Principle D2: Protocol content

Study protocols should include clear instructions on how participation changes should be practically managed.

This should include, where necessary, study-specific definitions for different types of participation change expected over the time the study will take place. Researchers should decide how these participation changes affect the specific research question they want to answer.

Protocols should also include a pre-defined plan, developed with patient involvement, for appropriate actions to take if study researchers lose contact with study participants.

Study protocols should give clear instructions for the researchers running the study about how to practically manage different types of participation change.

The instructions should be designed with the involvement of patient and public contributors, and approved by an independent research ethics committee before they are put into practice.

Instructions should include what to do when participants stop their study treatment and what information to give to a participant if they say they want to stop their study visits.

They should also include what to do if the research team loses contact with a study participant, which is different to participants saying they want to stop taking part.

Instructions for researchers should say that when a participant says they want to stop taking part, the researchers should try to find out exactly which parts of the study the participant wants to stop and which they are happy to continue.

Researchers should be instructed to keep a written record (for example, in the participants’ medical notes) of what the participant has said about how they want their participation to change.

This record should be kept confidential, with access only for those who really need it. Any personal or sensitive details about the participant’s changing circumstances (including their own reasons for changing their participation) should only be used for the study if they are relevant and the participant has agreed they can be used.

However, it is important to keep a good record of the participant’s wishes so that researchers can make sure they are doing what the participant wants.

In each study, the reasons why study participants might stop participating will vary, and this could be important to the study’s research question.

For example, if someone needs to stop receiving study treatment, this might be because the treatment has not worked. This would be important to know if we are looking at how well the treatment works.

Researchers designing studies should think about this before they start the study, and think about whether they need to prepare for any particular situations.

They should also decide exactly what research question they are trying to answer, given the possible ways that participation could change. Researchers should define this by describing exactly what numerical value the study is aiming to estimate – also known as the ‘estimand’ – to answer the research question.

See also:

Relevant PeRSEVERE resources:

Relevant PeRSEVERE principles:

  • The instructions about what to do in the case of lost contact should be written in the knowledge that researchers losing contact with participants is not the same as participants expressing a wish to stop taking part. See principle O4 for more on this.
  • In line with principle O5 (data collection as default), data collection should only stop if participants want it to stop.
  • As per principle D5, participants should be encouraged to keep in contact with the researchers about how they are getting on with their participation in the study.
  • The instructions in the study protocol should be reinforced through relevant training and support. See principle D6 for more on this.
  • Good record keeping about participation changes means researchers can collect clear and complete data about the participation changes, and keep an eye on any general problems with participation in the trial. See principles M1 and M2 for more on this.
  • Researchers should consider the planned study analysis when they are initially writing the study protocol, and ensure that what is in the protocol is appropriate to the analysis. See principle R1 for more on this.
  • Study protocol: this is the document (or set of documents) that describes why a study is needed, what it aims to achieve and how it should be run.
  • We use the term “running” a study here to mean all activity involved in making a study happen, including getting the relevant approvals to start the study, working with the NHS and other organisations to set up study sites where participants will be recruited, making decisions about the management of the study, collecting and processing study data, and so on.
  • Estimand: a description of exactly what numerical value a study is aiming to estimate in order to answer the study’s specific research question.