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Generic Safety Officer Tables and Listings by NIHhealth

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									[Trial Name], [Principal Investigator] [Institution]
[Grant/Contract No.]

Data as of:__________________
Date of report________________
                                             Example Figure 2: Enrollment: Actual vs. Expected
                                                                   (In Aggregate)

                                                        Figure 1

                              350
     Number of Participants




                              300
                              250                                                                Series1
                              200
                              150
                              100                                                                Series2
                               50
                                0




                                                       Time Period*



*Time period to be determined per study protocol


             Expected     Actual
Time Period Number of pt Number of pt
      Jul-03            2         2
     Dec-03            40        36
      Jul-04          160       156
     Dec-04           225       224
     Jan-05           230       229
     Feb-05           235       246
     Mar-05           240       251
     Apr-05           245       256
     May-05           250       261
     Jun-05           255       261
      Jul-05          260       264
     Aug-05           265       268
     Sep-05
     Oct-05
     Nov-05
     Dec-05           306
[Trial Name], [Principal Investigator] [Institution]
[Grant/Contract No.]

Data as of:__________________
Date of report________________

 Table:___ Demographic and Key Baseline Characteristics by Blinded Treatment Group


                                      Group 1                 Group 2         Total
       Characteristics               N*    (%)**             N*    (%)**   N*     (%)**
Gender
      M
      F
Age
      Mean
      Median
      Maximum
      Minimum
Risk Factors
      xxx
Clinical Features
      xxx

* N- number of participants with particular characteristic
**% of total number of participants enrolled
[Trial Name], [Principal Investigator] [Institution]
[Grant/Contract No.]

Data as of:__________________
Date of report________________


              Table_________: Adverse Events by Severity Summary


                                         Total Number of Enrolled (N=)
                              Mild                Moderate                Severe
Body System              N*          (%)**       N*       (%)**        N*      (%)**
Cardiovascular
Myocardial
Infarction
Increased Blood
Pressure
etc.

Genitourinary
Yeast Infection
Vaginal Bleeding
etc.

Gastrointestinal



etc…


Site may need to aggregate adverse events if coding is not available.

* N- number of participants experienced AE (participant is to be counted only once for
each AE)
**% of total number of participants enrolled
[Trial Name], [Principal Investigator] [Institution]
[Grant/Contract No.]

Data as of:__________________
Date of report________________

                 Table ___: Adverse Events Summary


                                            Total Number of Enrolled
                                            (N= )

Body System                         N*        (%)**    Events***    (%)****
Cardiovascular
          Myocardial Infarction
     Increased Blood Pressure
                           etc.

Genitourinary
               Yeast Infection
              Vaginal Bleeding
                          etc.

Gastrointesitnal


etc.




Site may need to aggregate adverse events if coding is not available.

* N - number of participants experienced AE (participant is to be counted only once for each AE)
** % of total number of participants enrolled
*** - number of events
**** % of total events
[Trial Name], [Principal Investigator] [Institution]
[Grant/Contract No.]

Data as of:__________________

Date of report________________

                                   Listing________: Adverse Events-Details


                                                                                              Participant
                                                                           Relationship      Discontinued
Participant Treatment                         Adverse     AE                    to               from
     ID      Duration       Age     Gender     Event    Duration Severity* Treatment**        Treatment?




* NIAMS recommend using the following terms: Mild, Moderate, Severe
** NIAMS recommend using the following terms: Definitely, Probably, Possibly, Not Related.
[Trial Name], [Principal Investigator] [Institution]
[Grant/Contract No.]

Data as of:__________________
Date of report________________

                                       Listing________: Serious Adverse Events



                             Serious                                     SAE
Participant                  Adverse        Treatment    Treatment      Onset    SAE Stop Relationship
     ID        Age    Gender  Event         Onset Date   Stop Date      Date       Date   to Treatment* Outcome**




*NIAMS recommend using the following terms: Definitely, Probably, Possibly, Not Related.
**Outcome:
       Recovered, without treatment
       Recovered, with treatment
       Still Present, no treatment
       Still Present, being treated
       Residual effect(s) present-no treatment
       Residual effect(s) present-being treated
       Subject died
[Trial Name], [Principal Investigator] [Institution]
[Grant/Contract No.]

Data as of:__________________

Date of report________________

                                                       Listing________: Death


                                     Treatment      Date        Date of   Treatment     Treatment   Cause of   Related to
Patient ID    Gender       Age         Group       Enrolled     Death     Onset Date    Stop Date    Death     Treatment*




* NIAMS recommend using the following terms: Definitely, Probably, Possibly, Not Related.

								
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