Certificate in Trial Participant Screening Criteria
-- ViewingNowThe Certificate in Trial Participant Screening Criteria is a crucial course for professionals in the clinical research industry. This program focuses on the initial and vital stage of clinical trials - participant screening.
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⢠Eligibility Criteria for Clinical Trials: Understanding the basic requirements for trial participant screening, including medical history, physical examination, and lab tests.
⢠Inclusion and Exclusion Criteria: Identifying the factors that determine whether a participant can join a trial, such as age, sex, diagnosis, and previous treatments.
⢠Screening Process and Procedures: Learning the steps and documents involved in the screening process, from informed consent to baseline assessments.
⢠Safety Monitoring and Reporting: Ensuring the safety of trial participants by monitoring their health and reporting any adverse events to the research team and ethics committee.
⢠Data Management and Confidentiality: Handling and storing the trial data securely and respecting the participants' privacy and rights.
⢠Regulatory Compliance: Following the local, national, and international regulations and guidelines for clinical trials, such as Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) standards.
⢠Stakeholder Communication: Establishing effective communication channels with the trial participants, investigators, sponsors, ethics committees, and regulatory agencies.
⢠Quality Assurance and Improvement: Implementing the best practices and continuous improvement measures to enhance the trial conduct and outcomes.
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