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翻訳 - 英語 ００００ University (herein referred to as “the First Party”) and ００００ Inc. (herein referred to as “the Second Party”) do hereby agree to the conditions listed in the following agreement (herein referred to as “this Agreement”) regarding joint applications for and ownership rights to inventions created through cooperative research.
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Equity
Article 2: The First and Second Parties agree to share Patent Rights, the First Party retaining 35%, the Second Party 65%.
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Transference of Equity
Article 7: Neither Party may transfer part or all of their Patent Right equity to a third party, nor create a pledge for such a purpose, without the other Party’s written consent.
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Enforcement of Changes
Article 15: This Agreement assumes that any changes made in the Application regarding utility model registration also apply to relative divisional applications and claim of priority applications filed.
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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement in duplicate, and each Party shall keep one copy of the originals.
英語 から 日本語: 監査報告-Ａｕｄｉｔ Ｒｅｐｏｒｔ
原書のテキスト - 英語 Executive Summary: The auditor's overall impression of the site is that the study was conducted under GCP and ICH guidelines. There was one isolated instance of serious GCP non-compliance observed; Subject **** has a Legal Authorized Representative (LAR) because (the subject) had given away (their) power of attorney to (their child) due to memory loss, but the informed consent was signed by the subject instead of (their) LAR. ... In order to determine the significance of this issue and the appropriate actions to be taken, it is suggested that (Company A) consult a regulatory attorney who specialized in Informed Consent violations.
...The site regulatory binder review revealed numerous issuer to be corrected prior to study closure; however, a review of key regulatory documents (e.g. FDA ｆorm 1572, licenses) indicated that all key documents were present and accurate. The site had several issues with outdated or inaccurate information on the staff CV's present in the regulatory binder and there were multiple documents that required PI signature and date that had never been signed. ... The site staff who managed the study, (J) and (S), did an excellent job with source documentation, CRF completion, regulatory document maintenance, providing and documenting informed consent, and overall site management. However, the auditor noted that during the interview with Dr. (D), (Dr. D) was very disconnected from the study; (Dr. D) didn't know how many subjects had been enrolled and was unaware that the site had consented a subject with a LAR.
英語 から 日本語: Letter to the FDA / FDA宛の文通 General field: 医療 Detailed field: 医療: 製薬
原書のテキスト - 英語 Dear Dr. C:
By this communication, A Inc. (“A.I.”) wishes to inform FDA of the identification of instances of serious breach of compliance with Good Clinical Practices (GCP) in clinical study ****1. During October-November of 2008, A.I. secured the services of an independent GCP compliance auditor to evaluate ****1. The auditor selected two sites from among the United States sites based on pre-established criteria and conducted onsite inspections and interviews with site personnel. The auditor reported to A.I. the following top-line issues from her assessment:
• At one site, it was evident that subjects were not compensated in accordance with the Informed Consent Form (ICF). In addition, there is documentation suggesting that one subject was informed that she would not be compensated for any visits if she did not complete all visits (contrary to the ICF provisions).
• At one site, the ICF on file did not include a three-month follow up visit although subjects returned to the clinic for such visits.
• An ICF for one subject was not signed by the subject's Legal Authorized Representative even though the subject had delegated her power of attorney to a family member.
In addition to these findings, numerous other less serious issues were identified during the audits and are summarized in the full audit reports prepared by the auditor. The audit reports are provided as attachments to this letter.
In addition to the GCP noncompliance findings, significant issues related to the drug product quality were identified in a separate assessment. Specifically, it was discovered that the analytical methods used for release and stability testing of the clinical trial materials used in the two Phase III studies, ****1 and ****2, had not been shown to be stability-indicating or otherwise qualified in any manner. This finding brings into question the purity and potency of the CTM and, therefore, the validity of data collected during these studies.
Based on these issues, A.I. has initiated immediate study close-out for both studies. Since it is evident that the data collected from studies ****1 and ****2 will not be suitable for pivotal study registration, A.I. will perform study close-out according to the abbreviated process described below. The full study close-out procedure is available to FDA upon request. Furthermore, the abbreviated clinical study reports, as described in the close-out procedure which follows, will be submitted to FDA by February 15, 2009.
Study Close-Out Procedure:
All outstanding data queries on safety endpoint data will be resolved; however, queries of non-safety data will not be resolved prior to database lock and study close-out. Only sites with active drug product on-site will have a close-out monitoring visit; sites without drug on-site will have a telephone close-out visit. After database lock, an abbreviated clinical study report will be produced for each study that includes a high-level summary of safety data. Although no formal analyses will be performed, the study reports will include detailed narratives for all serious adverse events and adverse events that led to early discontinuation. Specific details regarding this orderly wind-down of clinical activities will be archived in the Trial Master File for each study.
As a result of the findings from the assessments performed, A.I. requests termination of IND ***** upon submission of the final abbreviated clinical study reports. Soon after that time, A.I. will cease to exist and will not seek to conduct clinical development of study drug D or any other FDA regulated product in the future.
A.I. recognizes the seriousness of noncompliance with the principles of Good Clinical Practice and Good Manufacturing Practice, especially as related to patient safety. By the measures outlined in this communication, A.I. commits to complete and orderly close-out of the clinical studies ****1 and ****2 and the IND under which they were conducted. A.I. welcomes the opportunity to meet with FDA to discuss these findings and our plans for resolution of the issues. If you require additional information of clarification of any of the issues presented herein, please do not hesitate to contact us through our authorized FDA representative, F Inc.
入会時期 Jul '26
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