Reporting Adverse Events. If the development or commercialization or a given Product mandates the mutual reporting of Adverse Events, then the Parties will establish procedures for tracking and informing each other concerning such Adverse Events as required by Applicable Law, and shall maintain such databases and execute such agreements as needed for this purpose.
Reporting Adverse Events. Promptly following the Effective Date but not later than 60 days thereafter, Braeburn and Camurus shall develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events (as defined in the then current edition of International Conference on Harmonization guidelines for good clinical practice, or ICH Guidelines, and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”), product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, Sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH Guidelines. The safety data exchange procedures shall be promptly updated if required by changes in legal requirements or by agreement between the Parties. In any event, each Party shall inform the other Party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. Braeburn or its Sublicensees shall be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Licensed Territory and Camurus or its licensees shall be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Camurus Territory. Each Party shall ensure that its Affiliates, Sublicensees and licensees, as applicable, comply with such reporting obligations. Each Party shall designate a safety liaison to be responsible for communicating with the other Party regarding the reporting of Adverse Events. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Reporting Adverse Events. Rhythm shall be responsible for reporting all adverse events (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”) relating to the Product to the appropriate regulatory authorities in the countries in the Territory in accordance with the appropriate laws and regulations of the relevant countries and authorities. Rhythm shall ensure that its Affiliates and Sublicensees comply with all such reporting obligations. In the event that Rhythm knows or acquires knowledge that any Adverse Event relating to the Product is attributable to the FC Technology and is not attributable to the Drug, then Rhythm shall provide prompt written notice of such Adverse Event to Camurus. In addition, at each meeting of the JDC, a representative of Rhythm shall present to the JDC, and the JDC shall review, all Adverse Event relating to the Product that have occurred since the last meeting of the JDC
Reporting Adverse Events. The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Products in the Territory, in each case, in accordance with the applicable regulatory Laws and regulations on pharmacovigilance and clinical safety. As soon as practicable after the Effective Date (but in no event longer than [**] after the Effective Date), the Parties will negotiate in good faith and execute an agreed pharmacovigilance agreement specifying the procedures and timeframes for complying with applicable Law pertaining to safety reporting for each Licensed Product and their related activities (a “Pharmacovigilance Agreement”), which Pharmacovigilance Agreement will be overseen by the JDC. The Pharmacovigilance Agreement will set forth each Party’s responsibilities and obligations pertaining to safety collection, assessment and reporting of the Licensed Products based on relevant guidelines and applicable Law. The allocation of responsibilities between the Parties will be governed by the Pharmacovigilance Agreement. The Party that [**] with respect to a Licensed Product will own the global safety database for such Licensed Product.
Reporting Adverse Events. Ascletis shall maintain, at its own cost, a common safety database for both clinical and post-marketing Adverse Events for the Products in the Territory in the Field, which database shall be managed by Ascletis and Ascletis shall ensure that 3-V, its Affiliates and any 3-V Collaborator is able to access the Safety Data from such database in order to comply with Applicable Law and obligations by Regulatory Authorities in their respective territories. 3-V shall maintain, at its own cost, a global safety database for both clinical and post-marketing Adverse Events for the Products, which database shall be managed by 3-V and 3-V shall ensure that Ascletis, its Affiliates and Sublicensees are able to access the Safety Data from such database in order to comply with Applicable Law and obligations by Regulatory Authorities in their respective territories. Ascletis will be responsible for reporting all Adverse Events to the appropriate Regulatory Authorities in the Territory, including the NMPA, in accordance with Applicable Law. In addition, Ascletis shall report all Adverse Events to 3-V in a timely manner in order for 3-V to comply with its reporting obligations to Regulatory Authorities outside the Territory (including FDA). 3-V shall report all Adverse Events to Ascletis in a timely manner in order for Ascletis to comply with reporting obligations in the Territory. 3-V will be responsible for reporting all Adverse Events to the appropriate Regulatory Authorities outside the Territory in accordance with Applicable Law. 3-V shall provide Ascletis through the JSC with the name of a contact at each 3-V Collaborator’s pharmacovigilance department so that Ascletis may coordinate with such 3-V Collaborator regarding the allocation of responsibilities and determination of any procedures between them with respect to the collecting, sharing and reporting to applicable Regulatory Authorities regarding Adverse Events and other safety information, including providing Ascletis with access to Safety Data in accordance with Section 2.7(c).
Reporting Adverse Events. Promptly following the Effective Date but in no event later than sixty (60) days thereafter. ENDO and ZARS will develop and agree upon safety data exchange procedures in a separate and detailed Safety Agreement. ZARS shall use commercially reasonable efforts to have any relevant Affiliates and other licensees become a party to such Safety Agreement. Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning adverse events relating to Licensed Products (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”), product quality and product complaints involving Adverse Events, sufficient to permit each party, its Affiliates, sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH guidelines. The safety data exchange procedures will be promptly updated if required by changes in legal requirements or by agreement between the parties. In any event, each party shall inform the other party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. ENDO will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Territory in accordance with the appropriate laws and regulations of the relevant countries and authorities and ZARS or its other licensees will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries outside the Territory. ENDO will ensure that its Affiliates and sublicensees comply with all such reporting obligations, and ZARS will ensure that its Affiliates and other licensees comply with all such reporting obligations. In addition, ENDO
Reporting Adverse Events. At each post enrollment visit, the investigator or designee will question the subject to elicit AEs using a non-directive question such as “Has there been any change in your health since the previous study visit?” The investigator or designee will monitor the 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 starting with the subject’s first study medication treatment at Visit 2 and continuing through Visit 11. All SAEs regardless of relationship to study medication must be collected and reported to Aclaris Therapeutics, Inc. from the time the Informed Consent is signed through Visit 11. Upon becoming aware of 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: 000-000-0000 Email: xxxxxxxxxxxx@xxxxxxxxx.xxx
3. Within 24-hours of becoming aware of the event, a SAE report form, an AE CRF and any other relevant information (e.g., concomitant medication CRF, medical history CRF, laboratory test results) must be faxed to the 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 investigator and Safety Monitor agree that the SAE is satisfactorily resolved.
5. Inform the Safety Monitor of SAE updates by telephone followed by an SAE form update sent by fax or by e mail.
6. Comply with the appropriate regulatory requirements and Aclaris Therapeutics, Inc. instructions regarding reporting of the SAE to the responsible Institutional Review Board (IRB) or Ethics Committee (EC).
Reporting Adverse Events. “THE INSTITUTE” and “THE INVESTIGATOR” must report events that, according to the Official Mexican Regulation NOM-220-SSA1-2016, Installation and operation of pharmacovigilance, Guidelines of the “International Conference on Harmonisation (ICH)” and Good Clinical Practice, as well as “THE PROTOCOL”, are considered as serious or non-serious adverse events, from baseline and during the execution of the RESEARCH PROJECT or Protocol, without authorization to such effect being required by “THE SPONSOR”. These adverse events shall be reported within no more than (24) twenty-four hours after “THE INVESTIGATOR” and/or “THE INSTITUTE” have become aware of the event.
Reporting Adverse Events. AEs, whether spontaneously reported by the subject or noted by authorized study personnel, will be recorded in the subject's medical record and on the appropriate AE CRF. Each recorded AE will be described by its duration (i.e., start and end dates), severity, regulatory seriousness criteria if applicable, suspected relationship to the RBM-007, actions taken and outcome. AEs that occur after any subject has provided written informed consent, before treatment, during treatment, or within 30 days following the cessation of treatment, whether they are related to the study, must be recorded. To improve the quality and precision of acquired AE data, Clinical Investigators should observe the following guidelines:
1. Whenever possible, use recognized medical terms when recording. Do not use colloquialisms and/or abbreviations.
2. If known, record the diagnosis (i.e., disease or syndrome) rather than component signs and symptoms and /or laboratory or test findings (e.g., record congestive heart failure rather than dyspnea, rales, and cyanosis, and enlarged heart on chest x-ray). However, other events that are considered unrelated to an encountered syndrome or disease should be recorded as individual AEs (e.g., if congestive heart failure and severe headache are observed at the same time and are clinically unrelated, each event should be recorded as an individual AE).
3. If the diagnosis is not known, then record the leading component sign, symptom or test finding and describe the other clinically related findings in the narrative description of the case. A suspected diagnosis can be used and described as such (e.g., record suspected or probable myocardial infarction); this has to be updated in the clinical database once the diagnosis is confirmed. AEs occurring secondary to other events (e.g., sequelae) should be identified by the primary cause. A primary AE, if clearly identifiable, generally represents the most accurate clinical term. If a primary AE is recorded, events occurring secondary to the primary event should be described in the narrative description of the case. For example:
a. The subject developed orthostatic hypotension and subsequently fainted and fell to the floor wherein she experienced a head trauma and neck pain.
b. The primary AE in this example is orthostatic hypotension. The fall, head trauma and neck pain should be described in the narrative description of the case.
4. For intermittent events (e.g., intermittent headache), the event onset da...
Reporting Adverse Events. All AEs reported or observed during the study will be recorded on the AE page of 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. The Medical Dictionary of Regulatory Activities (MedDRA) 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. 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 which meets SAE criteria (Section 7.3.1.1) must be reported to the sponsor within 24 hours of awareness (after the investigator has confirmed the occurrence of the SAE). The investigator will assess whether there is a reasonable possibility that the study drug caused the SAE. The sponsor will be responsible for notifying the relevant regulatory authorities of any SAE. The investigator is responsible for notifying the Institutional Review Board (IRB) or Ethics Committee (EC) directly as applicable per institutional policy. The sponsor or designee will provide regulatory authorities, IRB/ECs, and the investigator with clinical safety updates/reports according to local requirements In addition to entering the AE details in the eCRF, the study site should also complete the SAE eCRF page within 24 hours of awareness. In the event that EDC entry is not possible (e.g., eCRF system failure or access problems), the study site should complete/fax the paper SAE report form and fax the form within 24 hours of awareness and update the EDC as soon as it is available. For this study, the following contact information will be used for SAE reporting: Email (primary):
