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 procedure.
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?