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:
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. (c)
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 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 Chiltern and Sponsor, if required of any deviations from or failure to comply with the Protocol; (iii) promptly replying to any questions from Chiltern or Sponsor regarding any matter related to the Study; (iv) promptly notifying Chiltern 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 (b)
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 b)
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 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 nebezpečné povahy práce, používání náborářů, kteří jakýmkoliv způsobem porušují místní pracovní zákony země, kde nábor probíhá, používání náborářů, kteří účtují zaměstnancům „náborové poplatky“, poskytování či sjednávání ubytování, které nesplňuje normy hostitelské země a bezpečnostní standardy, neposkytnutí písemné pracovní smlouvy, náborové smlouvy nebo podobného pracovního dokumentu, pokud to zákon či smlouva požaduje, v rodném jazyce zaměstnance nejméně pět dnů předtím, než zaměstnanec odejde ze své země původu, nebo neuhrazení či nerefundování nákladů na zpětnou přepravu po skončení zaměstnání zaměstnancům, kteří byli přivedeni do země za účelem plnění této smlouvy. 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 pra...
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.
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 and EC/IRB, 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; (d) Zdravotnické zařízení souhlasí s tím, že provede formální výběr pacientů a randomizaci pro studii pouze poté, co Xxxxxxxx potvrdila písemně (což by mohlo být i elektronickou poštou) zdravotnickému zařízení, že všechny zásadní dokumenty, jak je definuje ICH/SKP (správná klinická praxe) nebo ekvivalentní norma, jsou na místě a že byl získán souhlas příslušné či vhodné etické komise, regulačního xxxxx x/xxxx xxxxxx xxxxxxxxxxxxx xxxxxx. 0. XXXXXXXX XXXXX Zdravotnické zařízení a zkoušející provádí studii v souladu s protokolem, touto smlouvou, písemnými pokyny od zadavatele nebo Xxxxxxxx (dále „pokyny“), platnými odbornými normami lékařské praxe, platnými, státními a místními zákony, směrnicemi, pravidly a předpisy, platnými zákony, pravidly a předpisy o ochraně soukromí a pokyny ICH-SKP (CPMP/ICH/135/95), ať již byly schváleny podle místních zákonů dané země, kde sídlí zdravotnické zařízení/zkoušející, nebo jinde. 3.
