All manufacturing activities will need to be conducted in a unit which has an Investigational Medicinal Product manufacturing authorisation with a named Qualified Person. This person ensures that an investigation medicinal product batch is only released if there is documentation to confirm compliance with Good manufacturing Practice (or equivalent).

Qualitative Research is used to explore and understand people’s beliefs, experiences, attitudes or behaviours. It asks questions about how and why. Qualitative Research might ask questions about why people want to stop smoking. It won’t ask how many people have tried to stop smoking. It does not collect data in the form of numbers. Qualitative researchers use methods like focus groups and interviews (telephone and face-to-face interviews).

In quantitative research, researchers collect data in the form of numbers. So, they measure things or count things. Quantitative research might ask a question like how many people visit their GP each year, or what proportion of children have had an MMR vaccine, or whether a new drug lowers blood pressure more than the drugs that are usually used. Quantitative researchers use methods like surveys and clinical trials.