOK SAE NOK Payments for protocol procedures that are not included in the per visit payment will be made as follows: Procedure X NOK Procedure Y NOK National Coordinator fee [If applicable:] (if applicable) As Dr. [PI] dr. [PI] is the National Coordinator for the Study, there will be a fee of NOK [X] [XX XXX] for contact with EC regarding initial and amendment applications for the Study. The National Coordinator will also have contact with EC regarding safety issues during the Study, and be the support for the conduct of the Study. Sponsor will pay NOK [5.444] X for extra work in relation to any Protocol amendments that require any EC submissions during the Study. Such submissions include i.e. review and input to amendment, submission to EC and implementation of the amendment. The Public Patient Travel Reimbursement “Pasientreiser” (xxxxx://xxxxxxxxxxxxx.xx/), within its limitations should, as the first instance, be used for reimbursement of Subjects’ Sponsor will reimburse reasonable travel expenses. Compensation will be expenses paid by Sponsor for any reasonable expenses not covered by Pasientreiser when travelling by e.g. public transport (taxi, ferry, train, plane etc.) or by own car (reimbursement rates as defined in “Xxxxxxxxxx.xx”) or when hotel accommodation the Institution and refund of expenses for accompanying persons is needed. Sponsor will cover costs incurred by Subjects by use of public transportation or private car within the Subjects, as described above, upon receipt of proper invoice from limits set in the InstitutionNorwegian Government travel allowance scale (“Statens reiseregulativ”). The Payee shall invoice Sponsor based on original documentation obtained by the Institution from the SubjectsSubject. The invoice to Sponsor must be blinded in regards to the Subjects’ Subject personal information, but the invoice must should contain information about which Subject number and which visits to be refunded. The Payee is responsible for reporting reportable remuneration to Norwegian authorities. VAT should not be added. Payee will forward these costs to Sponsor as pass-pass through costscosts plus an invoice fee of NOK 90, without revealing Subject Subjects identity. If any taxes apply, payee will add these to invoices, to be paid by Sponsor. Sponsor shall be entitled to inspect any further documentation supporting study subject costs, as deemed necessary by Sponsor.

Appears in 1 contract

Samples: Clinical Study Agreement

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