Monthly Scenarios – Handling Questionable Data

Scenario

Scenario

Part A
Sarah (a CRA) is monitoring a Migraine Study (Nomigra 400). At one of her sites
(Site 155, Prof. Hubbard) there are 2 subjects enrolled. During her first monitoring
visit to site 155, Sarah reviews the diary cards for these 2 subjects (subjects 001 and
002).

Look at the diary cards for subjects 001 and 002 ONLY. Do you notice any
potential issues? What should Sarah do at this stage?

Part B
When Sarah reviews the 2 diary cards she thinks that the handwriting for both
subjects looks similar, but she is not sure. She decides that it is probably ok and
therefore does not contact her CTM whilst at site.

When she returns to the office, Sarah decides to speak to her CTM about the diaries.
Adam, the CTM, tells Sarah that she should investigate further at her next visit.

At her next visit to the site, Sarah discovers that the site has enrolled 6 more
subjects.

When Sarah reviews all diary cards, she is concerned that the handwriting on the
diaries for all subjects looks similar. She decides to immediately confront the
Principal Investigator with her suspicions.

When Sarah confronts the PI, Prof. Hubbard, he insists that all subjects completed
their own diaries and that there is no problem. Sarah leaves the site without
contacting Adam (the CTM) and without taking any copies of the suspected
questionable data.

Look at all the diary cards for this site. What issues do you notice that may be
potential indicators of questionable data?

Do you think Sarah and Adam have handled the situation appropriately?
Would you do anything differently?

Monthly Scenario – Handling Questionable Data- Scenario

Global Learning and Performance
Final V1.0 23 Apr 2010 Page 1 of 2
LMS Code: CLN1-05223
Part C - The outcome:

When Sarah returns to the office, she discusses the situation with Adam. Adam
immediately informs CQA about the situation and requests that Sarah returns to the
site to collect copies of the subject diaries. At the site, Prof. Hubbard refuses to
permit Sarah to make copies.

Monthly Scenario – Handling Questionable Data- Scenario

Global Learning and Performance
Final V1.0 23 Apr 2010 Page 2 of 2
LMS Code: CLN1-05223