An ISS may (Select all that apply): - Include a budget for training
Assess a drug's efficacy in a new indication
Include an investigator meeting
The main purpose of IIS is to: - Improve available safety and efficacy data of the product
The investigator needs to present the following in a grant proposal: (select all that apply) - Budget
Protocol
Curriculum Vitae
An advantage of Investigator Initiated Studies is: - Results showing new drug indications
Name the type of application that requests additional funds to cover increased costs or to expand the
scope of work either for the current operating year or for any future year: - Administrative
supplementation
True or False: IIS can also be conducted on drugs/devices that are already available on market. - True
True or False: The funding authorities must continuously review the process of the projects/programs
upon offering the grants to the recipients. - True
True or False: A Company that manufactures the drug being studied by the investigator may design the
entire ISS protocol. - False
An explanation of the study objectives should be included in the: - Protocol
True or False: IIS are similar to industry sponsored trials in that they must be carried out in accordance
with GCP. - True
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