ࡱ> Y bjbjGG -b-b X X d$DL,`L000)))-`/`/`/`/`/`/`$XbeS` )Z()"*<L* S`00p h`Z-Z-Z-l*00-`Z-)-`Z-Z-[S0V0"+<+0T$`~`0`Tel,eHVVe~iW))Z-)))))S`S`Z-)))`))))e)))))))))X B : HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Subject Initials Subject ID  Date: / /  Month Day Year Subject Off Study Date subject went Off Study: / / Month Day Year Last Visit Completed:  FORMCHECKBOX 1 Visit #  FORMCHECKBOX 2 Visit #  FORMCHECKBOX 3 Visit #  FORMCHECKBOX 4 Visit #  FORMCHECKBOX 5 Visit #  FORMCHECKBOX 6 Visit #  FORMCHECKBOX 7 Visit #  FORMCHECKBOX 8 Visit # INDICATE OFF STUDY REASON: (select only one)  FORMCHECKBOX 1 Study Activities Completed If the subject was withdrawn prior to completing the study (i.e. early withdrawal), select one of the following:  FORMCHECKBOX 2 Subject withdrawn by Subject PRIOR to enrollment**  FORMCHECKBOX 3 Subject withdrawn by Subject AFTER enrollment**  FORMCHECKBOX 4 Subject withdrawn by PI PRIOR to enrollment**  FORMCHECKBOX 5 Subject withdrawn by PI AFTER enrollment**  FORMCHECKBOX 6 Death  FORMCHECKBOX 7 Other** If the subject was withdrawn, indicate specific reason(s): (select all that apply and enter as text into the Subject Console > Follow-up > Subject Off Study Update > Explain field)  FORMCHECKBOX 8 Subject lost to follow-up  FORMCHECKBOX 9 Subject refused follow-up  FORMCHECKBOX 10 Due to adverse events or complications  FORMCHECKBOX 11 Other** **Additional explanation required: (enter into the Subject Console > Follow-up > Subject Off Study Update > Explain field) FORM COMPLETED BY:  OnCore Entry Instructions: The Off Study form is not a separate eCRF in OnCore, but rather a standard form for every subject part of the Subject Console. To enter the off study data, click Follow-up menu item on the left side menu bar within the Subject Console. Enter the Off Study Date field. Select the appropriate Off Stud Reason. If the subject withdrew early, select Subject Withdrawn from the Off Study Reason drop down box with the corresponding indicator of PRIOR to or AFTER enrollment, and enter the specific reasons in the Explain field.     Form Number Version Date: 10/20/2016 Page  PAGE 1 of  NUMPAGES 1 PI: GERN, James, UWI-02, RG-HRV16 Inoculum Dose Determination Form Number: UWI-02-008, Version 1 Version Date: 08/26/2010 Page  PAGE 2 of  NUMPAGES 2  Optional Investigator Identifier (CDASH Domain: Common) CDASH/SDTM Variable Name: INVID  Highly Recommended Protocol/Study Identifier (CDASH Domain: Common) CDASH/SDTM Variable Name: STUDYID  Highly Recommended Subject Identifier (CDASH Domain: Common) CDASH/SDTM Variable Name: SUBJID  Highly Recommended Site No (If Applicable) (CDASH Domain: Common) CDASH/SDTM Variable Name: SITEID  Recommended/Conditional Date of Completion or Discontinuation (CDASH Domain: DS) CDASH Variable Name: DSSTDAT SDTM Variable Name: DSSTDTC (ISO 8601 format) To be modified per protocol  Highly Recommended Subject Status (CDASH Domain: DS) CDASH/SDTM Variable Name: DSDECOD (pre-printed list) & DSTERM (used for other, specify) ?@ABCDGVuvﶢwhh^hQGQ6 hUh hCJ<OJQJ^JaJ<h hOJQJ^JhUh hOJQJ^Jjhl0JUh h5CJOJQJ^JaJ#huh h5CJOJQJ^JaJ1jh h5CJOJQJU^JaJmHnHu&jh hOJQJU^JmHnHu.jh hCJOJQJU^JaJmHnHujh h0JU-jh(_wh h0JCJOJQJU^JaJ h(_wh hCJOJQJ^JaJB7 x y wwk [$\$gdTD [$\$gdW/ [$\$gdlH9$$d%d&d'd-DM NOPQ[$\$a$gdlH$[$\$a$gdlH[$\$^`gd h [$\$gd h$a$gd h ؿpaR@,&hQhlH56CJ OJQJ^JaJ #h-6yhlH5CJ OJQJ^JaJ hQ5CJ OJQJ^JaJ hlH5CJ OJQJ^JaJ #hlHh h5CJOJQJ^JaJh h5CJOJQJ^JaJhlH5CJOJQJ^JaJ hUh hCJOJQJ^JaJh hCJOJQJ^JaJ1jh h5CJ OJQJU^JaJ mHnHuhUh hOJQJ^J hUh hCJ<OJQJ^JaJ<h hOJQJ^J    % & 5 6 7 E V x y ֱ֠֏m``O> h3AhTDCJOJQJ^JaJ h%hTDCJ OJQJ^JaJ h hTDOJQJ^J&h3AhW/56CJOJQJ^JaJhW/CJOJQJ^JaJ hwhW/CJOJQJ^JaJ hwhW/CJ<OJQJ^JaJ< hwhW/CJOJQJ^JaJhW/OJQJ^Jjhl0JUhwhW/OJQJ^J7jhwhW/CJOJQJU\^JaJmHnHu  $ @ \ x y z { O "  <<[$\$^` gd&D <<[$\$gdFE,<<[$\$`gd&D [$\$gd3A [$\$gd h [$\$gdTD     ١ى١q١Y١/j\h3Ah hCJOJQJU^JaJ/jh3Ah hCJOJQJU^JaJ/jth3Ah hCJOJQJU^JaJh hCJOJQJ^JaJ#h3Ah hCJH*OJQJ^JaJ/jh3Ah hCJOJQJU^JaJ h3Ah hCJOJQJ^JaJ)jh3Ah hCJOJQJU^JaJ"    " # $ % 3 4 5 6 > ? 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