Table 4 Themes for avoiding specific amendments that were mentioned by interviewees

Addition of sites should have another way to add these as a ‘notification’ instead, e.g. stating the approximate number of sites to be added instead and informing the regulatory body of new sites added as part of annual progress reports, without amending the original application form^a

Allow whatever works locally at sites

Allowing flexible consent statement changes to version and date without an amendment

Being less specific and more flexible and inclusive where possible

Being specific about definitions and what sites can do

Casting the net wider for site recruitment

Flexibility of drug brands that can be used where possible

Having communication flexibility from the beginning where ethical

Include extended date from outset

Make visits follow standard care practice

Not including unnecessary eligibility criteria age limits

Only include procedures required for analysis

Planning numerous different potential recruitment pathways

Setting realistic site recruitment goals based on site feasibility and patient population

Using generic procedure names

Writing staff roles instead of specific names