CCRP SOCRA Exam - Responsibilities of
Sponsors and Investigators
____________________are responsible for selecting certified investigators, providing them with
the records they need to behavior an
research well, ensuring right tracking of the research(s), making sure that the research(s) is
performed in
accordance with the overall investigational plan and protocols contained inside the IND,
retaining an effective IND with appreciate to
the investigations, and making sure that FDA and all participating investigators are directly
knowledgeable of full-size new detrimental
outcomes or dangers with appreciate to the drug.
Sponsors
A__________ can also switch responsibility for any or all of the obligations set forth on this
component to a agreement research
enterprise.
Sponsor
A ______________ that assumes any obligation of a sponsor shall observe the unique
regulations on this chapter applicable to this obligation and shall be concern to the identical
regulatory motion as a sponsor for failure to conform with any obligation assumed below those
rules
Contract Research Organization
Sponsor shall achieve the information from investigator by means of manner of which shape?
Name/cope with, call/cope with of IRB, dedication by investigator that he or she will be able to
behavior the examine according with protocol, and many others.
Form FDA-1572
The ________shall screen the progress of all medical investigations being performed
underneath its IND.
Sponsor
Sponsors and Investigators
____________________are responsible for selecting certified investigators, providing them with
the records they need to behavior an
research well, ensuring right tracking of the research(s), making sure that the research(s) is
performed in
accordance with the overall investigational plan and protocols contained inside the IND,
retaining an effective IND with appreciate to
the investigations, and making sure that FDA and all participating investigators are directly
knowledgeable of full-size new detrimental
outcomes or dangers with appreciate to the drug.
Sponsors
A__________ can also switch responsibility for any or all of the obligations set forth on this
component to a agreement research
enterprise.
Sponsor
A ______________ that assumes any obligation of a sponsor shall observe the unique
regulations on this chapter applicable to this obligation and shall be concern to the identical
regulatory motion as a sponsor for failure to conform with any obligation assumed below those
rules
Contract Research Organization
Sponsor shall achieve the information from investigator by means of manner of which shape?
Name/cope with, call/cope with of IRB, dedication by investigator that he or she will be able to
behavior the examine according with protocol, and many others.
Form FDA-1572
The ________shall screen the progress of all medical investigations being performed
underneath its IND.
Sponsor
