Study Medication Clause Samples

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.

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. B. Zadavatel je a nadále zůstane jediným a výlučným vlastníkem Hodnoceného přípravku. Řešitelské centrum souhlasí, že prováděním Klinického hodnocení podle této Smlouvy nebo na základě jiných ustanovení této Smlouvy nemá ani nezíská žádná vlastnická práva nebo podíl na Hodno...

Study Medication. Compliance Removed use of the electronic dose reminder system. The system is not being used. Section 6.6 Switching to ALXN2050 Added guidance for dosing patients in Groups 2 and 3 who are switching from eculizumab to ALXN2050 or from danicopan to ALXN2050. To clarify dosing requirements

Study Medication. ACCOUNTABILITY

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 · Remind subject to take study medication as instructed · Remind subject to record study medication use Month 18 Recent health status · Document any changes since previous visit ▇▇▇▇▇ ▇▇▇▇▇, 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