When research is being conducted in multiple countries, determining which regulations apply to which country’s sites can sometimes be complicated. At Advarra, we’ve noticed some confusion about how ICH-GCP Guidelines can impact the study ICF, so in this blog I’d like to discuss the basics of this situation and how we at Advarra came to our updated policy on the topic.
When a specific study protocol will be conducted in multiple countries, it can save the sponsor some time and trouble to simply use the same protocol language for all countries. This may mean including a comprehensive statement that the study will be conducted according to ICH-GCP Guidelines, as many countries have adopted these guidelines as law or guidance (including EU member countries, Japan, Canada and the US).
In the US, FDA has adopted ICH-GCP Guidelines as guidance, meaning that they are not legally binding on the public or the agency.
ICH-GCP and the ICF
Among other things, ICH-GCP Guidelines requires certain additional elements be included in the ICF, like information on alternatives to the investigational treatment (e.g., types of drugs or therapies) and their important risks and benefits. (For details, see 4.8.10 in the ICH-GCP Guidelines.) This is where things can sometimes get confusing, as sponsors may not realize that complying with ICH-GCP means including these additional ICF elements.
When the protocol states that the study will comply with ICH-GCP, some IRBs will then turn to the ICF to make sure ICH-GCP elements are included. If they were not included by the sponsor, some IRBs then revise the ICF to include the additional elements. This may be surprising to sponsors who did not intend to include those elements in the US portion of their study: depending on the nature of the study, the additional elements can add quite a bit of content to the ICF.
At Advarra, we’ve discussed this topic with clients, regulators and other experts in the field to help establish an approach that is compliant as well as appropriately flexible for client needs. Moving forward, Advarra’s IRB will only review for ICH-GCP compliance in the ICF when the client submits the study ICF with these elements already included. If the protocol references ICH-GCP compliance but ICF is not submitted with the additional elements included, Advarra’s IRB will not revise the ICF to include those elements. For more information on this policy, please review this related news item.
Other policies and requirements may differ from Advarra’s and may impact how compliance is maintained, so we recommend checking with the site, sponsor and/or the IRB reviewing your study to help ensure you understand the applicable requirements.