Follow-Up of Subjects with Adverse Events Sample Clauses

Follow-Up of Subjects with Adverse Events. The Investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study.
Sample 1Sample 2Sample 3See All (5)
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Follow-Up of Subjects with Adverse Events. The investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study. The investigator should provide the study sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device. For AEs that are unresolved/ongoing at time of subject exit from study, any additional information received at follow-up should be documented in the eCRFs up to study completion (i.e., database lock). Any additional data received up to 1 month after subject discontinuation or exit must be documented and available upon the study sponsor’s request. All complaints received after this time period will be considered and processed as spontaneous and should be communicated to the medical device’s manufacturer as per local requirements. The investigator should also report complaints on non-Alcon products directly to the manufacturer as per the manufacturer’s instructions or local regulatory requirements.
Sample 1Sample 2See All (5)
Follow-Up of Subjects with Adverse Events. The investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study. The investigator should provide the study sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from study, any additional information received at follow-up should be documented in the eCRFs up to study completion (i.e., database lock). Any additional data received up to 3 months after subject discontinuation or exit must be documented and available upon the study sponsor’s request. All complaints received after this time period will be considered and processed as spontaneous (following the post-market vigilance procedures) and should be communicated to the medical device’s manufacturer as per local requirements. The investigator should also report complaints on non-Alcon products directly to the manufacturer as per the manufacturer’s instructions or local regulatory requirements.
Sample 1See All (5)
Follow-Up of Subjects with Adverse Events. The Investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study. The Investigator should provide the Study Sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from study, any additional information received at follow-up should be documented in the eCRFs up to study completion (ie, database lock). All complaints received after this time period will be considered and processed as spontaneous (following the post-market vigilance procedures) and should be communicated to the medical device’s manufacturer as per local requirements. The Investigator should also report complaints on non-Alcon products directly to the manufacturer as per the manufacturer’s instructions or local regulatory requirements.
Sample 1See All (4)
Follow-Up of Subjects with Adverse Events. The Investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study. The Investigator should provide the Study Sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from study, any additional information received at follow-up should be documented in the eCRFs up to study completion (ie, database lock). Alcon - Business Use Only Protocol - Clinical‌‌‌ Document: TDOC-0054506 Status: Effective Page 34 of 38 Any additional data received up to 1 month after subject discontinuation or exit must be documented and available upon the Study Sponsor’s request. All complaints received after this time period will be considered and processed as spontaneous and should be communicated to the medical device’s manufacturer as per local requirements. The Investigator should also report complaints on non-Alcon products directly to the manufacturer as per the manufacturer’s instructions or local regulatory requirements.
Sample 1
Follow-Up of Subjects with Adverse Events. The Investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study. The Investigator should provide the Study Sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from study, any additional information received at follow-up should be documented in the eCRFs up to study completion (ie, database lock). Printed By: Print Date: Document: TDOC-0054838 Status: Effective Page 38 of 43 Any additional data received up to 1 month after subject discontinuation or exit must be documented and available upon the Study Sponsor’s request. All complaints received after this time period will be considered and processed as spontaneous and should be communicated to the medical device’s manufacturer as per local requirements. The Investigator should also report complaints on non-Alcon products directly to the manufacturer as per the manufacturer’s instructions or local regulatory requirements.
Sample 1
Follow-Up of Subjects with Adverse Events. The Investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study. The Investigator should provide the study Sponsor with any new safety information (which includes new AEs and changes to previously reported AEs) that may affect the safety evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from study, any additional information received at follow-up should be documented in the eCRFs up to study completion (ie, database lock). All complaints received after study completion (ie, after database lock) will be considered and processed as spontaneous (following the post-market vigilance procedures) and should be communicated to the medical device’s manufacturer as per local requirements. The Investigator should report complaints on non-Alcon products directly to the manufacturer as per the manufacturer’s instructions or local regulatory requirements.
Sample 1
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Related to Follow-Up of Subjects with Adverse Events

  • Adverse Operating Effects The NYISO or Connecting Transmission Owner shall notify the Interconnection Customer as soon as practicable if, based on Good Utility Practice, operation of the Small Generating Facility may cause disruption or deterioration of service to other customers served from the same electric system, or if operating the Small Generating Facility could cause damage to the New York State Transmission System, the Distribution System or Affected Systems, or if disconnection is otherwise required under Applicable Reliability Standards or the ISO OATT. Supporting documentation used to reach the decision to disconnect shall be provided to the Interconnection Customer upon request. If, after notice, the Interconnection Customer fails to remedy the adverse operating effect within a reasonable time, the NYISO or Connecting Transmission Owner may disconnect the Small Generating Facility. The NYISO or Connecting Transmission Owner shall provide the Interconnection Customer with five Business Day notice of such disconnection, unless the provisions of article 3.4.1 apply.

  • Environmental Events The Borrower will, and will cause BPI to, promptly give notice in writing to the Agent (i) upon Borrower’s or BPI’s obtaining knowledge of any material violation (as determined by the Borrower or BPI in the exercise of its reasonable discretion) of any Environmental Law regarding any Real Estate Asset or Borrower’s or BPI’s operations, (ii) upon Borrower’s or BPI’s obtaining knowledge of any known Release of any Hazardous Substance at, from, or into any Real Estate Asset which it reports in writing or is reportable by it in writing to any governmental authority and which is material in amount or nature or which could materially affect the value of such Real Estate Asset, (iii) upon Borrower’s or BPI’s receipt of any notice of material violation of any Environmental Laws or of any material Release of Hazardous Substances in violation of any Environmental Laws, including a notice or claim of liability or potential responsibility from any third party (including without limitation any federal, state or local governmental officials) and including notice of any formal inquiry, proceeding, demand, investigation or other action with regard to (A) Borrower’s or BPI’s or any other Person’s operation of any Real Estate Asset, (B) contamination on, from or into any Real Estate Asset, or (C) investigation or remediation of off-site locations at which Borrower or BPI or any of its predecessors are alleged to have directly or indirectly disposed of Hazardous Substances, or (iv) upon Borrower’s or BPI’s obtaining knowledge that any expense or loss has been incurred by such governmental authority in connection with the assessment, containment, removal or remediation of any Hazardous Substances with respect to which Borrower or BPI or any Partially-Owned Real Estate Entity may be liable or for which a lien may be imposed on any Real Estate Asset; any of which events described in clauses (i) through (iv) above would have a material adverse effect on the business, assets or financial condition of the Borrower and its Subsidiaries, taken as a whole. As of the date hereof, the Borrower has notified the Agent of the matters referenced on Schedule 8.5(b), to the extent such matters are disclosed in the Form 10-K referred to therein.

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