Safety is Celerion's primary concern, so the first step in the screening process is informing participants of the details of the study. An information pack called the Informed Consent Form (ICF) is given to all participants. The ICF includes all study information, including potential side effects of the new medicine being tested, the rationale of the study and outlines all procedures that will take place. A trained medical professional reviews the ICF and answers any questions. This information may be taken home to review further with family, friends or a doctor. During any part of the process or study, participants may choose to withdraw from the study.
During the on-line registration process, participants complete the medical history questionnaire. Participants will be asked to review this medical history at screening and signing off on the information submitted.
Participants not completing the registration process on-line will be asked to complete all necessary documents at screening. Celerion recommends participants bring all important names and dates concerning personal medical history (i.e. dates of surgeries and names of current medications) to their screening appointment to ensure this information is documented. Once the medical history questionnaire is completed, additional screening assessments are undertaken. Celerion staff will track height, weight, temperature, blood pressure, pulse and collect urine and blood samples. An electrocardiogram (ECG) may also be completed. Additionally, a Celerion physician will conduct a physical exam. The screening process may also include other study specific procedures, such as allergy tests and x-rays. The screening process takes approximately 3 hours, but may be longer depending on the requirements of the study. In some instances the screening process may require multiple visits.