Trial Participants: Informed Consent, GCP, Patient Involvement

When a patient has decided that they would like to enrol in a trial, there are several essential steps that need to be followed before they can ‘sign up’:

• Enrolment - is the process of signing up or recruiting participants into a clinical trial.
  
  
• Eligibility - the number of participants enrolled in a study varies greatly depending on the phase of the trial and the trial design. It must be found out whether a participant will meet the requirements outlined in the protocol (inclusion/exclusion criteria) to join the trial.
  
  
• Informed Consent - the participant can then sign the written informed consent after going through the process with a suitably qualified person, usually a member of the research team.

Prior to formal enrolment into a clinical trial, patients who are interested in participating will go through a screening process. Details of a person’s medical condition will determine whether they can enter a clinical trial, usually based on information such as age, gender, the type and stage of a disease and previous treatment history (inclusion/exclusion criteria). Potential participants are usually asked to complete an initial questionnaire to determine whether they are eligible.

Those who meet the initial requirements are then invited for further screening, usually with a doctor or other healthcare professional directly involved in the trial.

Once the screening determines that the patient meets the inclusion criteria, the patient has a consultation where more and detailed information about the trial is provided, questions can be asked and an informed consent is signed (or refused).