Reporting a Pregnancy Sample Clauses

Reporting a Pregnancy. Pregnancy and lactation are exclusion criteria. Women of child bearing potential, defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (ie, who has had menses any time in the preceding 12 consecutive months) must agree to use highly effective contraceptive methods (as defined in Section 5.8.6) while on study drug and for at least 3 months after the last dose of MIRV. In addition, it is recommended that patients undergo monthly pregnancy test for at least 3 months after the last dose of MIRV. The Sponsor must be immediately notified in the event of a pregnancy occurring during the study and through 30 days after a patient’s last dose of study drug. If a patient becomes pregnant the patient will be withdrawn from study drug. Pregnancy is not an AE unto itself and therefore should not be reported as an AE. All pregnancies will be recorded on a Pregnancy Report and submitted according to the contact information on the form and in the completion guidelines. Pregnancies, with the permission of the mother, will be followed to completion or termination using the designated sections of the Pregnancy report form. Any SAE, occurring during the pregnancy to the mother or fetus, would require that a study SAE form also be completed/submitted.
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Reporting a Pregnancy. Pregnancy and lactation are exclusion criteria. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (ie, who has had menses any time in the preceding 12 consecutive months) must agree to use highly effective contraceptive methods (as defined in Section 5.9.6) while on study drug and for at least 3 months after the last dose of MIRV and for at least 6 months after the last dose of IC Chemo (Pac, PLD, and Topo). In addition, it is recommended that patients undergo monthly pregnancy tests for at least 3 months after the last dose of MIRV. The Sponsor must be immediately notified in the event of a pregnancy occurring during the study and through 30 days after a patient’s last dose of study drug. Pregnancy is not an AE unto itself and therefore should not be reported as an AE. All pregnancies will be recorded on a Pregnancy Report and submitted according to the contact information on the form and in the completion guidelines. Pregnancies, with the permission of the mother, will be followed to completion or termination using the designated sections of the Pregnancy report form. Any SAE, occurring during the pregnancy to the mother or fetus, would require that a study SAE form also be completed/submitted.
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Related to Reporting a Pregnancy

  • DATA REPORTING a) CONTRACTOR shall agree to provide all data related to student information and billing information with ▇▇▇. CONTRACTOR shall agree to provide all data related to any and all sections of this contract and requested by and in the format require by the LEA. CONTRACTOR shall provide the LEA with invoices, attendance reports and progress reports for LEA students enrolled in CONTRACTOR’s NPS/A. b) Using forms developed by the CDE or as otherwise mutually agreed upon by CONTRACTOR and ▇▇▇, CONTRACTOR shall provide LEA, on a monthly basis, a written report of all incidents in which a statutory offense is committed by any LEA student, regardless if it results in a disciplinary action of suspension or expulsion. This includes all statutory offenses as described in Education Code sections 48900 and 48915. CONTRACTOR shall also include, in this monthly report, incidents resulting in the use of a behavioral restraint and/or seclusion even if they were not a result of a violation of Education Code sections 48900 and 48915. c) The LEA shall provide the CONTRACTORS with approved forms and/or format for such data including but not limited to invoicing, attendance reports and progress reports. The LEA may approve use of CONTRACTORS-provided forms at their discretion.

  • Reporting Frequency During any period of time when you are subject to the requirement in paragraph 1 of this award term and condition, you must report proceedings information through ▇▇▇ for the most recent five year period, either to report new information about any proceeding(s) that you have not reported previously or affirm that there is no new information to report. Recipients that have Federal contract, grant, and cooperative agreement awards with a cumulative total value greater than $10,000,000 must disclose semiannually any information about the criminal, civil, and administrative proceedings.

  • Reporting Absences Employees are responsible for reporting to work on time on each scheduled work day. When an Employee is absent from work, they will notify their Supervisor or designate by telephone before the beginning of the work period or as soon as practicable. The Employee shall inform their Supervisor or designate of the reason for the absence, the expected time of their return to work and a telephone number where they may be reached in their absence.

  • Meteorological Data Reporting Requirement (Applicable to wind generation facilities only)

  • CHILD ABUSE REPORTING CONTRACTOR hereby agrees to annually train all staff members, including volunteers, so that they are familiar with and agree to adhere to its own child and dependent adult abuse reporting obligations and procedures as specified in California Penal Code section 11164 et seq. and Education Code 44691. To protect the privacy rights of all parties involved (i.e., reporter, child and alleged abuser), reports will remain confidential as required by law and professional ethical mandates. A written statement acknowledging the legal requirements of such reporting and verification of staff adherence to such reporting shall be submitted to the LEA.