Visit Descriptions. 9.4.1 Prescreening, Screening, and Baseline Evaluation (Pre-study) Prospective subjects will be prescreened by telephone according to an IRB-approved script to learn if they meet basic eligibility criteria. All individuals who are prescreened should be assigned a screening number and recorded on the Subject Screening Log where information on the selection of potential subjects in the trial should be collected. Upon signing the IRB-approved informed consent form (ICF), the potential subject may commence study-related screening activities. The screening number should also be recorded on the signed ICF. If a subject is enrolled, the study staff should record the enrollment date and assign a subject number. If a subject is not enrolled, an explanation should be recorded on the Screening Log. A CRF will not be completed for subjects who are not enrolled. These subjects will only be documented on the Screening Log and source records. It is the responsibility of the PI to file the Screening Log in the Investigator Site File (ISF) to be readily available for on-site monitoring and/or inspection by relevant authorities. Screening may take place over more than one day and should be complete by up to two months prior to enrollment. Screening may take up to two months, with the baseline CAPS being conducted no more than 8 weeks before the first experimental session, leaving room for appropriate medication washout of at least 5 half-lives of pre-study psychiatric medications and active metabolites, plus one week for stabilization. If the CAPS is completed outside of this window for a subject, the PI should consult the Sponsor CRA and Medical Monitor to determine if the baseline CAPS should be repeated. The maximum window from the start of screening to the first experimental session is 13 weeks. If, after reviewing all information, the PI concludes that a subject is eligible, they will enroll the subject in the study. Visits will be scheduled consecutively as described in the Time and Events Table.
