GCP PRIORITY SCENARIO

Please read the following scenario before answering the questions below:

You are a member of a Sponsor Project Team working through the agenda in the Monthly Project Team meeting for a global Randomised Double-blind Phase III Trial. The following items are on the agenda to be discussed and decisions need to be made to help resolve the issues.

1) There have been two dispensing errors at site 43. The dispensing errors occurred at the randomisation visit and the consequence was that patients 654, 655 were dispensed the incorrect trial medication. Subject 654 received subject 655s medication and vice versa, this meant that subject 654 was randomised to receive Treatment A but received Treatment B, and 655 should have received B but received A.

2) A CRA has reported that after visiting site 66 their Source Data Verification and CRF Review identified that subject 710 is not eligible for the trial but has been randomised and is currently taking trial medication. There is no information in the site file or sponsor TMF about why this subject was entered even though they were taking other medication which may interact with the trial medication.

3) Site 32 has recruited a large number of subjects. The site was recently audited and it was identified that all the emergency codebreak envelopes had been opened. Apart from this the site was of extremely high standard,

4) Site 22 is a very good recruiting site. At the last monitoring visit the CRA happened to see an advertisement outside the site that was being used to attract subjects into the trial. Reviewing the Site File there is no evidence that this advert has been reviewed and approved by an Ethics Committee.

GCP PRIORITY SCENARIO

Please read the following scenario before answering the questions below:

You are a member of a Sponsor Project Team working through the agenda in the Monthly Project Team meeting for a global Randomised Double-blind Phase III Trial. The following items are on the agenda to be discussed and decisions need to be made to help resolve the issues.

1) There have been two dispensing errors at site 43. The dispensing errors occurred at the randomisation visit and the consequence was that patients 654, 655 were dispensed the incorrect trial medication. Subject 654 received subject 655s medication and vice versa, this meant that subject 654 was randomised to receive Treatment A but received Treatment B, and 655 should have received B but received A.

2) A CRA has reported that after visiting site 66 their Source Data Verification and CRF Review identified that subject 710 is not eligible for the trial but has been randomised and is currently taking trial medication. There is no information in the site file or sponsor TMF about why this subject was entered even though they were taking other medication which may interact with the trial medication.

3) Site 32 has recruited a large number of subjects. The site was recently audited and it was identified that all the emergency codebreak envelopes had been opened. Apart from this the site was of extremely high standard,

4) Site 22 is a very good recruiting site. At the last monitoring visit the CRA happened to see an advertisement outside the site that was being used to attract subjects into the trial. Reviewing the Site File there is no evidence that this advert has been reviewed and approved by an Ethics Committee.