Reporting Serious Adverse Events Sample Clauses

Reporting Serious Adverse Events. All serious adverse events during the study period, whether or not considered to be related to study treatment must be reported to the respective CRO that is managing the site within 24 hours or, at the latest, on the following working day. At the time of the initial report, as much information as possible should be provided: patient allocation number, treatment, study identifiers, the phase of treatment during which the event occurred, a description of the event, its date of onset and current status; the start date, the start time, whether this treatment has been discontinued; the reason why the event is regarded as serious; the current assessment of causality, investigator's name and address. The investigator must fax the SAE form within the next 24 hours if it is not provided at the time of the initial notification. Any other diagnostic information, which will assist the understanding of the event should be provided at this time. The study patient has to be followed until the final outcome of the SAE is known, including any which are still ongoing at the end of the study. Significant new information on the SAE, and the final outcome, must be supplied promptly to the respective CRO that is managing the site. This should be done in the same way and time frame as for the original notification, using the SAE form and identifying this as follow up information. The investigator must report promptly any SAEs, which may be detected after the study, and are suspected to be related to study treatment. Investigators must report all SAEs to the IRB according to their institutional policy. 11 REGULATORY REQUIREMENTS
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Reporting Serious Adverse Events. All Serious Adverse Events (SAEs) must be reported immediately by the Investigator without filtration, whether considered to be associated with BL-1040 and whether or not considered related to BL-1040. The Investigator must report SAEs within one calendar day of becoming aware of the event by telephone, fax or e-mail to the Study Contact for Reporting Serious Adverse Events as indicated below. This initial notification should include minimal, but sufficient information to permit identification of the reporter, the patient, study device, any medications administered, AEs, causality assessment and date of onset. The Investigator should not wait for additional information to fully document the event before providing notification. An acknowledgement letter will confirm the first notification. The report is then to be followed by submission of a completed SAE Report Form provided by Averion International as soon as possible but at latest within 3 calendar days of the initial telephone/fax or e-mail report detailing relevant aspects of the AEs in question. All actions taken by the Investigator and the outcome of the event must also be reported immediately. For documentation of the SAE, any actions taken, outcome and follow-up reports, the SAE Report Forms are to be used. Where applicable, hospital case records and autopsy reports should be obtained. Investigators must report SAEs to the appropriate ethics committee if requested by the committee and/or according to local legal requirements. Fax: e-mail: Tel: Averion International Xxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx +00-00-000-0000 XXX@xxxxxxxxxxx.xxx +00-00-000-0000 24/24 hour and 7/7 day availability Annotated Protocol incorporating Amendment 1, Amendment 2, Amendment 3, and Amendment 4 01 December 2008 Protocol BL-1040.01, Version 5.00 Safety and Feasibility study of BL-1040 Final CONFIDENTIAL
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Reporting Serious Adverse Events. Any SAE, regardless of relationship to study medication, which occurs in a patient from the time of study informed consent until 30 days after the last study treatment, must be recorded by the clinical site on an SAE report form. Only SAEs which are considered related to a study procedure (ie blood draw or fresh tumor biopsy) will be captured during the pre-screening period, ie from the time of signing the pre-screening consent (if one is utilized) until the signing of the main study informed consent, or until the patient is determined to be a screen failure. The SAE must also be recorded on the patient’s AE eCRF, including the Investigator’s assessment regarding the relationship of the SAE to the study drug (MIRV, Pac, PLD, or Topo). The Investigator will promptly supply all information requested by the Sponsor (or contract research organization [CRO]) regarding the SAE. The Investigator must submit the SAE Report Form to ImmunoGen Pharmacovigilance (or designee). This form must be completed and submitted within 24 hours of the Investigator’s learning of the event using the contact information printed on the SAE form and contained within the SAE form completion instructions. Follow-up information must also be submitted using a new SAE Report Form. When reporting SAEs, the following additional points should be noted: • The underlying diagnosis or syndrome should be reported as the primary SAE term, rather than the signs or symptoms (signs and symptoms may be described in the narrative). • An event term of “Death” should not be reported as an SAE, but rather be recorded as an outcome of a specific SAE term. Initially, the event term of “death” can be used until the actual cause of death is known. If an autopsy was performed, the autopsy report should be provided. It is the responsibility of the Sponsor to ensure that each Investigator receives a copy of any suspected unexpected serious adverse reaction (SUSAR) report (CIOMS/MedWatch) regarding the study drug and that the report is submitted to the appropriate national regulatory agencies. The Investigator (or Sponsor or contracted designee) must promptly report all SUSARs to the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for review in accordance with national regulations. IRB/IEC notification of the SUSAR may take the form of a submission of a copy of the CIOMS/MedWatch report or other format accepted by the IRB/IEC. A copy of the CIOMS/MedWatch report and notification to IRB/IEC shou...
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Reporting Serious Adverse Events. Any AE the investigator considers serious according to the previously described criteria must be reported within 24 hours from the time the site personnel first learn about the event. To report the SAE, fax the completed SAE form to (fax numbers listed in Table 7) within 24 hours of awareness.
Sample 1
Reporting Serious Adverse Events. A SAE CRFmust be completed with as much information available within 24 hours of knowledge of the event. To improve the quality and precision of acquired SAE data, Clinical Investigators should observe the following guidelines: • Death - Death is an outcome of an event. The event that resulted in the death should be recorded and reported as a SAE.
Sample 1
Reporting Serious Adverse Events. In order to adhere to all applicable laws and regulations for reporting an SAE(s), the study site must notify Sage or designee within 24 hours of the study site staff becoming aware of the SAE(s). The investigator must complete, sign and date the SAE report form, verify the accuracy of the information recorded on the SAE report form with the corresponding source documents, and send a copy to Sage or designee. Additional follow-up information, if required or available, should all be sent to Sage or designee within 24 hours of receipt on a follow-up SAE report form and placed with the original SAE information and kept with the appropriate section of the eCRF and/or study file. Serious adverse events occurring after the designated follow-up time for the study, should be reported to Sage or designee according to the timelines noted above only if the investigator considers the SAE related to IP. Sage, or designee, is responsible for notifying the relevant regulatory authorities of certain events. It is the principal investigator’s responsibility to notify the IRB/IEC of all SAEs that occur at his or her site. Investigators will also be notified of all suspected unexpected serious adverse reactions (SUSARs) that occur during the clinical study. IRBs/IECs will be notified of SAEs and/or SUSARs as required by local law. In addition, appropriate personnel in Sage Drug Safety and Pharmacovigilance or designee will unblind SUSARs for the purpose of regulatory reporting. Sage or designee will submit SUSARs (in blinded or unblinded fashion) to regulatory agencies according to local law. Xxxx, or designee, will submit SUSARS to investigators in a blinded fashion.
Sample 1
Reporting Serious Adverse Events. It is the responsibility of the Investigator that reporting is done adequately. In order to meet Regulatory reporting timelines, the study site is obligated to report any SAE(s) to the Sponsor or designee immediately and no later than 24 hours after receiving information of an event that meets at least one of the criteria for seriousness as defined in Section 11.2.2. Refer to the SAE Reporting Plan for further details on the submission of SAE Reports.
Sample 1
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Reporting Serious Adverse Events. Any SAE (fatal or life-threatening SAE and other SAEs), whether or not related to the study drug, must be reported immediately within 24 hours of the investigator’s awareness of the event by telephone and faxing the appropriate SAE forms to the CRO. Local reporting requirements other than described, will be taken into account and adhered to.
Sample 1
Reporting Serious Adverse Events. Any AE the investigator considers serious according to the previously described criteria must be reported within 24 hours from the time the site personnel first learn about the event. The eCRF system within the clinical database is the preferred method of reporting an SAE. To report the SAE, the investigator will complete the SAE form in the clinical database and submit (Refer to Table 6) within 24 hours of awareness. If the clinical database is down for any reason, the manual SAE forms should be used; however, sites are responsible for ensuring the information on the manual SAE forms is entered into the clinical database once available. Table 6: SAE Reporting Contact Information‌‌
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Related to Reporting Serious 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 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.

  • 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).

  • 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.

  • 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;

  • 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 Effect The Company shall notify the Buyer (and any subsequent holder of the Debentures), as soon as practicable and in no event later than three (3) business days of the Company’s knowledge of any Material Adverse Effect on the Company. For purposes of the foregoing, “knowledge” means the earlier of the Company’s actual knowledge or the Company’s constructive knowledge upon due inquiry.

  • Financial Statements; No Material Adverse Effect; No Internal Control Event (a) (i) The Audited Financial Statements (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; (ii) fairly present the financial condition of Borrower and its Consolidated Subsidiaries as of the date thereof and their results of operations for the period covered thereby in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; and (iii) show all material indebtedness and other liabilities, direct or contingent, of Borrower and its Consolidated Subsidiaries as of the date thereof, including liabilities for taxes, material commitments and Indebtedness. (b) The unaudited consolidated balance sheets of Borrower and its Consolidated Subsidiaries dated August 31, 2006, and the related consolidated statements of income or operations, shareholders’ equity and cash flows for the fiscal quarter ended on that date (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein, and (ii) fairly present the financial condition of Borrower and its Consolidated Subsidiaries as of the date thereof and their results of operations for the period covered thereby, subject, in the case of clauses (i) and (ii), to the absence of footnotes and to normal year-end audit adjustments. (c) Since the date of the Audited Financial Statements, there has been no event or circumstance, either individually or in the aggregate, that has had or could reasonably be expected to have a Material Adverse Effect. (d) To the best knowledge of Borrower, no Internal Control Event exists or has occurred since the date of the Audited Financial Statements that has resulted in or could reasonably be expected to result in a misstatement in any material respect, in any financial information delivered or to be delivered to Agent or Lenders, of (i) covenant compliance calculations provided hereunder or (ii) the assets, liabilities, financial condition or results of operations of Borrower and its Subsidiaries on a consolidated basis. (e) The forecasted balance sheet and statements of income and cash flows of Borrower and its Consolidated Subsidiaries delivered pursuant to Section 6.01(c) were prepared in good faith on the basis of the assumptions stated therein, which assumptions were fair in light of the conditions existing at the time of delivery of such forecasts, and represented, at the time of delivery, Borrower’s best estimate of its future financial condition and performance.

  • Absence of Material Adverse Change On the Closing Date, no circumstance shall exist that constitutes a REIT II Material Adverse Effect.

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