Clinical Trial Agreement Israel

(b) information that is already known independently of the Principal Investigator or staff of the Institute (or its affiliated hospitals) and that is exempt from confidentiality obligations prior to disclosure by the Proponent under this Agreement or any other agreement between the Project Leader and/or the Institution (or Affiliated Hospitals) and the Sponsor, as evidenced by contemporary written documents; or 16.8 Entire Agreement; Amendments. This Agreement, including but not limited to its Annexes, contains the entire agreement of the Parties with respect to its subject matter. Oral or prior written submissions or representations not contained in this Agreement shall have no force or effect, and no part of this Agreement or the Protocol may be modified, supplemented, replaced or otherwise modified unless there is a written letter signed in writing by all parties. With respect to any inconsistency between this Agreement and the Protocol, the Protocol shall prevail with respect to matters of the subjects of study and this Agreement shall prevail over all other matters. Our useful experience with multiple hospitals and IRB/EC allows us to select the most suitable locations for your study. Our proven systems and programs accelerate recruitment and be more effective at different stages of the study. The Israeli Ministry of Health and ethics committees accept written protocols in English, investigators` brochures, IMPD documents, CMC, IFU documents, etc. Even the clinical trial agreement and the quality agreement with the clinical sites can only be negotiated and conducted in English. The only documents that need to be translated into Hebrew are those given to patients (consent forms, questionnaires, etc.) and the protocol summary. 5.1 Publication of the study results in the scientific literature is recommended, but the principal investigator and the institution agree not to publish or publicly present the interim results of the study.

The Sponsor reserves the right to review any written article or other form of publication using the study data and to propose modifications before such article is submitted or submitted for publication in order to protect confidential information or patentable rights. No public submission may contain confidential information of the sponsor (with the exception of the results of the study). If the parties do not agree on the accuracy and appropriateness of the analysis and presentation of the data and/or on the confidentiality of the Sponsor`s confidential information, the institution and/or principal investigator agree to meet with the Sponsor`s representatives prior to the publication or submission of any publication in order to seek in good faith to discuss and resolve such issues or disagreements. however, the final decision on the content of this publication is at the discretion of the project manager. Principal Investigator, study personnel (collectively, the „Indemnitors“) by and against any claim or proceeding (including settlements or payments of gratuities made with the consent of the parties and reasonable legal and expert costs and costs (including attorneys` fees) incurred by or on behalf of a study participant against a person entitled to compensation for damages (including death) to study participants arising out of or as a result of the Conduct of the Study, whether successful or unsuccessful, against a person entitled to compensation for damage (including death) resulting from the conduct of the study or the proper administration of the investigational medicinal product under this Agreement or any clinical intervention or procedure provided for in the Protocol („Claims“). Novatrials can offer you a wide range of solutions tailored to your needs, from open-clinica to Rave Medidata. Yes, we do. There is a whole process of contract negotiations, including the budget agreement and the quality agreement. Thanks to our experience in clinical trials and our knowledge of each site, negotiations are concluded quickly.

to carry out all obligations and agreements of the former Principal Investigator under this Agreement. All translations are prepared to the highest standards for clinical trials and outsourced to an approved vendor, using a translator and validator for each document. A confidentiality agreement is confirmed by all suppliers prior to their approval. Unless the Sponsor gives its prior written consent, neither the Institution nor the Principal Investigator may use the Confidential Information for purposes other than those authorized in this Agreement, nor the Institution or Principal Investigator may disclose Confidential Information to any third party, except to the extent permitted by this Agreement or as required by law, including applicable regulations (the sponsor expressly authorized everything required the disclosure of confidential information to the IRB). or representatives of the regulatory authority or study staff participating in the study, based on the requirement that they be aware of it and who are bound by agreements at least equivalent to the terms of that confidentiality agreement). The Institution and its officers, staff, directors and representatives, as well as clinical trials conducted at the Hospital, are covered for the duration of this Agreement and the Study by professional indemnity insurance under a required and customary insurance agreement in accordance with applicable Israeli laws and regulations and, as usual, by hospitals in Israel. The principal investigator and the institution agree that their names may be used in study publications and communications, including clinical trial websites and study newsletters, and the sponsor may disclose the name of the principal investigator and the institution, as well as the names of all investigators, the nature of the services provided by the principal investigator and the institution and/or an investigator to the sponsor in under this Agreement. the existence and terms of this Agreement, as well as the amount of remuneration paid by the Institution Sponsor in exchange for the services of the Principal Investigator and the institution or services of an auditor, solely to comply with applicable laws and regulations. The Principal Investigator and the Organization are responsible for ensuring that all auditors have agreed to these disclosure terms. If no multi-centre publication is made at all sites within eighteen (18) months of the end of the study, the Sponsor agrees to provide access to aggregated data from all study sites in full compliance with the ICMJE at the request of the institution or Principal Investigator, Institution or Principal Investigator.

If the sponsor is not required to provide access to the aggregated data set out above, the sponsor shall not unreasonably refuse to consent to such data being made available to the institution or principal investigator in order to facilitate a full publication proposed by the institution or principal investigator. Agreement with the hospital (as defined below) to conduct and conduct clinical trials using the hospital`s infrastructure, facilities and staff; AND required by a reasonable and prudent clinical investigator or physician. Only staff duly qualified and trained in the field of clinical research activities will be authorized by the institution or principal investigator to participate in the conduct of the study as study personnel. 5.3 If this study is part of a multi-centre clinical trial, the institution and the principal investigator agree that the first publication of the study results will be in conjunction with the submission of a joint multi-centre publication of the study results with the principal investigators from all sites providing data, analysis and comments, and that any subsequent publication by the principal investigator will refer to that publication. Main. 10.1.1 It has obtained all necessary approvals and approvals required by law to conduct the study (including with respect to the use of the material) and there is no impediment by any law or agreement to conduct the study; Each institution and the Principal Investigator acknowledge that they and all those acting on their behalf in connection with the study have no conflict of interest that would impede or impair their performance under this Agreement and confirm that their performance under this Agreement does not violate any other agreement with third parties. .