Study Medication Administration Sample Clauses

Study Medication Administration. Patients will self-administer study medication on a daily basis during the Treatment Period. The first self-administration is to occur at the study site under observation. On the days of clinic visits, study medication must be administered in the clinic to accommodate pre-injection and post-injection procedures; study personnel may administer the study medication. Patients will be trained by study personnel during the Pretreatment Period to self-inject study medication with the BA058/Placebo cartridge and pen device. Those patients who are subsequently randomized to teriparatide treatment on Day 1 will be trained in the use of the teriparatide pen on Day 1. If a patient requires assistance with study medication administration, an individual (e.g., a family member) who has been trained by study personnel may provide assistance. Patients will be instructed by the study site to inspect the contents of their study medication device before each injection. If the cartridge or pen contents are not clear and colorless, or if the contents contain particles, the patients will be instructed not to use that cartridge or pen and to contact the study site for further guidance. Injections should be administered in the morning and preferably at the same time each day. All injections are to be given in the periumbilical region, rotating the exact site of injection each day. If it is deemed medically necessary by the investigator for an injection to be administered at a site other than the abdomen, the alternate site of injection is to be recorded and the reason for the change documented in the medical chart. On the first day of study medication administration, the patient should self-inject while in a sitting or lying position at the study site and remain in that position for approximately 5 minutes. The patient is to remain under observation for a minimum of 60 minutes. An orthostatic blood pressure measurement will be taken 60 minutes after the injection. On the days when blood sampling is required after study medication injection, the patient is to remain in the vicinity of the clinic for the blood collections scheduled up to 4 hours post-injection. BA058 80 µg and Placebo will be supplied in cartridges, each containing enough study medication to deliver the required daily dose for 30 days. Patients are to be instructed to change cartridges after 30 days, regardless of how much medication is left in the initial cartridge. Teriparatide will be supplied as a pre-filled pe...
AutoNDA by SimpleDocs
Study Medication Administration. 5.4.1 Alendronate Administration Alendronate must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage or medicinal product (including antacids, calcium supplements and vitamins) of the day. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate. The following instructions should be followed exactly in order to minimize the risk of esophageal irritation and related adverse reactions. · Alendronate should only be swallowed after getting up for the day with a full glass of water (not less than 200 mL or 7 fl. oz.). · Subjects should only swallow alendronate whole. Subjects should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration. · Subjects should not lie down until after their first food of the day. · Subjects should not lie down for at least 30 minutes after taking alendronate. · Alendronate should not be taken at bedtime or before arising for the day. At the Month 3, Month 6, Month 12 and Month 18 visits, the unused alendronate tablets are to be returned to the clinic for counting and the subject will be dispensed additional alendronate. At the Month 24 visit, all unused alendronate tablets are to be returned to the study site.
Study Medication Administration 

Related to Study Medication Administration

  • Construction Administration Redeveloper shall be responsible for all components of the Redeveloper Improvements constructed by Redeveloper including construction management, coordination of contractors and regulatory permitting and other requirements. Redeveloper and its contractor(s) shall reasonably cooperate with City contractors performing work in the vicinity of the Redevelopment Project Area including, but not limited to, Redeveloper's scheduling of its work to provide for a smooth sequence of operations. The Redeveloper will be solely responsible for payment of all construction costs for the Redeveloper Improvements as set forth in this Redevelopment Agreement.

  • Agreement Administration SBBC has delegated authority to the Superintendent of Schools or his/her designee to take any actions necessary to implement and administer this Agreement.

  • Program Administration An activity relating to the general management, oversight and coordination of community development programs. Costs directly related to carrying out eligible activities are not included.

  • Construction Administration Phase Delete the following paragraph if Submittal Exchange isn’t going to be used: 2.

  • Claims Administration An employee will be required to comply with any and all rules and regulations and/or limitations established by the carrier or applicable third party administrator and contained in the policy, and employees and their dependents shall look solely to such carrier or third party administration for the adjudication of the payment of any and all benefits claims.

  • Grant Administration Grantee shall use the Grant funds only for the activities described in the approved Scope of Work. Grantee shall maintain financial records relating to the receipt and expenditure of all Grant funds in accordance with the terms set forth under this Agreement for a period of seven (7) years starting on the first day after final payment under the Agreement.

  • Administration of Medication CONTRACTOR shall comply with the requirements of California Education Code section 49423 when CONTRACTOR serves a student that is required to take prescription and/or over-the-counter medication during the school day. CONTRACTOR may designate personnel to assist the student with the administration of such medication after the student’s parent(s) provides to CONTRACTOR: (a) a written statement from a physician detailing the type, administration method, amount, and time schedules by which such medication shall be taken; and (b) a written statement from the student’s parent(s) granting CONTRACTOR permission to administer medication(s) as specified in the physician’s statement. CONTRACTOR shall maintain, and provide to LEA upon request, copies of such written statements. CONTRACTOR shall maintain a written log for each student to whom medication is administered. Such written log shall specify the student’s name; the type of medication; the date, time, and amount of each administration; and the name of CONTRACTOR’s employee who administered the medication. CONTRACTOR maintains full responsibility for assuring appropriate staff training in the administration of such medication consistent with physician’s written orders. Any change in medication type, administration method, amount or schedule must be authorized by both a licensed physician and parent.

  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • Settlement Administration 5.1. The Settlement Administrator shall, under the supervision of the Court, administer the relief provided by this Settlement Agreement by processing Claim Forms in a rational, responsive, cost effective, and timely manner. The Settlement Administrator shall maintain reasonably detailed records of its activities under this Settlement Agreement. The Settlement Administrator shall maintain all such records as are required by applicable law in accordance with its normal business practices and such records will be made available to Class Counsel and Defendant’s Counsel upon request. The Settlement Administrator shall also provide reports and other information to the Court as the Court may require. The Settlement Administrator shall provide Class Counsel and Defendant’s Counsel with information concerning Notice, administration, and implementation of the Settlement Agreement. Should the Court request, the Parties, in conjunction with the Settlement Administrator, shall submit a timely report to the Court summarizing the work performed by the Settlement Administrator, including a report of all amounts from the State-Specific Settlement Funds paid on account of Approved Claims. Without limiting the foregoing, the Settlement Administrator shall: (a) receive exclusion forms and other requests from Settlement Class Members and promptly provide a copy of such requests to Class Counsel and Defendant’s Counsel upon receipt. If the Settlement Administrator receives any exclusion forms or other requests from the Settlement Class after the Objection/Exclusion Deadline, the Settlement Administrator shall promptly provide copies thereof to Class Counsel and Defendant’s Counsel; (b) provide weekly reports to Class Counsel and Defendant’s Counsel, including, without limitation, reports regarding the number of Claim Forms received, the current number approved by the Settlement Administrator at that time from each of the Settlement Classes, and the number of opt-outs received; (c) make available for inspection by Class Counsel or Defendant’s Counsel the Claim Forms, any documentation submitted in support thereof, and any correspondence received by the Settlement Administrator at any time upon reasonable notice; (d) pay all Approved Claims according to the terms of this Settlement Agreement; (e) make all tax filings related to the Escrow Accounts, including making any required “information returns” as that term is used in 26 U.S.C. § 1, et seq. Neither Class Counsel nor Defendant makes any representations regarding the tax treatment of the Escrow Account, State-Specific Settlement Funds or any portion thereof; and (f) respond to questions about the Settlement from Settlement Class Members. 5.2. The Settlement Administrator shall employ reasonable procedures to screen claims for abuse or fraud. The Settlement Administrator, after consultation with Class Counsel, shall reject Claim Forms where there is evidence of abuse or fraud. 5.3. The Settlement Administrator shall reject any Claim Form that does not contain all requested information. The Settlement Administrator shall provide the individual with an opportunity to cure any deficient Claim Form within twenty-one (21) days after notice to such individual. If the individual fails to cure within the required time, the claim shall be rejected. 5.4. In the exercise of their duties outlined in this Agreement, the Settlement Administrator shall have the right to reasonably request additional information from the Parties or any Settlement Class Member.

  • Project Administration The Contractor shall provide project administration for all Subcontractors, vendors, suppliers, and others involved in implementing the Work and shall coordinate administration efforts with those of the A/E and ODR in accordance with these Uniform General and Supplementary Conditions and provisions of Division 1 Specifications, and as outlined in the Pre- construction Conference.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!