Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study of the Investigational Product in humans. Multi-centre Study is a Study conducted by several investigators according to a single protocol at more than one study site. NHMRC means the National Health and Medical Research Council of the Commonwealth of Australia. Personal Information has the same meaning as in the Privacy Act 1988 (Cth). Personnel means employees, agents and/or authorised representatives, and includes in the case of the Institution, the Principal Investigator. Principal Investigator is the person responsible for the conduct of the Study at the Study Site as described in Schedule 1.
Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study of the Investigational Product in humans.
Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study of the Investigational Product in humans. Multi-centre Study is a Study conducted by several investigators according to a single protocol at more than one study site.
Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study of the Investigational Product in humans. Multi-centre Study is a Study conducted by several investigators according to a single protocol at more than one study site. NHMRC means the National Health and Medical Research Council of the Commonwealth of Australia. Organisation means the entity so described on the first page of this Agreement. Personal Information has the same meaning as in the Privacy Xxx 0000 (Cth) Personnel means employees, agents and/or authorised representatives, and includes in the case of the Institution, the Principal Investigator. Principal Investigator is the person responsible for the conduct of the Study at the Study Site as described in Schedule 1.
Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study of the Investigational Product in humans. Intellectual Property means all industrial and intellectual property rights, including without limitation:
Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study of the Investigational Product in humans. Manufacturer means the organisation supplying Investigational Product, Equipment or Software to the CRG or Institution for the conduct of the Study.
Investigator’s Brochure. “IB”) The Charity will produce the Investigator Brochure. The Charity will provide an annual update to the IB or provide confirmation that an annual review of safety data has been carried out and no update is required. The Charity must promptly provide the Company with a copy of each version of the IB within fourteen (14) calendar days of the IB version being issued. Should the Charity disallow photocopying, it shall provide the other Party with sufficient copies of each version of the IB to allow at least one copy to be distributed to each of the Company’s investigational sites, plus two copies for the Company’s own use. If requested, the Company will distribute and document numbered copies of the IB.
Investigator’s Brochure. For NCI: For Collaborator: IB Coordinator, Pharmaceutical Management Branch, CTEP, DCTD, NCI 0000 Xxxxxxx Xxxxxx Xxxxx, Xx 0X000 Xxxxxxxxx, XX 00000-0000 Tel: (000) 000-0000 Name: Address: Tel: e-mail: XXXxxxxxxxxxx@xxxx.xxx.xxx
Investigator’s Brochure. Upon Option exercise, Isis will provide to Biogen Idec an up-to-date version of the Investigator’s Brochure. After Option Exercise, Biogen Idec will keep Isis reasonably informed with respect to the status, activities and progress of Development of Products by providing updated versions of the Investigator’s Brochure to Isis [***] and when Development of the Products results in any substantive change to the safety or risk to the Products. Biogen Idec’s obligations under this Section 5.1.3 will terminate if [***].
Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study of the Investigational Product in humans. ISO 14155 - means the version in force from time to time, or its replacement, of the International Standard ISO14155 - 'Clinical Investigation of medical devices for human subjects'. Know-how means any knowledge, proprietary information or data which is not generally known, including, without limitation, all manufacturing, formulation and scientific research information, whether or not capable of precise separate description.
