Common use of Procedures for Recording and Reporting Clause in Contracts

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. consent Any pre-existing medical conditions or signs/symptoms present in a subject prior to the start of the study (iei.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 investigator must document all device deficiencies reported or observed with test and control 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: • ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect eCRF within 24 hours of the Investigatorinvestigator’s or site’s awareness. • Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of the Investigatorinvestigator’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, 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 (iei.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 investigator must document all device deficiencies reported or observed with test and control 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: • ADEs or All SAEs are documented on the Serious Adverse Event and Adverse Device Effect eCRF must be reported immediately (within 24 hours hours) of the Investigator’s or site’s awareness. • Device ADEs that do not meet seriousness criteria and device deficiencies are documented on the Device Deficiency eCRF must be reported within 24 hours 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 any changes to concomitant medications on the appropriate eCRFssource. • Document all relevant information from Discharge Summary, Autopsy Report, • Certificate of Death, 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 preexisting medical conditions or signs/symptoms present in a subject prior to the start of the study (iei.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 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 • ADEs or All SAEs are documented on the Serious Adverse Event and Adverse Device Effect eCRF must be reported immediately (within 24 hours hours) of the Investigatorinvestigator’s or site’s awareness. • Device ADEs that do not meet seriousness criteria and device deficiencies are documented on the Device Deficiency eCRF must be reported within 24 hours 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 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.