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, uchovávat úplné, aktualizované záznamy prokazující přijetí, vydání a vracení 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. 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 applicable laws and regulations.
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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. 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 
Sample 1

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