October 23rd, 2017
Further to the publication of the September 2017 edition of the
BHBIA Legal and Ethical Guidelines, a change has been regarding the
review of MR materials.
Revised guidance on review of MR materials - Stimulus Material – Section E 5.4 of the Guidelines
Following discussion with the PMCPA we are revising our advice on the requirements for review of MR materials. The new guidance provides more flexibility and takes effect immediately.
The new guidance is as follows:
- The ABPI Code of Practice states that MR material should be examined by the commissioning client company to ensure that it does not contravene the ABPI Code (certification is not required). The appointed person should be sufficiently familiar with the ABPI Code, and all MR materials i.e. screeners, guides/questionnaires and stimulus should be examined.
This replaces the previous guidance:
- The client company’s medical department must approve all stimulus materials before you use them in the field, regardless of their format or finish.
with immediate effect.