ࡱ> a bjbjZZ Y8Q\8Q\     8XtL Yy|,3FFFxxxxxxx${}x FNbDE"\F4Fx,36x$|J|J|JFR,3x|JFx|J|Jnn"4qplO[:Gdo"xy<Yy>o~GT~D4q4q~lqFF|JFFFFFxxHFFFYyFFFF~FFFFFFFFF > : HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title   Subject Initials Subject ID Informed Consent/HIPAA Authorization Obtained  FORMCHECKBOX  Consent Refused Date Signed: / / Time: (using 24 hour format)  Document(s) signedVersion DateApproval Date Consent Form, and related study documents, was thoroughly reviewed with the subject.  FORMCHECKBOX  Yes  FORMCHECKBOX  No Subject had sufficient time to review the documents and ask questions.  FORMCHECKBOX  Yes  FORMCHECKBOX  No Informed consent/HIPAA Authorization obtained prior to any study related procedures.  FORMCHECKBOX  Yes  FORMCHECKBOX  No A copy of the signed documents have been given to the subject.  FORMCHECKBOX  Yes  FORMCHECKBOX  No  Name of person that obtained consent:  Comments:  Informed Consent Refused  Time: (using 24 hour format)  FORMCHECKBOX  Not Applicable (e.g. hh:mm) Comments:  This form should be completed for each Informed Consent process (i.e. if Re-consented)  OnCore Entry Instructions: The Informed Consent form is not a separate eCRF in OnCore, but rather a set of standard data collected for every subject in OnCore, each time Informed Consent is obtained. To enter the Informed Consent data, click the Consent menu item on the left side menu bar within the Subject Console. Click Update and Add to and enter data obtained on the paper version of the form.     Form Number Version Date: 12/16/2016 Page 1 of 1  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 Site No (If Applicable) (CDASH Domain: Common) CDASH/SDTM Variable Name: SITEID  Highly Recommended Subject Identifier (CDASH Domain: Common) CDASH/SDTM Variable Name: SUBJID Time needed to confirm that informed consent was obtained prior to performing study procedures Time of day format based on International Organization for Standardization (ISO 8601:2004) Time of the day is the time representation, using the 24-hour timekeeping system. 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