Any trial must abide by the regulations which govern participating countries.
As regulatory frameworks vary widely between different nations, establishing the specific requirements of regulatory bodies within each country, and anticipating how the trial team will ensure requirements are adhered to, is an important activity to initiate during the early stages of trial set up.
Trials must adhere to the regulatory framework of the country in which they are run; coordinating centres cannot mandate regulations and principles in-country. However the requirements of Sponsors and funders must be adhered to, with the Sponsor and funder acknowledging the need to accommodate diversity in the regulatory environment.
Sponsors of international trials must develop processes and approaches to facilitate the delivery of such trials: this is an essential consideration for a multinational trial.
Although protocol development is covered in greater detail in a separate section, a key component in effective development of the protocol and patient-facing documents is to create flexibility which will allow collaborators to observe the principles of their own local regulatory frameworks, while also ensuring that UK regulations can be adhered to.
Protocols should be adaptable so that country- or site- specific information can be modified according to local requirements. Common considerations may be:
- What is the age of majority?
Due to different definitions between countries, it may be necessary to adhere to regulations governing the recruitment of vulnerable populations in some participating nations.
- Who is permitted to take trial-specific consent?
Appropriately trained nurses may be permitted to take consent dependent on country-specific guidelines; it may also be a requirement for operative and trial consent to be taken by different members of the clinical team.
- Are any of the trial interventions considered an ‘IMP’?
The answer to this question has significant ramifications which may alter the way in which the trial operates with regards to regulatory requirements, interventions supply, safety reporting, etc. It is essential that if the trial does constitute a CTIMP in any of the participating nations, it has been identified as such from the outset.
Input from collaborators is essential in establishing local requirements and anticipating queries from regulatory bodies.