DOCUMENTATION AND USE OF STUDY FINDINGS Sample Clauses

DOCUMENTATION AND USE OF STUDY FINDINGS. 36 13.1. Documentation of Study Results 36 13.2 Use of ComputeriZed Systems at the Clinical Trial CentEr 36 14. REFERENCES 37 15. APPENDICES 39 APPENDIX A – SCHEDULE OF ASSESSMENTS FOR PATIENTS STILL CONTINUING NI-0501 TREATMENT 00 Xxxxxxxx X - Investigational medicinal product (IMP) preparation and handling 42 LIST OF ABBREVIATIONS Abbreviation Term ADA Anti-drug antibodies AE Adverse event ALP Alkaline Phosphatase ALT Alanine aminotransferase aPTT Activated Partial Thromboplastin Time AST Aspartate aminotransferase ATG Anti-thymocyte globulin CBC Complete blood cell count CRF Case report form CRP C-reactive protein eCRF Electronic case report form γGT Gamma Glutamyl Transferase HLH Hemophagocytic Lymphohistiocytosis HSCT Hematopoietic stem cell transplantation HZ Herpes Zoster ICMJE International Committee of Medical Journal Editors IFNγ Interferon gamma IFPMA International Federation of Pharmaceutical Manufacturers & Associations IMP Investigational medicinal product IRB Institutional review board LDH Lactate Dehydrogenase NaCl Sodium Chloride PCR Polymerase Chain Reaction PD Pharmacodynamic PK Pharmacokinetic SAE Serious adverse event SAP Statistical analysis plan SUSAR Suspected Unexpected Serious Adverse Reaction TB Tuberculosis TMF Trial Master File WD Withdrawal Table 1: Schedule of Assessments for the Long-term Follow-Up of Patients Who Underwent or Will Undergo HSCT Assessments Follow-up pre-HSCT HSCT Follow-up post-HSCT UV 8 Baseline visit 1 Weekly visits pre- HSCT 2 Pre Condi- tioning visit 3 Weekly visits wk 1 – 2 – 3 4 D+30 visit 5 D+60 visit 5 D+100 visit 5 6 month visit 6 1 year visit 6 / WD 7 Subject information Informed consent X Demographics X Medical history / relevant treatment X Clinical Assessments Xxxxx xxxxx X X X X X X X X X X Physical examination9 X X X X X X X X X X Duration of response to treatment X X X X X Post-HSCT outcome measures10 X X X X X X Survival X X X X X X X X X X Laboratory CBC X X X X X X X X X X Coagulation X X X X X X X X X X Biochemistry Urinalysis X X X X X X X X X X X X X X X X Search for infections11 TB, Adenovirus, EBV, CMV X11 X11 X11 X11 X11 X11 X11 X11 X11 Imaging Chest X ray11 X11 X11 X11 X11 X11 X11 X11 X11 X11 Abdominal ultrasound12 X X X X X AE recording14 X X X X X X X X X X X Concomitant medications and procedures recording X X X X X X X X X X PK/PD (NI-0501 concentrations / total IFNγ & other biomarkers) X X X X X X X13 X13 X13 X13 Immunogenicity (ADA) X X X CBC: complete blood count (white blood...
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Related to DOCUMENTATION AND USE OF STUDY FINDINGS

  • Documentation and compliance (a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses.

  • Implementation of Agreement Each Party must promptly execute all documents and do all such acts and things as is necessary or desirable to implement and give full effect to the provisions of this Agreement.

  • Implementation and Review The Parties shall consult annually, or as otherwise agreed, to review the implementation of this Chapter and consider other matters of mutual interest affecting trade in services. (10) 10 Such consultations will be addressed under Article 170 (Free Trade Commission) of Chapter 14 (Administration of the Agreement).

  • APPLICATION AND SCOPE 4.1. All employers and employees within the clothing manufacturing industry, and their respective organisations are encouraged to use this Code to develop, implement and refine their HIV/AIDS policies and programmes to suit the needs of their workplaces.

  • Joint Network Implementation and Grooming Process Upon request of either Party, the Parties shall jointly develop an implementation and grooming process (the “Joint Grooming Process” or “Joint Process”) which may define and detail, inter alia:

  • Construction and Scope of Agreement The language of all parts of this Agreement shall in all cases be construed as a whole, according to its fair meaning, and not strictly for or against any party. This Agreement is the only, sole, entire, and complete agreement of the parties relating in any way to the subject matter hereof. No statements, promises, or representations have been made by any party to any other, or relied upon, and no consideration has been offered or promised, other than as may be expressly provided herein. This Assumption of Risk, Release of Claims, Indemnification, and Hold Harmless and Agreement supersedes any earlier written or oral understandings or agreements between the parties. Participant acknowledges that he/she has read this Assumption of Risk, Release of Claims, Indemnification and Hold Harmless Agreement, understands its meaning and effect, and agrees to be bound by it. Date:

  • Allocation and use of scarce resources Any procedures for the allocation and use of scarce resources, including frequencies, numbers and rights of way, will be carried out in an objective, timely, transparent and non-discriminatory manner. The current state of allocated frequency bands will be made publicly available, but detailed identification of frequencies allocated for specific government uses is not required.

  • APPLICATION AND PARTIES BOUND 5.1 The parties bound by this General Agreement are listed in Schedule 5.

  • LIMITATIONS ON REVERSE ENGINEERING, DECOMPILATION AND DISASSEMBLY You may not reverse engineer, decompile, or disassemble the Software, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation.

  • Reproduction of Agreement Section A: REPRODUCTION OF AGREEMENT Paragraph 1: Copies of the negotiated agreement shall be printed at the expense of the Board within thirty days after the negotiated agreement is signed and presented to all teachers now employed, and hereafter employed. The Board shall furnish a copy for each building and a copy for the Association office for its use.

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