3 Attach 5B CTRP Registry Complete Trial Participating Sit
The Clinical Trials Reporting Program (CTRP) Database (NCI)
Attach_5B_CTRP_Registry_Complete_Trial_Participating_Sites_Template.xlsx
Initial Registration
OMB: 0925-0600
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0600 can be found here:
Document [xlsx]
Download: xlsx | pdf
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 (Data Table 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 Participating Site 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. | ||
| Note: Although you can update Program Codes via the NCI CTRP Registration site, you can not update them via the batch file. | ||
| 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/7ZF4B |
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 | Yes | PO-ID for the organization must exist in the CTRP list of organizations | ||||||||
| 4 | Study Current Recruitment Status at site | Yes | Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn | ||||||||
| 5 | Study Current Recruitment Status date | Yes | Date in the format mm/dd/yyyy | Date that corresponds to the current recruitment status change | |||||||
| 6 | Site Target Accrual | Yes if either site or lead organization is cancer center | Number | Mandatory if either site or lead organization is cancer center | |||||||
| 7 | Program Code | Site-specific Data Table 4 program code for NCI designated cancer center | |||||||||
| Study site investigator's information | Several records per one participating site are accepted | ||||||||||
| 8 | Investigator's Person PO-ID | PO-ID for the Person must exist in the CTRP list of Persons | |||||||||
| 9 | Investigator's Role in the study | Yes | Principal Investigator, Sub-Investigator | ||||||||
| 10 | 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 | |||||||||||
| 11 | 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 | ||||||||||
| 12 | 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 | ||||||||
| 13 | Contact Email | Yes if generic contact is used | Email address specific to study | ||||||||
| 14 | Contact Phone | Yes if generic contact is used | Phone specific to study | ||||||||
| 15 | Contact Phone Extension | Mandatory if exists | |||||||||
| Person Contact | |||||||||||
| 16 | Contact Person's PO-ID | PO-ID for the Person must exist in the CTRP list of Persons | |||||||||
| 17 | Contact Email | Yes if personal contact is used and PO-ID is not provided | Email address specific to study | ||||||||
| 18 | Contact Phone | Yes if personal contact is used and PO-ID is not provided | Phone specific to study |
Sheet 5: Collaborator Data Spec
| # | Element | Mandatory? | Value | Note | |
| Collaborator information | Optional | ||||
| 1 | Collaborator # | Order in the list of collaborators | |||
| 2 | Collaborator Organization PO-ID | PO-ID for the organization must exist in the CTRP list of organizations | |||
| 3 | Collaborator role on the study | Yes | 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 | |||||||
| Site info | Site # | Local Trial Identifier | [Site] Organization PO-ID | 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 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 Email | Contact Phone | Note | |
| Study 1 | ||||||||||||||||||||||||
| 1 | LI01 | 321 | recruiting | 10/20/2008 | 55 | BM3 | 12345 | 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 | 23456 | Sub-investigator | NO | |||||||||||||||||||||
| 2 | LI02 | 432 | recruiting | 11/2/2008 | 125 | 34567 | Principal Investigator | NO | Site-Specific | [email protected] | 212-639-2000 | 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 | 432 | recruiting | 11/2/2008 | 125 | 34567 | 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 | 321 | recruiting | 10/20/2008 | 55 | BM3 | 12345 | Principal Investigator | NO |
Sheet 7: Collborator example
| 1 | 2 | 3 |
| Collaborator # | Collaborator Organization PO-ID | Collaborator role on the study |
| 1 | 123 | Laboratory |
| 2 | 234 | Agent Source |
| File Type | application/vnd.openxmlformats-officedocument.spreadsheetml.sheet |
| File Modified | 0000-00-00 |
| File Created | 0000-00-00 |
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