CTRP_Registry_Proprietary_Trial_Template

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CTRP_Registry_Proprietary_Trial_Template Powered By Docstoc
					CTRP Proprietary Trial Registration Data file (valid as for release 3.2)

I. Getting ready to send the batch file
1. Prepare data file
2. Email to CTRO at ncictro@mail.nih.gov

Note: your file will be processed by CTRO staff.
CTRO will register your trials using batch file data and as a submitter of trials will hold these trials ownersh
In order to transfer trials ownership you must include first, last name and email address of the person who
Please note, that transfer of ownership will only be enabled to the registered users.


II. Instructions for preparing the trial data file
1. The trial elements required for registration should be listed in the order specified in this document.
2. Each trial should be uniquely identified.
3. If trial NCT number exists and is provided, primary purpose, phase, disease and intervention data are n
4. If a trial is identified as a duplicate to an existing trial, you can request to add your organization
information to the existing trial as a participating site using the same record
or create a separate request using Participating Sites Template for proprietary trials and email to CTRO a
5. If more than one disease or intervention is included, list them on additional lines,
one per line when adding local trial identifier to the first column (see Sample Trial Data tab).

Trial categories in CTRP based on protocol document availability

Proprietary Trial - a trial with a contractual obligation that restricts sharing of the protocol document.
Non-proprietary Trial - a trial with no contractual obligation that restricts sharing of the protocol documen


New in 3.2 release
1. Specification can be used for updating registered trials.
Only NCI trials identifier, submission type and updated elements need to be provided for an updated reco
2. Site target accrual is added to the submission list
3. Person or Organization PO-ID can be provided in lieu of person or organization mandatory attributes.
d these trials ownership.
 ss of the person who will manage your registered trials.




 this document.

 tervention data are not required.
  organization

and email to CTRO at ncictro@mail.nih.gov.

ata tab).



otocol document.
 he protocol document.




 for an updated record.

andatory attributes.
Trial    Trial data element                                Required?
elements
Order
1        Local Trial Identifier                            Yes



2        Submission Type                                   Yes




3        NCI Trial Identifier                              Yes for submitting update
                                                           only
4        [Submitting Organization] Organization PO-ID


5        [Submitting Organization] Name                    Yes if PO-ID is not
                                                           provided
6        [Submitting Organization] Street Address          Yes if PO-ID is not
                                                           provided
7        [Submitting Organization] City                    Yes if PO-ID is not
                                                           provided
8        [Submitting Organization] State/Province          Yes for
                                                           US/Canada/Australia and if
                                                           PO-ID is not provided

9        [Submitting Organization] Zip/Postal code         Yes if PO-ID is not
                                                           provided
10       [Submitting Organization] Country                 Yes if PO-ID is not
                                                           provided
11       [Submitting Organization] Email Address           Yes if PO-ID is not
                                                           provided
12       [Submitting Organization] Phone


13       [Submitting Organization] TTY
14       [Submitting Organization] FAX
15       [Submitting Organization] URL
16       [Submitting Organization] Organization Type




17       Is Submitting Organization a NCI Designated Cancer Yes
         Center?
18       [Lead Organization] CTEP Organization PO-ID


19       [Lead Organization] Name                          Yes if PO-ID is not
                                                           provided
20   [Lead Organization] Street Address      Yes if PO-ID is not
                                             provided
21   [Lead Organization] City                Yes if PO-ID is not
                                             provided
22   [Lead Organization] State/Province      Yes for
                                             US/Canada/Australia and if
                                             PO-ID is not provided

23   [Lead Organization] Zip/Postal code     Yes if PO-ID is not
                                             provided
24   [Lead Organization] Country             Yes if PO-ID is not
                                             provided
25   [Lead Organization] Email Address       Yes if PO-ID is not
                                             provided
26   [Lead Organization] Phone


27   [Lead Organization] TTY
28   [Lead Organization] FAX
29   [Lead Organization] URL
30   [Lead Organization] Organization Type




31   Lead Organization Trial Identifier      Yes


32   NCT Trial Identifier




33   Title                                   Yes

34   Trial Type                              Yes


35   Primary Purpose                         Yes, if NCT number is not
                                             provided




36   Phase                                   Yes, if NCT number is not
                                             provided
37   [Site Principal Investigator] Person PO-ID


38   [Site Principal Investigator] First Name          Yes if PO-ID is not
                                                       provided
39   [Site Principal Investigator] Middle Name

40   [Site Principal Investigator] Last Name           Yes if PO-ID is not
                                                       provided
41   [Site Principal Investigator] Street Address      Yes if PO-ID is not
                                                       provided
42   [Site Principal Investigator] City                Yes if PO-ID is not
                                                       provided
43   [Site Principal Investigator] State/Province      Yes for
                                                       US/Canada/Australia and if
                                                       PO-ID is not provided

44   [Site Principal Investigator] Zip/Postal code     Yes if PO-ID is not
                                                       provided

45   [Site Principal Investigator] Country             Yes if PO-ID is not
                                                       provided

46   [Site Principal Investigator] Email Address       Yes if PO-ID is not
                                                       provided

47   [Site Principal Investigator] Phone               Yes if PO-ID is not
                                                       provided

48   [Site Principal Investigator] TTY

49   Site [Principal Investigator] FAX

50   [Site Principal Investigator] URL
51   Summary 4 Funding Category                        Yes for NCI designated
                                                       cancer center


52   [Summary 4 Funding Sponsor/Source] Organization
     PO-ID




53   [Summary 4 Funding Sponsor/Source] Organization   Yes for NCI designated
     Name                                              cancer center and if PO-ID
                                                       is not provided
54   [Summary 4 Funding Sponsor/Source] Street         Yes for NCI designated
     Address                                           cancer center and if PO-ID
                                                       is not provided
55   [Summary 4 Funding Sponsor/Source] City         Yes for NCI designated
                                                     cancer center and if PO-ID
                                                     is not provided
56   [Summary 4 Funding Sponsor/Source]              Yes for NCI designated
     State/Province                                  cancer center, if country is
                                                     USA, Canada or Australia
                                                     and if PO-ID is not
                                                     provided
57   [Summary 4 Funding Sponsor/Source] Zip/Postal   Yes for NCI designated
     code                                            cancer center and if PO-ID
                                                     is not provided
58   [Summary 4 Funding Sponsor/Source ] Country     Yes for NCI designated
                                                     cancer center and if PO-ID
                                                     is not provided
59   [Summary 4 Funding Sponsor/Source ] Email       Yes for NCI designated
     Address                                         cancer center and if PO-ID
                                                     is not provided
60   [Summary 4 Funding Sponsor/Source ] Phone
61   [Summary 4 Funding Sponsor/Source ] TTY
62   [Summary 4 Funding Sponsor/Source ] FAX
63   [Summary 4 Funding Sponsor/Source ] URL
64   [Submitting Site specific] Program Code         Yes for NCI designated
                                                     cancer center and if PO-ID
                                                     is not provided

65   Site Recruitment Status                         Yes




66   Site Recruitment Status Date                    Yes

67   Date Opened for Accrual                         Yes if study is or was
                                                     opened for accrual

68   Date Closed for Accrual                         Yes if study is or was
                                                     closed for accrual
69   Site Target Accrual                             Yes for NCI designated
                                                     Cancer Center

70   Disease Name                                    Yes if NCT number is not
                                                     provided




71   Disease Lead Indicator                          Yes if NCT number is not
                                                     provided
72   Intervention Type           Yes if NCT number is not
                                 provided




73   Intervention Name           Yes if NCT number is not
                                 provided



74   Trial Owner First Name      Yes




75   Trial Owner Last Name       Yes




76   Trial Owner Email Address   Yes
Valid Values                   Comments                       Definition



                               Trial identifier as assigned
                               by the submitting
                               organization

O, U                           O- Original is default. U-     Original submission is the first time
                               update                         submission of a trial to CTRP. Update
                                                              means submitting an update to the already
                                                              registered trial in CTRP.
                               Ignored in case of original
                               submission
                               PO-ID or all organization
                               mandatory attributes are
                               required




2-letter state/province code
required for US/Canada, 2-3
letter code required for
Australia




                               Include Phone Extension if
                               any in the same field




Institution, ordering group,
repository, research based,
cooperative group, cancer
center, consortium, drug
company, network
yes, no                        no is default

                               PO-ID or all organization
                               mandatory attributes is
                               required
2-letter state/province code
required for US/Canada, 2-3
letter code required for
Australia




                                          Include Phone Extension if
                                          any in the same field




Institution, ordering group,
repository, research based,
cooperative group, cancer
center, consortium, drug
company, network
                                          AS IS in the protocol
                                          document & assigned by
                                          the lead organization
                                          This value or at least one
                                          disease and one
                                          intervention record are
                                          required in attached
                                          proprietary trial template

Max 4000 characters                       Title from the protocol
                                          document
Interventional, Observational             Currently only
                                          Interventional trials are
                                          accepted
Treatment, Prevention,                    Mandatory if value in row
Supportive Care, Screening,               32 is NULL (if NCT number
Early Detection, Diagnostic,              is NULL)
Epidemiologic, Outcome,
Observational, Ancillary,
Correlative, Health Service
Research, Other, Basic
Science
0, I, I/II, II, II/III, III, IV, Pilot,   Mandatory if value in row
N/A, Other                                32 is NULL (if NCT number
                                          is NULL)
                               PO-ID or all mandatory
                               person attributes are
                               required




2-letter state/province code
required for US/Canada, 2-3
letter code required for
Australia




                               Include Phone Extension if
                               any in the same field




National, Externally Peer-     Mandatory if value in row
Reviewed, Institutional,       17 is 'yes' (for NCI
Industrial                     designated cancer centers)

                               Mandatory if value in row
                               17 is 'yes' (for NCI
                               designated cancer
                               centers). PO-ID or all
                               organization mandatory
                               attributes is required,
2-letter state/province code
required for US/Canada, 2-3
letter code required for
Australia




Submitting Site specific           Submitting Site specific,
                                   'Not specified' is default.
                                   Mandatory if value in row
                                   17 is 'yes'.
Not yet recruiting; Recruiting;
Enrolling by invitation; Active,
not recruiting; Completed;
Suspended; Terminated;
Withdrawn

                                   Date when the recruitment
                                   status has come in effect




                                   Mandatory if value in row
                                   17 is 'yes'. '0' can be used
                                   if value is unknown
                                   If more that one disease is
                                   provided, use the additional
                                   line for a new disease (see
                                   Trial Data Sample)

Yes, No                            If more that one disease is
                                   provided, use the additional
                                   line for a new disease (see
                                   Trial Data Sample)
Drug, Device,                   If more that one
Biological/Vaccine,             intervention is provided,
Procedure/Surgery, Radiation,   use the additional line for
Behavioral, Genetic, Dietary    an additional intervention
Supplement, Other               (see Trial Data Sample)

                                If more that one
                                intervention is provided,
                                use the additional line for
                                an additional intervention
                                (see Trial Data Sample)
                                This information is required
                                for trial ownership transfer.
                                Note: user must be
                                registered in CTRP

                                This information is required
                                for trial ownership transfer.
                                Note: user must be
                                registered in CTRP

                                This information is required
                                for trial ownership transfer.
                                Note: user must be
                                registered in CTRP
           A           B              C          D             E                 F           G
    Local Trial   Submission   NCI Trial    [Submitting   [Submitting     [Submitting   [Submitting
    Identifier    Type         Identifier   Organization] Organization]   Organization] Organization]
                                            Organization Name             Street        City
                                            PO-ID                         Address

1
    1             O                                       Mayo Clinic     5777 East     Phoeniz
                                                          Hospital        Mayo
                                                                          Boulevard




2
    1

3
4
                   H                  I             J              K               L
    [Submitting Organization]   [Submitting   [Submitting   [Submitting      [Submitting
    State/Province              Organization] Organization] Organization]    Organization]
                                Zip/Postal    Country       Email Address    Phone
                                code

1
    AZ                          85054        United States ncictepcoppaser
                                                           vices@mail.nih.
                                                           gov




2


3
4
           M                  N              O                  P                Q
    [Submitting     [Submitting         [Submitting   [Submitting         Is Submitting
    Organization]   Organization] FAX   Organization] Organization]       Organization a
    TTY                                 URL           Organization Type   NCI Designated
                                                                          Cancer Center?

1
                                                     Research Based       Yes




2


3
4
           R                       S                      T                    U
    [Lead            [Lead Organization] Name   [Lead Organization]   [Lead Organization]
    Organization]                               Street Address        City
    CTEP
    Organization PO-
    ID
1
    12345




2


3
4
           V                     W               X             Y             Z            AA
    [Lead            [Lead Organization]   [Lead         [Lead         [Lead         [Lead
    Organization]    Zip/Postal code       Organization] Organization] Organization] Organization]
    State/Province                         Country       Email         Phone         TTY
                                                         Address

1




2


3
4
          AB             AC            AD                AE               AF
    [Lead         [Lead           [Lead         Lead Organization NCT Trial
    Organization] Organization]   Organization] Trial Identifier  Identifier
    FAX           URL             Organization
                                  Type

1
                                  cancer center




2


3
4
                  AG                      AH          AI          AJ         AK              AL
    Title                           Trial Type   Primary      Phase    [Site           [Site
                                                 Purpose               Principal       Principal
                                                                       Investigator]   Investigator]
                                                                       Person PO-      First Name
                                                                       ID
1
    Phase III study of priming with  Intervention Treatment   III                      Harry
    granulocyte-macrophage colony al
    stimulating factor (rhu-gm-
    csf)and of three induction
    regimens in adult patients (over
    55) with acute non-lymphocytic
    leukemia
2


3
4
                AM               AN              AO              AP              AQ              AR            AS
    [Site Principal        [Site           [Site           [Site           [Site           [Site         [Site Principal
    Investigator] Middle   Principal       Principal       Principal       Principal       Principal     Investigator]
    Name                   Investigator]   Investigator]   Investigator]   Investigator]   Investigator] Country
                           Last Name       Street          City            State/Provin    Zip/Postal
                                           Address                         ce              code
1
                           Long            5777 East       Phoeniz         AZ              85054         United States
                                           Mayo
                                           Boulevard




2


3
4
               AT               AU              AV                  AW                AX
    [Site Principal       [Site Principal [Site Principal Site [Principal   [Site Principal
    Investigator] Email   Investigator] Investigator] Investigator] FAX     Investigator] URL
    Address               Phone           TTY


1
    Harry.Long@mayo.or
    g




2


3
4
         AY           AZ             BA              BB             BC          BD               BE
    Summary 4    [Summary 4     [Summary 4     [Summary 4     [Summary 4   [Summary 4      [Summary 4
    Funding      Funding        Funding        Funding        Funding      Funding         Funding
    Category     Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour Sponsor/Sour    Sponsor/Sour
                 ce]            ce]            ce] Street     ce] City     ce]             ce] Zip/Postal
                 Organization   Organization   Address                     State/Provinc   code
1                PO-ID          Name                                       e
    Industrial                  Novartis       One Health     East Hanover NJ              07936-1080
                                Pharmaceutic   Plaza
                                als
                                Corporation



2


3
4
          BF             BG             BH             BI             BJ             BK             BL
    [Summary 4     [Summary 4     [Summary 4     [Summary 4     [Summary 4     [Summary 4     [Submitting
    Funding        Funding        Funding        Funding        Funding        Funding        Site specific]
    Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Program
    ce ] Country   ce ] Email     ce ] Phone     ce ] TTY       ce ] FAX       ce ] URL       Code
                   Address
1
    United States ncictepcoppa
                  services@ma
                  il.nih.gov




2


3
4
         BM            BN             BO          BP            BQ           BR             BS
    Site          Site          Date Opened Date Closed   Site Target   Disease       Disease Lead
    Recruitment   Recruitment   for Accrual for Accrual   Accrual       Name          Indicator
    Status        Status Date


1
    Active        03/01/2009    03/01/2009                50            acute non-    Yes
                                                                        lymphocytic
                                                                        leukemia




2
                                                                        stage III non- No
                                                                        lymphocytic
3                                                                       leukemia
4
          BT             BU             BV            BW            BX      BY   BZ
    Intervention   Intervention   Trial Owner   Trial Owner   Trial Owner
    Type           Name           First Name    Last Name     Email
                                                              Address


1
    Biological/Va granulocyte- Mary             Smith         m.smith@ma
    ccine         macrophage                                  yo.org
                  colony
                  stimulating
                  factor


2


3
4
    CA   CB   CC   CD   CE   CF   CG




1




2


3
4
    CH   CI   CJ   CK   CL   CM   CN




1




2


3
4
    CO   CP   CQ   CR   CS   CT   CU




1




2


3
4
    CV   CW   CX   CY   CZ   DA   DB




1




2


3
4
    DC   DD   DE   DF   DG   DH   DI




1




2


3
4
    DJ   DK   DL   DM   DN   DO   DP




1




2


3
4
    DQ   DR   DS   DT   DU   DV   DW




1




2


3
4
    DX   DY   DZ   EA   EB   EC   ED




1




2


3
4
    EE   EF   EG   EH   EI   EJ   EK




1




2


3
4
    EL   EM   EN   EO   EP   EQ   ER




1




2


3
4
    ES   ET   EU   EV   EW   EX   EY




1




2


3
4
    EZ   FA   FB   FC   FD   FE   FF




1




2


3
4
    FG   FH   FI   FJ   FK   FL   FM




1




2


3
4
    FN   FO   FP   FQ   FR   FS   FT




1




2


3
4
    FU   FV   FW   FX




1




2


3
4
Country         Country 3-letter code State/Province
UNITED STATES   USA
                                      Alabama
                                      Alaska
                                      Arizona
                                      Arkansas
                                      California
                                      Colorado
                                      Connecticut
                                      Delaware
                                      Florida
                                      Georgia
                                      Hawaii
                                      Idaho
                                      Illinois
                                      Indiana
                                      Iowa
                                      Kansas
                                      Kentucky
                                      Louisiana
                                      Maine
                                      Maryland
                                      Massachusetts
                                      Michigan
                                      Minnesota
                                      Mississippi
                                      Missouri
                                      Montana
                                      Nebraska
                                      Nevada
                                      New Hampshire
                                      New Jersey
                                      New Mexico
                                      New York
                                      North Carolina
                                      North Dakota
                                      Ohio
                                      Oklahoma
                                      Oregon
                                      Pennsylvania
                                      Rhode Island
                                      South Carolina
                                      South Dakota
                                      Tennessee
                                      Texas
                                      Utah
                                      Vermont
                                      Virginia
                                      Washington
                                      West Virginia
                                      Wisconsin
                                      Wyoming
CANADA    CAN
                Alberta
                British Columbia
                Manitoba
                New Brunswick
                Newfoundland and Labrador
                Northwest Territories
                Nova Scotia
                Nunavut
                Ontario
                Prince Edward Island
                Quebec
                Saskatchewan
                Yukon
AUSTRIA   AUT
                Australian Capital Territory
                New South Wales
                Northern Territory
                Queensland
                South Australia
                Tasmania
                Victoria
                Western Australia
2-3 letter state/province code   Old values

AL
AK
AZ
AR
CA
CO
CT
DE
FL
GA
HI
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
NE
NV
NH
NJ
NM
NY
NC
ND
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VT
VA
WA
WV
WI
WY
AB
BC
MB
NB
NL
NT
NS
NU
ON
PE
QC
SK
YT

ACT
NSW
NT
QLD
SA
TAS
VIC
WA

				
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