In Grief, loss is acknowledged and in Depression, it is usually denied. In short, when it comes to a Grief process, the symptoms, unlike Depression, are only related to the loss situation (for example, the death of a loved one), that is, the pain is a reflection of the loss.
Part One
After the following scenarios, describe the stage of grief represented in each one.1. Molly's cat is dead on the street in front of her house, but she tells herself he's just sleeping. Stage: acceptance
2. Since his father died, Isaac hasn't been able to do anything but sleep and watch TV. stage: depression
3. Natalie tells God that if he makes her grandmother well again, she will be well forever. Stage: acceptance
4. Noah finds himself yelling at his little sister since their mother died. stage: anger
5. A year after she lost her home to foreclosure, Veronica finally understands how it happened and is making plans to improve her financial situation. Stage: overcoming
Part two
In each of the following scenarios, provide an alternative and useful statement in the form of a sentence or paragraph:1. "It's been two months since your mother died. It's time to move on." Alternative statement: life goes on
2. "Aren't you over it?" Alternative statement: you have to get over it and you will get over it
3. "Joseph's father died last month, and he's over it. Why can't you?" Alternative statement: do not compare situations
4. "Be strong. Never let them see you cry." Alternative statement: don't hold back your feelings
5. "Sorry, your wife died, but I think you knew this was coming. She was old anyway." Alternative statement: only miss those who once loved
part THREE
In each of the following scenarios, say whether you think the person is suffering from complicated grief or depression and why you think so:1. Since her partner died two years ago, Charlotte hasn't been interested in doing anything. She just feels numb. depression
2. Ever since he lost his home last year, all Abe can think about is how he should have done things differently. mourning
3. It's been three years since her husband died, but Mimi still sets a place for him at the dinner table and talks to him as if he were there. mourning
4. Larry is consumed by thoughts of guilt over losing his business last year. mourning
5. Clara's best friend was diagnosed with cancer last year, and Clara hasn't been able to enjoy anything ever since. mourning
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5
Charlie wants to conserve as much as possible so always makes out a shopping list before heading to the grocery store. That way, Charlie only buys the things needed. To make sure of this, what is the MOST important step should Charlie take BEFORE leaving the house?
A.
Ask other family members what they would like to eat for the week.
B.
Check the cabinets for ingredients already on hand.
C.
Carefully examine any produce before purchasing it.
D.
Research the nutritional value of the food on the list.
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are following ICH E6, they must:
If investigators are following ICH E6, they must be the monitor, auditor, IRB/IEC, and regulatory authorities must expressly advise participants in the informed consent form that they may access their medical records.\
E6- Qualified professionals should plan and carry out clinical experiments. 6.1 Throughout all stages of a clinical trial, professionals with various backgrounds and specialties are required, including doctors, scientists, ethicists, technology specialists, and statisticians.
The goal of this ICH GCP guidance is to offer a single standard for the European Union, Japan, and the United States in order to make it easier for the regulatory authorities in these nations to accept clinical trials from each other. Both the sponsor and investigator/institution (site) conducting the trial should save their respective essential documents in a system that offers mechanisms for locating the document and for document identification, according to a requirement added to ICH E6(R2) in the introduction section.
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If investigators follows ICH E6, Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records
The objective of ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in their jurisdictions.
In addition,ICH E6(R2) adds more about document control, specifying that the sponsor should not have exclusive control of case report form (CRF) data submitted by the investigator, and that the investigator/institution should have control of all of their own essential documents before, during, and after the trial.
The committee (IRB/IEC) should safeguard the rights, safety, and well-being of all trial subjects. with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.
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