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Protocol Initiation
Protocol initiation brings the investigator face-to-face with operational
details that may not have received a great deal of attention during the
protocol submission and approval phase of the study. Adequate preparation
prior to enrollment assures human subject safety and data integrity.
The RSA routinely meets with investigators prior to enrollment to assist
with operational details. This can include assistance with structuring the
informed consent/assent process, and setting up databases, structuring of
case report forms. Young investigators find this especially useful and a
way to assure proper regulatory documentation.
The RSA may be reached at
303-764-8538.
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