CASE STUDIES

ICRI MUMBAI
 CASE 1
• A 15 year-old unconscious boy is
admitted to the emergency room. His
parents are with him. The physician on
duty is participating in a clinical trial
and after an initial assessment the
considers the patient suitable for the
study.
• Please describe the informed consent
procedure.
 CASE 2
• Dr. MMJ is a leading psychiatrist. He has a
new sub-investigator who is responsible for
obtaining consent from patients. You find
that a good number of patients have been
screened. However, very few patients have
agreed to participate in this particular study.
You did not anticipate problem with patient
recruitment as in the past, this site has
enrolled the required number of patients.
• What steps will you take to correct the
situation?
 CASE 3
• Patient SSK can read and understand
English and hence has been given the ICF
and PIL in English. After having verbally
agreed to participate, he signs and dates
the ICF in Marathi. The auditor has
pointed out this discrepancy. What steps
would you take to preempt an audit
finding.
• How will you convince him/her that the
patient was in fact given the ICF in the
language he understands.
 CASE 4
• A study investigator working in his own
practice has a Russian patient who hardly
speaks English. His daughter, fluent in
English, is with him when he needs to see
the investigator can include the patient in to
an ongoing clinical study.
• Please describe the informed consent
procedure.
 CASE 5
• The assistant of a study investigator is
delegated to obtain consent from patients
in an ongoing clinical study in acute
migraine. The study requires the subject to
fill diary cards for two months. One of the
patients screened fulfils the entry criteria,
but is unable to read and write. Both her
husband and son residing with her, are
literate.
• Please describe the informed consent
procedure.
 CASE 6
• An independent auditor hired by a CRO is
reviewing the ICF of patient NNM, enrolled
in a diabetes study. The English version of
ICF has been signed by the patient,
However the auditor notes that this illiterate
patient NNM has signed and dated the ICF.
An impartial witness has also signed and
dated the ICF. He expresses concern and
raises the question to the
investigator/monitor.
• What would you do if you were the monitor?
 CASE 7
• The assistant of a study investigator is
working as a study nurse in an ongoing
clinical study. One day the investigator
wants to include a patient who cannot read
or write. However the literate wife of this
patient is present during the visit.

• Please describe the informed consent

procedure.
 CASE 8
• Patient AMK was on his way to office and
is a victim of hit and run case. He is
rushed to a nearby hospital by an auto-
rickshaw driver. AMK is bleeding
profusely and has head injury. He is
unconscious and is admitted to Critical
Care. The physician has participated in a
study of a new molecule known to stop
blood loss and wants to enroll this
patient.
• Please describe the informed consent
 CASE 9

• You are a Monitor responsible for a non-

therapeutic studies (ie, studies in which
there is no anticipated direct clinical
benefit to the subject) at St. Mark’s
Hospital. The investigator reassures you
that consent is not required in case of
such studies.

• What would you do?

 CASE 10

• You go on routine Monitoring visit and

review the 7 ICFs of the patients enrolled
so far. One striking feature you notice is
that all the ICFs have been dated in black
ink and the writing is similar. It looks like
one investigator has dated all the forms.

• What would you do?

 CASE 11
• During the study on a new drug for breast
carcinoma, an interim analysis is
performed. It is revealed that a few patients
on study for more than 6 months, are
affected with different stages of uterine
cancer. The result warrants an immediate
change in the ICF with new safety
information to be included.

• What would you do?

 CASE 12

• You are involved in a study on a new

drug for worm infestation in pediatric
population. The subjects to be included
in the study are 3-18 years. You have to
train the site staff to obtain consent
from such patients.

• What would you do?

 CASE 13

• You are monitoring a study on a new

drug for manic depression. All eligible
patients will have H/O episodes of
mania and depression , for more than 2
years. You have to train the site staff to
obtain consent from such patients.

• What would you do?