Case Report Forms. The Investigator is responsible for maintaining adequate and accurate medical records from which accurate information will be transferred into the study database. Case Report Forms (CRFs) should be completed by the Investigator or delegated personnel. CRFs will be provided for each patient. All data will be entered in black ink. Data/corrections entered will be signed or initialed by the study personnel undertaking that procedure. Overwriting data or use of liquid correcting fluid is not allowed. Detailed instructions are provided with the CRF.
Case Report Forms. For all subjects enrolled in the Study, Institution or Investigator will complete all case report forms required for the Study in the form and/or electronic medium supplied or specified by Sponsor and/or CRO (the “CRFs”) and within twenty-four (24) hours of the subject visit during the dose escalation phase and within three (3) days of the subject visit for the remainder of the Study specified by Sponsor and/or CRO. Institution and Investigator will not be required to disclose information in CRFs which would permit personal identification of a subject enrolled in, or a candidate for, the Study. CRFs will be provided to CRO in a timely manner as they are completed. At the request of Sponsor and/or CRO, Institution or Investigator will promptly correct any errors and/or omissions to the CRFs for the Study and will make available to Sponsor and/or CRO the corrected CRFs and supporting records for further verification. (d) Záznamy subjektu hodnocení. Za všechny subjekty zařazené do Studie budou Zdravotnické zařízení nebo Zkoušející do dvaceti čtyř (24) hodin od návštěvy subjektu během fáze postupného zvyšování dávky a do tří (3) dnů od návštěvy subjektu po zbývající dobu trvání Studie stanovenou Zadavatelem a/nebo CRO vyplňovat veškeré formuláře pro záznamy subjektů hodnocení požadované pro Studii ve formuláři a/nebo na elektronickém médiu dodaném nebo stanoveném Zadavatelem a/nebo CRO (dále „formuláře CRF“). Do formulářů CRF nebudou muset Zdravotnické zařízení a Zkoušející zapisovat informace, z nichž by mohla být zjištěna totožnost subjektu ve Studii nebo zájemce o účast ve Studii. Formuláře CRF budou CRO poskytovány včas, jakmile budou vyplněny. Na žádost Zadavatele a/nebo CRO Zdravotnické zařízení nebo Zkoušející neprodleně opraví případné chyby a/nebo opomenutí ve formulářích CRF a předá Zadavateli a/nebo CRO opravené formuláře CRF včetně podkladů k dalšímu ověření.
Case Report Forms. The Sponsor will provide the INSTITUTION with a sufficient quantity of Case Report Forms ("CRF's"), necessary questionnaires or other required documentation to conduct the Study. All original CRF's will be the sole property of the SPONSOR. All other original records of the work completed under this Agreement, including patient medical records, laboratory records and reports, scans, films and information on pre-existing INSTITUTION databases will be INSTITUTION property. INSTITUTION will retain a copy of all Study documents for internal research, teaching and archival purposes. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS - The INSTITUTION must, if necessary, ensure that all investigators listed in the Study protocol and conducting the Study provide the SPONSOR with all information on their significant financial commitments, such as patent and all other intellectual property rights related to the Study, ownership of shares in the Study Devices.
Case Report Forms. 4.1.1 (1) zadávateľ bez úhrady poskytne skúšajúcemu skúšaný produkt, komparátor, placebo a dokumenty ne- vyhnutné pre vedenie skúšania (napr. xxxxxxxxx xxxxx- xxxx xxxxxxxxx klinického skúšania).
Case Report Forms. [***] is responsible for the development and subsequent revisions of case report forms for Clinical Studies (“CRF”) subject to review and approval of the CSOG. Sponsor will be responsible for distributing the CRFs and any amendments to the CRFs to all Participating Sites in a timely manner. For each Clinical Study conducted at MSKCC, MSKCC shall prepare and maintain CRFs and other patient records and case histories with all pertinent data documented as required by the applicable Study Protocol. Sponsor shall not disclose patient names, except to the extent that the patient consent form permits or as required by applicable law or regulation. All CRFs shall be owned by Sponsor.
Case Report Forms. For all subjects enrolled in the Study, Institution shall ensure that the Investigator will complete all case report forms required for the Study in the form supplied or specified by Sponsor and/or CRO (the “CRFs”) and within the timeframe specified by Sponsor and/or CRO. Institution will not be required to disclose information in CRFs which would permit identification of a subject enrolled in, or a candidate for, the Study and should ensure that the Investigator will not disclose such information. Institution will ensure that CRFs will be completed within 5 business days after visit occurred. At the request of Sponsor and/or CRO, Institution will ensure that the Investigator will promptly (within 5 business days) correct any errors and/or omissions to the CRFs for the Study and will make available to Sponsor and/or CRO the corrected CRFs and supporting records for further verification.
Case Report Forms. Z áznamy subjektu hodnocení.
Case Report Forms. Medpace will design the electronic case report forms (eCRFs) for the trial, including completion instructions, according to the final protocols and the Medpace template. VIVUS must review and approve the eCRFs before they are finalized.
Case Report Forms. All case report form data will be entered in paper or electronic forms at the investigational site. A 21 CFR Part 11 compliant Electronic Data Capture system (EDC) will be used to capture data electronically for all randomized patients.
Case Report Forms. The Principal Investigator shall complete full clinical evaluations of paper or electronic CRFs, as appropriate, on each Study Subject in accordance with the Protocol, Case Report Form Guidelines and Applicable Law. The Principal Investigator shall ensure that each CRF is completed in accordance with CRF completion guidelines. If requested by SynteractHCR or Sponsor, the Principal Investigator shall deliver to SynteractHCR all completed CRFs or Queries in a timely manner. 4.1 Záznamy subjektů hodnocení. Hlavní zkoušející provede kompletní klinické hodnocení formulářů CRF, dle potřeby v tištěné nebo elektronické podobě, od každého ze studijních subjektů a v souladu s protokolem, pokyny pro záznamy subjektů hodnocení a platnými právními předpisy. Hlavní zkoušející zajistí, aby byl každý formulář CRF vyplněn v souladu s pokyny pro vyplnění formulářů CRF. V případě požadavku ze strany společnosti SynteractHCR nebo zadavatele hlavní zkoušející společnosti SynteractHCR včas doručí všechny vyplněné formuláře CRF nebo dotazy. 4.2
