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["CTRP Trial Registration Batch Upload Specification for Abbreviated Trials"]
[]
[]
[]
["About this Document"]
[]
["This document provides you with everything you need to upload clinical trial data to the CTRP Trial Registration system, including the following:"]
[]
["Template Instructions"]
[null,"The Template Instructions worksheet provides detailed instructions for preparing your data and uploading them to the system."]
[]
["Sample Trial Data"]
[null,"The Sample Trial Data worksheet provides an example of what a typical batch upload file looks like.  "]
[null,"Note: A batch upload file must contain only one (1) worksheet (tab)"]
[]
["Batch Upload Data Element Specifications"]
[null,"The specifications worksheet includes the following information:"]
[null,1,"Data elements"]
[null,2,"Order in which the data elements must be presented"]
[null,3,"Data element requirements. Requirements differ for original updated, and amended submissions."]
[null,4,"Valid values. The system accepts only those values listed in this document."]
[null,5,"Comments.  Additional information that helps you to ensure successful upload of your data."]
[]
["State and Provence Codes"]
[null,"The State and Province Codes worksheet lists the 2- or 3-letter state/province/territory codes for the United States, Canada, and Australia."]

{"sheet":"Template Instructions","index":2,"n_rows":48,"n_cols":4,"rows_kept":48,"cut":false,"hidden":false,"merged":[],"flags":["formulas_cached_only"]}
[]
["How to Submit Abbreviated Trial Data to the CTRP Trial Registration System"]
[]
["Before You Begin"]
[]
["Contact the CTRO at ncictro@mail.nih.gov to request approval for sending batch files to CTRP.  Include your login name, first and last names, and email address stored in your CTRP profile."]
["Note: Once you have received approval, you do not have to request approval for subsequent batches."]
[]
[]
["Main Steps for Uploading Your Data"]
[]
[1,"Prepare the trial data file"]
[2,"Email your files to the CTRO at ncictro@mail.nih.gov"]
[]
["Note: CTRO staff will register your trials using your batch file data. As the trial submitter, the CTRO maintains trial ownership by default. "]
["To transfer trial ownership email the CTRO with the first name, last name and email address of the person who will manage your registered trials. The new owner must be a registered CTRP account holder."]
[]
["Preparing Trial Data Files"]
[]
[1,"Ensure that your trial conforms to the supported criteria. This template supports the following:"]
[]
[null,"*","Interventional trials"]
[null,"*","Abbreviated trials (Summary 4 Funding Sponsor Category is Industrial)"]
[null,"*","Updates to abbreviated CTRP trials with the processing status \"Accepted\" and beyond "]
[null,"*","100 trials per data file"]
[]
[2,"Prepare an Excel spreadsheet (.xls) containing the mandatory and optional data for the trial(s) as specified in this document."]
[]
[null,"You must adhere to the following requirements:"]
[null,"* List trial elements required for registration in the order specified in the Abbreviated Trial Data Spec tab in this spreadsheet."]
[null,"* Do not change the spelling of data elements or valid values. Changes to spelling or to the order of the trial elements will cause the upload to fail. Similarly, the addition of new/extra trial elements will also cause a failure."]
[null,"* Conform to the valid values guidelines when entering trial data. Valid values for each of the trial elements, where applicable, are listed under Column D in the Abbreviated Trial Data Spec tab in this spreadsheet."]
[null,"* Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name."]
[null,"* If you provide an NCT number the primary purpose, phase, disease and intervention data are not required."]
[null,"* 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 template or create a separate request using the Participating Sites Template for abbreviated trials and email it to the CTRO at ncictro@mail.nih.gov. "]
[null,"* 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).   "]
[null,"* List persons and organizations with PO-IDs."]
[" ",null,null,"Note: You can request a list of CTRP persons and organizations along with  PO-IDs from the CTRO at ncictro@mail.nih.gov."]
[null,null,null,"Or, you can use the organization/person lookup features in the CTRP Trial Registration application to search for PO-IDs."]
[]
[]
["Emailing Your Files"]
[]
["Email your file as an attachment to the CTRO at ncictro@mail.nih.gov."]
[]
[]
["For detailed instructions for registering trials, refer to the NCI CTRP Reporting Program Registration Site User's Guide at:"]
[null,"https://wiki.nci.nih.gov/x/7qViAw"]

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["Local Trial Identifier","Submission Type","NCI Trial Identifier","[Submitting Organization] Organization PO-ID","[Submitting Organization] Name","[Submitting Organization] Street Address","[Submitting Organization] City ","[Submitting Organization] State/Province","[Submitting Organization] Zip/Postal code ","[Submitting Organization] Country","[Submitting Organization] Email Address","[Submitting Organization] Phone","[Submitting Organization] TTY","[Submitting Organization] FAX","[Submitting Organization] URL","[Submitting Organization] Organization Type","Is Submitting Organization a NCI Designated Cancer Center?","[Lead Organization] CTEP Organization PO-ID","[Lead Organization] Name","[Lead Organization] Street Address","[Lead Organization] City ","[Lead Organization] State/Province","[Lead Organization] Zip/Postal code ","[Lead Organization] Country","[Lead Organization] Email Address","[Lead Organization] Phone","[Lead Organization] TTY","[Lead Organization] FAX","[Lead Organization] URL","[Lead Organization] Organization Type","Lead Organization Trial Identifier","NCT Trial Identifier","Title","Trial Type","Primary Purpose","If Primary Purpose is 'Other',  describe","Phase","Pilot Trial?","[Site Principal Investigator] Person PO-ID","[Site Principal Investigator] First Name","[Site Principal Investigator] Middle Name","[Site Principal Investigator] Last Name","[Site Principal Investigator] Street Address","[Site Principal Investigator] City","[Site Principal Investigator] State/Province ","[Site Principal Investigator] Zip/Postal code","[Site Principal Investigator] Country","[Site Principal Investigator] Email Address","[Site Principal Investigator] Phone ","[Site Principal Investigator] TTY","Site [Principal Investigator] FAX","[Site Principal Investigator] URL","Summary 4 Funding Sponsor/Source Category","[Summary 4 Funding Sponsor/Source] Organization PO-ID","[Summary 4 Funding Sponsor/Source] Organization Name","[Summary 4 Funding Sponsor/Source] Street Address","[Summary 4 Funding Sponsor/Source] City ","[Summary 4 Funding Sponsor/Source] State/Province","[Summary 4 Funding Sponsor/Source] Zip/Postal code","[Summary 4 Funding Sponsor/Source ] Country","[Summary 4 Funding Sponsor/Source ] Email Address","[Summary 4 Funding Sponsor/Source ] Phone","[Summary 4 Funding Sponsor/Source ] TTY","[Summary 4 Funding Sponsor/Source ] FAX","[Summary 4 Funding Sponsor/Source ] URL","[Submitting Site specific] Program Code","Site Recruitment Status","Site Recruitment Status Date","Date Opened for Accrual","Date Closed for Accrual","Site Target Accrual ","Disease Name","Intervention Type","Intervention Name","Trial Owner First Name","Trial Owner Last Name","Trial Owner Email Address"]
[1,"O",null,null,"Mayo Clinic Hospital","5777 East Mayo Boulevard","Phoeniz","AZ",85054,"United States","ncictepcoppaservices@mail.nih.gov",{"$nulls":4},"Research Based","Yes",12345,{"$nulls":11},"cancer center",null,null,"Phase III study of priming with granulocyte-macrophage colony stimulating factor (rhu-gm-csf)and of three induction regimens in adult patients (over 55) with acute non-lymphocytic leukemia","Interventional","Other","Laboratory","III",null,null,"Harry",null,"Long","5777 East Mayo Boulevard","Phoeniz","AZ",85054,"United States","Harry.Long@mayo.org","123-345-7654",null,null,null,"Industrial",null,"Novartis Pharmaceuticals Corporation","One Health Plaza","East Hanover","NJ","07936-1080","United States","ncictepcoppaservices@mail.nih.gov",{"$nulls":5},"Active","03/01/2009","2009-03-01",null,50,"acute non-lymphocytic leukemia","Biological/Vaccine","granulocyte-macrophage colony stimulating factor","Mary","Smith","m.smith@mayo.org"]
[1,{"$nulls":70},"stage III non-lymphocytic leukemia"]

{"sheet":"Abbreviated Trial Data Spec ","index":4,"n_rows":78,"n_cols":6,"rows_kept":78,"cut":false,"hidden":false,"merged":[],"flags":["formulas_cached_only"]}
["Trial elements Order","Trial data element","Required?","Valid Values","Comments","Definition"]
[1,"Local Trial Identifier","Yes",null,"Trial identifier as assigned by the submitting organization "]
[2,"Submission Type","Yes","O, U","O- Original is default.  U-update","Original submission is the first time submission of  a trial to CTRP. Update means submitting an update to the already registered trial in CTRP."]
[3,"NCI Trial Identifier","Yes for submitting update only",null,"Ignored in case of original submission"]
[4,"[Submitting Organization] Organization PO-ID",null,null,"PO-ID or all organization  mandatory attributes are required"]
[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","2-letter state/province code required for US/Canada, 2-3 letter code required for Australia "]
[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",null,null,"Include Phone Extension if any in the same field"]
[13,"[Submitting Organization] TTY"]
[14,"[Submitting Organization] FAX"]
[15,"[Submitting Organization] URL"]
[16,"[Submitting Organization] Organization Type",null,"Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network"]
[17,"Is Submitting Organization a NCI Designated Cancer Center?","Yes","yes, no","no is default"]
[18,"[Lead Organization] CTEP Organization PO-ID",null,null,"PO-ID or all organization mandatory attributes is required"]
[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","2-letter state/province code required for US/Canada, 2-3 letter code required for Australia "]
[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","Yes if PO-ID is not provided",null,"Include Phone Extension if any in the same field"]
[27,"[Lead Organization] TTY"]
[28,"[Lead Organization] FAX"]
[29,"[Lead Organization] URL"]
[30,"[Lead Organization] Organization Type",null,"Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network"]
[31,"Lead Organization Trial Identifier","Yes",null,"AS IS in the protocol document & assigned by the lead organization"]
[32,"NCT Trial Identifier",null,null,"This value or at least one disease and one intervention record are required in attached proprietary trial template"]
[33,"Title","Yes","Max 4000  characters","Title from the protocol document"]
[34,"Trial Type","Yes ","Interventional, Observational","Currently only Interventional trials are accepted"]
[35,"Primary Purpose","Yes, if NCT number is not provided","Treatment, Prevention, Supportive Care, Screening, Diagnostic, Health Service Research, Basic Science, Other ","Mandatory if value in row 32 is NULL (if NCT number is NULL)"]
[36,"If Primary Purpose is 'Other',  describe","Yes, if Primary Purpose value is 'Other'",null,"Provide free text value if Primary Purpose value is  'Other'. Not aplicable if Primary Purpose is not 'Other'"]
[37,"Phase","Yes, if NCT number is not provided","0, I, I/II, II, II/III, III, IV, N/A","Mandatory if value in row 32 is NULL (if NCT number is NULL)"]
[38,"Pilot Trial?",null,"Yes, No","Only applicable if Phase is 'N/A; Default is No"]
[39,"[Site Principal Investigator] Person PO-ID",null,null,"PO-ID or all mandatory person attributes are required"]
[40,"[Site Principal Investigator] First Name","Yes if PO-ID is not provided"]
[41,"[Site Principal Investigator] Middle Name"]
[42,"[Site Principal Investigator] Last Name","Yes if PO-ID is not provided"]
[43,"[Site Principal Investigator] Street Address","Yes if PO-ID is not provided"]
[44,"[Site Principal Investigator] City","Yes if PO-ID is not provided"]
[45,"[Site Principal Investigator] State/Province ","Yes for US/Canada/Australia and if PO-ID is not provided","2-letter state/province code required for US/Canada, 2-3 letter code required for Australia "]
[46,"[Site Principal Investigator] Zip/Postal code","Yes if PO-ID is not provided"]
[47,"[Site Principal Investigator] Country","Yes if PO-ID is not provided"]
[48,"[Site Principal Investigator] Email Address","Yes if PO-ID is not provided"]
[49,"[Site Principal Investigator] Phone ","Yes if PO-ID is not provided",null,"Include Phone Extension if any in the same field"]
[50,"[Site Principal Investigator] TTY"]
[51,"Site [Principal Investigator] FAX"]
[52,"[Site Principal Investigator] URL"]
[53,"Summary 4 Funding Sponsor/Source Category","Yes ","Industrial "]
[54,"[Summary 4 Funding Sponsor/Source] Organization PO-ID","PO-ID or the rest of mandatory attribute for the organization is mandatory "]
[55,"[Summary 4 Funding Sponsor/Source] Organization Name","Yes if  PO-ID is not provided"]
[56,"[Summary 4 Funding Sponsor/Source] Street Address","Yes if  PO-ID is not provided"]
[57,"[Summary 4 Funding Sponsor/Source] City ","Yes if  PO-ID is not provided"]
[58,"[Summary 4 Funding Sponsor/Source] State/Province","Yes if  PO-ID is not provided and for the following  courtiers: USA, Canada and Australia","2-letter state/province code required for US/Canada, 2-3 letter code required for Australia "]
[59,"[Summary 4 Funding Sponsor/Source] Zip/Postal code","Yes if  PO-ID is not provided"]
[60,"[Summary 4 Funding Sponsor/Source ] Country","Yes if  PO-ID is not provided"]
[61,"[Summary 4 Funding Sponsor/Source ] Email Address","Yes if  PO-ID is not provided"]
[62,"[Summary 4 Funding Sponsor/Source ] Phone"]
[63,"[Summary 4 Funding Sponsor/Source ] TTY"]
[64,"[Summary 4 Funding Sponsor/Source ] FAX"]
[65,"[Summary 4 Funding Sponsor/Source ] URL"]
[66,"[Submitting Site specific] Program Code","Yes for NCI designated cancer center","Submitting Site specific","Submitting Site specific, 'Not specified' is default. Mandatory if value in row 17 is 'yes'."]
[67,"Site Recruitment Status","Yes","Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn"]
[68,"Site Recruitment Status Date","Yes",null,"Date when the recruitment status has come in effect"]
[69,"Date Opened for Accrual","Yes if study is or was opened for accrual"]
[70,"Date Closed for Accrual","Yes if study is or was closed for accrual"]
[71,"Site Target Accrual ","Yes for NCI designated Cancer Center",null,"Mandatory if value in row 17 is 'yes'. '0' can be used if value is unknown"]
[72,"Disease Name","Yes if NCT number is not provided",null,"If more that one disease is provided, use the additional line for a new disease (see Trial Data Sample)"]
[73,"Intervention Type","Yes if NCT number is not provided","Drug, Device, Biological/Vaccine, Procedure/Surgery, Radiation, Behavioral, Genetic, Dietary Supplement, Other","If more that one intervention is provided, use the additional line for an additional intervention (see Trial Data Sample)"]
[74,"Intervention Name","Yes if NCT number is not provided",null,"If more that one intervention is provided, use the additional line for an additional intervention (see Trial Data Sample)"]
[75,"Trial Owner First Name","Yes",null,"This information is required for trial ownership transfer. Note: user must be registered in CTRP"]
[76,"Trial Owner Last Name","Yes",null,"This information is required for trial ownership transfer. Note: user must be registered in CTRP"]
[77,"Trial Owner Email Address","Yes",null,"This information is required for trial ownership transfer. Note: user must be registered in CTRP"]

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["Country","Country 3-letter code","State/Province","2-3 letter state/province code","Old values"]
["UNITED STATES","USA"]
[null,null,"Alabama ","AL"]
[null,null,"Alaska ","AK"]
[null,null,"Arizona ","AZ"]
[null,null,"Arkansas ","AR"]
[null,null,"California ","CA"]
[null,null,"Colorado ","CO"]
[null,null,"Connecticut ","CT"]
[null,null,"Delaware ","DE"]
[null,null,"Florida ","FL"]
[null,null,"Georgia ","GA"]
[null,null,"Hawaii ","HI"]
[null,null,"Idaho ","ID"]
[null,null,"Illinois ","IL"]
[null,null,"Indiana ","IN"]
[null,null,"Iowa ","IA"]
[null,null,"Kansas ","KS"]
[null,null,"Kentucky ","KY"]
[null,null,"Louisiana ","LA"]
[null,null,"Maine ","ME"]
[null,null,"Maryland ","MD"]
[null,null,"Massachusetts ","MA"]
[null,null,"Michigan ","MI"]
[null,null,"Minnesota ","MN"]
[null,null,"Mississippi ","MS"]
[null,null,"Missouri ","MO"]
[null,null,"Montana ","MT"]
[null,null,"Nebraska ","NE"]
[null,null,"Nevada ","NV"]
[null,null,"New Hampshire ","NH"]
[null,null,"New Jersey ","NJ"]
[null,null,"New Mexico ","NM"]
[null,null,"New York ","NY"]
[null,null,"North Carolina ","NC"]
[null,null,"North Dakota ","ND"]
[null,null,"Ohio ","OH"]
[null,null,"Oklahoma ","OK"]
[null,null,"Oregon ","OR"]
[null,null,"Pennsylvania ","PA"]
[null,null,"Rhode Island ","RI"]
[null,null,"South Carolina ","SC"]
[null,null,"South Dakota ","SD"]
[null,null,"Tennessee ","TN"]
[null,null,"Texas ","TX"]
[null,null,"Utah ","UT"]
[null,null,"Vermont ","VT"]
[null,null,"Virginia ","VA"]
[null,null,"Washington  ","WA"]
[null,null,"West Virginia ","WV"]
[null,null,"Wisconsin  ","WI"]
[null,null,"Wyoming  ","WY"]
["CANADA","CAN"]
[null,null,"Alberta  ","AB"]
[null,null,"British Columbia ","BC"]
[null,null,"Manitoba ","MB"]
[null,null,"New Brunswick ","NB"]
[null,null,"Newfoundland and Labrador ","NL"]
[null,null,"Northwest Territories ","NT"]
[null,null,"Nova Scotia ","NS"]
[null,null,"Nunavut ","NU"]
[null,null,"Ontario ","ON"]
[null,null,"Prince Edward Island ","PE"]
[null,null,"Quebec ","QC"]
[null,null,"Saskatchewan ","SK"]
[null,null,"Yukon ","YT"]
["AUSTRIA","AUT"]
[null,null,"Australian Capital Territory","ACT"]
[null,null,"New South Wales","NSW"]
[null,null,"Northern Territory","NT"]
[null,null,"Queensland","QLD"]
[null,null,"South Australia","SA"]
[null,null,"Tasmania","TAS"]
[null,null,"Victoria","VIC"]
[null,null,"Western Australia","WA"]