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					TITLE:
CTRC#
PI:



                            Screening Statistics
Enrollment Target:                                     m         Gender         f
Total Enrolled:      0                             0                                0
Demographic 1
Demographic 2
Demographic 3


         MRN             Name (Last, First)                DOB            Age           Sex (m/f)
                                      Phone Screen Date
Demographic Demographic Demographic                       Eligible   Enrolled
                                      (add to comments
    1           2           3                              (y/n)      (y/n)
                                         if multiple)
                    Reason Color Code
                    x = exclusion criteria
                    m = exclusion medication
                    h = health condition
                    d = declined
                    u = unable to contact (phone disconnected, etc.)
                    f = follow up later (make comment)
                                                                       Screened
     Reason
                                             Comments                      by
(if not enrolled)
                                                                        (initials)
TITLE:
CTRC#
PI:
                                                            Enrollment Statistics
                         Demographics                                                      Race
Target Enrollment                            Female                        0 c = Caucasian/White
Total Enrolled      0                                       0              0 b = African American/Black
Demographic 1                                                              0 a = Asian American/Pacific Islander
Demographic 2                                Male                          0 n = American Indian/Alaskan Native
Demographic 3                                               0              0 m = Multi-racial
                                                                           0 u = Unknown


     Subject ID         Name (Last, First)            MRN          DOB               Age            Sex (m/f)      Race
Cell formatting stops after this line   Cell formatting stops after this line
              Ethnicity
          0 y = Hispanic
          0 n = Non-Hispanic
          0 u = Unknown




Ethnicity -
 Hispanic        Primary Phone   Secondary Phone   Address   Demographic 1   Demographic 2
 (y/n/u)
                                                 Exclusion Reason Color Code
                                        x = exclusion criteria
                                        m = exclusion medication
                                        h = health condition
                                        d = declined
                                        u = unable to contact (no show)
                                        f = follow up later (make comment)
                                                                               Enrolled
                Screen   Screened by                                           (Date or
Demographic 3                                              Comments                        Subject ID
                 Date      (initials)                                          exclusion
                                                                                 code)
Cell formatting stops after this line
                              Location:                                     Location:                                     Location:
                              Occurrence:                  weeks            Occurrence:                  weeks            Occurrence:
                              Window:                                       Window:                                       Window:
                                      from:                weeks                    from:                weeks                    from:
Visit Status Code Key                                     post enrollment                               post enrollment
       within                             to:              weeks                        to:              weeks                        to:
      outside                                             post enrollment                               post enrollment
     missed (x)
        due


                                  From            To           Actual           From            To           Actual           From


 Name (Last, First)     MRN                     Visit 1                                       Visit 2
                            Location:                                     Location:                                     Location:
           weeks            Occurrence:                  weeks            Occurrence:                  weeks            Occurrence:
                            Window:                                       Window:                                       Window:
           days                     from:                weeks                    from:                weeks                    from:
          post enrollment                               post enrollment                               post enrollment                               post enro
           days                         to:              weeks                        to:              weeks                        to:
          post enrollment                               post enrollment                               post enrollment                               post enro




  To           Actual           From            To           Actual           From            To           Actual           From            To


Visit 3                                       Visit 4                                       Visit 5                                       Visit 6
                  Location:                                     Location:                                     Location:
 weeks            Occurrence:                  weeks            Occurrence:                  weeks            Occurrence:                  weeks
                  Window:                                       Window:                                       Window:
 weeks                    from:                weeks                    from:                weeks                    from:                weeks
post enrollment                               post enrollment                               post enrollment                               post enrollment
 weeks                        to:              weeks                        to:              weeks                        to:              weeks
post enrollment                               post enrollment                               post enrollment                               post enrollment




     Actual           From            To           Actual           From            To           Actual           From            To           Actual


                                    Visit 7                                       Visit 8                                       Visit 9
      Location:
      Occurrence:                   weeks
      Window:
              from:                 weeks
ent                                post enrollment
                  to:               weeks
ent                                post enrollment




          From            To            Actual


                        Visit 10                     Subject ID   Name (Last, First)   MRN
Title:
CTRC#
PI:


                                                     Visit 1
            Location
            Duration         hrs
           Occurance         weeks post enrollment
                Staff
            Materials




         Coordinator Tasks




                                                     Visit 2
            Location
            Duration         hrs
          Occurrence         weeks post enrollment
                Staff
           Materials




         Coordinator Tasks
                                            Visit 3
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks




                                            Visit 4
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks
                                            Visit 5
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks




                                            Visit 6
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks
                                            Visit 7
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks




                                            Visit 8
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks
                                            Visit 9
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks




                                            Visit 10
   Location
   Duration         hrs
 Occurrence         weeks post enrollment
       Staff
  Materials




Coordinator Tasks
   Visit 1




Next Steps   Completed




   Visit 2




Next Steps   Completed
   Visit 3




Next Steps   Completed




   Visit 4




Next Steps   Completed
   Visit 5




Next Steps   Completed




   Visit 6




Next Steps   Completed
   Visit 7




Next Steps   Completed




   Visit 8




Next Steps   Completed
   Visit 9




Next Steps   Completed




  Visit 10




Next Steps   Completed
Title:
CTRC#
PI:

                                           Drug

                                           Received Date              Initials

                                           Received Quantity          Initials

                                           Shipped        to
                                                         from

   Subject ID   Name (Last, First)   MRN          Date          Qty    Unit      Initials
Manufacturer                                Dispensation Method                       Drug
                                            Dose
Returned Date         Initials              Route                                     Received Date
                                            Frequency
Returned Qty          Initials              Comments                                  Received Quantity

Dispensed to                                                                          Shipped        to
                                                         Returned
         from                                                                                       from

    Date        Qty    Unit      Initials       Date       Qty      Unit   Initials          Date
                                       Manufacturer                                Dispensation Method
                                                                                   Dose
                 Initials              Returned Date         Initials              Route
                                                                                   Frequency
ved Quantity     Initials              Returned Qty          Initials              Comments

                                       Dispensed to
                                                                                                Returned
                                                from

           Qty    Unit      Initials       Date        Qty    Unit      Initials       Date       Qty      Unit
ned


      Initials
Title:
CTRC#
PI:


   Deviation Date   Date of Notice   Subject ID   Personnel
Reported to IRB   Description
Title:
CTRC#
PI:


         AE Date   Date of Notice   Subject ID   Personnel
Reported to IRB   Description

				
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posted:11/4/2011
language:English
pages:187