E6: Contract Research Organization (CRO)

Question 1

5.2 Contract Research Organization (CRO)

5.2.1

Answer 1

A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.

Question 2

Contract Research Organization (CRO)

5.2.2

Answer 2

Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).

Question 3

Contract Research Organization (CRO)

5.2.3

Answer 3

Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.

Question 4

Contract Research Organization (CRO)

5.2.4

Answer 4

All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial related duties and functions of a sponsor.