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. 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 double-masked with subjects randomized to use PRECISION1 or INFUSE for the duration of one-week treatment period and then crossover and use the other study product for one-week treatment period. The subjects, investigators, and sponsor personnel (other than site monitors, Clinical Operations Lead, 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. 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.
Sample 1See All (5)
AutoNDA by SimpleDocs
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.
Sample 1Sample 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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1

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) Upon reasonable advance written notice, and subject to applicable logistical restrictions or limitations as a result of COVID-19 or any COVID-19 Measures, the Company shall afford Parent and Parent’s representatives reasonable access, during normal business hours between the date of this Agreement and the earlier of the Acceptance Time and the date of termination of this Agreement, to the Acquired Companies’ (i) officers, employees, and other personnel, (ii) assets and (iii) all books and records, and, during such period, the Company shall furnish promptly to Parent all information, including financial and operating data, concerning its business as Parent may reasonably request; provided, however, that the Acquired Companies shall not be required to permit any inspection or other access, or to disclose any information to the extent such disclosure in the reasonable judgment of the Company could: (i) result in the disclosure of any trade secrets of Third Parties; (ii) jeopardize protections afforded to any of the Acquired Companies under the attorney-client privilege or the attorney work product doctrine; (iii) violate any Law; or (iv) materially and adversely interfere with the conduct of the Acquired Companies’ business; and provided further that any such access shall be afforded and any such information shall be furnished solely at Parent’s expense. All requests for access pursuant to this Section 6.5(a) must be directed to the Chief Legal Officer of the Company or another person designated in writing by the Company. Notwithstanding anything herein to the contrary, Parent and Merger Sub shall not, and shall cause their respective representatives not to, contact any partner, licensor, licensee, customer or supplier of the Company in connection with the Offer, the Merger or any of the other Transactions without the Company’s prior written consent (which consent shall not be unreasonably withheld, conditioned or delayed). (b) Parent and the Company hereby acknowledge and agree to continue to be bound by the Confidentiality Agreement. All information provided by or on behalf of the Acquired Companies pursuant to this Agreement or obtained by Parent and its representatives pursuant to Section 6.5(a) shall be treated as confidential information of the Acquired Companies for purposes of the Confidentiality Agreement.

  • 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 All data, regardless of form, including originals, images and reproductions, prepared by, obtained by or transmitted to the Professional in connection with this Agreement is confidential, proprietary information owned by NBU. Except as specifically provided in this Agreement, the Professional shall not intentionally disclose data generated in the performance of the Services to any third party without the prior, written consent of NBU.

  • 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”).

  • Data Protection and Confidentiality 9.5.1 The Tenant’s personal data, which will be processed in the execution of this Agreement will be handled in accordance with the General Data Protection Regulation (EU) 2016/679. Further details regarding this processing activity is set out in the associated Privacy Notice, which can be found at: xxxxx://xxx.xxxxxxx.xxx/privacy-policy

  • Recordkeeping/Confidentiality 1. Price Services shall keep records relating to the Services to be performed hereunder, in the form and manner as it may deem advisable, provided that Price Services shall keep all records in such form and in such manner as required by applicable law. 2. Price Services and the Fund agree that all books, records, information and data pertaining to the business of the other party which are exchanged or received pursuant to the negotiation or the carrying out of this Agreement shall remain confidential, and shall not be voluntarily disclosed to any other person, except: (a) after prior notification to and approval in writing by the other party hereto, which approval shall not be unreasonably withheld and may not be withheld where Price Services or the Fund may be exposed to civil or criminal contempt proceedings for failure to comply; (b) when requested to divulge such information by duly constituted governmental authorities; or (c) after so requested by the other party hereto. Without limiting the foregoing, Price Services has implemented, and will maintain during the term of this Agreement, reasonable measures designed to (i) ensure the security and confidentiality of identifying information concerning Shareholders, (ii) use such information to provide the Services hereunder, (iii) protect against any anticipated threats or hazards to the security or integrity of such information, (iv) protect against unauthorized access to or use of such information that could result in substantial harm or inconvenience to the subject of such information, and (v) ensure appropriate disposal of such information, to the extent such information is being disposed of by Price Services.

  • Ownership of Materials and Confidentiality a. CONSULTANT shall furnish, at his/her own expense, all labor, materials, equipment, supplies and other items necessary to complete the services to be provided pursuant to this Contract unless otherwise specifically stated in the Contract. CONSULTANT’s services will be performed, findings obtained, reports and recommendations prepared in accordance with generally and currently accepted principles and practices of his/her profession. b. All materials and data, including but not limited to, data on magnetic media and any materials and data required to be made or kept pursuant to federal, state or local laws, rules or regulations, prepared or collected by CONSULTANT pursuant to this AGREEMENT, shall be the sole property of the DISTRICT, except that CONSULTANT shall have the right to retain copies of all such documents and data for its records. DISTRICT shall not be limited in any way in its use of such materials and data at any time, provided that any such use not within the purposes intended by this AGREEMENT shall be at DISTRICT’s sole risk and provided that CONSULTANT shall be indemnified against any damages resulting from such use, including the release of this material to third parties for a use not intended by this AGREEMENT. c. All such materials and data shall be provided to the DISTRICT, or such other agency or entity as directed by DISTRICT or required by law, rule or regulation, immediately upon completion of the term of this AGREEMENT as directed by DISTRICT. Should DISTRICT wish to obtain possession of any such materials or data during the term of this AGREEMENT, it shall make its request in writing. Such information shall be provided to the DISTRICT within forty-eight (48) hours of its request.

  • Definition of Proprietary Information The Executive acknowledges that he may be furnished or may otherwise receive or have access to confidential information which relates to the Company’s past, present or future business activities, strategies, services or products, research and development; financial analysis and data; improvements, inventions, processes, techniques, designs or other technical data; profit margins and other financial information; fee arrangements; compilations for marketing or development; confidential personnel and payroll information; or other information regarding administrative, management, or financial activities of the Company, or of a third party which provided proprietary information to the Company on a confidential basis. All such information, including in any electronic form, and including any materials or documents containing such information, shall be considered by the Company and the Executive as proprietary and confidential (the “Proprietary Information”).

  • Confidentiality and Data Protection We are a data controller for the information you provide to us including individual, identification and financial details, policy history and special category data (such as medical or criminal history). Details of our legal basis for processing your information, along with details of any third party recipient whom it may be necessary to share your personal data with in order to fulfil the contract, retention period for data held, security of your data, your rights under the UK General Data Protection Regulations (UK GDPR) including the right to complain can be found in our full ‘Privacy Notice’ attached to these terms of business and/or on our website at xxx.xxxxxxxxxxxxxxxx.xx.xx.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!