4th Sep 2012, 12:46 PM
IMP Transfer from one study site to another
I want to know if there is a guidance or regulation in UK or EU which defines under which circumstances a sponsor is allowed to transfer IMP from one site to another during the course of a clinical trial. If so can anyone please provide a link to such a guidance or regulation. If there is no guidance or regulation, how can a sponsor define such a site to site transfer of IP in its SOPs.
4th Sep 2012, 10:06 PM
This might help.
Volume 4 ANNEX 13 MANUFACTURE OF INVESTIGATIONAL MEDICINAL PRODUCTS. 03 February 2010. ENTR/F/2/AM/an D(2010) 3374
47. Transfers of investigational medicinal products from one trial site to another should remain the exception. Such transfers should be covered by standard operating procedures. The product history while outside of the control of the manufacturer, through for example, trial monitoring reports and records of storage conditions at the original trial site should be reviewed as part of the assessment of the product’s suitability for transfer and the advice of the Qualified person should be sought. The product should be returned to the manufacturer, or another authorised manufacturer, for re-labelling, if necessary, and certification by a Qualified Person. Records should be retained and full traceability ensured.
6th Sep 2012, 08:12 AM
Thanks for this info. But how do we define in our SOP what is an exceptional circumstance. In my opinion, there can be many circumstances encountered during a clinical trial which can require a transfer of IP from one site to another. E.g. if a patient visit is scheduled at a site and as per protocol patient is scheduled to receive IP at this visit but the site is running short of IP or the IP available at site is found unfit for use due to any reason and the drug depot does not have sufficient quantities of IP to provide to this site. Can such a situation be considered exceptional and IP transfered to this site from another site having adequate supplies of IP.
During conduct of trials, we come across such situations, although these are rare.
6th Sep 2012, 02:35 PM
You can define what "exceptional" is in your SOPs and what control measures are in place. The point is that transfer between sites is a risk. Perform a risk assessment to describe the hazard, the impact and likelihood and what measures are taken to mitigate risks. Transfer between sites should not be done impromtu and should be avoided by measures set out in the protocol & SOPs. Transfer should not be performed in place of a properly planned and executed IMP supply strategy. It should not be done primarily to save money. However a contrasting case might be that of orphan indications there may be few subjects, geographically spread-out and the IMP may be rare. In this case it is easily acceptable to transfer (with control & documentation by QP). Ask you QP for advice. Or get a GCP expert in for a consultancy about wording. You should be able to describe in your SOP what circumstances are acceptable and which not. Also many sponsors use IVRS to deliver their IMP with more precision from warehouses, thus avoiding having lots of supplies at poor recruiting centers and running out at high recruiting centers.
6th Sep 2012, 03:51 PM
Also, of course a risk assessment on the IMP itself. The QP will want to assess whether the IMP still remains inside specification before transferring to another site (as per Annex 13 above). Hence your SOP will need to include this assessment and whether IMPs that are more sensitive (such as those with only limited stability data, or those which need special handling , such as cool chain IMP) would be unlikely candidates for inter-site transfer.
Last edited by MHRA Moderator; 6th Sep 2012 at 04:23 PM.