Useful Research Terms:

Assent

Children give assent when they agree to take part in research. Children who are old enough (usually age 7 or older) to express that they want to be in a study sign an assent form. For this study children will provide assent once they are no longer on a breathing machine.

Banking or storing samples

Sometimes biological samples (like blood or saliva) from study participants are stored for researchers to use in future studies. The lab where these samples are stored is called a biobank.  Samples in these labs are always coded with a research number.

Coordinating Center

An individual or group of individuals responsible for oversight and management of the conduct of a multi-center study of al collaborating institutions. For this study we have two, the Clinical Coordinating Center (CCC) & the Data Coordinating Center (DCC).

Inclusion/exclusion criteria

Each study has a list of requirements of who can and cannot participate. The items that allow someone to participate in a study are called inclusion criteria. The factors that do not allow someone to participate are called exclusion criteria.

Institutional review board (IRB)

A group of people that might include doctors, researchers, community members, pharmacists and other experts who review and approve research studies before they begin.

Lead Investigator

The individual with primary responsibility for oversight and management of the conduct of the study at all participating research sites.

Click here to meet our lead investigators!

Parental permission

Parents/guardians give permission when they agree their child can take part in research. Parents/guardians sign a consent form to confirm that they understand the study and give permission for their child to participate.

Protocol

A carefully designed plan to keep study participants safe and answer specific research questions.

Site Principal investigator (PI)

The individual at each site who agreed to participle in the multi-center study and is responsible for the oversight of the conduct of the study at their center.

Click here to see our study sites!

Randomization

The process by which study participants are assigned to different study groups by random chance (like flipping a coin or pulling a name out of a hat).

If you have any questions about PROSpect please contact the CCC by email or phone.

PROSpect CCC study team: