Study Participation `` `` StudyParticipation_ 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='saveas'] { -moz-binding:url('./xbl/FileSaveXBL.xml#saveas'); } initialize(); HL7 Study Data - Study Participation XForm v1.0.0 `Copyright © 2010 U.S. Food and Drug Administration` Save Show Hints Hide Hints Study Information Investigator Site Subjects Copyright notice Study Information A collector of performed activities in a study including a description of the actual number of study subjects and the start and end dates of enrollment. A performed study occurs after a planned study has been approved for execution. Detailed information about the planned study or protocol is collected in the study design message Link to Study Design Pre-fill Subject Information: When importing a Study Design message, use the pre-fill option to set desired subject details, prior to importing. Pre-fill Subject Information defaults Human Study Human_Study Animal Study Animal_Study Begin Date (yyyymmdd) End Date (yyyymmdd) Status Begin Date (yyyymmdd) End Date (yyyymmdd) Status Type/Kind Species Strain Text Description Imports the Planned Study (Study Design) Message. To keep integrity of this message a study design file can no longer be imported. Study Design Identifier * Study Design Identifier: Identifies the study. This ID is used to link the Planned Study to the performed protocols. After importing the Study Design message, this value cannot be changed. Study Design Name * Study Design Name: The Planned Study name. After importing the Study Design message, this value cannot be changed. Study Participation Unique Protocol Identifier * Unique Protocol Identifier: The identifier of the performed study. This ID will be used when updating information about the performed study. For Clinical Studies, Use the ClinicalTrials.gov Identifier. Protocol Name * Protocol Name: The Protocol Name will usually be the same as the Study Design Name. 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 Study Information Investigator Site Subjects Copyright notice Investigator A researcher in a study who oversees aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. A study can have one study primary investigator, although this is not required. There is one site primary investigator for each site for a study. There could be many sub-investigators for a study site. UsageNotes: 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. Primary of Study (Principal) primary Sub of Study sub First Name Last Name * Suffix Street Address City State PostalCode Country Telephone Number Email Address Start Date (yyyymmdd) End Date (yyyymmdd) Investigator Status 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 Sponsoring Organization Sponsoring Organization: The sponsoring organization of the investigator. Note: The investigator may only have one sponsoring organization. Org ID (DUNS #) * Sponsor Name Street Address City State PostalCode Country Delete Add Sponsoring Organization Delete Investigator Add Investigator Study Information Investigator Site Subjects 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: - Site Identifier * The identifier for the study 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. Location Type * Hospital hospital Clinic clinic Building bldg Farm farm Name/Description Street Address City State Postal Code Country Delete Location 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 * Bed bed Building bldg Floor floor Room room Wing wing Pen pen Name/Description Street Address City State PostalCode Delete Place Add Place to Location Add Site Location Primary 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. Primary Investigator at Site * , - Remove from Site Add Primary Investigator to Site 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 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 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 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 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 Site Subjects Copyright notice Subject Information The experimental unit is the physical entity which is the primary unit of interest in a study. The experimental unit is also the unit of primary statistical analysis. Commonly the individual subject (animal or person) is the experimental unit. Different experimental units must be capable of receiving different experimental interventions. UsageNotes: The actual recording of the data will be in the subject data message Human Study Human_Study Animal Study Animal_Study If subjects share similar data, use this to create multiple subjects. Subjects Share Common Data defaults Subject Generator Begin Date (yyyymmdd) End Date (yyyymmdd) Status Add to Site Number of Subjects Subject Generator Site: - Number of Subjects at Site: ( )
Subject Identifier *
Begin Date (yyyymmdd)
End Date (yyyymmdd)
Status
Identifiers are auto generated and should not be changed manually. Delete Add Single Person Delete ALL Persons from Site If subjects share similar data, use this to create multiple subjects. Subjects Share Common Data defaults Subject Generator Begin Date End Date Status Type/Kind * Species Strain Text Description Add to Site Number of Subjects Subject Generator Site: - Animal Subjects ( )
Subject Identifier * Identifiers are auto generated and should not be changed manually.
Begin Date
End Date
Status
Type/Kind *
Species
Strain Text
Description
Delete Add Single Animal Delete ALL Animals from Site Subjects Share Common Data defaults Subject Generator Product Identifier Begin Date ((y(yyyymmdd))) End Date ((y(yyyymmdd))) Collection Status Type/Kind Name Form Code Lot Number Apply to Site # of Subjects to Generate Subject Generator Product Experimental Units Product Identifier Begin Date End Date Collection Status Type/Kind Name Form Code Lot Number Experimental Unit ID Add Single Product Delete Selected Product Delete ALL Product from Site Study Information Investigator Site Subjects Copyright notice Copyright Notice Copyright (c) 2010 U.S. Food and Drug Administration

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