21st Aug 2013, 09:38 AM
Licensed IMP used for licensed indication - accountability required?
A phase four trial using a licensed IMP for a licensed indication. IMP to be taken from commercial stock in a clinical area; as such no records of IMP delivery from supplier or temperature monitoring records are to be kept. Accountability limited to clinician entering brand and batch number of product on trial documentation when IMP used. Is this acceptable?
21st Aug 2013, 01:49 PM
You don't say if any blinding has been applied.
The MHRA GCP Guide (2012) section 6.12.2 says that you should use a risk based approach. Table 6.5 says that when "IMP and comparator(s) used within their authorisation" then this is "Normal prescribing practice.
No requirement for:
• Shipping receipt and destruction records
• Drug accountability, provided the sample size is acceptable to account for the variability in drug compliance. Alternatively, if the sample size is small, subjects may be asked to complete a diary card or return the remainder of the prescription
• Recording batch numbers and/or expiry dates, unless part of routine practice"
However if blinding is applied then you should look in section 6.13.4