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. 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. 8.1 The Institution must:
(1) ensure that all Investigational Product made available by the Sponsor is used strictly according to the Protocol and are not used for any other purposes, unless agreed in writing by the Sponsor;
(2) provide a written explanation accounting for any missing Investigational Product;
(3) not charge a Study Subject or third party payer for Investigational Product or for any services reimbursed by the Sponsor under this Agreement; and
(4) keep all Investigational Product under appropriate storage conditions as specified in the Protocol in a secured area accessible only to authorised Personnel, and that complete and current records are maintained for all received, dispensed and returned Investigational Product.
8.2 The Sponsor will supply the Principal Investigator with such quantities of the Investigational Product as will be required for the purpose of the Study. All supplied Investigational Product will be packaged in safe and appropriately labelled containers. The Sponsor will at all times remain the sole owner of the Investigational Product.
8.3 In the event of termination, the Institution must promptly return (or destroy if requested by the Sponsor, and provide evidence of such destruction) to the Sponsor any unused Investigational Product.
INVESTIGATIONAL PRODUCT. 8.1 The Institution must:
(1) ensure that all Investigational Product made available by the Sponsor is used strictly according to the Protocol and are not used for any other purposes, unless agreed in writing by the Sponsor;
(2) provide a written explanation accounting for any missing Investigational Product;
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. 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. 8.1 The Institution must
(1) ensure that all Investigational Product made available by the Sponsor is used strictly according to the Protocol and are not used for any other purposes, unless agreed in writing by the Sponsor;
(2) provide a written explanation accounting for any missing Investigational Product; Protocol Number: IHLOSAOLE1Site: Xxxxxx Health
(3) not charge a Study Participant or third-party payer for Investigational Product or for any services reimbursed by the Sponsor under this Agreement;
(4) keep all Investigational Product under appropriate storage conditions (including any conditions specified in the Protocol) and in a secured area accessible only to authorised Personnel; and
(5) ensure that complete and current records are maintained for all received, dispensed and returned Investigational Product.
8.2 The Sponsor will supply the Principal Investigator with such quantities of the Investigational Product as will be required for the purpose of the Study. All supplied Investigational Product will be packaged in safe and appropriately labelled containers. The Sponsor will at all times remain the sole owner of the Investigational Product.
8.3 On termination of this Agreement, the Institution must promptly return any unused Investigational Product to the Sponsor, or, if requested by the Sponsor, destroy it and provide evidence of such destruction.
INVESTIGATIONAL PRODUCT. Where a 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; 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, in accordance with applicable laws, regulations and the Institution’s policies and procedures.
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.
2.2 The activity performed under this Clinical Study shall be strictly limited to the activity which is considered permitted according to the conformity evaluation proceeding prior to the CE marking sub 2.1.
2.3 Sponsor represents and warrants to promptly inform the Institution and the Investigator about any changes in the conditions described in Subparagraphs 2.1 and 2.
INVESTIGATIONAL PRODUCT. 8.1 Investigational Product shall only be used for the conduct of a Study and strictly in accordance with the related Protocol and all Applicable Laws. AstraZeneca shall:
8.1.1 provide the Principal Investigator with all current and relevant information regarding the Investigational Product; and
8.1.2 provide Institution with all amounts of Investigational Product required for completion of a Study.
8.2 All Investigational Products supplied to the Institution for each Study shall remain the exclusive property of AstraZeneca until administered or dispensed to Subjects during the course of a Study. Upon termination of this Master Agreement, the Institution shall, at AstraZeneca’s expense, handle any quantities of unused Investigational Product, in accordance with AstraZeneca’s written instructions. The Institution shall maintain complete and accurate records relating to the disposition of Investigational Product supplied to the Institution.
