Patient Screening
The purpose of the Screening for clinical trials stop is to verify patient eligibility to participate in a clinical trial.
Description
Screening for clinical trials is an important part of the research process. It helps to ensure that only participants who fit the trial eligibility parameters are included. Screening also helps to protect the safety of participants by identifying those who may be at risk for harm from the trial, especially based on safety parameters assessed as part of screening.
The screening process typically includes the following steps:
- Inclusion criteria: The researcher confirms the potential participant meets all the criteria in order to be eligible for the trial.
- Exclusion criteria: The researcher confirms the potential participant does not meet any of criteria that disqualify them from participation.
- Questionnaire: The researcher may ask the participant a series of questions to assess their eligibility for the trial, including their willingness to participate for the duration of the trial and to comply with protocol requirements.
- Physical examination: The researcher or an HCP may perform a physical examination to assess the participant's health status.
- Laboratory tests: The researcher may order laboratory tests to assess the participant's health status.
DCT-specific Considerations/Inputs
Considerations specific to screening participants for a decentralized clinical research trial include the willingness and ability of the participant to access and use technology, as well as their willingness to participate in a study at locations other than a traditional clinical trial site. Here are some additional considerations:
- The participant's access to a stable internet connection and or a data collection device (e.g., smartphone with wifi).
- The participant's ability to follow study instructions and complete study tasks.
- The participant's willingness to share personal health information, including access to medical records for final eligibility confirmation.
Some assessments may be conducted at alternative site locations or with HCP involvement. There needs to be a clear plan to proceed to enrollment if screening is not done by the PI. The PI may need to establish a relationship with the participant if the individual is not a current patient.