SERIOUS ADVERSE EVENT REPORTING Sample Clauses

SERIOUS ADVERSE EVENT REPORTING. The Ambulatory Unit of the Principal Investigator's site is contacted during a serious AE in order to determine the physician on call, who is notified and apprised of the situation. A serious AE is defined as one of the following: - Death - An event which is life threatening. In the opinion of the investigator, the patient was at immediate risk of death due to the event as it occurred. - An event which results in persistent or significant disability/incapacity. - An event which requires inpatient hospitalization or prolongs hospitalization. - A laboratory abnormality which meets any of the above criteria. - An important medical event that, based upon appropriate medical judgement, may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
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SERIOUS ADVERSE EVENT REPORTING. A completed AE/SAE eCRF must be entered in the clinical study database for all SAEs within 24 hours of knowledge of the event. The site will also be responsible for submitting relevant source documentation for the SAE. If the subject is hospitalized because of or during the course of an SAE, then a copy of the hospital discharge summary must also be included with the SAE source documentation. When submitting copies of source documentation, all patient identifying information must be redacted and only the unique subject number will be used to label the forms for identification purposes. Withdrawal from the study and all therapeutic measures will be at the discretion of the investigator. All SAEs will be followed until satisfactory resolution or until the investigator deems the event to be chronic or the patient to be stable. Copies of any reports to regulatory agencies regarding serious and unexpected AEs will be provided to the investigators for review and submission to the Institutional Review Board (IRB). The investigator is responsible for informing the IRB of any SAEs and/or UADEs. Copies of SAE/UADE correspondence with the investigators and regulatory authorities must be retained with study records.
Sample 1
SERIOUS ADVERSE EVENT REPORTING. ‌ All Serious Adverse Events (SAE) must be reported to Xx. Xxxxxx X. Gallie and to a member of the clinical research (CRA) staff within 24 hours of becoming aware of the SAE. The initial report should contain as much information as available, at a minimum, the report must contain: • Participant Identification Code, • Adverse Event Term, • Study Drug Dose and Start/Stop Dates On the next working day email to CRA and REB completed trial-specific Serious Adverse Event form or Council for International Organizations of Medical Sciences (CIOMS) form. Only adverse drug reactions that are both serious and unexpected are subject to expedited reporting to Health Canada. Expedited reporting of reactions which are serious but expected is not required. Expedited reporting is also inappropriate for serious events from clinical investigations that are considered unrelated to the study product, whether or not the event is expected. During a clinical trial the Sponsor is required to inform Health Canada of any serious, unexpected adverse drug reaction (SUADR) that has occurred inside or outside Canada: a. where it is neither fatal nor life-threatening, within 15 days after becoming aware of the information; b. where it is fatal or life-threatening, immediately where possible and, within 7 days after becoming aware of the information; and c. within 8 days after having informed Health Canada of the SUADR, submit as complete a report as possible which includes an assessment of the importance and implication of any findings. Final reports of fatal or life-threatening reactions must include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar drugs. Each SUADR which is subject to expedited reporting should be reported individually in accordance with the data element(s) specified in the Health Canada / ICH Guidance Document E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. In situations when causality assessment and determination of expectedness is not straightforward, the report should be submitted in the expedited manner and the relevant issues addressed in a cover letter. STEP-RB Protocol 1.0, 4 February 2020 There are situations in addition to the above that may necessitate rapid communication to Health Canada, and appropriate scientific and medical judgment should be applied to each situation. For example, information that might influence the risk-benefit asse...
Sample 1
SERIOUS ADVERSE EVENT REPORTING. UC shall report any serious adverse events (“SAE”) associated with the Research Materials provided under this Agreement within 24 hours after identification of the SAE. UC shall report any unanticipated adverse device effects (“UADE”) within ten (10) working days after the identification of the UADE. Sponsor may terminate this Agreement immediately in the event UC fails to comply with its reporting obligations.
Sample 1
SERIOUS ADVERSE EVENT REPORTING. In order to satisfy regulatory requirements, any Serious Adverse Event, whether deemed study drug-related or not, must be reported to the Sponsor’s Medical Monitor or designee as soon as possible after the investigator or site coordinator has become aware of its occurrence but no later than 24 hours of becoming aware of the event. The SAE form completion and reporting must not be delayed even if all of the information is not available at the time of the initial contact. All completed SAE forms should be sent to sponsor’s pharmacovigilance unit on the email: X000@xxxxx.xxx Additional information (follow-up) about any SAE unavailable at the initial reporting should be forwarded by the site within 24 hours of the information becoming available to the Medical Monitor or designee. The following information should be provided by the investigator or designee to accurately and completely record the event: • Investigator name and center number • Subject number • Subject initials • Subject demographics • Clinical event o Description o Date of onset o Severity o Treatment (if blind needs to be broken) o Relationship to study drug (causality) o Action taken regarding study drug • If the AE results in death o Cause of death (whether or not the death was related to study drug) o Autopsy findings (if available) • Medical history case report form (copy) • Concomitant medication case report form (copy) • Any relevant reports (laboratory, discharge, x-ray, etc) Subjects who have had an SAE during the treatment period must be followed clinically until all parameters (including laboratory) have either returned to normal or have stabilized or are otherwise explained. The Medical Monitor for this study is: Xxxxxxx Xxxxxx, MD Title: Associate Medical Director, Lupin Inc. Tel: 000-000-0000 Email: xxxxxxxxxxxxxxxxxx@xxxxx.xxx The pregnancy should be followed up to determine outcome, including spontaneous or voluntary termination, details of birth, and presence or absence of any birth defect, congenital abnormalities or maternal and newborn complications. The pregnancies reporting procedure should be the same as the SAE reporting procedure.
Sample 1
SERIOUS ADVERSE EVENT REPORTING. An Investigator must report an SAE to Revance or the designated CRO’s authorized representative within Complete and return an SAE Form with all information known to date; including the Investigator’s assessment of causality. If the event is fatal or life-threatening, telephone Revance or the authorized representative as soon as the Investigator learns of the event. Obtain and maintain all pertinent medical records (discharge summary, autopsy report, etc.) and medical judgments of medical personnel who assisted in subject’s treatment and follow- up. Provide follow-up information to Revance or the authorized representative. All SAEs will be followed until satisfactory resolution or until the Investigator deems the event to be chronic or the participant is stable. Other supporting documentation of the event may be requested by the Data Coordinating Center (DCC)/study sponsor and should be provided as soon as possible. The study sponsor will be responsible for notifying the Food and Drug Administration (FDA) of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible, but in no case later than 7 calendar days after the sponsor’s initial receipt of the information. In addition, the sponsor must notify FDA and all participating investigators in an Investigational New Drug (IND) safety report of potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later than 15 calendar days after the sponsor determines that the information qualifies for reporting. Regulatory authorities, IRBs/IEC, and Investigators will be notified of SAEs in accordance with applicable regulations and requirements (e.g., GCPs, ICH Guidelines, national regulations and local requirements).
Sample 1
SERIOUS ADVERSE EVENT REPORTING. In the event that a serious adverse event is reported with respect to the Product in the Territory, the party receiving the report shall provide the other with a copy of any such reports within five (5) business days of receipt. The party holding the regulatory approval in the countries in which the serious adverse event needs to be reported shall report such incident promptly and in a manner that is generally acceptable in the industry and shall, within five (5) business days of any communication with the applicable regulatory body(s), provide the other party with copies of any such communications concerning the safety and efficacy of the Product. Once a serious adverse event has been reported and notice has been given to the other party, the parties agree to work together to formulate a plan as to how to deal with such event. Both parties acknowledge and agree that any delay in resolving such issues could result in significant harm and therefore both parties agree to deal with any such incidents promptly and in a manner that is generally acceptable in the industry. The cost of any action made necessary by the finding of a serious adverse event shall be attributed between the parties as provided for in Section 7(D).
Sample 1
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SERIOUS ADVERSE EVENT REPORTING. PRINCIPAL INVESTIGATOR and INSTITUTION shall notify SPONSORas soon as is practicable, but no later than twenty-four (24) hours after learning of any serious adverse drug event (as defined in the Protocols) (“SAE”) affecting any Study subject in the Studies,and shall provide a written confirmation report of such SAE promptly thereafter. PRINCIPAL INVESTIGATOR and INSTITUTION shall be responsible for reporting and tracking of all SAE’s in compliance with ApplicableLaw, and as specified in the Protocols. PRINCIPAL INVESTIGATOR shall be responsible for updating all SAEs, including any expedited safety reports. PRINCIPAL INVESTIGATOR and INSTITUTION shall promptly provide SPONSOR with all information in their possession or control as may be needed to assist SPONSOR in the identification and resolution of problems or unexpected occurrences involving the Study Drug or its use in the Studies.
Sample 1
SERIOUS ADVERSE EVENT REPORTING 
Sample 1

Related to SERIOUS ADVERSE EVENT REPORTING

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • No Material Adverse Event Since the respective dates as of which information is disclosed in the Registration Statement, the Prospectus and the Incorporated Documents, except as otherwise stated therein, there shall not have been (i) any change or decrease in previously reported results specified in the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Registration Statement, the Prospectus and the Incorporated Documents (exclusive of any amendment or supplement thereto) the effect of which, in any case referred to in clause (i) or (ii) above, is, in the sole judgment of the Manager, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery of the Shares as contemplated by the Registration Statement (exclusive of any amendment thereof), the Incorporated Documents and the Prospectus (exclusive of any amendment or supplement thereto).

  • Incident Reporting Transfer Agent will use commercially reasonable efforts to promptly furnish to Fund information that Transfer Agent has regarding the general circumstances and extent of such unauthorized access to the Fund Data.

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • Accident Reporting 25.1 If You or an Authorised Driver has an Accident or if the Vehicle is stolen You must report the Accident or theft to Us within 24 hours of it occurring and fully complete an Accident/Theft report form. 25.2 If the Vehicle is stolen or if You or an Authorised Driver of the Vehicle has an Accident where: (a) any person is injured; (b) the other party has failed to stop or leaves the scene of the Accident without exchanging names and addresses; or (c) the other party appears to be under the influence of drugs or alcohol, You or the Authorised Driver must also report the theft or Accident to the Police. 25.3 If You or an Authorised Driver has an Accident You and the Authorised Driver must: (a) exchange names and addresses and telephone numbers with the other driver and drivers licence details; (b) take the registration numbers of all vehicles involved; (c) take as many photos as is reasonable showing: (i) the position of the Vehicles before they are moved for towing or salvage; (ii) the Damage to the Vehicle; (iii) the damage to any third party vehicle or property; and (iv) the general area where the Accident occurred, including any road or traffic signs; (d) obtain the names, addresses and phone numbers of all witnesses; (e) not make any admission of fault or promise to pay the other party's claim or release the other party from any liability; (f) forward all third party correspondence or court documents to Us within 7 days of receipt together with a fully completed Accident Report Form (if not already submitted); and (g) co-operate with Us in the prosecution of any legal proceedings that We may institute or defence of any legal proceedings which may be instituted against You or Us as a result of an Accident, including: (i) attending Our lawyer's office; and (ii) any Court hearing.

  • Security Incident Reporting A security incident occurs when CDA information assets are or reasonably believed to have been accessed, modified, destroyed, or disclosed without proper authorization, or are lost, or stolen. Subrecipient must comply with CDA’s security incident reporting procedures located at xxxxx://xxx.xxxxx.xx.xxx/ProgramsProviders/#Resources.

  • Absence of Material Adverse Changes No material adverse change in the business, assets, financial condition, or prospects of the Company shall have occurred, no substantial part of the assets of the Company not substantially covered by insurance shall have been destroyed due to fire or other casualty, and no event shall have occurred which has had or will have a material adverse effect on the business, assets, financial condition or prospects of the Company.

  • Notice of Material Adverse Change Firm agrees to notify Citizens in writing of any “Material Adverse Change” to Firm within ten (10) days of said change. A “Material Adverse Change” means: (i) a change in the business operations or financial condition of Firm which negatively impacts its capacity to meet its professional or financial obligations;

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