Phase 1 Unit

Resources

2CA-Braga’s Phase 1 Unit is located in a hospitalization wing at the Hospital of Braga and has, at the moment, 12 beds distributed among 7 bedrooms. Its location facilitates access to various supporting and emergency services. Read More

2CA-Braga team has healthcare professionals (physicians, nurses, pharmacists, and coordinators) with vast experience in clinical trials. Under the guidance of a medical coordinator, this team is responsible for the continuous observation and monitoring of the participants. Read Less

Phase l Clinical Trials

In phase 1 clinical trials, the experimental medicine is administered for the first time in humans to assess its safety, tolerability, and pharmacokinetics. During this stage, low doses of that medicine are administered to a small number of participants, under the constant observation and monitoring of the assigned medical and nursing teams.

The trial details vary according to each protocol and depend on the drug characteristics. The number of volunteers needed also varies with the protocol and its objectives.

When the center is selected for a trial, this trial is presented to potential participants. Those who accept to participate will undergo several clinical evaluations to make sure that they meet all the necessary criteria to be included in the study.

Usually, the phase 1 clinical trials require hospitalization (one or several days, according to the protocol) to standardize all the trial conditions (meals, sample collection, and exercise, among others) and ensure the safety of the participant.

Volunteers

Participation is voluntary, and it can be interrupted at any time. This decision won’t affect the health care the participant is entitled to.

All the phase 1 clinical trials in progress at 2CA-Braga comply with the applicable national and international legislation, being previously approved by the Ethics Commission for the Clinical Investigation—CEIC (www.ceic.pt)—and by the National Authority of Medicines and Health Products - INFARMED (www.infarmed.pt).

Confidentiality

According to the Personal Data Protection Law in force, 2CA-Braga requested permission to the Portuguese Data Protection Authority to use clinical data from its volunteers (Permission Nr. 12602/2015), to create a database of healthy individuals and identify more easily potential participants for phase 1 clinical trials. With this permission, the confidentiality is ensured, as well as the possibility to access, correct, and delete them through the responsible team, if necessary, in compliance with the General Data Protection Regulation (EU) Nr. 679/2016.

Furthermore, the members of the research team have to comply with the duty of secrecy, keeping confidentiality regarding the volunteers who participate in the clinical trials. All the gathered information about the participants is confidential and will only be used according to the trial objectives.

Financial Compensation

The participants of phase 1 clinical trials will be financially compensated according to the applicable legislation. The amount of this compensation depends on the type and duration of the trial.

Submit Registration

The registration doesn’t automatically guarantee the participation. After the application, the potential participants will be contacted by a 2CA-Braga team member to schedule a preliminary appointment, which will be conducted by the medical coordinator of the phase 1 unit (or their medical representative) and will take place at 2CA-Braga facilities. The participant will be informed about the nature of his possible participation in phase 1 clinical trials, namely, its objectives, procedures, risks, and benefits, among other pieces of information mentioned in the free and informed consent form.

At any time, they will be able to reverse their decision to participate in phase 1 clinical trials, through the sending of a written notification to 2CA-Braga’s medical coordinator of the phase 1 unit. If their consent is withdrawn, the research team will cease collecting medical information about them and will delete the previously collected data.

In case you have any doubt, or you want to change any data mentioned in your registration, please contact 2CA-Braga through 2ca@ccabraga.org.

Registration