Collection of Pregnancy Information Sample Clauses

Collection of Pregnancy Information. ‌ Any pregnancy, including female partner pregnancies of male patients, that occurs or becomes confirmed during a clinical study will be reported to the Sponsor (or designee) within 24 hours of first knowledge of the pregnancy, as described in Section 8.3.6. The report will be provided on the pregnancy form. While pregnancy itself is not considered an AE, for the purposes of tracking, it should be reported on the pregnancy forms. All pregnancies temporally related to taking study medication should be followed and discussed with the Medical Monitor as follows: • The Investigator will follow up with the patient approximately every 3 months throughout the pregnancy to collect information on the status of the pregnancy. Generally, follow up will not be required for longer than 3 months beyond the estimated delivery date. • The Investigator will report any information on the status of the pregnancy to the Sponsor (or designee) using the pregnancy forms. The final outcome of the pregnancy will be reported to the Sponsor (or designee) using the pregnancy forms. Any termination of pregnancy will be reported, regardless of fetal status (ie, presence or absence of anomalies) or indication for the procedure. Any SAEs related to the pregnancy (see below), or occurring during the pregnancy, or after delivery, must be documented and reported to the Sponsor (or designee) on both the SAE form and the pregnancy forms. Serious adverse events occurring in the child (eg, congenital anomalies or other conditions present at birth, whether genetically inherited or occurring in utero) must also be documented on both the SAE form and the pregnancy forms. Reportable SAEs associated with pregnancy include, but are not limited to: • Pregnancy losses (eg, spontaneous abortion, late fetal death) • Life-threatening developments (eg, placental abruption, fetal distress) • Congenital anomalies • Neonatal or maternal death • Any event resulting in maternal or neonatal hospitalization/prolonged hospitalization
Sample 1
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Collection of Pregnancy Information. Male subjects with partners who become pregnant: Female subjects who become pregnant
Sample 1

Related to Collection of Pregnancy Information

  • Return or Destruction of Confidential Information If an Interconnection Party provides any Confidential Information to another Interconnection Party in the course of an audit or inspection, the providing Interconnection Party may request the other party to return or destroy such Confidential Information after the termination of the audit period and the resolution of all matters relating to that audit. Each Interconnection Party shall make Reasonable Efforts to comply with any such requests for return or destruction within ten days of receiving the request and shall certify in writing to the other Interconnection Party that it has complied with such request.

  • CONTRACT INFORMATION 1. The State of Arkansas may not contract with another party: a. Upon default, to pay all sums to become due under a contract. b. To pay damages, legal expenses or other costs and expenses of any party. c. To conduct litigation in a place other than Pulaski County, Arkansas d. To agree to any provision of a contract; which violates the laws or constitution of the State of Arkansas. 2. A party wishing to contract with the State of Arkansas should: a. Remove any language from its contract which grants to it any remedies other than: i. The right to possession. ii. The right to accrued payments. iii. The right to expenses of de-installation. iv. The right to expenses of repair to return the equipment to normal working order, normal wear and tear excluded. v. The right to recover only amounts due at the time of repossession and any unamortized nonrecurring cost as allowed by Arkansas Law. b. Include in its contract that the laws of the State of Arkansas govern the contract. c. Acknowledge that contracts become effective when awarded by the State Procurement Official.

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