Phase I accreditation - physician resuscitation experience

The MHRA requirements for supplementary accreditation for phase I units include a requirement either that 1) clinical research physicians participate on an ongoing basis in periodic participation in a hospital resuscitation team rota, or 2) that the unit uses physicians on contract with appropriate up to date experience, or that 3) the unit is based within a hospital with a critical care facility.

I am interested to find out what is considered acceptable practice for meeting the first option, for units which do not use contract physicians, and are not based within a hospital. How frequently is the ?periodic? participation and what does it involve ? carrying the crash bleep? Doing A&E shifts? Or something else?

All feedback gratefully received.

The purpose of these requirements is to ensure that in the event of medical emergency in these types of trials, that there are medics present that have recent and relevant experience in managing these scenarios. There are a number of ways in which this can be achieved, and there is no defined criteria such as number of days experience per year or specific areas to be covered. What needs to be taken into consideration is the following:
• The background and recent experience of the physician - for example the physician may have worked in an emergency department, or anaesthetics for a number of years previously. In which case they may not need additional training for 1 or maybe 2 years into the role of a Phase I physician.
• Periodic participation can be varied, for example some physicians, although not based in a hospital may be close to a hospital and carry long range bleepers so that they can attend emergency medical events in that hospital. Others may agree with their employer and a hospital Trust (outlined in an honorary contract) that they can spend a certain number of days per year in a relevant hospital setting. This could be in accident and emergency, or possibly in a therapeutic area that the unit specialises in (eg respiratory).
• However this is achieved it is important to document the time spent, the emergency events attended and the role the medic took in that setting (i.e. whether it was hands on or observing only)
• The physician needs to be confident hat they have sufficient experience, and that this is updated regularly. This should be agreed in the Phase I unit, and should be flexible depending on the training needs of the individual