ADR Detection in Clinical Trials

Detection of adverse reactions during clinical trials requires careful and systematic evaluation of study participants before/ during/ and after drug exposure. Objective data must be gathered to determine that study subjects meet all inclusion criteria and do not have any conditions that preclude their participation. Standard laboratory and diagnostic tests are used to establish patients baseline health and functional status. Such tests should be appropriate for the drug and condition under investigation and should be conducted at predetermined intervals. 

Typically/ serum chemistries and renal/ hepatiC/ hema-tologiC/ electrolyte/ and mineral panels are included. A complete medical history (including a review of all body systems) and physical examination and a complete medication history (including allergies and intolerances) should be included. Use of prescription/ nonprescriptioii/ and alternative and complementary medications by study participants should be specifically documented. 

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