INVESTIGATIONAL PRODUCT. 8.1 The Institution must:
INVESTIGATIONAL PRODUCT. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in the Clinical Study, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
INVESTIGATIONAL PRODUCT. Hodnocené léčivo Means the Investigational Product(s) which is/are the subject matter of the Protocol. Jedná se o hodnocené léčivo / hodnocená léčiva, které je / která jsou předmětem protokolu.
INVESTIGATIONAL PRODUCT. If the Organisation facilitates the supply to the Institution of any Investigational Product for use in the Study, the Organisation must ensure that all supplied Investigational Product is packaged in safe and appropriately labelled containers. In relation to any Investigational Product supplied by the Organisation, the Institution must: ensure that it is used strictly according to the Protocol and not used for any other purposes, unless agreed in writing by the Organisation; provide a written explanation accounting for any missing Investigational Product; not charge any Study Subject or third party payer for it; keep it under appropriate storage conditions as specified in the Protocol in a secured area accessible only to authorised Personnel; and maintain complete and current records for all received, dispensed and returned Investigational Product. When this Agreement ends, the Institution must promptly return (or destroy if requested by the Organisation, and provide evidence of such destruction) to the Organisation any unused Investigational Product. PROVISION OF EQUIPMENT The Organisation may provide the Institution and Principal Investigator with the Equipment; this will be at no charge. Unless otherwise agreed by the parties in writing, the Equipment will be used only by the Principal Investigator and Personnel involved in the conduct of the Study and only for the purposes of the Study. The Institution will ensure the Principal Investigator and Institution’s Personnel will use the Equipment in accordance with the Equipment's manufacturer's specifications and instructions. The Institution will take reasonable care in the use and secure storage of the Equipment. The parties will cooperate in maintaining the Equipment in good working order and ensuring that it is in a safe condition and compliant with the requirements of the relevant licensing and safety authorities so long as it continues to be used for the purposes of the Study. The parties will share equally any out of pocket expenses in doing so. When this Agreement ends, if requested by the Organisation the Institution must return the Equipment to the Organisation or dispose it in an appropriate manner. If the Organisation makes no such request within 7 days after the Agreement ends, the Institution will be deemed to be the owner of the Equipment and may use it in any manner it wishes. CONFIDENTIALITY AND PRIVACY Subject to clause 9.2, the Parties must not, and must ensure their Personnel do not, us...
INVESTIGATIONAL PRODUCT. 7.1If the Organisation facilitates the supply to the Institution of any Investigational Product for use in the Study, the Organisation must ensure that all supplied Investigational Product is packaged in safe and appropriately labelled containers.
INVESTIGATIONAL PRODUCT. Where the Subcontractor’s pharmacy will handle and dispense medicine(s) constituting an Investigational Product, it will: use the medicine(s) solely for the Study and not for any other purpose; abide by the same obligations and responsibilities as the Institution’s pharmacy under the Head Agreement; and dispose of, or destroy, the medicine(s) in accordance with the instructions of the Institution and the instructions of the Sponsor communicated by the Institution, and in accordance with applicable laws, regulations and the Institution’s policies and procedures.
INVESTIGATIONAL PRODUCT h.Producto en investigación. Manufacture. ULTRAGENYX certifies that the Investigational Product is manufactured in accordance with Good Manufacturing Practices. i. Fabricación. ULTRAGENYX certifica que el Producto en Investigación se fabrica de acuerdo con las Buenas Prácticas de Fabricación.
INVESTIGATIONAL PRODUCT. Eteplirsen Injection
INVESTIGATIONAL PRODUCT. STUDY INTERVENTION(S) OPT-302 is the only investigational product administered in this study. The other study drug to be used in the study is aflibercept. A pharmacy manual containing detailed information regarding the storage, preparation, and administration of OPT-302 will be provided as a separate document.
INVESTIGATIONAL PRODUCT. 2.1 The Investigational Product subject to this Clinical Study – and defined in the Protocol – is the Multigen Plus CCK, which is a post-CE marking medical device, according to CE certificate G7 075731 0069 dated 02-08-2019 released by TÜV SUD and has been marketed since 2009.
