There are many unplanned or unintentional violations/deviations or changes in study status that do not cause harm, place participants at increased risk of harm, or adversely affect data integrity. The IRB does not require reporting these minor violations/deviations. Examples of minor violations/deviations that do not need to be reported may include the following: Out of window visits Study procedures conducted out of timeframe Subject failure to initial each page of the ICF (as applicable) Subject failure to return subject materials (e.g., diaries, journals). Administrative hold on a study not related to safety issues