- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
- Keywords > clinical trials
- Keywords > clinical trials - social, legal and ethical implications
- Keywords > clinical trials in humans
- Keywords > controlled clinical trials
- Keywords > ethical practices and standards
- Keywords > GCP for trials on pharmaceutical products
- Keywords > Good Clinical Practice (GCP)
- Keywords > investigational product - clinical trials
- Keywords > WHO expert committee
(1995; 36 pages) [French] [Spanish]
4.3 Selection of trial subjects
The investigator is responsible for ensuring the unbiased selection and an adequate number of suitable subjects according to the protocol. It may be necessary to secure the cooperation of other physicians in order to obtain a sufficient number of subjects.
In order to assess the probability of recruiting an adequate number of subjects for the study, it may be useful to determine prospectively or to review retrospectively (e.g. on the basis of the clinic’s records) the availability of potential subjects. The investigator should check whether subjects so identified can or could be included according to protocol.
The patient’s own physician should, when relevant and with the patient’s consent, be informed of the patient’s participation in the clinical trial.