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(See page 5 for contact information).KEY CABINET EXTERIORA - Key Cabinet BodyB - Pull HandleC - 3 Wheel Combination DialKEY CABINET INTERIORD - Combination Dial HousingE - Pull Handle Mounting HoleF - Hanging Key RacksG - 2 Upper Mounting HolesH - 1 Lower Mounting HoleIMPORTANT - For added security, it is recommended to immediately program a new personal combination to replace the factory set combination. Open the Key Cabinet by turning the dials tothe factory set combination “0-0-0”. The 3 digits need to be in the same horizontal level. Then lay the Key Cabinet flat and follow steps below to change the factory combination to your own personal combination.CHANGING THE COMBINATION:1. Locate the back of the lock on the inside of the Key Cabinet and move the lever from position B to position A (Figure 1).2. With the lever in the A position you may now reset the dial combination to three numbers of your choosing (Figure 2).3. Return the Program Lever to position “B” to complete the programming function (Figure 3).4. With the Key Cabinet still open, turn the numbers to a combination different from the new combination you have set (Figure 4).5. The Key Cabinet should now be locked and can be re-opened by returning the dials to the newIMPORTANT - For your convenience, there are 3 pre-drilled mounting holes and hardware included to mount on a wall for added security. If you have additional questions about mounting the Key Cabinet, please check with your local home center/hardware retailer or independent contractor.1. Open the Key Cabinet (Figure 1).2. Locate Pull Handle and mounting screw (Figure 2).3. Insert screw through mounting hole screw the Pull Handle until firmly in place then tighten by usinga Phillips screwdriver (Figure 3).4. Close Key Cabinet and turn the numbers to a combination different from the new combination you have set to secure lock. (Figure 4).1. For your convenience, the Key Cabinet includes 40 numbered hanging key tags (Figure 1).2. Or if preferred, there are numbered stickers that can be adhered to the interior above each key (Figure 2).EMAIL:*******************************WEBSITE: ADDRESS: Consumer Assistance Dept.LH Licensed Products, Inc., 860 East Sandhill Avenue Carson, CA 90746 USA TELEPHONE: US/Canada 1-877-354-5457 (Toll Free)Mexico 01-800-288-2872 After English voice recording stops you must then enter 800-860-1677 to complete your call. (Toll Free)Australia 0011-800-5325-7000 (Toll Free)Germany/New Zealand 00-800-5325-7000 (Toll Free)Other Countries XX*-310-323-5722 (Toll Charges Apply)XX*- Dial U.S. Country Code firstCALL CENTER HOURS: US/Canada 7am – 5pm (PST**) Mon – Fri (Subject to change)CALL BACK HOURS: Other Countries 7am – 8pm (PST**) Mon – Fri (Subject to change) PST**- Local time in Los Angeles, CA, USAINTERNATIONAL CALL BACK HOURS:If you need to speak with a consumer assistant and cannot contact us during the CallCenter hours above, please send an email or leave a telephone message, including your Name,Telephone Number and the best time for us to contact you during the Call Back hours above and we will make every effort to contact you and help answer any of your questions or concerns.* Insert correct Country Code** Local Time based on Los Angeles California USA__-__-____-__-____-__-____-__-____-__-____-__-____-__-____-__-____-__-__Limited WarrantyLH Licensed Products, Inc., (“LHLP, Inc.”) warrants that for a period of one (1) year from the date of purchase, this product will be free from structural or mechanical defects resulting from materials or workmanship. LHLP, Inc., at its sole option and as the purchaser’s sole remedy under this warranty, will repair or replace this product or any component of the product found to be defective duringthe warranty period. Replacement or repair will be made with a new or remanufactured product or component. If the product is no longer available, replacement may be made with a similar product of equal or greater value.THIS IS YOUR EXCLUSIVE WARRANTY.Our goods come with guarantees that cannot be excluded under the Australian Consumer Law.You are entitled to a replacement or refund for a major failure and for compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.This warranty is only valid for the original retail purchaser from the date of initial retail purchase and is not transferable. You must keep the original sales receipt. Proof of purchase is required to obtain warranty service.LHLP, Inc. dealers, service centers, or retail stores selling this product do not have the right to alter, modify or in any way change the terms and conditions of this warranty.This warranty does not apply to the finish on the product. This warranty does not cover normal wear and tear of parts or damage resulting from any of the following: negligent use or misuse of the product, use contrary to the operating instructions, disassembly, repair or alteration by anyone other than LHLP, Inc. or an authorized service center, improper installation, or exposure to extremes of heat or humidity. Further, the warranty does not cover Acts of God, such as fire, flood, earthquakes, hurricanes and tornadoes.LHLP, Inc. shall not be liable for any incidental or consequential damages caused by the breach of any express or implied warranty or otherwise relating to the sale of this product. LHLP, Inc. is also not responsible for: costs associated with removing or installing the product; damage or loss ofthe contents of the product; nor for the unauthorized removal of the contents; or damages incurred during shipment.THE ABOVE WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND LHLP, INC. DISCLAIMS ANY AND ALL OTHER COVENANTS AND WARRANTIES. Except to the extent prohibited by applicable law, any implied warranty of merchantability orfitness for a particular purpose is limited in duration to the duration of the above warranty period. Some states, provinces or jurisdictions do not allow the exclusion or limitation of incidental or consequential damages or limitations on how long an implied warranty lasts, so the above limitations or exclusion may not apply to you. This warranty gives you specific legal rights, and you may also have other rights that vary from state to state, or province to province, or jurisdiction to jurisdiction.The Honeywell Trademark is used under license from Honeywell International Inc. Honeywell International Inc. makes no representations or warranties with respect to this product.Manufactured by:LH Licensed Products, Inc. 860 East Sandhill AvenueCarson, CA 90746。
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Guideline for Industry Clinical Safety Data Management: Definitions and Standards forExpedited ReportingICH-E2AMarch 1995TABLE OF CONTENTSI.INTRODUCTION (1)II.DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCE (2)A.Basic Terms (2)1.Adverse Event (or Adverse Experience) (3)2.Adverse Drug Reaction (ADR) (3)3.Unexpected Adverse Drug Reaction (4)B.Serious Adverse Event or Adverse Drug Reaction (4)C.Expectedness of an Adverse Drug Reaction (5)III.STANDARDS FOR EXPEDITED REPORTING (6)A.What Should be Reported (6)1.Single Cases of Serious, Unexpected ADRs (6)2.Other Observations (7)B.Reporting Time Frames (8)1.Fatal or Life-Threatening Unexpected ADRs (8)2.All Other Serious, Unexpected ADRs (8)3.Minimum Criteria for Reporting (8)C.How to Report (9)D.Managing Blinded Therapy Cases (9)E.Miscellaneous Issues (10)1.Reactions Associated with Active Comparator or PlaceboTreatment (10)2.Products with More Than One Presentation or Use (10)3.Post-study Events (11)rming Investigators and Ethics Committees/Institutional ReviewBoards of New Safety Information (11)IV.REFERENCE (11)KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS OFAttachment 1 SERIOUS ADVERSE DRUG REACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . .This guideline was developed within the Expert Working Group (Efficacy) of the 1International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, October 27,1994. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and the USA. This guidance was published in the Federal Register on March 1, 1995 (60 FR 11284) and is applicable to both drug and biological products. In the past, guidelines have generally been issued under § 10.90(b) [21 CFR 10.90(b)], which provides for the use of guidelines to state procedures or standards of general applicability that are not legal requirements but that are acceptable to FDA. The agency is now in the process of revising §10.90(b). Therefore, this guideline is not being issued under the authority of §10.90(b), and it does not create or confer any rights, privileges or benefits for or on any person, nor does it operate to bind FDA in any way. For additional copies of this guideline contact the Executive Secretariat Staff, HFD-8, Center for Drug Evaluation and Research,7500 Standish Place, Rockville, MD 20855, 301-594-1012. An electronic version of this guideline is also available via Internet by connecting to the CDER FTP server () using the FTP protocol.The time frames and definitions in this guideline differ from those in the Code of 2Federal Regulations [21 CFR 314.80]. Until the regulations are revised, the time frames and definitions in the CFR should be followed.GUIDELINE FOR INDUSTRY 1CLINICAL SAFETY DATA MANAGEMENT:DEFINITIONS AND STANDARDS FOR EXPEDITEDREPORTING 2I.INTRODUCTIONIt is important to harmonize the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development. Thus,agreed definitions and terminology, as well as procedures, will ensure uniform Good Clinical Practice standards in this area. The initiatives already undertaken for marketed medicines through the CIOMS-1 and CIOMS-2 Working Groups on expedited (alert) reports and periodic safety update reporting, respectively, are important precedents and models. However, there are special circumstancesinvolving medicinal products under development, especially in the early stages and before any marketing experience is available. Conversely, it must berecognized that a medicinal product will be under various stages of development and/or marketing in different countries, and safety data from marketingexperience will ordinarily be of interest to regulators in countries where themedicinal product is still under investigational only (Phase 1, 2, or 3) status. For this reason, it is both practical and well-advised to regard premarketing andpost-marketing clinical safety reporting concepts and practices asinterdependent, while recognizing that responsibility for clinical safety withinregulatory bodies and companies may reside with different departments,depending on the status of the product (investigational vs. marketed).There are two issues within the broad subject of clinical safety datamanagement that are appropriate for harmonization at this time:the development of standard definitions and terminology for key aspectsof clinical safety reporting, andthe appropriate mechanism for handling expedited (rapid) reporting, in theinvestigational (i.e., pre-approval) phase.The provisions of this guideline should be used in conjunction with other ICHGood Clinical Practice guidelines.II.DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH CLINICAL SAFETY EXPERIENCEA.Basic TermsDefinitions for the terms adverse event (or experience), adverse reaction,and unexpected adverse reaction have previously been agreed to byconsensus of the more than 30 Collaborating Centers of the WHOInternational Drug Monitoring Centre (Uppsala, Sweden). [Edwards, I.R.,et al, "Harmonisation in Pharmacovigilance," Drug Safety 10(2): 93-102,1994.] Although those definitions can pertain to situations involvingclinical investigations, some minor modifications are necessary,especially to accommodate the pre-approval, development environment.The following definitions, with input from the WHO Collaborative Centre,have been agreed:1.Adverse Event (or Adverse Experience)Any untoward medical occurrence in a patient or clinicalinvestigation subject administered a pharmaceutical product andwhich does not necessarily have to have a causal relationship with this treatment.An adverse event (AE) can therefore be any unfavorable andunintended sign (including an abnormal laboratory finding, forexample), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to themedicinal product.2.Adverse Drug Reaction (ADR)In the pre-approval clinical experience with a new medicinalproduct or its new usages, particularly as the therapeutic dose(s)may not be established:all noxious and unintended responses to a medicinalproduct related to any dose should be considered adversedrug reactions.The phrase "responses to a medicinal products" means that acausal relationship between a medicinal product and an adverseevent is at least a reasonable possibility, i.e., the relationshipcannot be ruled out.Regarding marketed medicinal products, a well-accepted definition of an adverse drug reaction in the post-marketing setting is foundin WHO Technical Report 498 [1972] and reads as follows:A response to a drug which is noxious and unintended andwhich occurs at doses normally used in man forprophylaxis, diagnosis, or therapy of disease or formodification of physiological function.The old term "side effect" has been used in various ways in thepast, usually to describe negative (unfavorable) effects, but alsopositive (favorable) effects. It is recommended that this term nolonger be used and particularly should not be regarded assynonymous with adverse event or adverse reaction.3.Unexpected Adverse Drug ReactionAn adverse reaction, the nature or severity of which is notconsistent with the applicable product information (e.g.,Investigator's Brochure for an unapproved investigationalmedicinal product). See section III.C.B.Serious Adverse Event or Adverse Drug ReactionDuring clinical investigations, adverse events may occur which, ifsuspected to be medicinal product-related (adverse drug reactions),might be significant enough to lead to important changes in the way themedicinal product is developed (e.g., change in dose, population, needed monitoring, consent forms). This is particularly true for reactions which,in their most severe forms, threaten life or function. Such reactionsshould be reported promptly to regulators.Therefore, special medical or administrative criteria are needed to define reactions that, either due to their nature ("serious") or due to thesignificant, unexpected information they provide, justify expeditedreporting.To ensure no confusion or misunderstanding exist of the differencebetween the terms "serious" and "severe," which are not synonymous,the following note of clarification is provided:The term "severe" is often used to describe the intensity (severity)of a specific event (as in mild, moderate, or severe myocardialinfarction); the event itself, however, may be of relatively minormedical significance (such as severe headache). This is not thesame as "serious," which is based on patient/event outcome oraction criteria usually associated with events that pose a threat toa patient's life or functioning. Seriousness (not severity) serves asa guide for defining regulatory reporting obligations.After reviewing the various regulatory and other definitions in use orunder discussion elsewhere, the following definition is believed toencompass the spirit and meaning of them all:A serious adverse event (experience) or reaction is any untowardmedical occurrence that at any dose:Results in death,Is life-threatening,NOTE: The term "life-threatening" in the definition of"serious" refers to an event in which the patient was at riskof death at the time of the event; it does not refer to anevent which hypothetically might have caused death if itwere more severe.Requires inpatient hospitalization or prolongation of existinghospitalization,Results in persistent or significant disability/incapacity, orIs a congenital anomaly/birth defect.Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as importantmedical events that may not be immediately life-threatening or result indeath or hospitalization but may jeopardize the patient or may requireintervention to prevent one of the other outcomes listed in the definitionabove. These should also usually be considered serious.Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsionsthat do not result in hospitalization; or development of drug dependencyor drug abuse.C.Expectedness of an Adverse Drug ReactionThe purpose of expedited reporting is to make regulators, investigators,and other appropriate people aware of new, important information onserious reactions. Therefore, such reporting will generally involve events previously unobserved or undocumented, and a guideline is needed onhow to define an event as "unexpected" or "expected"(expected/unexpected from the perspective of previously observed, noton the basis of what might be anticipated from the pharmacologicalproperties of a medicinal product).As stated in the definition (II.A.3.), an "unexpected" adverse reaction isone, the nature or severity of which is not consistent with information inthe relevant source document(s). Until source documents are amended, expedited reporting is required for additional occurrences of the reaction.The following documents or circumstances will be used to determinewhether an adverse event/reaction is expected:1.For a medicinal product not yet approved for marketing in acountry, a company's Investigator's Brochure will serve as thesource document in that country. See section III.F. and ICHGuideline for the Investigator's Brochure.2.Reports which add significant information on specificity or severityof a known, already documented serious ADR constituteunexpected events. For example, an event more specific or moresevere than described in the Investigator's Brochure would beconsidered "unexpected." Specific examples would be (a) acuterenal failure as a labeled ADR with a subsequent new report ofinterstitial nephritis and (b) hepatitis with a first report of fulminanthepatitis.III.STANDARDS FOR EXPEDITED REPORTINGA.What Should be Reported?1.Single Cases of Serious, Unexpected ADRsAll ADRs that are both serious and unexpected are subject toexpedited reporting. This applies to reports from spontaneoussources and from any type of clinical or epidemiologicalinvestigation, independent of design or purpose. It also applies tocases not reported directly to a sponsor or manufacturer (forexample, those found in regulatory authority generated ADRregistries or in publications). The source of a report (investigation,spontaneous, other) should always be specified.Expedited reporting of reactions that are serious but expected willordinarily be inappropriate. Expedited reporting is alsoinappropriate for serious events from clinical investigations that areconsidered not related to study product, whether the event isexpected or not. Similarly, nonserious adverse reactions, whetherexpected or not, will ordinarily not be subject to expeditedreporting.Information obtained by a sponsor or manufacturer on serious,unexpected reports from any source should be submitted on anexpedited basis to appropriate regulatory authorities if theminimum criteria for expedited reporting can be met. See sectionIII.B.Causality assessment is required for clinical investigation cases.All cases judged by either the reporting health care professional orthe sponsor as having a reasonable suspected causal relationshipto the medicinal product qualify as ADRs. For purposes ofreporting, adverse event reports associated with marketed drugs(spontaneous reports) usually imply causality.Many terms and scales are in use to describe the degree ofcausality (attributability) between a medicinal product and anevent, such as certainly, definitely, probably, possibly or likelyrelated or not related. Phrases such as "plausible relationship,""suspected causality," or "causal relationship cannot be ruled out"are also invoked to describe cause and effect. However, there iscurrently no standard international nomenclature. The expression"reasonable causal relationship" is meant to convey in general thatthere are facts (evidence) or arguments to suggest a causalrelationship.2.Other ObservationsThere are situations in addition to single case reports of "serious"adverse events or reactions that may necessitate rapidcommunication to regulatory authorities; appropriate medical andscientific judgment should be applied for each situation. Ingeneral, information that might materially influence the benefit-riskassessment of a medicinal product or that would be sufficient toconsider changes in medicinal product administration or in theoverall conduct of a clinical investigation represents suchsituations. Examples include:a.For an "expected," serious ADR, an increase in the rate ofoccurrence which is judged to be clinically important.b. A significant hazard to the patient population, such as lackof efficacy with a medicinal product used in treatinglife-threatening disease.c. A major safety finding from a newly completed animal study(such as carcinogenicity) .B.Reporting Time Frames1.Fatal or Life-Threatening Unexpected ADRsCertain ADRs may be sufficiently alarming so as to require veryrapid notification to regulators in countries where the medicinalproduct or indication, formulation, or population for the medicinalproduct are still not approved for marketing, because such reportsmay lead to consideration of suspension of, or other limitations to,a clinical investigation program. Fatal or life-threatening,unexpected ADRs occurring in clinical investigations qualify forvery rapid reporting. Regulatory agencies should be notified (e.g.,by telephone, facsimile transmission, or in writing) as soon aspossible but no later than 7 calendar days after first knowledge bythe sponsor that a case qualifies, followed by as complete a reportas possible within 8 additional calendar days. This report shouldinclude an assessment of the importance and implication of thefindings, including relevant previous experience with the same orsimilar medicinal products.2.All Other Serious, Unexpected ADRsSerious, unexpected reactions (ADRs) that are not fatal orlife-threatening must be filed as soon as possible but no later than15 calendar days after first knowledge by the sponsor that thecase meets the minimum criteria for expedited reporting.3.Minimum Criteria for ReportingInformation for final description and evaluation of a case reportmay not be available within the required time frames for reportingoutlined above. Nevertheless, for regulatory purposes, initialreports should be submitted within the prescribed time as long asthe following minimum criteria are met: an identifiable patient; asuspect medicinal product; an identifiable reporting source; and anevent or outcome that can be identified as serious andunexpected, and for which, in clinical investigation cases, there isa reasonable suspected causal relationship. Follow-up informationshould be actively sought and submitted as it becomes available.C.How to ReportThe CIOMS-I form has been a widely accepted standard for expeditedadverse event reporting. However, no matter what the form or formatused, it is important that certain basic information/data elements, whenavailable, be included with any expedited report, whether in a tabular ornarrative presentation. The listing in Attachment 1 addresses those data elements regarded as desirable; if all are not available at the time ofexpedited reporting, efforts should be made to obtain them. See section III.B.All reports must be sent to those regulators or other official partiesrequiring them (as appropriate for the local situation) in countries wherethe drug is under development.D.Managing Blinded Therapy CasesWhen the sponsor and investigator are blinded to individual patienttreatment (as in a double-blind study), the occurrence of a serious eventrequires a decision on whether to open (break) the code for the specificpatient. If the investigator breaks the blind, then it is assumed thesponsor will also know the assigned treatment for that patient. Although it is advantageous to retain the blind for all patients prior to final studyanalysis, when a serious adverse reaction is judged reportable on anexpedited basis, it is recommended that the blind be broken only for thatspecific patient by the sponsor even if the investigator has not broken the blind. It is also recommended that, when possible and appropriate, theblind be maintained for those persons, such as biometrics personnel,responsible for analysis and interpretation of results at the study'sconclusion.There are several disadvantages to maintaining the blind under thecircumstances described which outweigh the advantages. By retainingthe blind, placebo and comparator (usually a marketed product) casesare filed unnecessarily. When the blind is eventually opened, which may be many weeks or months after reporting to regulators, it must beensured that company and regulatory data bases are revised. If theevent is serious, new, and possibly related to the medicinal product, then if the Investigator's Brochure is updated, notifying relevant parties of thenew information in a blinded fashion is inappropriate and possiblymisleading. Moreover, breaking the blind for a single patient usually haslittle or no significant implications for the conduct of theclinical investigation or on the analysis of the final clinical investigationdata.However, when a fatal or other "serious" outcome is the primary efficacyendpoint in a clinical investigation, the integrity of the clinical investigation may be compromised if the blind is broken. Under these and similarcircumstances, it may be appropriate to reach agreement with regulatory authorities in advance concerning serious events that would be treated as disease-related and not subject to routine expedited reporting.E.Miscellaneous Issues1.Reactions Associated with Active Comparator or PlaceboTreatmentIt is the sponsor's responsibility to decide whether activecomparator drug reactions should be reported to the othermanufacturer and/or directly to appropriate regulatory agencies.Sponsors should report such events to either the manufacturer ofthe active control or to appropriate regulatory agencies. Eventsassociated with placebo will usually not satisfy the criteria for anADR and, therefore, for expedited reporting.2.Products with More Than One Presentation or UseTo avoid ambiguities and uncertainties, an ADR that qualifies forexpedited reporting with one presentation of a product (e.g., adosage form, formulation, delivery system) or product use (e.g., for an indication or population), should be reported or referenced toregulatory filings across other product presentations and uses.It is not uncommon that more than one dosage form, formulation,or delivery system (oral, IM, IV, topical, etc.) of thepharmacologically active compound(s) is under study or marketed;for these different presentations there may be some markeddifferences in the clinical safety profile. The same may apply for agiven product used in different indications or populations (singledose vs. chronic administration, for example). Thus,"expectedness" may be product or product use specific, andseparate Investigator's Brochures may be used accordingly.However, such documents are expected to cover ADR information that applies to all affected product presentations and uses. Whenrelevant, separate discussions of pertinent product-specific oruse-specific safety information will also be included.It is recommended that any adverse drug reactions that qualify forexpedited reporting observed with one product dosage form or use be cross referenced to regulatory records for all other dosageforms and uses for that product. This may result in a certainamount of overreporting or unnecessary reporting in obvioussituations (for example, a report of phlebitis on IV injection sent toauthorities in a country where only an oral dosage form is studiedor marketed). However, underreporting is completely avoided.3.Post-study EventsAlthough such information is not routinely sought or collected bythe sponsor, serious adverse events that occurred after the patienthad completed a clinical study (including any protocol requiredpost-treatment follow-up) will possibly be reported by aninvestigator to the sponsor. Such cases should be regarded forexpedited reporting purposes as though they were study reports.Therefore, a causality assessment and determination ofexpectedness are needed for a decision on whether or notexpedited reporting is required.rming Investigators and Ethics Committees/Institutional ReviewBoards of New Safety InformationInternational standards regarding such communication are discussedwithin the ICH GCP Guidelines, including the addendum on "Guideline forthe Investigator's Brochure." In general, the sponsor of a study shouldamend the Investigator's Brochure as needed, and in accord with anylocal regulatory requirements, so as to keep the description of safetyinformation updated.IV.REFERENCEFederal Register. Vol.60, No. 40, Wednesday, March 1, 1995, pages 11284-11287.Attachment 1 KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS OFSERIOUS ADVERSE DRUG REACTIONSThe following list of items has its foundation in several established precedents, including those of CIOMS-I, the WHO International Drug Monitoring Centre, and various regulatory authority forms and guidelines. Some items may not be relevant depending on the circumstances. The minimum information required for expedited reporting purposes is: an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Attempts should be made to obtainfollow-up information on as many other listed items pertinent to the case.1.Patient Details:Initials,Other relevant identifier (clinical investigation number, for example),Gender,Age and/or date of birth,Weight,Height,2.Suspected Medicinal Product(s):Brand name as reported,International Non-Proprietary Name (INN),Batch number,Indication(s) for which suspect medicinal product was prescribed ortested,Dosage form and strength,Daily dose and regimen (specify units - e.g., mg, mL, mg/kg),Route of administration,Starting date and time of day,Stopping date and time, or duration of treatment.3.Other Treatment(s):For concomitant medicinal products (including non-prescription/OTCmedicinal products) and non-medicinal product therapies, provide thesame information as for the suspected product.4.Details of Suspected Adverse Drug Reaction(s):Full description of reaction(s) including body site and severity, as well asthe criterion (or criteria) for regarding the report as serious should begiven. In addition to a description of the reported signs and symptoms,whenever possible, attempts should be made to establish a specificdiagnosis for the reaction.Start date (and time) of onset of reaction,Stop date (and time) or duration of reaction,Dechallenge and rechallenge information,Setting (e.g., hospital, out-patient clinic, home, nursing home),Outcome: Information on recovery and any sequelae; what specific testsand/or treatment may have been required and their results; for a fataloutcome, cause of death and a comment on its possible relationship tothe suspected reaction should be provided. Any autopsy or otherpost-mortem findings (including a coroner's report) should also beprovided when available. Other information: anything relevant to facilitateassessment of the case, such as medical history including allergy, drugor alcohol abuse; family history; findings from special investigations.5.Details on Reporter of Event (Suspected ADR):Name,Address,Telephone number,Profession (speciality).6.Administrative and Sponsor/Company Details:Source of report: Was it spontaneous, from a clinical investigation(provide details), from the literature (provide copy), other?Date event report was first received by sponsor/manufacturer,Country in which event occurred,Type of report filed to authorities: initial or follow-up (first, second, etc.),Name and address of sponsor/manufacturer/company,Name, address, telephone number, and FAX number of contact person inreporting company or institution,Identifying regulatory code or number for marketing authorization dossieror clinical investigation process for the suspected product (for exampleIND or CTX number, NDA number),Sponsor/manufacturer's identification number for the case (This numbershould be the same for the initial and follow-up reports on the samecase).。
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Quick reference guideThis Quick Guide describes only the The precautions and detailed operatingIndexGeneral Information1. TouchscreenExam Panel LayoutMultipurpose Panel LayoutAlphanumeric Keyboard Layout2. eTouchMenuConfigurationCustomized Touchscreen ConfigurationAssociation to Real Time Preset3. Starting an Exam4. Ending an ExamImage Optimization6. Tips in B-ModeTips to Optimize Superficial ImagingTips to Optimize Deep ImagingTips to Optimize Spatial ResolutionTips to Optimize Contrast ResolutionTips to Optimize Temporal Resolution7. Tips in M-ModeTips to Optimize Contrast Resolution8. Tips in Color Flow Mapping (CFM)Tips to Optimize Fast FlowsTips to Optimize Slow FlowsTips to Optimize Deep Flows9. Tips in DopplerTips to Optimize Fast FlowsTips to Optimize Slow FlowsTips to Optimize Deep Flows Measurements, Worksheet and Report10. MeasurementsH ow to Take Measurements11. MyLab Worksheet12. MyLab ReportMyLab ArchiveDark gray Dark blue Light blue Button with sub-menusEach lever can control two functions which depend on the active modality. The lever acts on the active control, displayed in the upper position.To switch to the other displayed function press theArea Function Guide GraphicalConventionScrolling ButtonNavigation Area Navigation tabsof the selectedfunctionsBROWN CAPITALLETTERS-Management Area General controlsof the activemodalityGREY CAPITALLETTERS ADV>>/BASIC<<Parameters Area More specificcontrols of theselected functionBLACK CAPITALLETTERS ADV>>/BASIC<<The menu shows:• in the center the touchscreen layout.• on the right the menu to record the macro and to edit the customized buttons.• on the bottom the fields where customized touchscreens are named and described.Archived exams are listed in alphabetic order. The folder symbol, when shown on the archived exams list, indicates that the corresponding exam contained images/ clips.The thumbnail of the selected exam is displayed on the right side of the screen: when more exams are selected, the thumbnail corresponds to the last selected exam.OPEN automatically displays the selected exam(s). When more exams have been selected, the tabs displayed above the thumbnails columns allows to browse the data of the reviewed exams.To display a thumbnail full screen, place the cursor on the desired thumbnail and press ENTER.141015100 R e v . 03ESAOTE S.p.A.Via Enrico Melen, 77 - 16152 Genoa, Italy Phone: +39 010 6547.1 - Internet: 。
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Name:______________________________ Date:____________________Chapter 7: Cell Structure and Function Study Guide Section 7-1: Life is Cellular1.Who was the first scientist to discover cells? What kind of cells did heobserve? Hooke – cork cells – he coined the term “Cell”2.Which scientist was the first to look at live cells under a microscope?Leuwenhoek – called them “animicules”3.Describe the works of Schleiden and Schwann. What did their researchcontributed to the cell theory?Schliden = all plants are made of cellsSchwann = all animals are made of cells- they contributed to the “all living things are made of cells” piece of the cell theory4.List the three parts of the cell theory:1) all living things are made of cells2) cells are the basic unit of structure and function within an organism3) cells come from preexisting cells5.What did Rudolf Virchow’s discoveries bring to our knowledge of cells? Cells come from preexisting cells.6.Biologists divide cells into two categories: PROKARYOTES__ andEUKARYOTES_.pare and Contrast these two types of cells? Give examples of both. BOTH ARE Types of cells, both have DNA, cytoplasm, a cell membrane and ribosomesProkaryotes – no nucleus or membrane bound organelles (super simple) EX: BacteriaEukaryotes – HAVE a true nucleus and many specialized membrane bound organelles – are usually larger and more complex – make up multicellular organisms EX: animal or plant cellSection 7-2: Eukaryotic Cell Structuresbel the structures on the illustration below of an animal and plant cell.--Also look over your cell organelle table (structure, function/location, and picture)9.What distinguishes rough ER from smooth ER? What is the difference inwhat they produce?Rough ER – has ribosomes (and smooth ER does not have ribosomes) - Rough ER helps to modify proteins (changes their shape to become functional)- Smooth ER makes lipids for the cell membrane10.What is the function of the nucleus?The nucleus stores the genetic information of the cell - DNA11.What important parts does the nucleus contain? What are theirfunctions?- nucleus contains the nucleolus (make ribosomes), the nuclear envelope (to monitor what comes into and leaves the nucleus), and DNA which codes for making all proteins within a cell12.What does chromatin consist of? When chromatin condenses during celldivision what does it form?Chromatin consists of DNA which is unwound and functioning within a cell – chromatin condenses during cell division into chromosomes13.What is the cytoskeleton? What are its functions?Supporting framework of the cell.a.Maintains cell shapeb.Means “Cell skeleton”Can aide in cell movement such as cilia or flagella or movement of things within a cell14.What takes place in the nucleolus?Ribosomes are made15.Circle the letter of EACH sentence that is true about lysosomes.a.They contain enzymes that help synthesize lipids.b.They break down organelles that have outlived their usefulness.c.They produce proteins that are modified by the ERd.They contain enzymes that break down lipids, carbs, and proteinsMATCHING:16._F_ Ribosome a. Uses energy from sunlight to make energy-richi.food17.__D__ ER b. Stack of membranes in which enzymes attachi.carbohydrates and lipids to proteins18._B_Golgi Apparatus c. Uses energy from food to make high-energypounds19.__G_ Lysosome d. An internal membrane system in whichcomponents of cell membrane and some proteins are constructed20.__E__ Vacuole e. Saclike structure that stores materials21._A_ Chloroplast f. Small particle of RNA and protein that produces22.__C_ Mitochondria g. Filled with enzymes used to break down foodinto particles that can be used by the cell23.True or False: Both chloroplasts and mitochondria contain their own DNA.24.Circle the letter of EACH structure that animal cells contain.a.Chloroplastsb. lysosomesb. c. cytoskeleton d. ER25.Circle the letter of EACH structure that plant cells contain.a.Cell Wallb. ERc. Lysosomesd. chloroplastSection 7-3: Cell Boundaries26.What are the main jobs of the Cell membrane?To monitor what comes into and leaves the cell, structure and support for the cell27.What is diffusion?Movement of molecules OTHER THAN WATER across a selectively permeable membraneNO ENERGY REQUIREDMoves from HIGH concentration to LOW concentration28.What is osmosis? Does it require energy?•Movement of WATER across a selectively permeable membrane (basically the diffusion of water)•NO ENERGY REQUIRED•Water moves from HIGH to LOW until equilibrium is reached29.Describe Isotonic, Hypertonic and Hypotonic.a.Isotonic: “equal strength”Same concentration on both sidesNO net movement of waterb. Hypertonic:“Above Strength”•GREATER concentration of water INSIDE the cell•Water moves OUT to balance with surroundings•As a result CELL WILL SHRINK!b. Hypotonic:“Below Strength”–LESS concentration of water INSIDE the cell–Water moves IN from surroundings to balance with surroundings–As a result the CELL WILL BURST!!30.What structures in the cell membrane aid in facilitated diffusion? What arethey made of?They have a SPECIFIC protein channels that allow them pass thru the membrane Made of PROTEINS…31.Describe the four types of Active Transport:•Endocytosis: Takes materials in with in pocketing–Forms a vacuole in cytoplasm•Phagocytosis: “cell eating”–Take in food or solids•Pinocytosis: “cell drinking”–Take in liquidsExocytosis: Sends materials out with an out pocketing»Gets rid of cellular wasteSection 7-4: The Diversity of Cellular Life32.What is cell specialization?– cells throughout and organism develop in different ways to performdifferent tasks.33.Describe the levels of organization from simplest level to the most complexlevel:•Cells – Basic unit of life•Tissues – Group of similar cells that perform the same function•Organs – Many tissues working together•Organ Systems – Group of organs working together to perform a specific function34.Give an example of each of the 4 levels of organization.•Cells – red blood cell•Tissues – Muscle tissue•Organs – Stomach, lung•Organ Systems – Digestive system, respiratory system。