Study Participation `` `` FDA_STUDYPART_ No No No 0 No 0 0 0 0 0 0 0 0 0 0 0 0 0 0 primary 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 @namespace xforms url(http://www.w3.org/2002/xforms); xforms|upload[appearance='open'] { -moz-binding:url('./xbl/FileSaveXBL.xml#open'); } xforms|upload[appearance='open2'] { -moz-binding:url('./xbl/FileSaveXBL.xml#open2'); } xforms|upload[appearance='open4'] { -moz-binding:url('./xbl/FileSaveXBL.xml#open4'); } xforms|upload[appearance='saveas'] { -moz-binding:url('./xbl/FileSaveXBL.xml#saveas'); } initialize(); HL7 Study Data - Study Participation XForm v1.2.0 `Copyright © 2012 U.S. Food and Drug Administration` Save Show Hints Hide Hints Study Information Investigator Service Provider Site Preview 1572 Copyright notice Study Information Sponsor-assigned Study ID * Sponsor-assigned Study ID: Unique identification assigned by the sponsoring organization NCT Number (clinicalTrials.gov) NCT Number: National Clinical Trial (NCT) number, another term for the ClinicalTrials.gov registry number unique to each record. The format for the ClinicalTrials.gov registry number is â€œNCTâ€ followed by an 8-digit number, e.g.: NCT00000419. Report Cutoff Date (yyyymmdd) Report Cutoff Date: The date the data is current of. Subject Accrual Status of Study Subject Accrual Status of Study: Subject enrollment ends when the planned number of subjects is reached. The accrual status of the study cannot be calculated from the accrual statuses of its sites, since it is possible that all current sites are closed for accrual but a new site will be opening soon.
Begin Date (yyyymmdd)
End Date (yyyymmdd)
Status
Delete Add Subject Accrual Status Data Collection Status of Study Data Collection Status of Study: The data collection status of the study cannot be calculated from the data collection statuses of its sites, since it is possible that all current sites are closed for data collection but a new site will be opening soon.
Begin Date (yyyymmdd)
End Date (yyyymmdd)
Status
Delete Add Data Collection Status . * = Required Field Study Information Investigator Service Provider Site Preview 1572 Copyright notice Investigator Usage Notes: Only add the investigator once. Refer to investigator by Id. Investigator: - Identifier * Identifier: The identifier for the investigator. Investigator Type * Investigator Type: A study can have one Study Primary investigator (Principal), although this is not required. There can be multiple Study Sub investigators. Note: Sub investigators at the study level can be primary investigators at the site level. Principal Investigator PRINCIPAL Sub-Investigator SUBINVESTIGATOR First Name Last Name * Suffix Street Address City State PostalCode Country Telephone Number * Email Address * Start Date (yyyymmdd) End Date (yyyymmdd) Investigator Status Investigator CV or Statement of Qualification An attachment... Links a document to an investigator. File Name Delete Licenses / Degrees A skill, achievement, etc, that demonstrates that a person capable or suitable to do a job etc. License/Degree Type * Start Date (yyyymmdd) End Date (yyyymmdd) License/Degree Status Delete License/Degree Issuer Name Street Address City State PostalCode Country Add License/Degree ID (DUNS #) Institution Name Delete Street Address City State PostalCode Country Delete Investigator Add Investigator Study Information Investigator Service Provider Site Preview 1572 Copyright notice Service Provider There are many service providers that are involved in a study. It is important to list some, not all, service providers involved in a study. For example, this information could be used to find all contract research organizations involved in all active studies. Note: An INSTUTIONAL REVIEW BOARD (IRB) should not be added as a Service Provider. The IRB should be added on the Site tab under "Subject Protection Approval". Service Provider: - Org ID (DUNS #) Provider Name * Start Date (yyyymmdd) End Date (yyyymmdd) Provider Status Street Address City State PostalCode Country Telephone Number Provider Role for Study * Study Role: The type of service the organization is providing for the entire study. If the organization is providing roles for specific sites, this can be added on the siteÂ tab. Delete Study Role: The type of service the organization is providing for the entire study. If the organization is providing roles for specific sites, this can be added on the siteÂ tab. Add Study Role Delete Provider Add Provider Study Information Investigator Service Provider Site Preview 1572 Copyright notice Site Information Represents all of the activities that are done at a specified Site. After defining the Investigators and Service Providers, return to this tab to allocate the Investigators and Service Providers to a particular Site. Site: - Sponsor Assigned Site ID * The identifier for the study site. Principal Investigator at Site There is one site primary investigator for each site for a study. Investigators need to be defined on the Investigators page before they can be assigned to a site. Principal Investigator at Site * , - Remove from Site Add Principal Investigator to Site Location(s) A physical location, typically a clinical research facility or a sponsor's office, that provides healthcare services. The main location where study activities are conducted. ID (DUNS #) The identifier for the location. Name/Description Delete Location Street Address City State Postal Code Country Place within Location If you need to specify a pen in a farm where the farm is the site. The most granular place is off of service delivery location. In this case, the pen would be the place off of service delivery location. Place Type * Name/Description Street Address City State PostalCode Delete Place Add Site Location Sub Investigator(s) at Site There can be many sub-investigators for a study site. Investigators need to be defined on the Investigators page before they can be assigned to a site.
Sub Investigators at Site *
, - Remove from Site Add Sub Investigator to Site Service Providers at Site There are many service providers that are involved in a study. It is important to list some, not all, service providers involved in a study. Service Providers need to be defined on the Service Providers page before they can be assigned to a site.
Service Provider Name *
Service Provider Role *
Remove from Site Add Service Provider to Site Subject Accrual Status at Site Subjects are enrolled to a site in study. Subject enrollment ends when the planned number of subjects is reached. The accrual status of the study cannot be calculated from the accrual statuses of its sites, since it is possible that all current sites are closed for accrual but a new site will be opening soon.
Begin Date (yyyymmdd)
End Date (yyyymmdd)
Status
Delete Add Subject Accrual Status Data Collection Status at Site Sites can be actively collecting data. The data collection status of the study cannot be calculated from the data collection statuses of its sites, since it is possible that all current sites are closed for data collection but a new site will be opening soon.
Begin Date (yyyymmdd)
End Date (yyyymmdd)
Status
Delete Add Data Collection Status Subject Protection Approval at Site The purpose of a subject protection approval (by an Institutional review board (IRB), independent ethics committee (IEC) or ethical review board (ERB)) is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Approval ID * The identifier for the approval. Appr. Date (yyyymmdd) Approval Date: When the approval was recorded by the ethical committee. Begin Date (yyyymmdd) Begin Time: The period of time during which the approval is in effect. End Date (yyyymmdd) End Time: The period of time during which the approval is in effect. Delete Approval Ethical Committee(s) Ethical Committee: Review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare
Identifier (DUNS #) *
Ethical Committee Name
Street Address
City
State
Postal Code
Country
Delete Add Ethical Committee Add Subject Protection Approval Delete Site Add Site Study Information Investigator Service Provider Site Preview 1572 Copyright notice Study Information Investigator Service Provider Site Preview 1572 Copyright notice Form FDA 1572 The 1572 below will be auto generated as data is entered in the other tabs. The 1572 is site driven (based on the data entered on the Site tab). For example: A Subinvestigator will only show in #6 (Names of the Subinvestigators) if the primary and Subinvestigator are assigned to the same site, on the Site tab. Print 1572 Note: Printing of the 1572 can also be done outside of the XForm application. To do this, open the saved Study Participation XML file in Internet Explorer. Refer to the User Guide for additional information on displaying style sheets. Study Information Investigator Service Provider Site Preview 1572 Copyright notice Copyright Notice Copyright (c) 2012 U.S. Food and Drug Administration

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