9/13/2013 CRC Basic 2.0: Introduction to GCP – Case Study
The principal investigator, Dr. Smith, is attending the IRB meeting during the review of a new study
protocol ABC-YZ-12-002. Members of the board ask Dr. Smith some questions about the drug and the
protocol. Dr. Smith is not able to answer the questions and is not familiar with the contents of the IRB
submission documents.
1.
2.
3.
4.
Was there a GCP violation?
If yes, identify the relevant ICH-GCP guideline.
How could this scenario have been prevented?
What actions, if any, may be required after this meeting?
After a repeat review, the above mentioned protocol was approved. Four weeks later, Dr. Smith
received the approval letter which refers to protocol ABC-YZ-12-003. (The study originally submitted was
protocol ABC-YZ-12-002).
1.
2.
3.
4.
Was there a GCP violation?
If yes, identify the relevant ICH-GCP guideline.
Should the study sponsor allow the study to proceed?
What actions, if any, may be required?
Dr. Smith decides to advertise in the local newspaper to increase recruitment for his clinical study. He
immediately submits the advertisement to the newspaper’s advertising department. Twenty-five
patients immediately respond to the advertisement within 24 hours of its publication. Four weeks later,
Dr. Smith has seen two of these patients.
1. Was there a GCP violation?
2. If yes, identify the relevant ICH-GCP guideline.
3. What actions, if any, may be required?
Mr. Gold is a patient in a clinical trial sponsored by the QRS Pharmaceutical Company. During the course
of the study he developed an infected in-grown toenail accompanied by a very high fever, for which he
was hospitalized by Dr. Smith on September 1, 2012. He was treated with IV antibiotics and an incision
and drainage of the toe was performed. He was discharged in stable condition on September 3, 2012.
Dr. Smith reported this as a serious adverse event with 2 other cases at the end of the month, with his
regular monthly report to the sponsor in which he identified each subject that experienced an SAE by
name and subject code.
1. Was there a GCP violation?
2. If yes, identify the relevant ICH-GCP guideline.
Protocol LMNOP, a multi center, international clinical trial was scheduled to begin patient recruitment
on July 1, 2012. An Investigator meeting for the purpose of training study investigators and study teams
was held June 15, 2012. All investigator sites were represented except ABC University Hospital. The
Primary Investigator, Dr. Able, was at another meeting out of state. Study drug and documents were
sent to all sites on June 21, 2012 and all sites began patient recruitment on schedule.
1. Was there a GCP violation?
2. If yes, identify the relevant ICH-GCP guideline.
3. What actions, if any, may be required?
The CRA conducted the first monitoring visit for a study 6 weeks after the first patient entered the study.
In reviewing patient #101, the monitor noted that no consent form was available for review. The
research nurse stated that the patient took the form home but forgot to return it to the clinic when he
came for his second visit. The research nurse states she believes that the fact that the patient returned
for his second visit implies he has given consent to participate in the study. The patient was started on
study medication. The study monitor also notes that patient #102 signed, but did not date, the informed
consent. The research nurses offers to enter the date on the form herself, since she knows the date of
the patient’s first visit. The CRA then notes that patient #103 has signed an older version of the informed
consent. The research nurse explains that she did not have enough copies of the current version. She
doesn’t believe there are significant differences between the two versions.
1. Were there any GCP violations?
2. If yes, identify the relevant ICH-GCP guidelines.
3. What actions, if any, may be required?
Dr. Green reported the following to the IRB:
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Two investigational drug dispensing errors occurred on Protocol ABCDEF. The errors occurred at
the randomization visit and patients #110 and #111 were dispensed incorrect trial medication.
They received each other’s medication. Subject #110 was randomized to receive Treatment A,
but received Treatment B – Subject #111 was randomized to receive Treatment B, but received
Treatment A.
Patient #106 was randomized and started on medication; it was later determined that the
patient was not eligible for the study because he was taking a prohibited medication
1. What ICH-GCP guidelines are relevant to these reports?
2. What actions may be required?