Pregnancy Report definition

Pregnancy Report means a report of pregnancy in a patient or trial subject to whom a Product has been administered or a report of a pregnancy where the father is a patient or trial subject to whom a Product has been administered.
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Pregnancy Report means a report of pregnancy in a patient or trial subject to whom a Medicinal Product or an Investigational Medicinal Product has been administered or a report of a pregnancy where the father is a patient or trial subject to whom a Medicinal Product or an Investigational Medicinal Product has been administered.
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Examples of Pregnancy Report in a sentence

  • A copy of the Shire Investigational and Marketed Products Pregnancy Report Form (and any applicable follow-up reports) must also be sent to the CRO/Shire medical monitor using the details specified in the emergency contact information section of the protocol.

  • In addition to the above, if the investigator determines that the pregnancy meets serious criteria, it must be reported as an SAE using the Shire Clinical Study Serious Adverse Event andNon-serious AEs Required by the Protocol Form as well as the Shire Investigational and Marketed Products Pregnancy Report Form.

  • All pregnancies are to be reported from the time informed consent is signed until the defined follow-up period stated in Section 7.1.3. Any report of pregnancy for any female study participant must be reported within 24 hours to the Shire Global Pharmacovigilance and Risk Management Department using the Shire Investigational and Marketed Products Pregnancy Report Form.

  • Additionally, the pregnancy outcome for patients on study should be reported via CTEP-AERS at the time the outcome becomes known, accompanied by the same Pregnancy Report Form used for the initial report.

  • Consent from the partner must be obtained before the Pregnancy Report Form is completed.

  • However, the outcome of all pregnancies (spontaneous miscarriage, elective termination, ectopic pregnancy, normal birth, or congenital abnormality), occurring from the date of the first dose until 2 days after the last dose of acalabrutinib, should, if possible, be followed up and documented in the Pregnancy Report Form.

  • The pregnancy will be reported immediately by phone and by faxing/emailing a completed Pregnancy Report to the Sponsor (or designee) within 24 hours of knowledge of the event.

  • The Investigator should notify the Sponsor (or designee) of the pregnancy outcome by submitting a follow-up Pregnancy Report.

  • All pregnancies must be reported by faxing a completed Pregnancy Report within 1 business day of becoming aware of the pregnancy to the UCL CTC:Fax: 020 7679 9861 Pregnancy Follow-Up ReportsAll pregnancies must be followed-up until an outcome is determined.

  • If a patient or the partner of a male patient becomes pregnant at any point during the trial, a completed trial specific Pregnancy Report must be submitted to the UCL CTC by fax within 1 business day of learning of its occurrence.

Related to Pregnancy Report

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • GLJ Report means the independent engineering reserves evaluation of certain oil, NGL and natural gas interests of the Company prepared by GLJ dated February 11, 2022 and effective December 31, 2021.

  • Survey Report means a report of the results of a Survey, containing the information set out in clause 12.4 and Schedule 6.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.

  • CREFC® Operating Statement Analysis Report The monthly report in the “Operating Statement Analysis Report” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • Acoustic Assessment Report means the report, prepared in accordance with Publication NPC-233 and Appendix A of the Basic Comprehensive User Guide,by HGC Engineering and dated August 22, 2008 submitted in support of the application, that documents all sources of noise emissions and Noise Control Measures present at the Facility and includes all up-dated Acoustic Assessment Reports as required by the Documentation Requirements conditions of this Certificate to demonstrate continued compliance with the Performance Limits following the implementation of any Modification.

  • Operating Statement Analysis Report format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • MI Report means a report containing Management Information submitted to the Authority in accordance with Framework Schedule 8 (Management Information);

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, Chief Executive Office State and the Borrower State and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.

  • ORSA summary report means a confidential high-level summary of an insurer or insurance group's ORSA.

  • Transparency Reports means a report in accordance with Schedule 7 Part 1 (Transparency Reports) containing the contract information as set out in the table for that Part for publication by the Authority in the interests of transparency.

  • Trauma-informed care means services that are based on an understanding of the vulnerabilities or triggers of those who have experienced violence, that recognize the role violence has played in the lives of those individuals, that are supportive of recovery, and that avoid retraumatization including trauma-focused services and trauma-specific treatment.

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • Feasibility Report means a detailed report, in form and substance sufficient for presentation to arm's length institutional lenders considering project financing, showing the feasibility of placing any part of the Property into commercial production as a Mine and shall include a reasonable assessment of the various categories of ore reserves and their amenability to metallurgical treatment, a complete description of the work, equipment and supplies required to bring such part of the Property into commercial production and the estimated cost thereof, a description of the mining methods to be employed and a financial appraisal of the proposed operations and including at least the following: (i) a description of that part of the Property to be covered by the proposed Mine; (ii) the estimated recoverable reserves of Minerals and the estimated composition and content thereof; (iii) the proposed procedure for development, mining and production; (iv) results of ore amenability treatment tests (if any); (v) the nature and extent of the facilities proposed to be acquired, which may include mill facilities if the size, extent and location of the ore body makes such mill facilities feasible, in which event the study shall also include a preliminary design for such mill; (vi) the total costs, including capital budget, which are reasonably required to purchase, construct and install all structures, machinery and equipment required for the proposed Mine, including a schedule of timing of such requirements; (vii) all environmental impact studies and costs of implementation; (viii) the period in which it is proposed the Property shall be brought to commercial production; and (ix) such other data and information as are reasonably necessary to substantiate the existence of an ore deposit of sufficient size and grade to justify development of a mine, taking into account all relevant business, tax and other economic considerations including a cost comparison between purchasing or leasing and renting of facilities and equipment required for the operation of the Property as a Mine.

  • Evaluation Report means a report on the evaluation of tenders prepared under CSO 12

  • Progress Report means the report similar in form and content to that attached hereto as Appendix III.

  • Summary report means the year end report containing the summary of a

  • Verification Report As defined in Section 4.19.

  • Statement Cycle means the period of time for which our credit union provides a summary of the financial activities and transactions that post and settle to the accountholder's account. See our website at www.wsfcu.com or contact one of our branch service representatives for specific Statement Cycle dates.

  • Sustainability Report the annual non-financial disclosure report prepared in accordance with the Standard for Sustainability Reporting publicly reported by the Borrowers and published on an Internet or intranet website to which each Bank and the Administrative Agent have been granted access free of charge (or at the expense of the Borrowers).

  • Health record means the same as that term is defined in § 32.1-127.1:03.

  • Inspection Report means the report delivered by the Master Servicer or the Special Servicer, as the case may be, substantially in the form of Exhibit L hereto.

  • Information Package means the most recent compilation of financial and other data with respect to the Failed Bank, including any amendments or supplements thereto, provided to the Assuming Institution by the Corporation on the web site used by the Corporation to market the Failed Bank to potential acquirers.

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;

  • ESDM Report means the Emission Summary and Dispersion Modelling Report prepared in accordance with the Procedure Document by Envision Compliance and dated July 3, 2007 submitted in support of the application, and includes any amendments to the ESDM Report listed in Schedule A and all up-dated ESDM Reports prepared as required by the Documentation Requirements conditions of this Certificate.

  • Medicare cost report means CMS-2552-10, the cost report for electronic filing of