Adverse events clinical trial guidelines

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. 

PCA syringe concentration is generally 0.2-0.3 mg per mL. This requires that up to 10 ampoules be opened and diluted with saline to make up a standard 30 mL PCA syringe. Earlier clinical trials employed oxymorphone PCA doses of 0.3 mg with a 6-8 minute lockout interval [9,10]. This dose was associated with a high incidence of nausea and vomiting, particularly when a 0.3 mg/hoiu- basal infusion was employed [ 11 ]. To reduce adverse events, we recommend lower doses of 0.1-0.2 mg every 6 min. PCA dosing guidelines for oxymorphone are presented in Table 24.1. 

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