Clinical Trial Submit

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	Visually Create and Edit ClinicalTrials.gov XML Files by PC or Laptop

	Easily Manage and Maintain Clinical Trial Protocol Data for Uploading to ClinicalTrials.gov

	Compatible with Windows 95, 98, ME, NT, 2000, XP, Vista, 7

Full Version Licenses

Enterprise Edition $495
Business Edition $195
Standard Edition $95
Education Edition $65

The Enterprise Edition license allows creating, editing, and managing an unlimited number of clinical trial protocol studies in the ClinicalTrials.gov XML editor, including usage by educational, business, and research-based organizations. This license includes:

	Unlimited time usage of software.
	Unlimited creating and editing of ClinicalTrials.gov clinical study protocols and XML files.
	One year of free software upgrades and support.

The Business Edition license allows creating, editing, and managing up to 10 clinical trial protocol studies in the ClinicalTrials.gov XML editor, including usage by educational, professional, business, and research-based organizations. This license includes:

	Unlimited time usage of software.
	Creating and editing of up to 10 ClinicalTrials.gov clinical study protocols and XML files.
	One year of free software upgrades and support.

The Standard Edition license allows creating, editing, and managing up to 3 clinical trial protocol studies in the ClinicalTrials.gov XML editor, including usage by educational, professional, business, and research-based organizations. This license includes:

	Unlimited time usage of software.
	Creating and editing of up to 3 ClinicalTrials.gov clinical study protocols and XML files.
	One year of free software upgrades and support.

The Education Edition license allows creating, editing, and managing up to 10 clinical trial protocol studies in the ClinicalTrials.gov XML editor, including usage by educational institutions, managing non-commercial clinical trial protocols. This license includes:

	Unlimited time usage of software.
	Creating and editing of up to 10 ClinicalTrials.gov clinical study protocols by educational institutions.
	One year of free software upgrades and support.

Description

Clinical Trial Submit is a desktop software application that allows you to create and edit ClinicalTrials.gov XML files, for uploading to the ClinicalTrials.gov (PRS) Protocol Registration System web site. Clinical Trial Submit helps to greatly reduce the time it takes to enter clinical trial study protocol information while manging clinical studies listed with the FDA's online Clinical Trials.gov protocol registration system.

With the powerful ability to import existing ClinicalTrials.gov XML files or create new ones from scratch, Clinical Trial Submit allows you to easily keep your protocol registration information updated, in a convenient and secure solution.

Clinical Trial Submit installs easily on a PC or laptop, making it the perfect solution for managing your ClinicalTrials.gov protocol information. From the office or on the road, Clinical Trial Submit is a must-have tool for working with the ClinicalTrials.gov protocol registration web site. Download the free trial to see how easy it is to manage your clinical trials.gov XML file, speed up your data entry time, and take your clinical trials .gov information management to the next level!


Create a new clinical trial protocol or import an existing XML file from the ClinicalTrials.gov web site. Select a clinical trial study protocol for editing to open the protocol details screen to manage your clinical study information.

With full support for single or multiple clinical trial protocols, Clinical Trial Submit allows you to create ClinicalTrials.gov protocol entries beginning with a blank template, or by importing an existing ClinicalTrials.gov XML file. From the protocol details screen, manage all required ClinicalTrials.gov PRS fields for medical and phamaceutical trials, including Interventional, Observational, and Expanded access studies.

Clinical Trial Submit contains a similar and familiar data entry process, in order to provide an easy and convienent solution for creating and editing protocol information. Data entry sections on the protocol details screen allow for editing of the following clinical trial information areas:

Title	FDA	Sponsor
Oversight	Summary	Status
Interventional Design	Observational Design	Expanded Access
Outcome Measures	Conditions	Interventions
Eligibility	Contacts	Locations
References

Clinical Trial Submit includes all neccessary and required fields per the FDA ClinicalTrials.gov data element definitions document, including Protocol Overall Description information, Study Type, FDA Regulated Interventions, IND and IDE Protocols, Section 801 Clinical Trials, Sponsor and Collaborator information, Board Approvals, Data Monitoring Committees and Oversight Authorities, Trial Purpose (Treatment, Prevention, Diagnostics, Health Services Research, Basic Sciences, etc), Study Phases (Phase 0, Phase 1, Phase 1/Phase 2, Phase 2, Phase 2/Phase 3, Phase 3, Phase 4, etc), Intervention Models, Arms, Groups and Cohorts, Study Endpoint Classifications, Enrollment, Biospecimens, Primary and Secondary Outcomes, Safety Issues, Conditions / Focus, Interventions (Drug, Device, Vaccine, Surgery, Radiation, Behavioral, etc), Study Groups. Also included, full Eligibility Criteria, Sampling and Study Populations, Central Contacts, Study Officials, Facility Locations and Investigators (Principle Investigator and Sub-Investigators), Citations and Links.

Clinical Trial Submit contains additional shortcuts for locating MEDLINE PubMed Identifier details regarding citation entries, as well as support for searching the MeSH Medical Subject Headings / National Library of Medicine.


The protocol details screen allows you to create and edit all sections of the ClinicalTrials.gov protocol registration data entry screen. Manage clinical study protocol data for Interventional, Observational, and Expanded Access studies and all associated data fields.

With integrated help on associated data entry fields, Clinical Trial Submit makes it easy to edit and manage clinical trial protocol details. Simply click the help icon next to relevant data entry fields to instantly display an integrated help screen, detailing the requirements for specific study protocol data fields.


Extensive help provided throughout the procotol details data entry process, allows you to get full field descriptions and help, directly from the ClinicalTrials.gov web site. Simply click the help icon next to any field to instantly display associated help and topics.

After creating and editing clinical trial protocol details, save and export your information to a ClinicalTrials.gov compatible XML file, for uploading and processing by the ClinicalTrials.gov Protocl Registration System web site. After uploading, the ClinicalTrials.gov web site will process and validate required information. You may then review and finalize any neccessary fields and submit for approval publishing on the Clinical Trials gov web site.

Download the free trial of Clinical Trial Submit and begin managing your ClinicalTrials.gov XML files with ease.

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