ABPI: Association of the British Pharmaceutical Industry

There should be consistency between the possible adverse events described for the study drug in the protocol, investigator s brochure and ICF. Most coimtries have specific requirements for their ICF. It is essential that the requirements are known when the country-specific ICF is prepared. These examples could easily have changed by the time the reader is checking an ICF. In the United Kingdom, reference should be made to the ABPI (Association of the British Pharmaceutical Industry) Clinical Trial Compensation Guidelines. In other countries, for example, Ireland, the study subject is allowed a specific length of time to decide whether to enter the study. 

ABPI Association of the British Pharmaceutical Industry, absorption In pharmacology, the uptake of a drug from its site of administration. 

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