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Asubject in a clinical research trial experiences a serious, unanticipated adverse drug experience. how should the investigator proceed, with respect to the irb, after the discovery of the adverse event occurrence? a. do not report the adverse drug experience to the irb since it is a common adverse experience. b. report the adverse drug experience to the irb only if there are several other occurrences. c. report the adverse drug experience as part of the continuing review report. d. report the adverse drug experience in a timely manner, in keeping with the irb's policies and procedures, using the forms or the mechanism provided by the irb

Acontractor was awarded a purchase order for commercial items for $1.5 million under the authority of far subpart 13.5. the purchase order contained all applicable clauses that were current as of the date of the purchase order. under the purchase order, the contractor is required to comply with a small business subcontracting plan that contains all of the required elements. question: which of the following is true? a. the contractor must submit a standard form 294, subcontracting report for individual contracts. b. the contractor must submit an individual subcontracting report through the electronic subcontracting reporting system (esrs). c. the contractor may submit either an sf 294 or report its subcontracting through esrs. d. the contractor is not required to submit any subcontracting reports.

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