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). 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 postmarket vigilance procedures) and should be communicated to the medical device’s manufacturer as per local requirements, as applicable. The Investigator should also report complaints on non-Alcon products directly to the manufacturer as per the manufacturer’s instructions or local regulatory requirements.
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.
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). 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.
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 postmarket 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.
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.
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.
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.
