Procedures for Recording and Reporting. AEs are collected from the time of informed consent. Any preexisting medical conditions or signs/symptoms present in a subject prior to the start of the study (i.e., before informed consent is signed) are not considered AEs in the study and should be recorded in the Medical History section of the eCRF. In addition, temporary lens awareness or visual changes during the fitting process are not considered AEs if the investigator assesses that the symptom(s) can reasonably resolve within the anticipated adaptation period. For each recorded event, the ADEs and SAEs documentation must include: date of occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness and causality. In addition, the investigator must document all device deficiencies reported or observed with Test and Comparator products on the Device Deficiency eCRF. The site must submit all available information on ADEs, SAEs, and device deficiencies to the study sponsor immediately as follows • All SAEs must be reported immediately (within 24 hours) of the investigator’s or site’s awareness. • ADEs that do not meet seriousness criteria and Device deficiencies must be reported within 10 calendar days of the investigator’s or site’s awareness. • A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or Device Deficiency eCRF must be included with product returns. • Additional relevant information after initial reporting must be entered into the eCRF as soon as the data become available. • Document all relevant information from Discharge Summary, Autopsy Report, Certificate of Death, etc., if applicable, in narrative section of the Serious Adverse Event and Adverse Device Effect eCRF.
Procedures for Recording and Reporting. AEs are collected from the time of informed consent. Any pre-existing medical conditions or signs/symptoms present in a subject prior to the start of the study (ie, before informed consent is signed) are not considered AEs in the study and should be recorded in the Medical History section of the eCRF. In addition, temporary lens awareness or visual changes during the fitting process are not considered AEs if the Investigator assesses that the symptom(s) can reasonably resolve within the anticipated adaptation period. • ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect eCRF within 24 hours of the Investigator’s or site’s awareness. • Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of the Investigator’s or site’s awareness. • A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or Device Deficiency eCRF must be included with product returns. • Additional relevant information after initial reporting must be entered into the eCRF as soon as the data become available. • Document any changes to concomitant medications on the appropriate eCRFs. • Document all relevant information from Discharge Summary, Autopsy Report, • Certificate of Death, etc, if applicable, in narrative section of the Serious Adverse Event and Adverse Device Effect eCRF.
Procedures for Recording and Reporting. AEs are collected from the time of informed consent. Any pre-existing medical conditions or signs/symptoms present in a subject prior to the start of the study (ie, before informed consent is signed) are not considered AEs in the study and should be recorded in the Medical History section of the eCRF. For each recorded event, the ADEs and SAEs documentation must include: date of occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness and causality. In addition, the Investigator must document all device deficiencies reported or observed with test and control products on the Device Deficiency eCRF. • ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect eCRF within 24 hours of the Investigator’s or site’s awareness. • Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of the Investigator’s or site’s awareness. • A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or Device Deficiency eCRF must be included with product returns. • Additional relevant information after initial reporting must be entered into the eCRF as soon as the data become available. • Document any changes to concomitant medications on the appropriate eCRFs. • Document all relevant information from Discharge Summary, Autopsy Report, Certificate of Death, etc, if applicable, in narrative section of the Serious Adverse Event and Adverse Device Effect eCRF.
Procedures for Recording and Reporting. AEs are collected from the time of informed consent. Any pre-existing medical conditions or signs/symptoms present in a subject prior to the start of the study (i.e., before informed consent is signed) are not considered AEs in the study and should be recorded in the Medical History source. Study Sponsor representatives may be contacted for any protocol related question. .
Procedures for Recording and Reporting. 11 Assess and record any AEs and device deficiencies reported or observed during the study visit.
Procedures for Recording and Reporting. AEs are collected from the time of informed consent. .
Procedures for Recording and Reporting. AEs are collected from the time of informed consent. Any pre-existing medical conditions or signs/symptoms present in a subject prior to the start of the study (ie, before informed consent is signed) are not considered AEs in the study and should be recorded as medical history. Any AEs and device deficiencies for non-study marketed devices/products (ie, OFR) will be considered and processed as spontaneous (following the postmarket vigilance procedures) and should be communicated to the device’s/product’s manufacturer as per local requirements. Study Sponsor representatives may be contacted for any protocol related question. The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that are upgraded from non-serious to serious or from unrelated to related.
Procedures for Recording and Reporting. AEs are collected from the time of informed consent. Any pre-existing medical conditions or signs/symptoms present in a subject prior to the start of the study (ie, before informed consent is signed) are not considered AEs in the study and should be recorded in the Medical History section of the eCRF. • ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect eCRF within 24 hours of the Investigator’s or site’s awareness. • Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of the Investigator’s or site’s awareness. • A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or Device Deficiency eCRF must be included with product returns. • Additional relevant information after initial reporting must be entered into the eCRF as soon as the data become available. • Document any changes to concomitant medications on the appropriate eCRFs. • Document all relevant information from Discharge Summary, Autopsy Report, Certificate of Death, etc, if applicable, in narrative section of the Serious Adverse Event and Adverse Device Effect eCRF.
Procedures for Recording and Reporting. AEs are collected from the time of informed consent. Any preexisting medical conditions or signs/symptoms present in a subject prior to the start of the study (i.e., before informed consent is signed) are not considered AEs in the study and should be recorded in the Medical History section of the eCRF. For each recorded event, the ADEs and SAEs documentation must include: date of occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness and causality. In addition, the investigator must document all device deficiencies reported or observed with test and control products on the Device Deficiency eCRF. The site must submit all available information on ADEs, SAEs, and device deficiencies to the study sponsor immediately as follows: • All SAEs must be reported immediately (within 24 hours) of the investigator’s or site’s awareness. • ADEs that do not meet seriousness criteria and device deficiencies must be reported within 10 calendar days of the investigator’s or site’s awareness.
Procedures for Recording and Reporting. If any serious adverse event occurs, the investigator will report the type of the serious adverse event to Alcon Japan within 24 hours after confirming the event. After obtainment of detailed information on the serious adverse event, the investigator will prepare a report and immediately submit it to Alcon Japan and the head of the study sites. All adverse events (related and unrelated to the medical device or test procedures) will be entered in the Adverse Event form. Surgically-related post-operative conditions that are normal consequences of the ocular surgery (see MOP) and not clinically relevant will be only reported as adverse events at the discretion of the investigator. In addition, the investigator must document all serious adverse events (related and unrelated) on the Serious Adverse Event Form. Any device deficiencies will be entered in the device deficiency form within 24 hours after confirming the event. Adverse events will also be reported for any clinically relevant change from informed consent in any protocol specific safety parameter evaluated during the study, based upon an assessment by the investigator following exposure to an investigational product. Regarding the relationship with the investigational lens, a judgment will be made whether “not related” or “related.” Adverse events will be reported for any change in an ongoing medication and/or addition of a new medication, based upon an assessment by the investigator. In addition, for all device deficiencies that have occurred, the details of it and the condition in which it have occurred will be entered in the device deficiency form within 24 hours after confirming the event. Study Sponsor contact information is provided in the Manual of Procedures (MOP).
