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rjs84 replied to the topic Project Scope: When the timeline you have doesn't work in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
I don’t think that a company can authorize any of the unethical examples you just suggested. If a new regulation was established, designing a placebo study to circumvent this regulation would not only be unethical but most likely illegal. The first option in this scenario would be to attempt to reevaluate the schedule and see if it is still possible to meet the original deadlines set. New tasks would need to be created and added to account for changes. Overtime may need to be offered to some employees in order to still complete all tasks by their deadlines. The next option would be to create the new tasks for this new regulation and then evaluate if the deadlines can be extended. The point here is that cuts made to the project or the process really should come as a last resort. Other measures should be taken first so that the quality of the product remains a priority.