Question26: Please prepare an informed consent form for the imaginary drug Happymycin that would treat Mood Disorders (Depressions) ?

Apr 8 • Clinical Research Associate, Clinical trail, CRA certification, cracertification_Q&A, cracertification.co.uk • 5704 Views • Comments

Question26: Please prepare an informed consent form for the imaginary drug Happymycin that would treat Mood Disorders (Depressions) ?

Answer:

INFORMED CONSENT FORM

You are invited to participate in a study of HappymycinWe hope to discover whether the drug Happymycin can treat mood disorder or notYou were selected as a possible participant in this study because you are suffering from mood disorder, between age  18 -60 yrs and willing to give informed consent.If you decide to participate, we will put you on either placebo or test drug to find out the effectiveness of the drug this procedure will take 24 months to be followed.You may experience some of the following side effects:

  • Dry mouth
  • Urinary retention
  • Blurred vision
  • Constipation
  • Sedation (can interfere with driving or operating machinery)
  • Sleep disruption
  • Weight gain
  • Headache
  • Nausea
  • Gastrointestinal disturbance/diarrhea
  • Abdominal pain
  • Inability to achieve an erection
  • Inability to achieve an orgasm (men and women)
  • Loss of libido
  • Agitation
  • Anxiety

 

The benefit you might achieve from the test drug are as follows improvement in mood, reduction in depression episodes or stoppage of depressive episodes, peaceful sleeps, improvement in ability to perform a task and increase memory.

There are several antidepressant drugs available in the market which you can use as an alternate of this procedure such as :

1.           SSRI’s

2.           Atypical antidepressants

3.           MAOI antidepressants

4.           Tricyclic antidepressants

5.           Other antidepressant such as: venlafaxine | brand name: Effexor, Nefazodone | brand name: Serzone, Bupropion | brand name: Wellbutrin, Mirtazapine | brand name: Remeron, trazodone | brand name: Desyrel

You will be offered a copy of this form to keep.

 

You are making a decision whether or not to participate. Your signature indicates that you have read the information provided above and have decided to participate. You may withdraw at any time without penalty or loss of benefits to which you may be entitled after signing this form

should you choose to discontinue participation in this study.

_____________________________________ __________________________

Signature Date

_____________________________________ ___________________________

Signature of Parent/Legal Guardian (If necessary) Date

_____________________________________ ___________________________

Signature of Witness (If appropriate) Signature of Investigator

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