Subject Numbering Sample Clauses

Subject Numbering. Prior to enrollment, subjects will be tracked with a secondary identifier number and a screening number assigned sequentially starting at “001”. Subjects who meet the enrollment criteria will be enrolled in the study and assigned a 5-digit subject number. The first two digits identify the study site. The next three digits identify the subject within the site and will be assigned sequentially, with 01 corresponding to the first subject enrolled, e.g. the first enrolled subject will be 04001, second 04002, etc. Study Phase Screen/ Baseline Preparatory Sessions Experimental Session 1 Experimental Session 2 Primary Endpoint Experimental Session 3 End of Stage 1 Visit # Prior to enrollment V1,2,3 V4 V5,6,7 V8 V9,10,11 V12 V13 N V14,15,16N V17N Type of Visit Screening/Baseline Preparatory Experimental Integrative Experimental Integrative Outcome Experimental Integrative Outcome Visit Timing Up to 2 months prior to V1 1 week apart 3-5 weeks post baseline Between V4 and V8 3-5 weeks post V4 Between V8 and V12 1 month post V8 After V12 Between V13 and V17 2 months post V13 Initial Phone Screen ! Informed Consent ! Medical/Psychiatric History ! General Physical Exam, ECG ! Brief Neurological Exam ! SCID-I-RV (IR) ! Clinical Lab Tests with HIV test ! Collect Concomitant Medication ! ! ! ! ! ! ! ! ! ! Medication Taper (if applicable) ! Study Enrollment (if eligible) !O Record to Audio/Video ! ! ! ! ! ! ! General Wellbeing ! ! ! ! ! ! ! ! Drug Screen ! ! ! ! Pregnancy Screen (if applicable) ! ! ! ! Obtain Container Assignment !B !B CAPS, GAF, BDI-II, NEO-PI, PSQI,PTGI, DES-II ! !L ! Q RBANS/PASAT ! ! ! PDS ! !M ! !M ! C-SSRS ! !G !C, D, E !I !C, D, E !I ! !C, D, E !I ! Administer Drug + Therapy ! ! ! Monitoring of BP, Pulse, and Temp. ! ! ! SUD !F, E !F, E !F, E Belief of Condition Assignment !K !K Overnight Stay, SOCQ ! ! ! Integrative Therapy Session !A !A !A 7 Days Integrative Telephone Contact ! ! ! AEs Requiring Medical Attention ! ! ! ! ! ! ! ! Spont. Reported Reactions & All AEs !J ! !J ! ! !J ! Changes in Tinnitus and/or Pain !P !E,P !E,P !E,P !E,P !P !E,P !E,P !P AEs of Psychiatric Status or Withdrawal ! ! ! ! ! ! ! ! ! Serious Adverse Events ! ! ! ! ! ! ! ! ! Issue Memory Aid Card !H Unblinding ! Perception of Experimental Sessions !N !N RRPQ !H A = First Integrative session is one day after experimental session; B = At least 24 hours prior to experimental session; C = Approximately six hours post MDMA; D = At the beginning of the session; E = As needed; F = ...