Study Medication Sample Clauses

Study Medication. A. Sponsor shall make commercially reasonable efforts to provide sufficient quantities of the Study Medication on a timely basis. All Study Medication shall be used by the Site, under the supervision of the Investigator, solely for the purpose of conducting the Study according to the Protocol. The Site shall keep all Study Medication in a locked, secured area at all times and maintain complete, up-to-date records showing receipt, dispensing, and returns of the Study Medication as required Hodnocených přípravků, jak požaduje Protokol a Platné právní předpisy. Hodnocený přípravek bude uchováván při takové teplotě a za takových podmínek, jaké jsou přiměřeně požadovány Zadavatelem a Protokolem. Zkoušející nebude poskytovat Hodnocený přípravek žádné osobě, která není podle Platných právních předpisů oprávněna jej dostat. V průběhu Klinického hodnocení bude Zkoušející zodpovědný za kontrolu, přístup a podávání Hodnoceného přípravku v souladu s platnými právními předpisy a nařízeními. by the Protocol and Applicable Law. The Study Medication shall be stored at such temperature and other conditions as reasonably required by Sponsor and as required by the Protocol. The Investigator shall not supply the Study Medication to any person not authorized under Applicable Law to receive it. During the course of the Study, the Investigator shall be responsible for the control of, access to, and administration of the Study Medication in compliance with applicable laws and regulations.
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Study Medication. Any remaining medication at the end of the clinical phase of the Study will be retained by PRA for a period of [**] months, after this period upon Sponsor’s instructions and sole discretion, PRA will either destroy the remaining medication with evidence of destruction provided to Sponsor, provided however, PRA will notify the Sponsor at least [**] prior to the date that the medication is due to be destroyed or if Sponsor requests in writing, the medication will be sent by PRA to the Sponsor at Sponsor's expense, in compliance with all applicable laws and regulations and using proper industry standards to ensure a safe and non-perishable delivery. Storage may be continued by PRA beyond the specified time at Sponsor's expense and PRA shall take commercially reasonable precautions to safeguard Test Articles entrusted to PRA’s control.
Sample 1
Study Medication. A. Sponsor shall make commercially reasonable efforts to provide sufficient quantities of the Study Medication on a timely basis required for a proper performance of the Study. All Study Medication shall be used by the Site, under the supervision of the Investigator, solely for the purpose of conducting the Study according to the Protocol. The Site shall keep all Study Medication in a locked, secured area at all times and maintain complete, up-to-date records showing receipt, dispensing, and returns of the Study Medication as required by the Protocol and Applicable Law. The Study Medication shall be stored at such temperature and other conditions as reasonably required by Sponsor and as required by the Protocol. The Investigator shall not supply the Study Medication to any person not authorized under Applicable Law to receive it. During the course of the Study, the Investigator shall be responsible for the control of, access to, and administration of the Study Medication in compliance with kontrolu, přístup a podávání Hodnoceného přípravku v souladu s platnými právními předpisy a nařízeními. Zadavatel/CRO zajistí distribuci zásilky hodnoceného léčiva do lékárny Zdravotnického zařízení, kde je odpovědný farmaceut převezme a zkontroluje (tzn., není-li poškozena, v případě zvláštních požadavků na transport, byly-li tyto požadavky dodrženy a příjem zásilky potvrdí), následně si Hlavní zkoušející na žádanku hodnocené léčivo převezme a je za ně plně zodpovědný. Zadavatel prohlašuje, že jsou splněny veškeré podmínky stanovené příslušnými právními předpisy pro výrobu (dovoz) dodávaného hodnoceného léčiva a jejich distribuci do Zdravotnického zařízení. applicable laws and regulations. Sponsor/CRO ensure distribution of the Study Medication to Institutional pharmacy where Delegated pharmacists takes over and checks the shipment (if not damaged, in the case of special transport requirements, if these requirements are met and confirm receipt of the shipment), Investigator then takes over and assume full responsibility of the Study Medication. Sponsor declares that all conditions set up by applicable law for manufacturing (import) and distribution to the Institution of the Study Medication are met.
Sample 1
Study Medication. ACCOUNTABILITY The US FDA requires accounting of all investigational drug received by each study center. Records of drug disposition required by federal law include the date received by the center, date administered, quantity administered, and the patient to whom study drug was administered. The Investigator is responsible for the accountability of all used and unused study drug containers and unused study drug. Each study center is to use a study drug accountability log to document study drug disposition. All items on this form are to be completed in full. The investigator identification number and patient initials and identification number are to be recorded on each study drug accountability log. Each time study personnel dispenses study drug for a patient, he or she is to record the date dispensed, and his or her initials. Study personnel are to monitor the inventory of clinical supplies and maintain a count of all used and unused study drug. The CRA is to review study drug accountability records and remaining drug supplies during routine monitoring visits.
Sample 1
Study Medication. Dispense six month supply of alendronate · Assess subject’s supply of calcium and vitamin D supplements; resupply as necessary, instruct subject to take daily until they are discharged from the study Scheduling and instructions for next clinic visit · Remind subject to take study medication as instructed · Remind subject to record study medication use Month 18 Visit for Study BA058-05-005 Day 540 (±5 days) VISIT Activities Month 18 Recent health status · Document any changes since previous visit Xxxxx xxxxx, height and weight measurement Subject diary review · Review study medication diary/dispense new diary if necessary · Record deviations in dosing or any AEs in source documents and CRFs. · Collect diaries and enter data into CRF Study medication · Dispense six month supply of aalendronate · Assess subject’s supply of calcium and vitamin D supplements; resupply as necessary, instruct subject to take daily until they are discharged from the study Scheduling and instructions for next clinic visit · Remind subject to take study medication as instructed · Remind subject to record study medication use
Sample 1
Study Medication 
Sample 1

Related to Study Medication

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  • Durable Medical Equipment (DME), Medical Supplies, Prosthetic Devices, Enteral Formula or Food, and Hair Prosthesis (Wigs) This plan covers durable medical equipment and supplies, prosthetic devices and enteral formula or food as described in this section. Durable Medical Equipment (DME) DME is equipment which: • can withstand repeated use; • is primarily and customarily used to serve a medical purpose; • is not useful to a person in the absence of an illness or injury; and • is for use in the home. DME includes supplies necessary for the effective use of the equipment. This plan covers the following DME: • wheelchairs, hospital beds, and other DME items used only for medical treatment; and • replacement of purchased equipment which is needed due to a change in your medical condition or if the device is not functional, no longer under warranty, or cannot be repaired. DME may be classified as a rental item or a purchased item. In most cases, this plan only pays for a rental DME up to our allowance for a purchased DME. Repairs and supplies for rental DME are included in the rental allowance. Preauthorization may be required for certain DME and replacement or repairs of DME. Medical Supplies Medical supplies are consumable supplies that are disposable and not intended for re- use. Medical supplies require an order by a physician and must be essential for the care or treatment of an illness, injury, or congenital defect. Covered medical supplies include: • essential accessories such as hoses, tubes and mouthpieces for use with medically necessary DME (these accessories are included as part of the rental allowance for rented DME); • catheters, colostomy and ileostomy supplies, irrigation trays and surgical dressings; and • respiratory therapy equipment. Diabetic Equipment and Supplies This plan covers diabetic equipment and supplies for the treatment of diabetes in accordance with R.I. General Law §27-20-30. Covered diabetic equipment and supplies include: • therapeutic or molded shoes and inserts for custom-molded shoes for the prevention of amputation; • blood glucose monitors including those with special features for the legally blind, external insulin infusion pumps and accessories, insulin infusion devices and injection aids; and • lancets and test strips for glucose monitors including those with special features for the legally blind, and infusion sets for external insulin pumps. The amount you pay differs based on whether the equipment and supplies are bought from a durable medical equipment provider or from a pharmacy. See the Summary of Pharmacy Benefits and the Summary of Medical Benefits for details. Coverage for some diabetic equipment and supplies may only be available from either a DME provider or from a pharmacy. Visit our website to determine if this is applicable or call our Customer Service Department. Prosthetic Devices Prosthetic devices replace or substitute all or part of an internal body part, including contiguous tissue, or replace all or part of the function of a permanently inoperative or malfunctioning body part and alleviate functional loss or impairment due to an illness, injury or congenital defect. Prosthetic devices do not include dental prosthetics. This plan covers the following prosthetic devices as required under R.I. General Law § 27-20-52: • prosthetic appliances such as artificial limbs, breasts, larynxes and eyes; • replacement or adjustment of prosthetic appliances if there is a change in your medical condition or if the device is not functional, no longer under warranty and cannot be repaired; • devices, accessories, batteries and supplies necessary for prosthetic devices; • orthopedic braces except corrective shoes and orthotic devices used in connection with footwear; and • breast prosthesis following a mastectomy, in accordance with the Women’s Health and Cancer Rights Act of 1998 and R.I. General Law 27-20-29. The prosthetic device must be ordered or provided by a physician, or by a provider under the direction of a physician. When you are prescribed a prosthetic device as an inpatient and it is billed by a provider other than the hospital where you are an inpatient, the outpatient benefit limit will apply. 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