Investigator Obligations. Investigator will devote his/her best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include but are not limited to the following: (i) exercise of independent medical judgment as to the compatibility of each Study patient with the Protocol requirements; (ii) notification of Labcorp and Sponsor, if required of any deviations from or failure to comply with the Protocol; (iii) promptly replying to any questions from Labcorp or Sponsor regarding any matter related to the Study; (iv) promptly notifying Labcorp of any significant changes that occur at any time during the Study which may affect Investigator or Institution’s ability to conduct the Study, including but not limited to, changes in personnel involved in the Study (v) record and document all Adverse Events and laboratory abnormalities identified in the Protocol as critical to the safety evaluation; (vi) report all Serious Adverse Events to Labcorp and/or the Sponsor without undue delay but not later than within twenty-four (24) hours of obtaining knowledge of the events, unless, for certain Serious Adverse Events, the Protocol provides that no immediate reporting is required.
Investigator Obligations. Investigator will devote his/her best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include but are not limited to the following: (
Investigator Obligations. Investigator will devote best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include but are not limited to the following: (i) exercise of independent medical judgment as to the compatibility of each Study patient with the Protocol requirements; (ii) notification of Fortrea and Sponsor, if required of any deviations from or failure to comply with the Protocol; (iii) promptly replying to any questions from Fortrea or Sponsor regarding any matter related to the Study; (iv) promptly notifying Fortrea of any significant changes that occur at any time during the Study which may affect Investigator or Institution’s ability to conduct the Study, including but not limited to, changes in personnel involved in the Study; and (v) supervision of Research Staff to ensure compliance with this Agreement and Applicable Law. (d)
Investigator Obligations. As indicated on FDA Form 1572, the Principal Investigator is responsible for ensuring that all study site personnel, including Sub-Investigators and other study staff members, adhere to all FDA regulations and guidelines regarding clinical trials both during and after study completion.
Investigator Obligations. Sponsoring Institution will require the SCOR Director, all Key Sponsoring Institution Investigators, or all Sponsoring Institution Investigators (as applicable) to acknowledge the provisions of Sections 3.1, 6, 7 and 8 of this Agreement (“Investigator Obligations”). Sponsoring Institution will be responsible for all Sponsoring Institution Investigators’ compliance with such provisions.
Investigator Obligations. Investigator agrees to devote his/her best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include by are not limited to the following:
(i) exercise of independent medical judgment as to the compatibility of each Study patient with the Protocol requirements;
(ii) notification of Xxxxxxxx and Sponsor, if required of any deviations from or failure to comply with the Protocol;
(iii) promptly replying to any questions from Xxxxxxxx or Sponsor regarding any matter related to the Study;
(iv) promptly notifying Xxxxxxxx of any significant changes that occur at any time during the Study which may affect Investigator or Institution’s ability to conduct the Study, including but not limited to, changes in personnel involved in the Study
Investigator Obligations. Investigator will devote best efforts to accurately and efficiently perform the work required under this Agreement, which efforts shall include but are not limited to the following: (i) exercise of independent medical judgment as to the compatibility of each Study patient with the Protocol requirements; (ii) notification of Labcorp and Sponsor, if required of any deviations from or failure to comply with the Protocol; (iii) promptly replying to any questions from Labcorp or Sponsor regarding any matter related to the Study; (iv) promptly notifying Labcorp of any significant changes that occur at any time during the Study which may affect Investigator or Institution’s ability to conduct the Study, including but not limited to, changes in personnel involved in the Study; and (v) supervision of Research Staff to ensure compliance with this Agreement and Applicable Law. (vi) record and document all Adverse Events and laboratory abnormalities identified in the Protocol as critical to the safety evaluation; (vii) report all Serious Adverse Events to Labcorp and/or the Sponsor without undue delay but not later than within twenty-four (24) hours of obtaining knowledge of the events, unless, for certain Serious Adverse Events, the Protocol provides that no immediate reporting is required čehokoli hodnotného ve prospěch Smluvních stran nebo jejich zaměstnanců nebo jakéhokoli subjektu nebo osoby spojených se Smluvními stranami nebo jejich zaměstnanci ani pro jakýkoli jiný očekávaný přínos jako pobídku k určitému jednání nebo zdržení se tohoto jednání, nebo za účelem získání nebo zachování neoprávněné obchodní výhody v souvislosti s touto Smlouvou, a zajistí, že tak neučiní ani Výzkumný personál. Zdravotnické zařízení bude spolupracovat s Labcorp a/nebo Zadavatelem a účastnit se jakýchkoliv šetření, auditů nebo jiných kontrol, které vyplynou z údajného porušení shora učiněných ujištění, ať již formálních či neformálních, jak to přiměřeně požaduje Labcorp, Zadavatel nebo jeho zástupci. Taková spolupráce nevyžaduje zřeknutí se jakýchkoliv stávajících práv vyplývajících ze vztahu mezi advokátem a jeho klientem ze strany Zkoušejícího a/nebo Zdravotnického zařízení nebo jakéhokoliv práva Zkoušejícího a/nebo Zdravotnického zařízení nebo kteréhokoliv z jejich vedoucích pracovníků, členů představenstva, vlastníků, zaměstnanců nebo zástupců nezpůsobit sobě trestní stíhání.
Investigator Obligations. The following administrative items are meant to guide the investigator in the conduct of the study and may be subject to change based on industry and government standard operating procedures, working practice documents, or guidelines. Changes will be reported to the IRB but will not result in protocol amendments.
Investigator Obligations. 31 14. ADMINISTRATIVE CONSIDERATIONS .............................................. 32 15. REFERENCES ................................................................. 34 APPENDIX A: STUDY DIAGRAM ...................................................... 40 APPENDIX B: PERFORMANCE STATUS ................................................. 41 APPENDIX C: SKIN TESTING PROCEDURE ............................................. 42 APPENDIX D: QUALITY OF LIFE QUESTIONAIRE ....................................... 44 APPENDIX E: BRIEF PAIN INVENTORY ............................................... 47 APPENDIX F: PATIENT REGISTRATION FORM........................................... 49 APPENDIX G: NPCP CRITERIA....................................................... 51 APPENDIX H: OFF STUDY FORM...................................................... 53 APPENDIX I: OFF STUDY PATIENT RE-ENTRY FORM..................................... 54 APPENDIX J: LEUKAPHERESIS PROCEDURE INFORMATION................................. 55 APPENDIX K: INFORMED CONSENT.................................................... 57 APPENDIX L: NCI COMMON TOXICITY CRITERIA ....................................... 61 APPENDIX M: TOXICITY MODULE .................................................... 64
Investigator Obligations. 4.1 The Investigator shall adhere to any and all laws, regulations and guidelines, including (a) any applicable Guidelines for Good Clinical Practice, (b) the laws and customs governing medical practice and ethics prevailing in the country where the Study takes place, and (c) all guidelines and instructions supplied by POI and/or the Sponsor. Strict compliance by the Investigator with the Study Protocol is required (slight deviations based on medical necessity will not violate this provision). Any modifications recommended by the Investigator or the Institution's Institutional Review Board ("IRB") before initiation of the Study or during the review process must be brought to the attention of POI. The Protocol may not be altered without the prior written consent of POI and/or the Sponsor for the Study, and a subsequent review and approval by the IRB. The Principal Investigator thoroughly understands the Protocol and, as of the date of signing this Agreement, has no further questions or concerns about the Study's design or conduct.
4.2 The Investigator shall exercise independent medical judgment as to the compatibility of each patient with the Protocol and obtain written informed consent before including any patient in the Study. Investigator shall maintain independent records that corroborate that the informed consent was executed before the inclusion of the patient in the Study.
4.3 The Investigator shall obtain written IRB approval to conduct the Study. The IRB shall receive a copy of the Protocol as part of the original submission to the IRB as well as any Protocol modifications that are made after IRB approval has been obtained. When required, the patient informed consent form approved by the IRB shall be modified to reflect changes in the Protocol. The modified form shall be submitted to the IRB for approval, and upon IRB approval signed by each patient participating in the Study.
4.4 The Investigator is expected to be available during normal business hours for consultation with POI's clinical research associates by telephone and during periodic site visits to assess Study progress.
4.5 The Investigator shall have a study coordinator to assist the Investigator with the administration of the Study. The Study coordinator shall be available during normal business hours for consultation with POI by telephone and during periodic site visits.
4.6 All Study Drug and other materials provided by POI and/or the Sponsor shall be used solely for the purposes of co...
