Ethical Conduct of the Study. The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and its most recent amendment (2008) and are consistent with ICH/GCP and other applicable regulatory requirements.
Ethical Conduct of the Study. The study will be conducted in accordance with applicable national and international laws and regulations, the ICH-GCP guideline and the ethics principles that have their origins in the Declaration of Helsinki. The protocol and the proposed informed consent form have to been reviewed and approved by a properly constituted Independent Ethics Committee (IEC/IRB) before study start at a particular study site. Prior to study start, the principal investigator is required to sign the protocol signature page (page 3 of this study protocol) confirming his agreement to conduct the study in accordance with these documents and all of the instructions and procedures found in this protocol and to give access to all relevant data and records to monitors, auditors, IRBs/IECs, and regulatory authorities as required.
Ethical Conduct of the Study. This clinical study was designed and shall be implemented and reported in accordance with the ICH Harmonised Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (e.g., US Code of Federal Regulations Title 21, European Directive 2001/20/EC), and with the ethical principles laid down in the Declaration of Helsinki. The principal investigator agrees to conduct the study in accordance with the International Conference on Harmonization (ICH) for Guidance for Industry on Good Clinical Practice (GCP) ICH E6(R1) [xxxx://xxx.xxx.xxx/fileadmin/Public_Web_Site/ICH_Products/Guidelines/ Efficacy/E6/E6_R1_Guideline.pdf] and the principles of the Declaration of Helsinki [xxxx://xxx.xxx.xxx/en/30publications/10policies/b3/]. The principal investigator must conduct all aspects of this study in accordance with all national, state, and local laws or regulations.
Ethical Conduct of the Study. This protocol is written in accordance with the principles established by the 18th World Medical Assembly General Assembly (Helsinki, 1964) and amendments and clarifications adopted by subsequent General Assemblies. The investigator will make sure that the study described in this protocol is conducted in full conformance with those principles, the protocol, current FDA regulations, ICH Good Clinical Practices (GCP) guidelines, Good Laboratory Practices (GLP) guidelines, local ethical and regulatory requirements, including the Federal Food, Drug and Cosmetic Act, U.S. applicable Code of Federal Regulations (title 21), any EC requirements relative to clinical studies. As required by the US FDA, the study drug may not be shipped to any participating investigator until the requisite study documentation has been submitted to the IND. Should a conflict arise, the investigator will follow whichever law or guideline affords the greater protection to the individual patient. The investigator will also make sure he or she is thoroughly familiar with the appropriate administration and potential risks of administration of the study drug, as described in this protocol and the Investigator’s Brochure, prior to the initiation of the study.
Ethical Conduct of the Study. This study will be conducted in compliance with IRB or IEC, and regulatory requirements. This study will also be conducted in compliance with the protocol, GCP guidelines, International Conference on Harmonization (ICH) guidelines, the Declaration of Helsinki, and Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Ethical Conduct of the Study. The Sponsor will use information developed in this clinical study in connection with the development of A-101 40% and, therefore, may disclose it as required to other clinical Investigators participating in other studies and to regulatory agencies. In order to allow the use of the information derived from this clinical study, the Investigator understands that he/she has an obligation to provide all data produced during this study to the Sponsor. The Sponsor considers that clinical data (complete or incomplete) constitute financially sensitive information. Consequently, the Sponsor requires that discussion of results in any form, electronic, verbal, or written before study completion and full reporting should only be undertaken with the Sponsor’s prior written consent. Individual subjects’ medical information obtained as a result of this study is considered confidential. The Investigator and the study center will adhere to all applicable laws relating to the protection of subject information. To assure that subjects’ confidentiality is maintained, subjects’ data will be identified by a study-assigned number and date of birth only. All Sponsor personnel will handle subjects’ data in a confidential manner in accordance with applicable regulations governing clinical research. Subjects’ records will be inspected only in connection with this research project. Information generated as a result of a subject’s participation in this study may be disclosed to third parties for research and regulatory purposes in any country as determined by the Sponsor. However, subjects will not be individually identified but will be referred to only by the study assigned number and the subject’s date of birth.
