Subject Confidentiality and Methods Used to Minimize Bias Sample Clauses

Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor. This study is subject-masked with subjects randomized to use LID017569 or Biofinity for 30 days and then crossover and use the other study product for 30 days. The Sponsor personnel (other than site monitors, lead clinical site manager, CDMA PL, Alcon Observer, person responsible for generating the randomization schedule, and unmasked clinical data managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity of the contact lens being administered. This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked. Masked study personnel must avoid seeking information that may compromise masking. Unmasked study personnel must not disseminate information that is potentially unmasking to any masked personnel. The masked and unmasked site personnel must coordinate all study activities as necessary to protect masking and minimize bias during the trial.
View SourceView Similar (5)
Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study.
View SourceView Similar (2)
Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. All documents submitted to the Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor. This an open label study with all subjects assigned to wear LID020098 bilaterally for the duration of the 2-week treatment period.
View Source
Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor will identify the subjects exclusively by number and demographic information. No other personally identifying information should be transmitted to the Sponsor. Sponsor personnel (other than site monitors, lead clinical site manager, person responsible for generating the randomization schedule, and unmasked clinical data managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity of the contact lens being administered. This level of masking will be maintained throughout the conduct of the study. Unmasking will occur only after all planned study data have been validated, and the database locked.‌‌‌ This study is open label with randomized subjects to use either DAILIES TOTAL1 or Acuvue Oasys 1-Day for the duration of the 4-week treatment period. Visual acuity is the primary endpoint and the study is controlled DAILIES TOTAL1 or Acuvue Oasys 1-Day wearers will be excluded.
View Source
Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with confidential identifying information that corresponds to the subject numbers and initials of each study participant. At the end of the clinical study, the Sponsor will collect a copy of the enrollment log without any identifying subject information. All documents submitted to the Sponsor will identify the subjects exclusively by subject ID and demographic information. No other personally identifying information should be transmitted to the Sponsor. The intent of masking is to limit the occurrence of conscious and unconscious bias in the conduct and interpretation of the clinical study. Bias could arise from the influence that the knowledge of a specific treatment assignment may have on the recruitment and allocation of subjects, their subsequent care, the assessment of end points, the handling of withdrawals, and so on. The essential aim of masking, therefore, is to prevent identification of the test article(s) by the Investigator, subject, and others associated with the conduct of the study until all such opportunities for bias have passed. This study is Investigator-masked and subject quasi-masked (masked to test solution brand only), with subjects randomized to the order in which they will use OFPM and their HMPS for 30 ± 3 days each. The Investigator will not be aware of the specific treatment being administered and the subject will not be aware of the brand of the test solution. Alcon study personnel will be masked, with the exception of the following: Study monitor, Lead CSM, and person responsible for generating the randomization schedule. This level of masking will be maintained throughout the conduct of the study. Subjects will be assigned treatment order based on the randomization schedule; it will be blocked to ensure a balance of study treatment allocations within investigational sites. The randomization scheme will be generated and maintained by the Sponsor. In the event of a medical emergency where the knowledge of subject treatment is required, an individual Investigator will have the ability to unmask the treatment sequence assignment for a specific subject.
View Source
Subject Confidentiality and Methods Used to Minimize Bias. The Investigator must ensure that the subject’s anonymity is maintained throughout the course of the study. This is an open label study with all subjects assigned to wear LID021201 bilaterally for the duration of the 1-week treatment period.
View Source

Related to Subject Confidentiality and Methods Used to Minimize Bias

  • Confidentiality and Non-Use In consideration of receiving Confidential Information, the QCP and PA agree as follows: a. The Parties hereby acknowledge that any Confidential Information received by either Party is the property of the disclosing Party and the Property Owner, as applicable, and that the receiving Party shall hold confidential and not disclose to any Person, without the prior written consent of the disclosing Party or as otherwise required by law, and if such consent is given, obtain a written commitment from such third party, all Confidential Information and any information about the Project, or the terms or conditions or any other facts relating thereto, including, without limitation, the fact that discussions are taking place with respect thereto or the status thereof, or the fact that Confidential Information has been made available to the receiving Party or its Representatives; provided, however, that the Parties may disclose such Confidential Information to their Representatives and their potential or actual direct or indirect investors and potential or actual third party participants in the Project or third party assignees or transferees of all or any portion of the Project, who are actively and directly participating in the Party’s evaluation of the Project or who otherwise need to know the Confidential Information for the purpose of the Project; b. Each Party shall cause all its Representatives to observe the terms of this Agreement and shall be responsible for any breach of the terms of this Agreement by it or its Representatives; and, c. The receiving Party shall return or destroy all Confidential Information (including all copies thereof) within ten (10) days of receipt of a written request made by the disclosing Party, except for one record copy that may be maintained by the receiving Party in its legal archives. Further, the receiving Party shall delete all Confidential Information contained in electronic files. Notwithstanding the foregoing, the Parties may retain copies of any computer records and files containing Confidential Information that have been created pursuant to their automatic electronic archiving and back-up procedures until such computer records and files have been deleted in the ordinary course. Any copies retained as described shall be maintained as Confidential Information in accordance with the terms of this Agreement. d. In addition to the foregoing, neither Party will use the Confidential Information for any purpose other than directly in connection with the Project and as expressly authorized in writing by the disclosing Party or, if the Confidential Information is the property of the Property Owner, by the Property Owner.

  • Access; Confidentiality (a) Between the date of this Agreement and the Closing, Seller shall (i) afford each of Parent, Purchaser, Purchaser's Subsidiary and their authorized representatives reasonable access to all offices and other facilities of the Business and to all books and records relating to the Business and to the employees and personnel of the Business, (ii) permit each of Parent, Purchaser and Purchaser's Subsidiary to make such inspections and to make copies of such books and records as they may reasonably require and (iii) furnish each of Parent, Purchaser and Purchaser's Subsidiary with such financial and operating data and other information concerning the Business as they may from time to time reasonably request. Each party will direct its employees to render any assistance which the other party may reasonably request in examining or utilizing records referred to in this Section 6.2. (b) On and after the Closing, during normal business hours, Seller will permit each of Parent, Purchaser, Purchaser's Subsidiary and their authorized representatives, to have access to and examine and make copies of all books and records of Seller relating to the Business which are not delivered to Purchaser or Purchaser's Subsidiary pursuant hereto (including correspondence, memoranda, books of account, Tax records and the like) and relating to events occurring prior to the date hereof and to transactions or events occurring prior to the date hereof. (c) Parent, Purchaser and Purchaser's Subsidiary shall cooperate with Seller, at Seller's expense, and make available to Seller such documents, books, records or information transferred to Purchaser or Purchaser's Subsidiary and relating to activities of the Business or Seller prior to the Closing as Seller may reasonably require after the Closing in connection with any tax determination or contractual obligations to third parties or to defend or prepare for the defense of any claim against Seller or to prosecute or prepare for the prosecution of claims against third parties by Seller relating to the conduct of the business of the Business by Seller prior to the Closing or in connection with any governmental investigation of Seller or any of its Affiliates. (d) Each party agrees not to destroy any files or records which are subject to this section without giving reasonable notice to the other, and within 15 days of receipt of such notice, such other party may cause to be delivered to it the records intended to be destroyed, at such other party's expense. (e) Parent, Purchaser, Purchaser's Subsidiary and their authorized representatives (including its designated engineers or consultants) may at any time enter into and upon all or any portion of the Business' or any Business Subsidiary's properties (including all Real Property) in order to investigate and assess, as Parent, Purchaser and Purchaser's Subsidiary deem necessary or appropriate in their sole and absolute discretion, the environmental condition of such properties or the business conducted thereat. Such investigation may include, but need not be limited to, the performance of soil and surface or ground water sampling, monitoring, borings or testing and any other tests, investigations, audits, assessments, studies, inspections or other procedures relating to environmental conditions or Materials of Environmental Concern. Seller shall, and shall cause the Business and any Business Subsidiary to, cooperate with each of Parent, Purchaser, Purchaser's Subsidiary and their authorized representatives in conducting such investigation, shall allow Parent, Purchaser, Purchaser's Subsidiary and their authorized representatives full access to their properties and businesses, together with full permission to conduct such investigation, and shall provide to Parent, Purchaser, Purchaser's Subsidiary and their authorized representatives all plans, soil or surface or ground water tests or reports, any environmental investigation results, reports or assessments previously or contemporaneously conducted or prepared by or on behalf of, or in the possession of or reasonably available to Seller or any Business Subsidiary or any of their engineers, consultants or agents and all other information relating to environmental matters in respect of the Business. Purchaser shall restore, repair or replace Assets that are damaged or destroyed, other than ordinary wear and tear, as a result of Purchaser's action. Purchaser shall indemnify Seller for all such damage or destruction, including the damage or destruction arising out of an inspection conducted by Purchaser or Purchaser's representatives. (f) Any information regarding the Business or Assets heretofore or hereafter obtained from Seller or its Subsidiaries by Parent, Purchaser, Purchaser's Subsidiary or their representatives shall be subject to the terms of the Confidentiality Agreement, and such information shall be held by Parent, Purchaser, Purchaser's Subsidiary and their representatives in accordance with the terms of the Confidentiality Agreement provided, however, that following the Closing, this Section 6.2 and the Confidentiality Agreement shall not prohibit Parent, Purchaser or Purchaser's Subsidiary from using and providing to third parties such information concerning the Assets or the Business as it may deem appropriate. The foregoing shall not preclude Parent, Purchaser or Purchaser's Subsidiary from (i) the use or disclosure of such information which currently is known generally to the public or which subsequently has come into the public domain, other than by way of disclosure in violation of this Agreement, (ii) the use or disclosure of such information that becomes available to Parent, Purchaser or Purchaser's Subsidiary on a non- confidential basis from a source other than Seller or the Seller's representatives, provided that such source is not known by Purchaser or Purchaser's Subsidiary to have a legal obligation prohibiting the disclosure of such information, or (iii) the disclosure of such information required by law or court order, provided that, to the extent practicable, prior to such disclosure required by law or court order Parent, Purchaser or Purchaser's Subsidiary will give Seller prior written notice of the nature of the law or order requiring disclosure and the disclosure to be made in accordance therewith.

  • Definition of Confidential Information The term “Confidential Information” shall mean all information that either party discloses (a “Disclosing Party”) to the other party (a “Receiving Party”), whether in writing, electronically, or orally and in any form (tangible or intangible), that is confidential, proprietary, or relates to clients or shareholders (each either existing or potential). Confidential Information includes, but is not limited to:

  • Data Confidentiality Revvity will not use or provide the Test Subject’s personal information or the data from Sequencing Test to any third party, unless (1) the Test Subject or Legal Guardian has given consent for such use or disclosure, or (2) the use or disclosure is required by law, including a subpoena, court order, or order of another governmental body of competent jurisdiction. Revvity may share Client contact information with a third-party vendor for purposes of processing communications regarding the Sequencing Services, and any such vendors will be bound by confidentiality requirements prohibiting them from using Client information for any purpose other than processing such communications. Revvity will provide your contact information to the Ordering Provider to facilitate Client’s completion of required documentation. Sequencing Test results are confidential and may not be released to anyone without the Test Subject’s or Legal Guardian’s written and informed consent, except as permitted or required by applicable law or regulation, including a subpoena, court order, or order of another governmental body of competent jurisdiction. Revvity Omics will provide results of the Sequencing Test only to the Ordering Provider, as described herein, to the Test Subject’s healthcare provider, or otherwise as required by applicable law or regulation.

  • Confidential Information Definition Grantee acknowledges it and its employees or agents may, in the course of performing its responsibilities, be exposed to or acquire information that is: (i) confidential to Agency or Project participants or (ii) the disclosure of which is restricted under federal or state law, including without limitation: (a) personal information, as that term is used in ORS 646A.602(12), (b) social security numbers, and (c) information protected by the federal Family Educational Rights and Privacy Act under 20 USC § 1232g (items (i) and (ii) separately and collectively “Confidential Information”).