Clinical Study Participation Process

Create an On-Line Profile

To create a profile participants are asked to provide their name and contact information as well as age, gender, race, ethnicity, height/weight, and medical history. These questions ensure that the minimum criteria required by Celerion are met, as well as other study specific requirements. At our Belfast, Northern Ireland facility, a General Practitioner's (GP) name and contact information also needs to be provided. The GP will be contacted prior to participation in studies at our Belfast location.

Once the participant profile is completed, a confidential file is created that houses personal and medical information. This file is referenced to determine potential studies of which participants may qualify. Once the registration process is completed, participants may visit Find a Clinical Study section to review details of all current studies at Celerion. Once a study has been selected, pre-screening takes place to ensure minimum qualifications are met. The minimum qualifications typically include age, weight, gender, and various medical history requirements. If the pre-screening criteria are met the next step is to schedule a screening appointment at a Celerion facility. Celerion will provide information for the number and length of screening visits required.

Screening

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 on a 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 screening a complete medical history questionnaire must be completed. 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 generally takes 60 minutes but may be longer depending on the requirements of the study. In some instances the screening process may require multiple visits.

Results Call

Screening results are obtained from Celerion's "Result Line". Information for the date and time of the results call is provided during the screening visit. The Celerion results call is a competitive process - the first call is at the top of the list. It is critical that calls are made promptly as this improves the chances of continuing in a study. Celerion uses this competitive call method to give all participants an equal chance of enrolling in a study.

Study Acceptance

Following the results call, if the participant is chosen/eligible to continue, the date and time for check-in and any special instructions is provided. A reminder is sent prior to the check-in date. Placement in a study is however, never guaranteed, and the decision rests with the physician and our clients. If participants are not able to enroll in the study, Celerion should be notified immediately. Failure to check-in can result in restricting eligibility to participate in future studies at Celerion.

Check-in

During the screening appointment, a list of items that may be brought with you for check-in is provided as well as a list of expectations and responsibilities. Please be advised that ALL items will be searched at check-in, and items not allowed in the facility will be removed and returned at departure. For a detailed list of our check-in guidelines please visit Locations and review for your local clinic.

Orientation by a Celerion Study Manager is conducted at check-in. This includes an explanation of the overall experience during the study, a review of the study schedule, an optional tour of the facility and the expectations for study participants.

Clinical Study Conduct

In a clinical study there is a defined schedule of events, however, there may be some free time where our participants may read, watch movies, or spend time on the internet. For most studies, breakfast, lunch, dinner and a late snack are provided. Participants are not permitted to leave the clinic during the clinical study. If a participant no longer wishes to stay, they may withdraw consent at any time.

Compensation

Celerion recognizes and values our study participants, and without their efforts and commitment, studies could not be successfully completed. Celerion therefore offers appropriate compensation for participation in clinical studies. Stipends are based on the amount of time involved in a study and the events included in the schedule. The stipend amount is communicated during the registration and ICF process for the study.

Upon completion of a study, the check can be picked up at a specified time or mailed to the address on file. Taxes are not taken out of the stipend amount so if the payment is over $600, the appropriate forms may need to be completed for income tax. Information for the US and UK will be communicated during the screening process.

The Next Study

Celerion is pleased that many study participants return to complete additional studies. There is typically at least a 30 day washout period (90 days in Belfast, Northern Ireland) required from completion of one study, and prior to check-in for the next one. Please visit Find a Clinical Study for listing of all current studies.