A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at twice the approved pr
escribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. The investigator would submit an SAE report for: A. Neither of the subjects
B. Subject 603 only
C. Subject 20 only
D. Both of the subjects
Even though these episodes cannot be explained on the basis of the pharmacological properties of the drug being tested or the subjects' medical history, the episodes occurred during study procedures, so it is necessary for the investigator to send an SAE report to both patients, since everything that happens in a study must be reported.
Answer: Resiliency means the ability/capacity to recover quickly from challenges/difficulties. In another definition it also means toughness. And from the above choices "Processing feelings of anger and guilt about a situation" can help a person get back on his/her feet more quickly also not running away from/denying the situation does not go along with toughness.
When you are stressed you can often become lazy. You start to eat and you either don't stop because it makes you feel better or you just sit and never get up. This also is the case for break ups not just death. This can lead to mental heath issues to including depression.
