Outline of study procedures Sample Clauses

Outline of study procedures. All study procedures are outlined in the Schedule of Assessments below (Table 6.1). A more detailed description of the study procedures performed at each study stage/visit is given in the following sections. Table 6.1 Schedule of Events Hospitalization Post discharge follow-up Visits/Week Study days Screening Day (-7) to Day (-1) Day 1 Day of application(1) Daily during hospitalization(2) Day of discharge Telephone Contact Day 8 (+ 1 day) Day 30 (+ 5 days) Day 90 (+ 5 days) Day 180 (+ 7 days) End of Study Visit Follow-up Safety Visits (Months 12, 24, 36, 48 60, + 30 days) AM1 X Hospitalization X Coronary angiography, PCI, stent(1) X Informed consent X Inclusion/exclusion criteria X Pregnancy test X Demography medical history; concurrent illnesses X Physical examination X X X X X X X X Xxxxx xxxxx (temperature, arterial BP. weight) X X X X X X X X 12-lead ECG X X (4) X X X X X X Laboratory safety parameters X (5) X (6) X (6) X X X X Total CK/CK MB X X (7) NT-proBNP X X (8) X (6) X X X Echocardiography/MRI X X X X X Continuous ECG monitoring X (9) Cardiac catheterization; application of BL- 1040; coronary angiography X PTT or ACT measurements X (10) 24-hour ambulatory Xxxxxx monitoring X X X X X Safety contact for discharged patients X Minnesota Living with Heart Failure® X X X X Serious/Adverse events and concomitant medication X X X X X X X X X
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Outline of study procedures. Patients will be recruited from specialised study sites, with an intensive care unit. For a detailed description of the schedule of visits and assessments, please refer to the Schedule of Assessment Error! Reference source not found. (Screening and Treatment Period 1) and Table 3 (Treatment Period 2 and Follow-up Period). The informed consent form must be signed by the patient or his/her legally authorized representative prior to any study-related procedures, with the assent of patients who are legally capable of providing it. Some procedures are not to be done systematically but only if clinically relevant. For example: • ECG is only mandatory at screening, after first infusion, after last infusion and at the end of the study, but can also be done at any other time point, if relevant, • Brain MRI should be done in case of neurological symptoms occurrence, • Lumbar puncture for CSF analysis is done (providing that coagulation allows) only at screening but should be repeated during the study course if the initial analysis at screening was abnormal or in case of occurrence of neurological symptoms, • Search for pathogens during the study should be done if there is any suspicion of infection, • Chest X-ray during the study should be done more frequently than indicated in case of clinical suspicion of a pulmonary infection. Analysis done on blood samples will favour as much as possible the use of micro-sampling techniques. In case of a need for prioritization of blood analysis, laboratory safety parameters (which would have been done as normal disease monitoring) will be prioritized. For details on blood sampling, please refer to Appendix C. For safety laboratory and search for pathogens, the planned schedule of assessment is in accordance with recommendations for the monitoring of disease evolution and potential for infection in these severely sick patients (HLH-2004 protocol of the Histiocyte Societyiii). This has been agreed by the study’s Scientific Steering Committee (SSC). The additional amounts of blood which will be drawn for study mandatory specific assessments represent only 24.5 mL for PK assessments and 1.5 mL for immunogenicity monitoring. A maximum of 29 ml of blood are required for PD assessments, and will be only taken if the amount of blood required is acceptable in the context of the EMA guidelineiv. The following situations will not be considered as protocol deviations: - Missing data if not occurring at 2 consecutive time-points, - Missing ...
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Related to Outline of study procedures

  • New Procedures New procedures as to who shall provide certain of these services in Section 1 may be established in writing from time to time by agreement between the Fund and the Transfer Agent. The Transfer Agent may at times perform only a portion of these services and the Fund or its agent may perform these services on the Fund's behalf;

  • Filing Procedures The Company shall (A) permit counsel to the Investor an opportunity to review and comment upon (i) each Registration Statement at least three (3) Trading Days prior to its filing with the SEC and (ii) all amendments and supplements to each Registration Statement (including, without limitation, the Prospectus contained therein) (except for Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any similar or successor reports or Prospectus Supplements the contents of which is limited to that set forth in such reports) within a reasonable number of days prior to their filing with the SEC, and (B) shall reasonably consider any comments of the Investor and its counsel on any such Registration Statement or amendment or supplement thereto or to any Prospectus contained therein. The Company shall promptly furnish to the Investor, without charge, (i) electronic copies of any correspondence from the SEC or the Staff to the Company or its representatives relating to each Registration Statement (which correspondence shall be redacted to exclude any material, non-public information regarding the Company or any of its Subsidiaries), (ii) after the same is prepared and filed with the SEC, one (1) electronic copy of each Registration Statement and any amendment(s) and supplement(s) thereto, including, without limitation, financial statements and schedules, all documents incorporated therein by reference, if requested by the Investor, and all exhibits and (iii) upon the effectiveness of each Registration Statement, one (1) electronic copy of the Prospectus included in such Registration Statement and all amendments and supplements thereto; provided, however, the Company shall not be required to furnish any document to the extent such document is available on XXXXX).

  • Loan Procedures □ (a) Loans will be provided under the default loan procedures set forth in Section 13 of the Plan, unless modified under this Appendix B.

  • Reply Procedures In connection with any Auction, each Lender holding the relevant Term Loans subject to such Auction may, in its sole discretion, participate in such Auction and may provide the Auction Agent with a notice of participation (the “Return Bid”) which shall be in a form reasonably acceptable to the Auction Agent, and shall specify (i) a discount to par (that must be expressed as a price at which it is willing to sell all or any portion of such Term Loans) (the “Reply Price”), which (when expressed as a percentage of the par principal amount of such Term Loans) must be within the Discount Range and (ii) a principal amount of such Term Loans, which must be in whole increments of $1,000,000 (or, in any case, such lesser amount of such Term Loans of such Lender then outstanding or which is otherwise reasonably acceptable to the Auction Agent) (the “Reply Amount”). Lenders may only submit one Return Bid per Auction, but each Return Bid may contain up to three bids only one of which may result in a Qualifying Bid. In addition to the Return Bid, the participating Lender must execute and deliver, to be held in escrow by the Auction Agent, an Assignment and Assumption with the dollar amount of the Term Loans to be assigned to be left in blank, which amount shall be completed by the Auction Agent in accordance with the final determination of such Lender’s Qualifying Bid pursuant to clause (c) below. Any Lender whose Return Bid is not received by the Auction Agent by the Auction Response Date shall be deemed to have declined to participate in the relevant Auction with respect to all of its Term Loans.

  • Billing Procedures (a) PROVIDER agrees all claims shall be submitted to OHCA in a format acceptable to OHCA and in accordance with the OHCA Provider Manual.

  • Review Procedures The Parties agree to jointly conduct a review, sampling transactions of the incidents managed under this Agreement. Findings that are inconsistent with the normal or accepted way of doing business will be reconciled on a case by case basis. Any decision to further examine records will be considered on a case by case basis and appropriate follow up action agreed upon by all agencies involved. Payment for Protection Services (use if appropriate) Geographic, Statewide or Sub-Geographic (local) operating plans and procurement documents or agreement will establish billing procedures for Fee Basis Protection Services.

  • Offering Procedures (a) The following terms have the specified meanings for purposes of this Agreement:

  • Reporting Procedures Enter in the XXX Entity Management area the information that XXX requires about each proceeding described in paragraph 2 of this award term and condition. You do not need to submit the information a second time under assistance awards that you received if you already provided the information through XXX because you were required to do so under Federal procurement contracts that you were awarded.

  • General Procedures If at any time on or after the date the Company consummates a Business Combination the Company is required to effect the Registration of Registrable Securities, the Company shall use its best efforts to effect such Registration to permit the sale of such Registrable Securities in accordance with the intended plan of distribution thereof, and pursuant thereto the Company shall, as expeditiously as possible:

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