Meldingsprocedures Saes En Susars

This document describes the procedures related to financial transactions between the European Group for Research In Schizophrenia (EGRIS) and participating centers involved in the European Long-acting Antipsychotics in Schizophrenia Trial (EULAST). A distinction has been made between:

1) travel expenses related to study meetings

2) the costs related to regulatory approvals

3) the fees related to the conduct of study visits for participating study subjects

4) the fees related to country coordinator tasks

All related forms which need to be used for submission of costs can be found on the study website:

Travel expenses related to study meetings

Travel arrangements to study meetings (including training sessions) will be made by the meeting attendees themselves. Travel expenses can be reimbursed using the ‘Reimbursement Form Travel Expenses’. Airplane tickets booked for attendance at study meetings will be reimbursed, but if they are booked in economy class. For each meeting, a maximum amount of money to be reimbursed on hotel stays, as well as a maximum number of overnight stays that will be reimbursed, will be included in the personal invitation to the study meeting. For costs to be eligible for reimbursement, invoices have to be send together with the Reimbursement form Travel Expenses to Emmy Drost at , who will consult the project managers for approval. Payment will be made within 60 days of receipt of (complete documentation related to) the Reimbursement Form.

Costs related to regulatory approvals

If possible, costs for obtaining regulatory approval (including both the Ethical Review Board and the Competent Authority) should be paid by the participating center, and will subsequently be reimbursed by EGRIS using the ‘Reimbursement form Regulatory Approval’. For costs to be eligible for reimbursement, invoices have to be send together with the Reimbursement form Regulatory Approval to Emmy Drost at However, if institutions strongly prefer to have EGRIS pay the invoice directly, please notify EGRIS and/or the project managers up front to facilitate a swift payment. Payment will be made within 60 days of receipt of (complete documentation related to) the Reimbursement Form.

Fees related to patient visits

The fees for patient visits have been communicated through the site specific budget, which is included in the contract between EGRIS and individual participating centers. Fees will be paid per visit which has been conducted. That is, this fee will not be paid for patient visits which did not take place (i.e. have been skipped regardless of the reason). Each participating center can regularly submit the applicable Patient Fee Overview, which lists the patients visits that have been conducted since the beginning of the study or since the previous payment request. This Patient Fee Overview automatically calculates the total amount of fees to be claimed, based on the number of conducted patient visits which are entered into this overview by the individual participating centers. Participating centers are kindly asked to submit such a request quarterly or bi-annually. Each center will receive the Patient Fee Overview which is tailored to the site specific budget. The following information is requested in this Patient Fee Overview:

• in the column ‘Number of times this visit was conducted’ the participating center can indicate for how many patients, since the start of the study (for the first payment request) or the previous payment request (for any subsequent payment requests), each individual visit number has been conducted (e.g., visit 2 was conducted for 11 patients, visit 5 was conducted for 7 patients, and 2 All Cause Discontinuation Visits were conducted). The Overview will automatically calculate the total patient fee to be paid for the current payment request.
• in the column ‘Please specify the applicable patient numbers’ the participating center is kindly asked to enter the patient numbers for whom you claim the patient visit fee (e.g., following the example from the previous point, indicate for visit 5 that this specific visit was conducted for patient numbers 1207, 1209, 1210, 1211 and 1215).

Completed Patient Fee Overviews (original excel file) can be send to Emmy Drost at , who will consult the project managers for approval. Payment will be made within 60 days of receipt of complete Patient Fee Overviews.

Fees related to country coordination tasks

The annual fee of € 5.000 for the country coordinating tasks will be automatically transferred to the bank account which is indicated before the start of the trial. The first payment will be made once the contract has been signed. This annual payment will continue up to 4 years, provided that there are still subjects participating in the study in the applicable country.

EULAST financial procedures, version 1, dated August 18, 20141