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Someone who wants to leave a study may express different preferences about which activities should stop. Staff should listen first, without turning the conversation into an attempt to persuade them to continue. Explaining available options should support their decision rather than undermine it.
Define the workflow
Questions about study product, visits, contact and data processing may have different implications. The investigator and authorized team explain them using approved information and applicable arrangements. Avoid universal promises that all collected data will be erased or that every follow-up activity is mandatory.
Worked example
For example, a participant is tired of frequent visits but would consider telephone contact if appropriate. The coordinator records that preference and refers it to the investigator. Available follow-up options are assessed, and clinical staff explain safety issues. Telephone contact is not presented as a hidden requirement for leaving.
Practical checks
- Understand in the person’s own words which activities they want to stop.
- Review data, samples, product and follow-up questions separately with authorized specialists.
- Record the decision and explained options without making contact beyond what is appropriate.
Decision and boundaries
An acceptable process preserves the person’s preference and prevents conflicting messages between teams. Do not pressure them to disclose a reason. Refer clinical care questions to the investigator. Explain consequences for records and data retention according to the country, study and relevant legal framework.
Frequently asked questions
- Must someone provide a reason for withdrawing?
- They should not be pressured to do so. Information shared voluntarily may help improve the study process.
- Will every record be deleted after withdrawal?
- Do not promise universal deletion. The authorized team should explain applicable requirements for data and study records.