Concept paper quality in fda-regulated clinical research, fda homepage
If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training?
In addition to the Application Guide instructions, this section must also include: Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? He then attended the University of Chicago Law School and graduated with the degree of Doctor of law with honors insubsequently practicing health care law and litigation.
Specific Aims are required. Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection?
Significance Does the Center address an important problem or a critical barrier to progress in the field? Are those that requires FDA oversight Where the risks to participants are higher than encountered in routine medical or behavioral care or procedures potential to cause physical or psychological harm Are intended to formally establish efficacy NIH-defined Phase III clinical trial.
For example, a Center that by its nature is not innovative may be essential to advance a field. Describe the frequency of planned auditing activities e.
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