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”) 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. 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) Formuláře záznamů o subjektech hodnocení (Case Report Forms, CRF). Pro všechny subjekty zařazené do Studie bude Poskytovatel zdravotních služeb nebo Zkoušející vyplňovat všechny formuláře záznamů o subjektech pro účely Studie na formuláři a/nebo elektrickém médiu dodávaném nebo specifikovaném Zadavatelem a/nebo CRO („CRF“), a to během dvaceti čtyř (24) hodin od návštěvy subjektu během fáze eskalace dávky a během tří (3) dnů od návštěvy subjektu během zbývající části Studie. Od Poskytovatele zdravotních služeb a Zkoušejícího se nebude požadovat nezveřejnění informací v CRF, které umožňují osobní identifikaci zařazeného subjektu nebo kandidáta na účast ve Studii. CRF budou dodávány CRO včas po jejich vyplnění. Na žádost Zadavatele a/nebo CRO Poskytovatel zdravotních služeb nebo Zkoušející ihned opraví jakékoli chyby a/nebo vynechávky v CRF týkajících se Studie a předají Zadavateli a/nebo CRO opravené CRF a podpůrné záznamy pro další ověření.
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. 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. 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. 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. 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. Project Initiation Prior to the study site initiation visits, a project kickoff meeting will be held at Medpace involving Medpace and VIVUS personnel to review the study protocol, eCRFs, and overall project coordination. Medpace project team members and VIVUS personnel will participate in this meeting.
Case Report Forms. All the clinical data will be captured by the site on electronic case report forms (eCRFs). The eCRFs will be used for all consented patients. The investigator and trained trial personnel will enter and edit the data via a secure network, with secure identification and password requirement. A complete electronic audit trial will be maintained. The investigator will be required to provide approval of all data to confirm accuracy. Copies of the eCRFs will be provided to the investigator at the conclusion of the trial.
Case Report Forms. Zkoušející vynaloží maximální úsilí, aby získal pouze způsobilé účastníky, a vědomě do studie nezařadí žádné účastníky, kteří podle jeho nejlepšího odborného úsudku dostatečně nesplňují kritéria stanovená pro způsobilé účastníky. Hlavní zkoušející vynaloží maximální úsilí, aby získal přibližně 8 pacientů. Zvýšení počtu pacientů, kteří mají být do studie zařazeni, vyžaduje písemné schválení zadavatelem, nikoli však dodatek k této smlouvy.
