Reporting of Pregnancy Sample Clauses

Reporting of Pregnancy. Pregnant women are not eligible to participate in the study. Subjects must be counseled regarding prevention of pregnancy and encouraged to make every effort to avoid pregnancy during study participation. If a female subject becomes pregnant during study participation, study drug dosing will be discontinued, and the subject will be withdrawn from the study. The pregnancy itself is not considered an SAE. However, the investigator must complete the pregnancy report form and fax it to PPD Pharmacovigilance within 24 hours of knowledge of the pregnancy. After delivery or termination of pregnancy, the follow-up pregnancy report form should be completed and submitted via fax to PPD Pharmacovigilance. Spontaneous abortions should always be reported as SAEs. Pregnancy data will be captured and followed by PPD. All pregnancies and outcomes will be tracked. The case will not be closed until after the child is followed for 3 months. If there are complications during the pregnancy, the complications will be recorded as AEs in the usual manner. The subject will be asked to report the outcome of the pregnancy. If there is a congenital anomaly in the infant, this will be recorded as an SAE in the data forms for the mother (ie, the study subject). If a subject becomes pregnant during the study after receiving the study drug, all safety evaluations will be collected as per protocol. In addition, at the time that the pregnancy is reported, consent will be requested to contact the subject and her physician in the postpartum period to assess delivery and health status of the neonate. If the partner of a male subject becomes pregnant, the partner will be asked for consent to allow her treating physician to provide SIGA or its designee with follow-up information regarding the pregnancy and its outcome. 6.2.2 Clinical Laboratory Testing
Sample 1
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Reporting of Pregnancy and Lactation to the Sponsor Female patients that are pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment are excluded from participating in the trial. However in the unlikely event that pregnancy or lactation occurs during the course of the patient’s participation in the trial the following section describes the required reporting of these events. Although pregnancy and lactation are not considered adverse events, it is the responsibility of investigators or their designees to report any pregnancy or lactation in a patient (spontaneously reported to them) that occurs during the trial. Pregnancies and lactations that occur after the consent form is signed but before treatment allocation/randomization must be reported by the investigator if they cause the patient to be excluded from the trial, or are the result of a protocol-specified intervention, including but not limited to washout or discontinuation of usual therapy, diet, placebo treatment or a procedure. Pregnancies and lactations that occur from the time of treatment allocation/randomization through 120 days following cessation of trial medication or 30 days following cessation of trial treatment if the patient initiates new anticancer therapy, whichever is earlier, must be reported by the investigator. All reported pregnancies must be followed to the completion/termination of the pregnancy. Pregnancy outcomes of spontaneous abortion, missed abortion, benign hydatidiform mole, blighted ovum, fetal death, intrauterine death, miscarriage and stillbirth must be reported as serious events (Important Medical Events). If the pregnancy continues to term, the outcome (health of infant) must also be reported. Such events must be reported within 24 hours to the Sponsor. The Sponsor will report within 24 hours (working days) to Merck Global Safety.
Sample 1
Reporting of Pregnancy. Pregnancy will not be considered an SAE. Any report of pregnancy recorded for any female subject or a female partner of a male subject should be reported. To ensure subject safety, each pregnancy must be reported to the Sponsor or its designee within 2 weeks of learning of its occurrence using a clinical trial pregnancy report form. A Pregnancy Report Form should be completed and submitted by email and/or fax to the Sponsor or its designee. The pregnant female subject must be withdrawn from the study. Every effort should be made to gather information regarding the pregnancy outcome until eight weeks post-partum. It is the responsibility of the Investigator to obtain all pregnancy information. Pregnancy complications and elective terminations for medical reasons must be reported as an AE or SAE. Spontaneous abortions must be reported as an SAE. Any SAE occurring in association with a pregnancy brought to the Investigator’s attention after the subject has completed the study and considered by the Investigator as possibly related to the study treatment, must be promptly reported to the Sponsor. The Investigator also must attempt to collect and report to the Sponsor or its designee pregnancy information on any female partner of male study subjects who become pregnant while the subject is enrolled in the study.
Sample 1
Reporting of Pregnancy. If a participant becomes pregnant, the study will continue and the participant will complete the evaluations/procedures. Pregnancy will be documented in the study file and any unexpected complications during the pregnancy will be documented as an AE. If the outcome of the pregnancy meets the criteria for classification as a SAE, (e.g., ectopic pregnancy, spontaneous abortion, stillbirth, neonatal death or congenital anomaly) this will be documented and reported accordingly.
Sample 1
Reporting of Pregnancy. During the trial, all WOCBP should be instructed to contact the Investigator immediately (within 24 hours) if they suspect they might be pregnant (e.g., missed or late menstrual cycle). The Investigator must immediately notify Revance or designated Contract Research Organization (CRO) of any female subject who becomes pregnant any time during study participation, record the information on the Pregnancy Notification Form and send the form to the CRO. The site will be asked to follow-up with the subject periodically during the pregnancy for ongoing health and safety information through term, as applicable. Subjects will remain on the trial. 8.5 UNANTICIPATED ADVERSE EVENTS
Sample 1

Related to Reporting of Pregnancy

  • REPORTING OF ACCIDENTS The Contractor shall report to the Engineer details of any accident as soon as possible after its occurrence. In the case of any fatality or serious accident, the Contractor shall, in addition, notify the Engineer immediately by the quickest available means. The Contractor shall also notify the relevant authority whenever the Laws of Kenya require such a report.

  • Reporting of Reportable Events If Xxxxx determines (after a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, Xxxxx shall notify OIG, in writing, within 30 days after making the determination that the Reportable Event exists.

  • Reporting of Compliance Matters (a) The Sub-Adviser shall promptly provide to the Trust’s Chief Compliance Officer (“CCO”) the following documents: (i) copies of all SEC examination correspondences, including correspondences regarding books and records examinations and “sweep” examinations, issued during the term of this Agreement, in which the SEC identified any concerns, issues or matters (such correspondences are commonly referred to as “deficiency letters”) relating to any aspect of the Sub-Adviser’s investment advisory business and the Sub-Adviser’s responses thereto; (ii) a report of any material violations of the Sub-Adviser’s Compliance Program or any “material compliance matters” (as such term is defined in Rule 38a-1 under the 0000 Xxx) that have occurred with respect to the Sub-Adviser’s Compliance Program; (iii) a report of any material changes to the policies and procedures that compose the Sub-Adviser’s Compliance Program; (iv) a copy of the Sub-Adviser’s chief compliance officer’s report (or similar document(s) which serve the same purpose) regarding his or her annual review of the Sub-Adviser’s Compliance Program, as required by Rule 206(4)-7 under the Advisers Act; and (v) an annual (or more frequently as the Trust’s CCO may reasonably request) representation regarding the Sub-Adviser’s compliance with Paragraphs 7 and 8 of this Agreement. (b) The Sub-Adviser shall also provide the Trust’s CCO with: (i) reasonable access to the testing, analyses, reports and other documentation, or summaries thereof, that the Sub-Adviser’s chief compliance officer relies upon to monitor the effectiveness of the implementation of the Sub-Adviser’s Compliance Program; and (ii) reasonable access, during normal business hours, to the Sub-Adviser’s facilities for the purpose of conducting pre-arranged on-site compliance related due diligence meetings with personnel of the Sub-Adviser.

  • Reporting of Non-Force Majeure Events Each Party (the “Notifying Party”) shall notify the other Parties when the Notifying Party becomes aware of its inability to comply with the provisions of this Agreement for a reason other than a Force Majeure event. The Parties agree to cooperate with each other and provide necessary information regarding such inability to comply, including the date, duration, reason for the inability to comply, and corrective actions taken or planned to be taken with respect to such inability to comply. Notwithstanding the foregoing, notification, cooperation or information provided under this Article shall not entitle the Party receiving such notification to allege a cause for anticipatory breach of this Agreement.

  • Reporting of Sick Leave The employee will call in sick or returning in accordance with Article 14.05 to the designated employer for purposes of payment. For purposes of notification of absence, the employee will notify the appropriate home in accordance with Article 14.05 of their absence that shift.

  • Reporting Status Until the date on which the Buyers shall have sold all of the Registrable Securities (the “Reporting Period”), the Company shall timely file all reports required to be filed with the SEC pursuant to the 1934 Act, and the Company shall not terminate its status as an issuer required to file reports under the 1934 Act even if the 1934 Act or the rules and regulations thereunder would no longer require or otherwise permit such termination.

  • Reporting of Sales to TIPS by Vendor The Participation Fee that was published as part of the Solicitation and the fee published is the legally effective fee, along with any fee conditions stated in the Solicitation. Collection of the fees by TIPS is required under Texas Government Code §791.011 Et seq. Fees are due on all TIPS purchases reported by either Vendor or Member. Fees are due to TIPS upon payment by the Member to the Vendor, Reseller or Vendor Assigned Dealer. Vendor, Reseller or Vendor Assigned Dealer agrees that the participation fee is due to TIPS for all Agreement sales immediately upon receipt of payment including partial payment, from the Member Entity and must be paid to TIPS at least on a monthly basis, specifically within 31 calendar days of receipt of payment, if not more frequently, or as otherwise agreed by TIPS in writing and signed by an authorized signatory of TIPS. Thus, when an awarded Vendor, Reseller or Vendor Assigned Dealer receives any amount of payment, even partial payment, for a TIPS sale, the legally effective fee for that amount is immediately due to TIPS from the Vendor and fees due to TIPS should be paid at least on a monthly basis, specifically within 31 calendar days of receipt of payment, if not more frequently. Vendor is required to report all sales under the TIPS contract to TIPS. When a public entity initiates a purchase with a TIPS Awarded Vendor, if the Member inquires verbally or in writing whether the Vendor holds a TIPS Contract, it is the duty of the Vendor to verify whether or not the Member is seeking a TIPS purchase. Once verified, the Vendor must include the TIPS Contract number on any communications and related sales documents exchanged with the TIPS Member entity. To report sales, the Vendor must login to the TIPS Vendor Portal online at xxxxx://xxx.xxxx-xxx.xxx/vendors_form.cfm and click on the PO’s and Payments tab. Pages 3-7 of the Vendor Portal User Guide will walk you through the process of reporting sales to TIPS. Please refer to the TIPS Accounting FAQ’s for more information about reporting sales and if you have further questions, contact the Accounting Team at xxxxxxxxxx@xxxx-xxx.xxx. The Vendor or vendor assigned dealers are responsible for keeping record of all sales that go through the TIPS Agreement and submitting same to TIPS. Failure to render the participation fee to TIPS shall constitute a breach of this agreement with our parent governmental entity, Texas Education Service Center Region 8, as established by the Texas legislature and shall be grounds for termination of this agreement and any other agreement held with TIPS and possible legal action. Any overpayment of participation fees to TIPS by a Vendor will be refunded to the Vendor within ninety (90) days of receipt of notification if TIPS receives written notification of the overpayment not later than the expiration of six (6) months from the date of overpayment and TIPS determines that the amount was not legally due to TIPS pursuant to this agreement and applicable law. It is the Vendor’s responsibility to identify which sales are TIPS Agreement sales and pay the correct participation fee due for TIPS Agreement sales. Any notification of overpayment received by TIPS after the expiration of six (6) months from the date of overpayment will be non-refundable. Region 8 ESC and TIPS reserve the right to extend the six (6) month deadline to notify if approved by the Region 8 ESC Board of Directors. TIPS reserves all rights under the law to collect the fees due. Please contact TIPS at xxxx@xxxx-xxx.xxx or call (000) 000-0000 if you have questions about paying fees.

  • Freedom of Information and Transparency 20.1 The Recipient acknowledges that the Commissioner is subject to the provisions of the FOIA and agrees to assist and co-operate with the Commissioner (at the Recipient’s expense) where necessary to enable the Commissioner to comply with any requests received under the FOIA relating to this Agreement. This includes, but is not limited to, transferring to the Commissioner any request received by the Recipient under the FOIA relating to this Agreement as soon as practicable following receipt and in any event within three working days of receipt. 20.2 In no event shall the Recipient respond to a request under the FOIA relating to this Agreement without obtaining the prior written consent of the Commissioner. 20.3 The Recipient acknowledges that the Commissioner may be obliged to disclose information under the FOIA: 20.3.1 Without consulting the Recipient; or 20.3.2 Following consultation with the Recipient and having taken into account its views. Provided that where clause 20.3.1 applies the Commissioner shall, in accordance with the recommendations of the Secretary of State for Constitutional Affairs’ Code of Practice on the discharge of a public authorities’ functions under Part 1 of FOIA, take reasonable steps, to give the Recipient advanced notice or to draw the disclosure to the Recipient’s attention after any such disclosure. 20.4 The Recipient shall ensure it retains for disclosure all information (as defined in the FOIA) produced in the course of this Agreement or relating to this Agreement and shall allow the Commissioner to inspect such records from time to time upon request. 20.5 The Recipient acknowledges that the Commissioner is subject to certain transparency and disclosure obligations set out in the Elected Local Policing Bodies Specified Information Order 2011 (as amended) (“Transparency Obligations”) 20.6 The Recipient consents to the Commissioner publishing the contents of this Agreement and information regarding any tender process related to the Purpose of the Agreement to enable the Commissioner to comply with their Transparency Obligations. 20.7 The Recipient acknowledges that: 20.7.1 The Commissioner shall be responsible for determining, at their absolute discretion, whether any information is exempt from disclosure or should be disclosed pursuant to the FOIA and/or the Transparency Obligations and to what extent any information disclosed shall be redacted; and 20.7.2 Any lists or schedules provided by the Recipient outlining confidential information are of an indicative value only and that the Commissioner may be obliged to disclose confidential information in accordance with Clause 20.3 and/or Clause 20.5.

  • Workplace Violence Prevention and Crisis Response (applicable to any Party and any subcontractors and sub-grantees whose employees or other service providers deliver social or mental health services directly to individual recipients of such services): Party shall establish a written workplace violence prevention and crisis response policy meeting the requirements of Act 109 (2016), 33 VSA §8201(b), for the benefit of employees delivering direct social or mental health services. Party shall, in preparing its policy, consult with the guidelines promulgated by the U.S. Occupational Safety and Health Administration for Preventing Workplace Violence for Healthcare and Social Services Workers, as those guidelines may from time to time be amended. Party, through its violence protection and crisis response committee, shall evaluate the efficacy of its policy, and update the policy as appropriate, at least annually. The policy and any written evaluations thereof shall be provided to employees delivering direct social or mental health services. Party will ensure that any subcontractor and sub-grantee who hires employees (or contracts with service providers) who deliver social or mental health services directly to individual recipients of such services, complies with all requirements of this Section.

  • General Reporting Requirements The MA-PD Sponsor agrees to submit to information to CMS according to 42 CFR §§423.505(f), 423.514, and the “Final Medicare Part D Reporting Requirements,” a document issued by CMS and subject to modification each program year.

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