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.
Sample 1See All (4)
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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
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. 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...
Sample 1
Study Medication. ACCOUNTABILITY
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. 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 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

Related to Study Medication

  • Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: minimum 21 days/3 weeksuntil patient’s weight >2000g, averaged 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months following enterostomy closure (12- month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 months of overall study duration).

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

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