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TRIAL SUMMARY DATASET — TS

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					                TRIAL SUMMARY DATASET — TS
ts.xpt, Trial Summary — Trial Design, Version 3.1.2.One record per trial summary parameter value
                                    Controlled
  Variable
              Variable Label Type Terms, Codelist        Role                            CDISC Notes                              Core
   Name
                                    or Format
STUDYID       Study        Char                       Identifier Unique identifier for a study.                                   Req
              Identifier
DOMAIN        Domain       Char TS  2006H             Identifier Two-character abbreviation for the domain.                       Req
              Abbreviation
TSSEQ         Sequence     Num                         Identifier Sequence number given to ensure uniqueness within a             Req
              Number                                              dataset. Allows inclusion of multiple records for the same
                                                                  TSPARMCD, and can be used to join related records.
TSGRPID        Group ID       Char                     Identifier Used to tie together a group of related records                 Perm
TSPARMCD Trial                Char TSPARMCD
                                    1384H
                                                       Topic      TSPARMCD (the companion to TSPARM) is limited to 8              Req
               Summary                                            characters and does not have special character restrictions.
               Parameter                                          These values should be short for ease of use in programming,
               Short Name                                         but it is not expected that TSPARMCD will need to serve as
                                                                  variable names. Examples: AGEMIN, AGEMAX
TSPARM         Trial          Char   TSPARM
                                    1385H
                                                       Synonym Term for the Trial Summary Parameter. The value in                 Req
               Summary                                 Qualifier TSPARM cannot be longer than 40 characters. Examples
               Parameter                                          Planned Minimum Age of Subjects, Planned Maximum Age
                                                                  of Subjects
TSVAL          Parameter      Char *                   Result     Value of TSPARM. Example: ―ASTHMA‖ when TSPARM                  Req
               Value                                   Qualifier value is ―Trial Indication‖. TSVAL cannot be null – a value is
                                                                  required for the record to be valid. Text over 200 characters
                                                                  can be added to additional columns TSVAL1-TSVALn.
TSVALNF Parameter             Char NULLFLAVOR Result              Null flavor for the value of TSPARM, to be populated if and     Perm
               Null Flavor                             Qualifier only if TSVAL is null.
TSVALCD Parameter             Char *                   Result     This is the code of the term in TSVALCD. For example;           Exp
               Value Code                              Qualifier 6CW7F3G59X is the code for Gabapentin, C49488 is the
                                                                  code for Y.
TSVCDREF Name of the Char                              Result     The name of the Reference Terminology from which                Exp
               Reference                               Qualifier TSVALCD is taken. For example; CDISC, SNOMED, ISO
               Terminology                                        8601.
TSVCDVER Version of the Char                           Result     The version number of the Reference Terminology, if             Exp
               Reference                               Qualifier applicable.
               Terminology
 * Indicates variable may be subject to controlled terminology, (Parenthesis indicates CDISC/NCI codelist code value)
               ASSUMPTIONS FOR TRIAL SUMMARY DATASET MODEL
Note: the assumptions below are in addition to the original 10 assumptions that have been published in SDTMIG V3.1.2.
 11. The randomization ratio is the number of planned subjects to be exposed to investigational therapy divided by the number of planned subjects NOT to be
      exposed to investigational therapy, then the value is always a single number for parallel design. There are cases where the ratio is infinite. e.g. crossover
      study or open label study where all are exposed to investigational therapy. This parameter is only expected when INTMODEL is ―PARALLEL‖ and there is only
      one investigational treatment.
 12. Not all protocols describe objectives in a way that specifically designates each objective as ―primary‖ or ―secondary.‖ If the protocol does not provide
     information about which objectives meet the definition of TSPARM=OBJPRIM (i.e., ―The principle purpose of the trial‖), then all objectives should be given
     as values of TSPARM=OBJPRIM. The Trial Summary Parameter ―Trial Secondary Objective‖ is defined as ―The auxiliary purpose of the trial.‖ A protocol
     may use multiple designations for objectives that are not primary (E.g., Secondary, Tertiary, and Exploratory), but all these non-primary objectives should be
     given as values of TSPARM=OBJSEC.
 13. If a primary objective is assessed by means of multiple outcome measures, then all of these outcome measures should be provided as values of TSPARM=OUTMSPR.
      Similarly, all outcome measures used to assess secondary objectives should be provided as values of TSPARM=OUTMSSEC.
 14. There is no code value for TSVALCD when TSVAL is numeric or text, for example; when TSPARMCD = PLANSUB or TSPARMD = TITLE.
 15. The number of planned subjects to be exposed to investigational therapy divided by the total number of planned subjects. The value is between zero and one.
     Zero means no subjects were planned to be exposed to investigational treatment and one means all subjects were planned to be exposed to investigational
     treatment.
 16. Trial Indication: A clinical pharmacology study on healthy volunteers, whose sole purpose is to collect pharmacokinetic data would have no trial indication,
     so TSVAL would be null and TSVALNF would be NA. A vaccine study on healthy subjects, whose intended purpose is to prevent influenza infection, would
     have INDIC=Influenza. If the trial is to treat diagnosis or prevent a disease, then INDIC is expected.
 17. TSVALNF contains a ―null flavor,‖ a value that provides additional coded information when TSVAL is null. For example, for TSPARM = MAXAGE, there
     is no value if a study does not specify a maximum age. In this case, the appropriate null flavor is PINF, which stands for positive infinity. In a clinical
     pharmacology study conducted in healthy volunteers for a drug which may indications are not yet established, the appropriate null flavor for TINDC would
     be NA, which stands for not applicable. TSVALNF can also be used in a case where the value of a particular parameter is unknown.


               EXAMPLES FOR TRIAL SUMMARY DATASET MODEL
Example 1:
This example shows all of the parameters that are required or expected in the Trial Summary dataset.
 Use controlled terminology for TSVAL (NCI EVS Terminology Resources (access to CDISC, FDA and other terminology)   1391




 Note: For this review only there is a row between the current approved (maintained on NCI EVS) parameters and the new ones. Controlled terminology for the
                   yellow shaded boxes was released for public review on 22 July 2011. For the final release approved terms will be added.

Row   STUDYID     DOMAIN       TSSEQ    TDGRPID      TSPARMCD             TSPARM                 TSVAL           TSVALNF     TSVALCD       TSVCDREF       TSVCDVER
 1                                                                   Added on to Existing
        XYZ           TS          1                     ADDON                                       Y                         C49488          CDISC           2011-06-10
                                                                          Treatments
 2                                                                    Planned Maximum
        XYZ           TS          1                    AGEMAX                                     P70Y                                       ISO 8601
                                                                        Age of Subjects
 3                                                                    Planned Minimum
        XYZ           TS          1                    AGEMIN                                     P18M                                       ISO 8601
                                                                        Age of Subjects
 4      XYZ           TS          1                    LENGTH        Planned Trial Length          P3M                                       ISO 8601
 5                                                                    Planned Number of
        XYZ           TS          1                    PLANSUB                                     300
                                                                            Subjects
 6      XYZ           TS          1                    RANDOM        Trial is Randomized              Y                       C49488          CDISC           2011-06-10
 7      XYZ           TS          1                     SEXPOP        Sex of Participants          BOTH                       C49636          CDISC           2011-06-10
 8                                                                                            Interim Analysis
        XYZ           TS          1                   STOPRULE         Study Stop Rules
                                                                                                 for Futility
9       XYZ           TS          1                    TBLIND        Trial Blinding Schema   DOUBLE BLIND                     C15228          CDISC           2011-06-10
10      XYZ           TS          1                    TCNTRL             Control Type          PLACEBO                       C49648          CDISC           2011-06-10
11                                                                                           Neurofibromatosis
        XYZ           TS          1                     TDIGRP         Diagnosis Group           Syndrome                     19133005       SNOMED
                                                                                                 (Disorder)
12      XYZ           TS          1                     TINDTP       Trial Indication Type    TREATMENT                       C49656          CDISC           2011-06-10
13                                                                 A 24 Week Study
                                                                         of Oral
                                                                    Gabapentin vs.
                                                                   Placebo as add-on
       XYZ            TS   1    TITLE           Trial Title           treatment to
                                                                      phenytoin in
                                                                     Subjects with
                                                                    Epilepsy due to
                                                                   Neurofibromatosis
14                                             Trial Phase
       XYZ            TS   1    TPHASE                               Phase II Trial      C15601     CDISC    2011-06-10
                                              Classification
15     XYZ            TS   1    TTYPE          Trial Type             EFFICACY           C49666     CDISC    2011-06-10
16     XYZ            TS   2    TTYPE          Trial Type              SAFETY            C49667     CDISC    2011-06-10
17                                                                                     6158TKW0
                                           Current Therapy or
       XYZ            TS   1   CURTRT                                 Phenytoin            C5        UNII
                                               Treatment
18                                                                  Reduction in the
                                              Trial Primary         3-month seizure
       XYZ            TS   1   OBJPRIM
                                               Objective            frequency from
                                                                         baseline
19                                                                 Percent reduction
                                             Trial Secondary         in the 3-month
       XYZ            TS   1    OBJSEC
                                                Objective          seizure frequency
                                                                      from baseline
20                                                                  Reduction in the
                                                                    3-month tonic-
                                             Trial Secondary
       XYZ            TS   2    OBJSEC                                clonic seizure
                                                Objective
                                                                    frequency from
                                                                         baseline
21     XYZ            TS   1   SPONSOR    Clinical Study Sponsor        Pharmaco        1234567      DUNS
22                                                                    Tonic-Clonic
       XYZ            TS   1    INDIC        Trial Indication            Epilepsy      352818000    SNOMED
                                                                        (Disorder)
23                                           Investigational                           6CW7F3G59
       XYZ            TS   1     TRT                                  Gabapentin                     UNII
                                          Therapy or Treatment                            X
     New Parameters
24                                           Randomization
       XYZ            TS   1   RANDQT                                    0.67
                                                 Quotient
25     XYZ            TS   1   STRATFCT    Stratification Factor         SEX
26                                                                                     NCT1234567
       XYZ            TS   1    REGID       Registry Identifier     NCT123456789                    CT.GOV
                                                                                           89
27     XYZ            TS   2    REGID       Registry Identifier      XXYYZZ456         XXYYZZ456    EUDRAC
28                                          Primary Outcome
       XYZ            TS   1   OUTMSPRI                            Seizure Frequency
                                                Measure
29                                          Secondary Outcome
     XYZ   TS   1               OUTMSSEC                             Seizure Frequency
                                                  Measure
30                                          Secondary Outcome
     XYZ   TS   2               OUTMSSEC                             Seizure Duration
                                                  Measure
31                                         Exploratory Outcome
     XYZ   TS   1               OUTMSEXP                             Seizure Intensity
                                                  Measure
32                                         Pharmacological Class
                                                                       Anti-epileptic
     XYZ   TS   1                PCLAS       of Investigational                          N0000175753   NDF-RT
                                                                          Agent
                                                  Therapy
33                                          Planned Country of
     XYZ   TS   1                FCNTRY                                    USA              USA        ISO 3166
                                           Investigational Site(s)
34                                          Planned Country of
     XYZ   TS   2                FCNTRY                                    CAN              CAN        ISO 3166
                                           Investigational Site(s)
35                                          Planned Country of
     XYZ   TS   3                FCNTRY                                    MEX              MEX        ISO 3166
                                           Investigational Site(s)
36   XYZ   TS   1                ADAPT       Adaptive Design                N              C49487       CDISC     2011-06-10
37   XYZ   TS   1   DateDesc1   DCUTDTC      Data Cutoff Date           2011-04-01                     ISO 8601
38                  DateDesc1                   Data Cutoff
     XYZ   TS   1               DCUTDESC                              Database Lock
                                                Description
39   XYZ   TS   1               INTMODEL    Intervention Model         PARALLEL                        CDISC
40                                          Planned Number of
     XYZ   TS   1                NARMS                                       3
                                                   Arms
41                                                                   INTERVENTION
     XYZ   TS   1                STYPE          Study Type                                             CDISC
                                                                           AL
42   XYZ   TS   1               INTTYPE     Intervention Type             DRUG                          CDISC
43   XYZ   TS   1                SSTDTC      Study Start Date           2009-03-11                     ISO 8601
44   XYZ   TS   1               SENDTC       Study End Date             2011-04-01                     ISO 8601
45                                          Actual Number of
     XYZ   TS   1                ACTSUB                                     304
                                                 Subjects
46                                           Healthy Subject
     XYZ   TS   1               HLTSUBJI                                     N             C49487      CDISC      2011-06-10
                                                 Indicator
                                              Stable Disease
47   XYZ   TS   1               SDMDUR                                     P3W                         ISO 8601
                                           Minimum Duration
                                           Confirmed Response
48   XYZ   TS   1               CRMDUR                                     P28D                        ISO 8601
                                           Minimum Duration
 Example 2:
 This example shows an example of how to implement the null flavor in TSVALNF when the value in TSVAL is missing.

Row    STUDYID    DOMAIN       TSSEQ      TDGRPID      TSPARMCD            TSPARM                  TSVAL            TSVALNF         TSVALCD   TSVCDREF    TSVCDVER
                                                                       Planned Maximum
 1       XYZ         TS           1                       AGEMAX                                                        PINF                  ISO 21090
                                                                        Age of Subjects
                                                                           Trial Phase
 2       XYZ         TS           1                       TPHASE                                                         NA                   ISO 21090
                                                                          Classification

 3       XYZ         TS           1                       INTTYPE      Intervention Type                                OTH                   ISO 21090




 The Parameter table includes text to indicate if the parameter should be included in the dataset.
 The ―Use‖ column and designation has been requested by FDA. Most of the new parameters are coming from ct.gov and we are aligning controlled terminology
 with them. The notes column provides some additional information about the specific parameter.
 All definitions of the parameters are maintained in NCI EVE.


     TSPARMCD    TSPARM                    TSVAL (Codelist
                                                                      Use                                 Notes
                                           Name or Format)
                   Added on to Existing
      ADDON                                 No Yes Response         Required
                         Treatments
                  Planned Maximum Age
      AGEMAX                                    ISO 8601            Required     If there is no maximum age, TSVALNF = PINF
                         of Subjects
                 Planned Minimum Age of                             Required     If there is no minimum age, populate TSVAL with
      AGEMIN                                    ISO 8601
                           Subjects                                              P0Y
      LENGTH       Planned Trial Length         ISO 8601            Required
                    Planned Number of                               Required
     PLANSUB                                     number
                           Subjects
      RANDOM        Trial is Randomized     No Yes Response         Required
       SEXPOP       Sex of Participants     Sex of Participants     Required
                                                                    Required     Protocol-specified stopping rule. If there is no
     STOPRULE       Study Stop Rules               text
                                                                                 stopping rule record ―NONE‖ in this field.
                                              Trial Blinding        Required
      TBLIND      Trial Blinding Schema
                                                 Schema
      TCNTRL          Control Type            Control Type          Required
                                                                                       If the study population is healthy subjects (i.e. healthy
                                                                                       subjects flag is Y), this parameter is not expected. If
                                                                       Conditionally   the healthy subject flag is N then this parameter would
  TDIGRP             Diagnosis Group              SNOMED CT
                                                                         Required      contain the diagnosis/medical problem of the study
                                                                                       population. [Validation rule; IF healthy volunteers = N
                                                                                       then TDIGRP must be present and not null]

                                                                                       If study type is ―INTERVENTIONAL‖ this parameter
                                                                       Conditionally
  TINDTP           Trial Indication Type       Trial Indication Type                   is required. A study in healthy volunteers may have
                                                                         Required
                                                                                       TSVAL null and TSVALNF = NA.
   TITLE                 Trial Title                   text              Required      Use as many rows as needed.
  TPHASE         Trial Phase Classification        Trial Phase           Required
   TTYPE                 Trial Type                Trial Type            Required      Use as many rows as needed.
                                                 SRS Preferred                         Required when ADDON equals ―Y‖.
                    Current Therapy or                                 Conditionally
  CURTRT                                       Substance Name (or                      Use as many rows as needed for combination or
                        Treatment                                        Required
                                                 Device Name)                          multiple therapies.
 OBJPRIM          Trial Primary Objective              text              Required
                      Trial Secondary                                                  If applicable.
  OBJSEC                                               text              Expected
                         Objective                                                     Use as many rows as needed.
 SPONSOR          Clinical Study Sponsor              DUNS               Required
                                                                                       If applicable.
                  Comparative Treatment           SRS Preferred
 COMPTRT                                                                 Expected      Don’t include if there are no active comparators.
                         Name                    Substance Name
                                                                                       Use as many rows as needed.
                                                                                       If applicable.
                                                                                       Don’t include if the sole purpose is to collect PK data.
   INDIC              Trial Indication            SNOMED CT              Expected
                                                                                       See Assumption 16 above.
                                                                                       Use as many rows as needed.
                 Investigational Therapy                               Conditionally   If study type is ―INTERVENTIONAL‖ this parameter
    TRT                                               UNII
                        or Treatment                                     Required      is required.
Parameters below this line are the new ones.
                                                                       Conditionally   Required only when INTMODEL is ―PARALLEL‖
  RANDQT          Randomization Quotient             number
                                                                         Required      and there is only one investigational treatment.
                                                 Any allowable                         If applicable.
STRATFCT            Stratification Factor                                Expected
                                                  variable name                        Use as many rows as needed, one for each factor.
   REGID             Registry Identifier       CT.GOV / EUDRAC           Required      Use as many rows as needed, one for each registry ID
                     Primary Outcome
OUTMSPRI                                               text              Required      Use as many rows as needed.
                         Measure
                                                                                       If applicable, ie, if the trial has secondary outcome
                    Secondary Outcome
OUTMSSEC                                               text              Expected      measure.
                         Measure
                                                                                       Use as many rows as needed.
                   Exploratory Outcome                                                 If applicable, ie, if the trial has exploratory outcome
OUTMSEXP                                               text              Expected
                         Measure                                                       measure.
                                                                            Use as many rows as needed.
           Pharmacological Class of                         Conditionally   If study type is ―INTERVENTIONAL‖ this parameter
 PCLAS                                     NDF-RT
            Investigational Therapy                           Required      is required.
              Planned Country of
 FCNTRY                                ISO 3166-1 alpha-3     Required      Use as many rows as needed, one for each country
             Investigational Site(s)
                                                                            Does the protocol include any adaptive design
 ADAPT         Adaptive Design         No Yes Response        Required
                                                                            features?
                                                                            Use GRPID to associate the Data Cutoff Date to Data
DCUTDTC        Data Cutoff Date            ISO 8601           Required
                                                                            Cutoff Description.
                                                                            Use GRPID to associate the Data Cutoff Date to Data
DCUTDESC   Data Cutoff Description            text            Required
                                                                            Cutoff Description.
                                                            Conditionally   If study type is ―INTERVENTIONAL‖ this parameter
INTMODEL      Intervention Model       Intervention Model
                                                              Required      is required.
 NARMS     Planned Number of Arms           number            Required
 STYPE           Study Type               Study Type          Required
                                                            Conditionally   If study type is ―INTERVENTIONAL‖ this parameter
INTTYPE       Intervention Type        Intervention Type
                                                              Required      is required.
 SSTDTC       Study Start Date             ISO 8601           Required
 SENDTC        Study End Date              ISO 8601           Required
              Actual Number of
 ACTSUB                                     number            Required
                  Subjects
                                                                            If the study population is healthy subjects (i.e. healthy
                                                                            subjects flag is Y), this variable is not expected. If the
                                                                            healthy subject flag is N then this variable would
HLTSUBJI   Healthy Subject Indicator   No Yes Response        Required
                                                                            contain the diagnosis/medical problem of the study
                                                                            population. [Validation rule; IF healthy volunteers = N
                                                                            then TDIGRP must be present and not null]
           Stable Disease Minimum
SDMDUR                                     ISO 8601           Expected      If applicable.
                   Duration
             Confirmed Response
CRMDUR                                     ISO 8601           Expected      If applicable.
              Minimum Duration

				
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