Investigator Sponsored Study definition

Investigator Sponsored Study means a human clinical trial initiated and conducted, alone or with others, by an investigator who is not an employee of the Parties, or by a company, institution or organization other than the Parties.

Investigator Sponsored Study means any Clinical Study with respect to a Licensed Compound or Licensed Product where the sponsor of the study is a physician or group of physicians acting as sponsor-investigator(s) and neither of the Parties nor any of their Affiliates accept the role of sponsor or co-sponsor of such study.

Investigator Sponsored Study or “ISS” means any clinical study with respect to the Product in the Field where the sponsor of the study is a physician or group of physicians acting as sponsor-investigator(s) and neither of the Parties nor any of their Affiliates or sublicensees accept the role of sponsor or co-sponsor of such a study.

Examples of Investigator Sponsored Study in a sentence

• Investigator Sponsored Study (ISS) refers to a clinical study that is independently initiated, designed and conducted by an external investigator (who assumes both the sponsor and principal investigator role) or medical institution, collaborative research group or academic research organisation (which assumes the sponsor role and appoints principal investigator(s) for the study).

• Each Party agrees not to enter into any agreement with a Third Party for and not to provide any Licensed Product or funding for an Investigator Sponsored Study prior to receiving Regulatory Approval without the prior written approval of the of the other Party.

• A cover page should accompany the MedWatch form indicating the following:• ZD6474 Investigator Sponsored Study (ISS)• The investigator IND number assigned by the FDA• The investigator’s name and address• The trial name and AstraZeneca Reference number Send by way of fax to:(302) 886-1528,Attention ZACTIMA ISS Safety Representative If a non-serious AE becomes serious, this and other relevant follow-up information must also be provided to AstraZeneca and the FDA.

• This preliminary clinical work will be conducted as an Investigator Sponsored Study (‘ISS’), led by Dr Marjolein Geurts, neuro-oncologist at the Erasmus University Medical Centre, the Netherlands.

• AstraZeneca International Investigator Sponsored Study Programme.

More Definitions of Investigator Sponsored Study

Investigator Sponsored Study or “ISS” means a clinical trial on the Product in the Field wherein a Third Party that is not a sublicensee or subcontractor of either Party holds the investigational new drug application or equivalent thereof (if any) for such trial and is solely responsible for all aspects of the trial, including: trial design; ensuring appropriate institutional and regulatory approval; conducting such trial, including responsibility for ensuring appropriate medical safeguards, medical monitoring and medical supervision; analysis and interpretation of the results of such trial; and communication (e.g., publications) of the results of such trial; provided, if either Party has any responsibility for any of the foregoing, then such trial shall not be considered an Investigator-Sponsored Study.

Investigator Sponsored Study means a Clinical Trial using the Licensed Product, either as a Monotherapy or as a Combination Regimen sponsored and initiated by a Third Party.

Investigator Sponsored Study. (ISS) shall mean a study in which an individual both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. In addition to the standard investigator responsibilities, the sponsor-investigator is also responsible for planning, conducting, and monitoring the study, managing data, preparing reports, and providing oversight, monitoring, and compliance with regulatory reporting requirements.

Investigator Sponsored Study means any Clinical Study with respect to a Licensed Compound or Licensed Product where the sponsor of the study is a physician or group of

Investigator Sponsored Study means a human clinical study of a Product that is sponsored and conducted by a Third Party investigator, pursuant to an IND owned by such Third Party investigator, under an agreement with a Party or its Affiliate pursuant to which such Party or such Affiliate provides clinical supplies of the Product or funding for such clinical study.

Investigator Sponsored Study or “ISS” means a clinical trial on the Product in the Field wherein a Third Party that is not a sublicensee or subcontractor of either Party holds the investigational new drug application or equivalent thereof (if any) for such trial and is solely responsible for all aspects of the trial, including: trial design; ensuring appropriate institutional and

Investigator Sponsored Study means, with respect to a Licensed Product, the conduct of a human study (excluding any Phase III Study or Pivotal Study) of such Licensed Product for which (a) the sponsor is (i) a natural person who is a physician, nurse, dentist, or other health professional) or (ii) anot-for-profit organization, including without limitation a governmental body (for example, the National Institutes of Health) or institution (for example, a hospital or university trust); and (b) Sage and its Affiliates do not directly or indirectly provide more than 50% of the funding for the study.