![]() Read Our Blog: Clinical Trial Design Best Practices 3. Once complete, the protocol must be approved by the Food and Drug Administration (FDA) and reviewed by the appropriate boards. Designing a ProtocolĪ clinical trial protocol should include key milestones that need to be met, any testing subject inclusion and exclusion criteria, and a schedule of events.Īccording to ACM Associate Director Regina Harrison, “One of the most important aspects of the protocol is the inclusion and exclusion material, including what milestones patients need to achieve to be included in the trial.” Harrison adds that “Based on this inclusion and exclusion material, we will break down the testing schedule to determine what is needed from us and when.” Read Our Blog: Effective Steps to Clinical Study Management 2. If samples require temperature control, specialty shipping and storing and additional costs may be necessary. Temperature control: Related to shipping cost is temperature control.Some things to consider when thinking about shipping include how many sites will be shipping out samples and how many times ACM will be shipping samples to their referral labs. Shipping: Shipping is one of the major expenses when it comes to a clinical trial.This includes the time between patient visits and how long it might take for blood testing results to come in to determine if a subject is eligible. ![]()
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