Investigator’s responsibilities. The Investigator should ensure that all persons assisting with the trial are appropriately qualified and adequately informed about the protocol, amendments, study treatments, as well as study-related duties and functions. The Investigator should maintain a list of sub-investigators and other appropriately qualified persons to whom he or she has delegated significant study-related duties. The Investigator is responsible for keeping a record of all patients (or their legally authorized representative) who have signed an informed consent document to enter the study. Patients not participating in the NI-0501-05 study, despite having participated in a previous NI-0501 protocol, must have the reason(s) recorded in their source documents and the study participant log. In the event that N-0501 treatment needs to be prolonged beyond Week 8, the treating physician has to comply with local requirements and regulations. The Investigator should maintain source documents and trial records that include all pertinent observations on each of the site’s trial subjects. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. The Investigator/institution should maintain a record of the location(s) of the essential documents (which include source documents). The storage system (irrespective of the media used) should provide for document identification, search, and retrieval. The Investigator should promptly notify Sobi AG or designee of any inspections scheduled by any regulatory authorities and promptly forward to Sobi AG copies of any inspection reports received. The Investigator, or a designated member of the Investigators’ staff, must be available during monitoring visits, audits and inspections to review data, resolve queries and allow direct access to patient’ records (e.g. medical/hospital records, office charts, hospital charts, and study-related charts) for source data and other types of verification. The Investigator must ensure timely and accurate completion of CRFs and queries.
Investigator’s responsibilities. (1) Investigators shall do all work necessary to complete each assigned employment investigation and to complete the work described by the Contract above, including but not limited to interviewing witnesses, researching legal issues, preparing investigative summaries and final reports if and as requested. Such reports shall include a description of the investigative procedures used, a detailed summary of the evidence reviewed - including witnesses interviews - and a conclusion that determines if the allegations were substantiated or unsubstantiated.
Investigator’s responsibilities. Before participating in the study, all Investigators must agree to respect and fulfill the terms of this Investigational Plan and sign and date an Investigator Agreement (separately provided to this document) as well as certification and disclosure of financial interest. The Principal Investigator at each clinical site will have the following responsibilities: • Obtaining IRB approval • Obtaining informed consent from patients • Enrolling of patients, performing medical procedures • Adhering to the Clinical Investigational Plan, signed agreement with the sponsor, applicable FDA regulations and any conditions of approval imposed by an IRB or FDA • Supervise the use of the investigational device (LiquiBand FIX8®) and ensure the device is to be used only on subjects under the investigator's supervision and shall not supply an investigational device to any person not authorized to receive it. • Following patients through the end of the study • Completing CRFs on time, completely, and accurately • Reporting Adverse Events in a timely manner • Supplying the sponsor with his/her updated curriculum vitae and that of the co- Investigators as applicable • Maintaining records and providing reports according to regulations (21 CFR 812.140(a) • Sharing all relevant study-related information with co-Investigators • Filing and archiving study documentation as per regulations in force • Disclosure to the sponsor sufficient accurate financial information through completion and accurate certification or disclosure statements required under 21CFR54. The investigator and Sub-Investigator(s) shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study. • Disposing of device: Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator shall return to the sponsor any remaining supply of the device.
