Common use of Reporting Adverse Events Clause in Contracts

Reporting Adverse Events. All AEs reported or observed during the study will be recorded in the source documentation and on the AE page in the eCRF. Information to be collected includes drug treatment, type of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drug, time of resolution of the event, seriousness, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary of Regulatory Activities will be used to code all AEs. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE but will be recorded as medical history. However, if it deteriorates at any time during the study, it should be recorded as an AE. Any AE that is considered serious by the investigator or that meets SAE criteria (Section 6.2.1.1) must be reported to the sponsor (or the sponsor’s designee) following the guidelines provided on the study SAE form as soon as site personnel/investigator have become aware of the event and no later than 24 hours regardless of the relationship to the study drug. The investigator will assess whether there is a reasonable possibility that the study drug caused the SAE. Serious AE report form completion and reporting must not be delayed even when information is incomplete at the time of the initial report. Any additional (follow-up) information that becomes available after the initial reporting should be forwarded in a follow-up SAE report form by the site personnel within 24 hours of the information becoming available. All SAEs should be followed until resolution or stabilization of all parameters (including laboratory) return to baseline or until the investigator assesses them as stable or until the subject is lost to follow-up. The sponsor will be responsible for notifying the relevant regulatory authorities of any SAE as outlined in US Title 21 Code of Federal Regulations (CFR) Parts 312 and 320. The investigator is responsible for notifying the institutional review board (IRB) directly. For this study, the following contact information will be used for SAE reporting:

Reporting Adverse Events. All ‌ At each post enrollment visit, the investigator or designee will question the subject to elicit AEs reported using a non-directive question such as “Has there been any change in your health since the previous study visit?” The investigator or observed during designee will monitor the study subject for at least 20 minutes after the Treatment Completion Time at Visit 2, and if applicable at Visit 5 and Visit 7 to elicit AEs in a similar manner. If appropriate, based on the subject’s response to non-directed questioning regarding AEs, the investigator or designee will follow-up with directed questions and appropriate evaluations. Non-serious AEs should be recorded in starting with the source documentation subject’s first study medication treatment at Visit 2 and on the AE page in the eCRFcontinuing through Visit 11. Information to be collected includes drug treatment, type All SAEs regardless of event, time of onset, dosage, investigator-specified assessment of severity and relationship to study drugmedication must be collected and reported to Aclaris Therapeutics, Inc. from the time the Informed Consent is signed through Visit 11. Upon becoming aware of resolution a SAE the investigator must: 1. Take the appropriate medical action to ensure the subject’s safety 2. Immediately inform the Safety Monitor of the SAE: Serious Adverse Event Facsimile: ▇▇▇-▇▇▇-▇▇▇▇ Email: ▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇.▇▇▇ 3. Within 24-hours of becoming aware of the event, seriousnessa SAE report form, any required treatment or evaluations, and outcome. Any AEs resulting from concurrent illnesses, reactions to concurrent illnesses, reactions to concurrent medications, or progression of disease states must also be reported. All AEs will be followed until they are resolved, stable, or judged by the investigator to be not clinically significant. The Medical Dictionary of Regulatory Activities will be used to code all AEs. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE but will be recorded as CRF and any other relevant information (e.g., concomitant medication CRF, medical history. Howeverhistory CRF, if it deteriorates at any time during the study, it should be recorded as an AE. Any AE that is considered serious by the investigator or that meets SAE criteria (Section 6.2.1.1laboratory test results) must be reported faxed to the sponsor (SAE Fax line listed above. 4. Monitor and document the progress of the SAE until it resolves or, if not resolved after the subject’s last study visit, until in the opinion of the investigator the SAE reaches a clinically stable outcome with or without sequelae AND the sponsor’s designee) following investigator and Safety Monitor agree that the guidelines provided on SAE is satisfactorily resolved. 5. Inform the study Safety Monitor of SAE updates by telephone followed by an SAE form as soon as site personnel/investigator have become aware update sent by fax or by e mail. 6. Comply with the appropriate regulatory requirements and Aclaris Therapeutics, Inc. instructions regarding reporting of the event and no later than 24 hours regardless of the relationship SAE to the study drug. The investigator will assess whether there is a reasonable possibility that the study drug caused the SAE. Serious AE report form completion and reporting must not be delayed even when information is incomplete at the time of the initial report. Any additional (follow-up) information that becomes available after the initial reporting should be forwarded in a follow-up SAE report form by the site personnel within 24 hours of the information becoming available. All SAEs should be followed until resolution or stabilization of all parameters (including laboratory) return to baseline or until the investigator assesses them as stable or until the subject is lost to follow-up. The sponsor will be responsible for notifying the relevant regulatory authorities of any SAE as outlined in US Title 21 Code of Federal Regulations (CFR) Parts 312 and 320. The investigator is responsible for notifying the institutional review board Institutional Review Board (IRB) directly. For this study, the following contact information will be used for SAE reporting:or Ethics Committee (EC).