Reporting of Serious Adverse Events Clause Samples

Reporting of Serious Adverse Events. All SAEs (as defined below) regardless of treatment group or suspected relationship to IMP must be reported immediately (within 24 hours of the investigator’s knowledge of the event) to the pharmacovigilance contact specified at the beginning of this protocol. If the immediate report is submitted by telephone, this must be followed by detailed written reports using the SAE report form. An SAE is any AE that: 1) Results in death 2) Is life threatening, that is any event that places the subject at immediate risk of death from the event as it occurred. It does not include an event that, had it occurred in a more severe form, might have caused death 3) Results in in-patient hospitalisation or prolongation of existing hospitalisation, excluding admission for social or administrative reasons (see further) 4) Results in a persistent or significant disability/incapacity, where disability is a substantial disruption of a person’s ability to conduct normal life functions 5) Results in congenital anomaly/birth defect in the offspring of a subject who received the IMP 6) Is an important medical event that may not result in death, be life threatening, or require hospitalisation when, based upon appropriate medical judgement, may jeopardise the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in in-patient hospitalisation, or the development of drug dependency or drug abuse. In addition to the above criteria, any additional AE that the sponsor or an investigator considers serious should be immediately reported to the sponsor and included in the corporate SAEs database system. • Hospitalisation is defined as any in-patient admission (even if less than 24 hours). For chronic or long-term in-patients, in-patient admission also includes transfer within the hospital to an acute/intensive care in-patient unit • Prolongation of hospitalisation is defined as any extension of an in-patient hospitalisation beyond the stay anticipated/required in relation to the original reason for the initial admission, as determined by the investigator or treating physician. For protocol-specified hospitalisation in clinical studies, prolongation is defined as any extension beyond the length of stay described in the protocol. Prolongation in the absence of a...

Reporting of Serious Adverse Events. Every SAE, regardless of the causal relationship to the study treatment, occurring after the patient has signed informed consent, until at least 30 days after the patient has stopped study treatment, must be reported to the Karyopharm Pharmacovigilance. The investigational site personnel must use the SAE Report Form (paper or electronic) provided by Karyopharm for reporting any SAE to the Karyopharm Pharmacovigilance Department. The immediate report should be made by the investigator within a very short period of time and under no circumstances should this exceed 24 hours following knowledge of the SAE. After the 30-day follow-up period SAEs should only be reported to Karyopharm if the Investigator suspects that the SAE has a causal relationship to the study treatment. To complete the electronic SAE Report Form, a Log Line must first be completed in the Adverse Events eCRF. The SAE will then be linked to an electronic SAE Report Form. It is then necessary to complete a Log Line in the corresponding SAE Report Form eCRF within 24 hours of learning of the SAE’s occurrence. It is not necessary to submit a paper SAE Report Form if the SAE was originally declared using the electronic SAE Report Form. If the SAE is to be reported via a paper SAE Report Form, upon completion, the SAE Report Form must be immediately emailed or faxed to: Email: ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇▇ Fax: +▇-▇▇▇-▇▇▇-▇▇▇▇ (USA) +▇▇-▇▇-▇▇▇▇-▇▇▇▇ (Germany) Recurrent episodes, complications, or progression of the initial SAE must be reported, as follow- up to the original episode, within 24 hours of the Investigator receiving the follow-up information. An SAE should be followed until its resolution or until it is judged to be permanent. An assessment should be made at each study visit (or more frequently, if necessary) of any changes in severity of the event, the suspected relationship to the study treatment, the interventions required to treat the event, and the outcome of the event

Reporting of Serious Adverse Events. In agreeing to the provisions of this protocol, the Investigator accepts all legal responsibilities for immediately reporting of SAEs to La Jolla. Immediate reporting implies within 24 hours of becoming aware of the occurrence of a SAE. All SAEs that occur from initiation of study drug treatment, during treatment, and through the Day 28 follow-up, regardless of the causal relationship to the investigational product, must be reported to La Jolla by following the instructions provided in this Section. Redacted medical record source documentation will be requested for all SAEs and emergency room visits. The method for reporting a SAE is by completing and sending the Serious Adverse Event Report Form and completing the AE CRF. The Serious Adverse Event Report Form and if applicable, a copy of redacted source documents (such as hospital discharge summary, medical records, etc.) related to the SAE will be sent as: • e-mail to: ▇▇▇▇▇▇@▇▇▇▇.▇▇▇; or • fax to: +▇ (▇▇▇) ▇▇▇-▇▇▇▇ The Investigator will assess whether the event is causally related to the investigational product. La Jolla will also assess whether the event is causally related to the investigational product, in addition to assessing the overall safety profile of the investigational product. La Jolla will notify the appropriate regulatory authorities in accordance with country regulations. It is the Investigator’s responsibility to notify the IRB or independent ethics committee (IEC) of all SAEs that occur at his or her site, according to local requirements. Investigators will be informed about SAEs according to applicable local regulations. Each site is responsible for notifying its IRB/IEC of these additional SAEs, per local policy. Following the initial report, any additional information obtained by the Investigator about the SAE must be reported promptly to La Jolla in the same manner as described above for the initial SAE report.

Reporting of Serious Adverse Events. The investigator is responsible for reporting all SAEs observed by the investigator or reported by the subject. Unless otherwise indicated in Table 6 below, all SAEs will be reported within 24 hours and recorded in the CRF.

Reporting of Serious Adverse Events. Any AE considered serious by the investigator or which meets SAE criteria (Section 6.2.1.1), or any other event or condition regardless of grade, which in their judgment represents a reportable event, must be reported to the medical monitor and SIGA as soon as the investigator becomes aware of the event. In addition, the event must be reported to PPD via the SAE hotline. The PPD SAE Report Form must be submitted within 24 hours of knowledge of the event. SIGA (or designee) 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. In addition, the investigator (or designee) must report any Grade 3 (severe) AE that they deem possibly, probably, or definitely related to study drug to the medical monitor and SIGA within 24 hours after becoming aware of the event. • Grade 3 (Severe): Events interrupt a subject’s usual daily activity, may require systemic drug therapy or other treatment, and are usually incapacitating. • Grade 4 (Life-threatening): Event that, in the opinion of the investigator, places the subject at immediate risk of death from the reaction as it occurred (ie, it does not include a reaction that, had it occurred in a more severe form, might have caused death). • Grade 5 (Death). Changes in the severity of an AE should be documented to allow an assessment of the duration of the event at each level of intensity to be performed. An AE characterized as intermittent requires documentation of onset and duration of each episode.

Reporting of Serious Adverse Events. If a Serious Adverse Event (“SAE”) occurs during any Study, it shall be reported without undue delay (i.e., within 1 business day after Study Site becomes aware of such SAE) to the designated pharmacovigilance unit at the CRO or at Sponsor or at any other third party designated by Sponsor and identified to Study Site. The Study Site shall answer any possible questions relevant to such SAE to its best knowledge.

Reporting of Serious Adverse Events. ‌ Every SAE, regardless of the causal relationship to the study treatment, occurring after the patient has signed informed consent, until at least 30 days after the patient has stopped study treatment, must be reported to the Karyopharm Pharmacovigilance Department with the timeframe not to exceed 24 hours of the Investigator becoming aware of the event. The investigational site personnel must use the SAE Report Form provided by Karyopharm for reporting any SAE to the Karyopharm Pharmacovigilance Department. Upon completion, the SAE Report Form must be immediately emailed or faxed to: Email: ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇▇ Fax: +▇-▇▇▇-▇▇▇-▇▇▇▇ (USA) Any SAE observed after the 30-day follow-up period should only be reported to Karyopharm if the Investigator suspects that the SAE has a causal relationship to the study treatment. Recurrent episodes, complications, or progression of the initial SAE must be reported, as follow-up to the original episode, within 24 hours of the Investigator receiving the follow-up information. An SAE should be followed until its resolution or until it is judged to be permanent. An assessment should be made at each study visit (or more frequently, if necessary) of any changes in severity of the event, the suspected relationship to the study treatment, the interventions required to treat the event, and the outcome of the event.

Reporting of Serious Adverse Events