1 CTRP Registration Complete Participating Sites Template
The Clinical Trials Reporting Program (CTRP) Database (NCI)
Attach_5B_CTRP_Registry_Complete_Trial_Participating_Sites_Template.xls
Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)
OMB: 0925-0600
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0600 can be found here:
Document [xlsx]
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Readme First
Template Instructions
Participating Site Data Spec
Collaborator Data Spec
Participating Site example
Collborator example
Overview
DisclaimerReadme First
Template Instructions
Participating Site Data Spec
Collaborator Data Spec
Participating Site example
Collborator example
Sheet 1: Disclaimer
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Sheet 2: Readme First
| CTRP Trial Registration Participating Site Specification for Complete 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 participating sites and collaborator data to the CTRP Trial Registration system, including the following: | ||
| Template Instructions | ||
| The Template Instructions worksheet provides detailed instructions for preparing your data and uploading them to the system. | ||
| Participating Site Data Specification and Collaborator Data Specification | ||
| The specifications worksheets includes the following information: | ||
| 1 | Data elements | |
| 2 | Order in which the data elements must be presented | |
| 3 | Data element requirements | |
| 4 | Valid values. The system accepts only those values listed in this document | |
| 5 | Notes. Additional information that helps you to ensure successful submission of your data | |
| Participating Site and Collaborator Examples | ||
| These worksheets provide examples of a typical participating sites/collaborator data file. |
Sheet 3: Template Instructions
| How to Submit Complete 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: | |
| * | Interventional trials | |
| * | Complete trials (Summary 4 Funding Sponsor Category is National, Externally Peer Reviewed, or Institutional | |
| * | Processing Statuses for trial updates: Accepted and beyond | |
| * | Processing Statuses for trial amendments: Abstraction Verified Response or Abstraction Verified No Response | |
| 2 | Prepare an Excel spreadsheet (.xls) containing the mandatory and optional data for the trial(s) as specified in this document. | |
| You must adhere to the following requirements: | ||
| * List trial elements required for registration in the order specified in the Abbreviated Trial Data Spec tab in this spreadsheet. | ||
| * Do not change the spelling of data elements or valid values. | ||
| * Conform to the valid values guidelines when entering trial data. | ||
| * Identify each trial uniquely | ||
| * Participating site information must include the following data elements: | ||
| * Study participating site data | ||
| * At least one study site investigator's information | ||
| * Participating site primary or central contact information. Generic contact information is accepted. | ||
| * Organization attribute | ||
| * Current recruitment status | ||
| * Status date | ||
| * 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. | ||
| * Study site investigator's information must include the following data elements: | ||
| * Study site investigator data with person's attributes | ||
| * Investigator's role in the study at the site. | ||
| Note: When registering multiple investigators for a single trial, create one line per investigator/site, using the participating site number as reference. | ||
| * Participating site contact information is optional if the contact person is the investigator, or if the central contact information is provided. | ||
| * List persons and organizations with PO-IDs. | ||
| Note: You can request a list of CTRP persons and organizations along with PO-IDs from the CTRO at [email protected]. | ||
| 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. | ||
| For detailed instructions for registering trials, refer to the NCI CTRP Reporting Program Registration Site User's Guide at: | ||
| https://wiki.nci.nih.gov/x/7qViAw |
Sheet 4: Participating Site Data Spec
| Element order | Element | Required? | Allowed values | Note | |||||||
| Study participating site data | For participating sites only; lead organization must be included if it is also a participating site | ||||||||||
| 1 | Site # | Yes | Order in the list of participating sites | ||||||||
| 2 | Local Trial Identifier | Trial identifier at site | |||||||||
| 3 | [Site] Organization PO-ID | PO-ID or organization mandatory attributes is required | |||||||||
| 4 | [Site] Name | Yes if PO-ID is not provided | |||||||||
| 5 | [Site] Street Address | Yes if PO-ID is not provided | |||||||||
| 6 | [Site] City | Yes if PO-ID is not provided | |||||||||
| 7 | [Site] State/Province (US/Canada/Australia) | Yes for US, Canada, Australia and if PO-ID is not provided | US, Canada, Australia only for the case when PO-ID is not provided | ||||||||
| 8 | [Site] Zip/Postal code | Yes if PO-ID is not provided | |||||||||
| 9 | [Site] Country | Yes if PO-ID is not provided | |||||||||
| 10 | [Site] Email | Yes if PO-ID is not provided | |||||||||
| 11 | [Site] Phone | ||||||||||
| 12 | [Site] Phone extension | If exists and phone is provided | |||||||||
| 13 | [Site] TTY | ||||||||||
| 14 | [Site] FAX | ||||||||||
| 15 | [Site] URL | ||||||||||
| 16 | Is it NCI designated cancer center? | Yes | Yes/No | Indicate if organization is a NCI designated cancer center | |||||||
| 17 | Study Current Recruitment Status at site | Yes | Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn | ||||||||
| 18 | Study Current Recruitment Status date | Yes | Date in the format mm/dd/yyyy | Date that corresponds to the current recruitment status change | |||||||
| 19 | Site Target Accrual | Yes if either site or lead organization is cancer center | Number | Mandatory if either site or lead organization is cancer center | |||||||
| 20 | Program Code | Site-specific Summary 4 program code for NCI designated cancer center | |||||||||
| Study site investigator's information | Several records per one participating site are accepted | ||||||||||
| 21 | Investigator's Person PO-ID | Person PO-ID or all mandatory person attributes is required | |||||||||
| 22 | Investigator's First Name | Yes if PO-ID is not provided | |||||||||
| 23 | Investigator's Middle name | Only initials | |||||||||
| 24 | Investigator's Last Name | Yes if PO-ID is not provided | |||||||||
| 25 | Investigator's Email | Yes if PO-ID is not provided | Email address specific to study | ||||||||
| 26 | Investigator's Phone | Yes if PO-ID is not provided | Phone specific to study | ||||||||
| 27 | Investigator's Phone Extension | Mandatory if exists and PO-ID is not provided | |||||||||
| 28 | Investigator's Street Address | Yes if PO-ID is not provided | |||||||||
| 29 | Investigator's Zip/Postal Code | Yes if PO-ID is not provided | |||||||||
| 30 | Investigator's City | Yes if PO-ID is not provided | |||||||||
| 31 | Investigator's State/Province (US/Canada, Australia) | Yes if country is US, Canada, Australia and PO-ID is not provided | Only for US/Canada/Australia in case if PO-ID is not provided | ||||||||
| 32 | Investigator's Country | Yes if PO-ID is not provided | |||||||||
| 33 | Investigator's TTY | ||||||||||
| 34 | Investigator's FAX | ||||||||||
| 35 | Investigator's URL | ||||||||||
| 36 | Investigator's Role in the study | Yes | Principal Investigator, Sub-Investigator | ||||||||
| 37 | Use investigator as site contact for the study | Yes | Yes/No | IF YES is selected, investigator will play participating site contact role for the study and no other participating site contact will be required | |||||||
| Study/Site Contact information | |||||||||||
| 38 | Contact type | Yes | Site-Specific, Study-specific or central | Provide single contact for the study (study-specific) or site-specific contact for each participating site. This attribute is not required if site's investigator is assigned as site contact. There is no need to replicate central contact in each participating site record if central contact is selected and provided in the first record | |||||||
| Generic Contact | Generic contact or personal contact is required | ||||||||||
| 39 | Title for generic contact | Yes if generic contact is used | Several records per one participating site are accepted in case of site-specific contact type | ||||||||
| 40 | Contact Email | Yes if generic contact is used | Email address specific to study | ||||||||
| 41 | Contact Phone | Yes if generic contact is used | Phone specific to study | ||||||||
| 42 | Contact Phone Extension | Mandatory if exists | |||||||||
| Personal Contact | |||||||||||
| 43 | Contact Person's PO-ID | PO-ID or all mandatory person attributes is required | |||||||||
| 44 | Contact Person's First Name | Yes if personal contact is used and PO-ID is not provided | Several records per one participating site are accepted in case of site-specific contact type | ||||||||
| 45 | Contact Person's Middle Name | Only initials | |||||||||
| 46 | Contact Person's Last Name | Yes if personal contact is used and PO-ID is not provided | |||||||||
| 47 | Contact Email | Yes if personal contact is used and PO-ID is not provided | Email address specific to study | ||||||||
| 48 | Contact Phone | Yes if personal contact is used and PO-ID is not provided | Phone specific to study | ||||||||
| 49 | Contact Phone Extension | Mandatory if exists and the phone is provided | |||||||||
| 50 | Contact Person's Street Address | Yes if personal contact is used and PO-ID is not provided | |||||||||
| 51 | Contact Person's Zip/Postal Code | Yes if personal contact is used and PO-ID is not provided | |||||||||
| 52 | Contact Person's City | Yes if personal contact is used and PO-ID is not provided | |||||||||
| 53 | Contact Person's State/Province (US/Canada/Australia) | Yes for personal contact and if country is US, Canada, Australia | Only for US/Canada/Australia in case if PO-ID is not provided | ||||||||
| 54 | Contact Person's Country | Yes if personal contact is used and PO-ID is not provided | |||||||||
| 55 | Contact Person's TTY | ||||||||||
| 56 | Contact Person's FAX | ||||||||||
| 57 | Contact Person's URL |
Sheet 5: Collaborator Data Spec
| # | Element | Mandatory? | Value | Note | |
| Collaborator information | Optional | ||||
| 1 | Collaborator # | Order in the list of collaborators | |||
| 3 | Collaborator Organization PO-ID | PO-ID or all mandatory organization attributes is required | |||
| 2 | Collaborator Name | Yes if PO-ID is not provided | |||
| 4 | Collaborator Street Address | Yes if PO-ID is not provided | |||
| 5 | Collaborator City | Yes if PO-ID is not provided | |||
| 6 | Collaborator State/Province (US/Canada/Australia) | Yes for US, Canada, Australia and PO-ID is not provided | US, Canada, Australia only in case if PO-ID is not provided | ||
| 7 | Collaborator Zip/Postal code | Yes if PO-ID is not provided | |||
| 8 | Collaborator Country | Yes if PO-ID is not provided | |||
| 9 | Collaborator Email | Yes if PO-ID is not provided | |||
| 10 | Collaborator Phone | ||||
| 11 | Collaborator Phone extension | If exists and phone is provided | |||
| 12 | Collaborator TTY | ||||
| 13 | Collaborator FAX | ||||
| 14 | Collaborator URL | ||||
| 15 | Collaborator role on the study | Yes if PO-ID is not provided | Funding Source, Agent Source, Laboratory |
Sheet 6: Participating Site example
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | 40 | 41 | 42 | 43 | 44 | 45 | 46 | 47 | 48 | 49 | 50 | 51 | 52 | 53 | 54 | 55 | 56 | 57 | ||||||||
| Site info | Site # | Local Trial Identifier | [Site] Organization PO-ID | [Site] Name | [Site] Street Address | [Site] City | [Site] State/Province (US/Canada) | [Site] Zip/Postal code (US/Canada) | [Site] Country | [Site] Email | [Site] Phone | [Site] Phone extension | [Site] TTY | [Site] FAX | [Site] URL | Is it NCI designated cancer center? | Study Current Recruitment Status at site | Study Current Recruitment Status date | Site Target Accrual | Program Code | Site Investigator | Investigator's Person PO-ID | Investigator's First Name | Investigator's Middle name | Investigator's Last Name | Investigator's Email | Investigator's Phone | Investigator's Phone Extension | Investigator's Street Address | Investigator's Zip/Postal Code (US/Canada) | Investigator's City | Investigator's State/Province (US/Canada) | Investigator's Country | Investigator's TTY | Investigator's FAX | Investigator's URL | Investigator's Role in the study | Use investigator as site contact for the study | Site Contact Info | Contact type | Genetic Contact | Title | Contact Email Address | Contact Phone | Contact Phone Extension | Personal Contact | Contact Person's PO-ID | Contact Person's First Name | Contact Person's Middle Name | Contact Person's Last Name | Contact Email | Contact Phone | Contact Phone Extension | Contact Person's Street Address | Contact Person's Zip/Postal Code (US/Canada) | Contact Person's City | Contact Person's State/Province (US/Canada) | Contact Person's Country | Contact Person's TTY | Contact Person's FAX | Contact Person's URL | Note | ||
| Study 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1 | LI01 | The University of Texas M. D. Anderson Cancer Center | 1515 Holcombe Blvd | Houston | TX | 77030 | USA | [email protected] | (713) 792-5410 | http://www.mdanderson.org | YES | recruiting | 10/20/2008 | 55 | BM3 | Mary | A | Simpson | [email protected] | (713) 792-5410 | 235 | 1515 Holcombe Blvd | 77030 | Houston | TX | USA | Principal Investigator | YES | Site-Specific | Site is a NCI designated cancer center, includes 2 investigators. One of the investigators is selected as this site contact. | ||||||||||||||||||||||||||||||||||
| 1 | Brandy | S | White | [email protected] | (713) 792-5410 | 254 | 1515 Holcombe Blvd | 77030 | Houston | TX | USA | Sub-investigator | NO | |||||||||||||||||||||||||||||||||||||||||||||||||||
| 2 | LI02 | Memorial Sloan-Kettering Cancer Center | 1275 York Avenue | New York | NY | 10065 | USA | [email protected] | 212-639-2000 | http://www.mskcc.org | YES | recruiting | 11/2/2008 | 125 | Helen | T | Harold | [email protected] | 212-639-2000 | 3224 | 1275 York Avenue | 10065 | New York | NY | USA | Principal Investigator | NO | Site-Specific | Terry | Smith | [email protected] | 212-639-2000 | 4444 | 1275 York Avenue | 10065 | New York | NY | USA | Site is a NCI designated cancer center, includes 1 investigator. Site-Specific contact is used (investigator is not used for site contact) | |||||||||||||||||||||||||
| Study 2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1 | LI04 | Memorial Sloan-Kettering Cancer Center | 1275 York Avenue | New York | NY | 10065 | USA | [email protected] | 212-639-2000 | http://www.mskcc.org | YES | recruiting | 11/2/2008 | 125 | Helen | T | Harold | [email protected] | 212-639-2000-145 | 3224 | 1275 York Avenue | 10065 | New York | NY | USA | Principal Investigator | NO | Study_specific | Clinical Study Department | [email protected] | 212-639-2000 | 123 | Generic study-specific contact is used; no need to provide contact for each site separately. | |||||||||||||||||||||||||||||||
| 2 | LI06 | The University of Texas M. D. Anderson Cancer Center | 1515 Holcombe Blvd | Houston | TX | 77030 | USA | [email protected] | (713) 792-5410 | http://www.mdanderson.org | YES | recruiting | 10/20/2008 | 55 | BM3 | Mary | A | Simpson | [email protected] | (713) 792-5410 | 235 | 1515 Holcombe Blvd | 77030 | Houston | TX | USA | Principal Investigator | NO |
Sheet 7: Collborator example
| 1 | 3 | 2 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 |
| Collaborator # | Collaborator Organization PO-ID | Collaborator Name | Collaborator Street Address | Collaborator City | Collaborator State/Province (US/Canada) | Collaborator Zip/Postal code (US/Canada) | Collaborator Country | Collaborator Email | Collaborator Phone | Collaborator Phone extension | Collaborator TTY | Collaborator FAX | Collaborator URL | Collaborator role on the study |
| 1 | Publitek, Inc. dba Fotosearch | 21155 Watertown Road | Waukesha | WI | 53186-1898 | USA | [email protected] | 1-800-827-3920 | 262-717-0745 | http://www.fotosearch.com | Laboratory | |||
| 2 | AstraZeneca International | P.O. Box 15437 | Wilmington | DE | 19850-5437 | UK | [email protected] | 1 302 886 3000 | 302 886 2972 | www.astrazeneca-us.com | Agent Source |
| File Type | application/vnd.ms-excel |
| Author | nshimko |
| Last Modified By | David Loose |
| File Modified | 2013-04-03 |
| File Created | 2008-12-04 |
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