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. 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 control articles 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 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 Adverse Device Effect (for related AEs) and Serious Adverse Event 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. For each recorded event, the ADEs ADE and SAEs SAE 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 articles 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 • ADEs or SAEs must be reported immediately (are documented on the Serious Adverse Event and Adverse Device Effect eCRF within 24 hours) hours of the Investigator’s or site’s awareness.  ADEs that do not meet seriousness criteria and device • Device deficiencies must be reported are documented on the Device Deficiency eCRF within 10 calendar days 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 Death, etc., if applicable, in narrative section of the Serious Adverse Event and Adverse Device Effect (for related AEs) and Serious Adverse Event eCRF.

Procedures for Recording and Reporting. AEs are collected from the time of informed consent. 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 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 articles comparator products on the Device Deficiency eCRF. The site must submit all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor study sponsor immediately as follows:  • All SAEs must be reported immediately (within 24 hours) of the Investigatorinvestigator’s or site’s awareness.  • ADEs that do not meet seriousness criteria and device deficiencies must be reported within 10 calendar days 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 Adverse Device Effect (for related AEs) and Serious Adverse Event eCRF. Note: Should the EDC system become nonoperational, the site must complete the appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form. The completed form is emailed to the study sponsor at xxxx.xxxxxx@Xxxxx.xxx according to the timelines outlined above; however, the reported information must be entered into the EDC system once it becomes operational. Any AEs and device deficiencies for nonstudy marketed devices/products (i.e. CLEAR CARE Cleaning & Disinfecting Solution, LacriPure (or equivalent)) 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. Further, depending upon the nature of the AE or device deficiency being reported, the study sponsor may request copies of applicable portions of the subject’s medical records. The investigator must also report all AEs and device deficiencies that could have led to a SADE according to the requirements of regulatory authorities or IRB/IEC.

Procedures for Recording and Reporting. AEs are collected from the time of informed consent. 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 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 articles comparator products on the Device Deficiency eCRF. The site must submit all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor study sponsor immediately as follows:  • All SAEs must be reported immediately (within 24 hours) of the Investigatorinvestigator’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 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 eCRF and Adverse Device Effect(for related AEs) eCRF. Note: Should the EDC system become nonoperational, the site must complete the appropriate paper Serious Adverse Event and Adverse Device Effect (and/or Device Deficiency Form. The completed form is emailed to the study sponsor at xxxx.xxxxxx@xxxxx.xxx for US according to the timelines outlined above; however, the reported information must be entered into the EDC system once it becomes operational. Study sponsor representatives may be contacted for any protocol-related AEs) question and Serious Adverse Event eCRFtheir contact information is provided in the Manual of Procedures that accompanies this protocol. Further, depending upon the nature of the AE or device deficiency being reported, the study sponsor may request copies of applicable portions of the subject’s medical records. The investigator must also report all AEs and device deficiencies that could have led to a SADE according to the requirements of regulatory authorities or IRB/IEC.

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 (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. 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 articles 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 • ADEs or SAEs must be reported immediately (are documented on the Serious Adverse Event and Adverse Device Effect eCRF within 24 hours) hours of the Investigator’s or site’s awareness.  ADEs that do not meet seriousness criteria and device • Device deficiencies must be reported are documented on the Device Deficiency eCRF within 10 calendar days 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  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 (for related AEs) and Serious Adverse Event 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 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 Test and control articles Comparator products on the Device Deficiency eCRF. The site must submit all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor study sponsor immediately as follows:  follows • All SAEs must be reported immediately (within 24 hours) of the Investigatorinvestigator’s or site’s awareness.  • ADEs that do not meet seriousness criteria and device Device deficiencies must be reported within 10 calendar days 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  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 (for related AEs) and Serious Adverse Event 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. 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 articles 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 ADEs or SAEs must be reported immediately (are documented on the Serious Adverse Event and Adverse Device Effect eCRF within 24 hours) hours of the Investigator’s or site’s awareness.  ADEs that do not meet seriousness criteria and device Device deficiencies must be reported are documented on the Device Deficiency eCRF within 10 calendar days 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 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 (for related AEs) and Serious Adverse Event eCRF.