{"text_format":"2","workbook":"xls","n_sheets":4,"sheets":["Disclaimer","Readme First","Template Instructions","Abbreviated Trial Data Spec "],"not_rendered":{"charts":0,"images":1,"macros":0,"external_links":1,"defined_names":1,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"run_cost":"one","rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"Disclaimer","index":0,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[],"flags":["formulas_cached_only"]}

{"sheet":"Readme First","index":1,"n_rows":19,"n_cols":3,"rows_kept":19,"cut":false,"hidden":false,"merged":[],"flags":["formulas_cached_only"]}
["CTRP Trial Registration Participating Site Specification for Abbreviated Trials"]
[]
[]
["The participating sites template is designed for recording participating site data for interventional trials, especially if site-specific data is not included in the trial protocol. "]
["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."]
[]
[]
["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"]
[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 submission of your data"]

{"sheet":"Template Instructions","index":2,"n_rows":51,"n_cols":3,"rows_kept":51,"cut":false,"hidden":false,"merged":[],"flags":["formulas_cached_only"]}
[]
["How to Submit Abbreviated Trial Participating Sites Data to the CTRP Trial Registration System"]
[]
[]
[]
["Main Steps for Uploading Your Data"]
[]
[1,"Prepare the trial data file"]
[2,"Upload the file in the Trial-Related Documents section in the Registration application"]
[]
["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 "]
[]
[]
[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. "]
[null,"* Conform to the valid values guidelines when entering trial data."]
[null,"* Identify each trial uniquely"]
[null,"* Participating site information must include the following data elements:"]
[null,null,"* Study participating site data"]
[null,null,"* At least one study site investigator's information"]
[null,null,"* Participating site primary or central contact information. Generic contact information is accepted."]
[null,null,"* Organization attribute"]
[null,null,"* Current recruitment status"]
[null,null,"* Status date"]
[null,null,"* Target accrual. This is mandatory if the target accrual is for a study at a participating site or if the lead organization is an NCI-designated Cancer Center.  Optionally, provide a local trial identifier."]
[null,"* Study site investigator's information must include the following data elements:"]
[null,null,"* Study site investigator data with person's attributes"]
[null,null,"* Investigator's role in the study at the site."]
[null,null,"Note: When registering multiple investigators for a single trial, create one line per investigator/site, using the participating site number as reference."]
[null,"* Participating site contact information is optional if the contact person is the investigator, or if the central contact information is provided."]
[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,"Or, you can use the organization/person lookup features in the CTRP Trial Registration application to search for PO-IDs."]
[]
["Uploading Your File"]
[]
["Upload your file in the Trial-Related Documents section of the CTRP Registration Site's Register Trial page. Or, email your file to the CTRO at ncictro@mail.nih.gov."]
[null,null,"Note: You can use the Abbreviated Batch Upload Template instead of this one. If you use the batch template, identify the trial to which you want to add your site information by its NCI Trial ID."]
[]
[]
["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"]

{"sheet":"Abbreviated Trial Data Spec ","index":3,"n_rows":38,"n_cols":6,"rows_kept":38,"cut":false,"hidden":false,"merged":[],"flags":["formulas_cached_only"]}
["Trial elements Order","Trial data element","Required?","Valid Values","Comments","Definition"]
[1,"NCI Trial Identifier","Yes",null,"NCI trial identifier of the existing in CTRP trial to which this site is to be added"]
[2,"Local trial identifier","Yes",null,"Trial identifier as assigned by the submitting organization"]
[3,"[Submitting Organization] Organization PO-ID",null,null,"PO-ID or all mandatory organization attributes are required"]
[4,"[Submitting Organization] Name","Yes if PO-ID is not provided"]
[5,"[Submitting Organization] Street Address","Yes if PO-ID is not provided"]
[6,"[Submitting Organization] City ","Yes if PO-ID is not provided"]
[7,"[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 "]
[8,"[Submitting Organization] Zip/Postal code ","Yes if PO-ID is not provided"]
[9,"[Submitting Organization] Country","Yes if PO-ID is not provided"]
[10,"[Submitting Organization] Email Address","Yes if PO-ID is not provided"]
[11,"[Submitting Organization] Phone",null,null,"Include Phone Extension if any in the same field"]
[12,"[Submitting Organization] TTY"]
[13,"[Submitting Organization] FAX"]
[14,"[Submitting Organization] URL"]
[15,"[Submitting Organization] Organization Type",null,"Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network"]
[16,"[Site Principal Investigator] Person PO-ID",null,null,"PO-ID or all mandatory person attributes are required"]
[17,"[Site Principal Investigator] First Name","Yes if PO-ID is not provided"]
[18,"[Site Principal Investigator] Middle Name"]
[19,"[Site Principal Investigator] Last Name","Yes if PO-ID is not provided"]
[20,"[Site Principal Investigator] Street Address","Yes if PO-ID is not provided"]
[21,"[Site Principal Investigator] City","Yes if PO-ID is not provided"]
[22,"[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 "]
[23,"[Site Principal Investigator] Zip/Postal code","Yes if PO-ID is not provided"]
[24,"[Site Principal Investigator] Country","Yes if PO-ID is not provided"]
[25,"[Site Principal Investigator] Email Address","Yes if PO-ID is not provided"]
[26,"[Site Principal Investigator] Phone ","Yes",null,"Include Phone Extension if any in the same field"]
[27,"[Site Principal Investigator] TTY"]
[28,"Site [Principal Investigator] FAX"]
[29,"[Site Principal Investigator] URL"]
[30,"[Site Principal Investigator] Phone ","Yes if PO-ID is not provided",null,"Phone specific to study"]
[31,"[Site Principal Investigator] Phone Extension",null,null,"Mandatory if exists and PO-ID is  not provided"]
[32,"[Site specific] Program Code",null,null,"applicable for NCI-designated Cancer Center"]
[33,"Site Recruitment Status","Yes","Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn"]
[34,"Site Recruitment Status Date","Yes","Format mm/dd/yyyy","Date when the recruitment status has come in effect"]
[35,"Date Opened for Accrual","Yes if study is opened for accrual","Format mm/dd/yyyy"]
[36,"Date Closed for Accrual","Yes if study is closed for accrual","Format mm/dd/yyyy"]
[37,"Site Target Accrual",null,null,"Necessary for NCI designated cancer centers"]