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close this bookGuidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)
close this folder10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
View the document(introductory text...)
View the document10.1 Supply and storage
View the document10.2 Investigational labelling and packaging
View the document10.3 Responsibilities of the investigator
View the document10.4 Responsibilities of the sponsor and monitor1

10.3 Responsibilities of the investigator

The investigator is responsible for ensuring:

· Proper and safe handling of the investigational and, when appropriate, comparator products during and after the clinical trial, preferably in cooperation with a pharmacy (see Section 10.1);

· That the investigational product is used only in accordance with the protocol, which implies use only for subjects included in the trial and by designated staff responsible to the investigator, and that this use is documented in such a way as to ensure appropriate dosage;

· That the dosage and instructions for use are correct and that every subject involved understands them properly;

· That unused investigational and, when appropriate, comparator products are returned in accordance with the protocol to the pharmacy or sponsor or destroyed, and that proper records of these activities are kept.