Add New Study

Go to Add New Study from the Studies menu. On the next page you will need to complete the form to add the study. Each field has a description provided for it. Those marked with an asterisk are required. After all fields have been completed click Continue.

 

The form fields are listed below:

• Study Name: 12 characters max, matches name on scanner and archive.
• IRB Title: Formal approved IRB title required.
• Study Archive Directory: location study data is archived.
• Principal Investigator: you will select the PI from a drop down menu. If you do not see the PI this list you will need to add them with the Add a PI tool in the Studies menu. Check Cross-Site PIs to see a list of all PIs in COINS.
• Co-Investigator: Optional, you can select the Co-PI from a drop down menu. If you do not see the Co-PI this list you will need to add them with the Add a PI tool in the Studies menu. Check Cross-Site PIs to see a list of all PIs in COINS.
• Site: Site study will be at. If the study will be performed at multiple sites, additional sites can be added to the study. The assignment of URSI prefix at the time of subject enrollment is determined by the site selected at time of enrollment. To account for this, you can allow studies to be associated with multiple sites. Click Add Site to add another site to the study. Click Remove to remove a site for a study. The first site selected will be the default site. When enrolling a subject (from the Enter a new subject and Study Enrollment pages), after selecting the study, a site drop down will appear to allow you to select the appropriate site and create an URSI with that site's prefix.
• IRB: Indicate the IRB the study is using. Click Add IRB to add another IRB to the list. IRBs can also be added and viewed in the site configuration page.
• Radiology Review Email List: list of emails notifications will be sent to when reviews are completed (only for sites with radiology enabled)
• Allow Radiology Review Auto Reading: allow scans with no structural data or scans done within the last 6 months (3 months for adolescents) to be automatically reviewed, skipping the radiologist (only for sites with radiology enabled)
• IRB Number: Default IRB Number to consent subjects under.
• Internal Study Number: Must be unique. The correct number is crucial for receiving scans from the scanners.
• Initial Approval Date: IRB/HRRC study initial approval date.
• Expiration Date: IRB/HRRC study expiration date.
• Approved Participants: IRB/HRRC number of approved participants.
• Allows URSI Sharing: Does the study allow URSI sharing?
• Expiration/Enrollment Warning Email List: Emails that the study expiration warnings are sent.
• Share Instrument Email List: Emails that shared instruments have been change by the owner are sent.
• Sponsor: Optional, NIH for example
• Grant Number: Optional, Study’s grant number
• URL Reference: Optional, An http link to your consortium, portal, grant body, etc.
• URL Description: Optional, Describe URL reference.
• Status: There are five possible study statuses
• Active: Allows enrolling subjects and entering scans
• Closed to enrollment: Cannot enroll subjects, but you can still enter scans
• Data Analysis Only: can only access data but cannot enroll subjects or enter scans
• Closed with the IRB: The study is frozen. Cannot enroll subjects, enter scans, or access any data
• Expired: The study is frozen. HRRC reactivation required.
• Never Started: IRB approval was obtained, but study procedures never initiated. Subjects cannot be enrolled and data cannot be collected.
• Suspended: The study has been suspended by the IRB. Subjects cannot be enrolled and data cannot be collected.
• Default Radiologist (only for sites with radiology enabled): the default radiologist for image reads.
• Primary Research Area: Optional, Select from a drop down menu.
• Secondary Research Area: Optional, Select from a drop down menu.
• Comments/Notes: Any relevant comments or notes
• Hide Save and Exit in SA: Choose whether Save and Exit is displayed in Self Assessment. Click here for more information on Self Assessment.
• Nonstop Queue in SA: Choose if Self Assessment for this study should default to a nonstop queue. Click here for more information about nonstop queues.
• Study Mapping: Denote if the study is part of a data sharing initiative to enable initiative specific study features. Currently NDA and FITBIR initiatives are supported.
• Enable Self Enrollment: if Self Enrollment is allowed for the study
• Recruitment Study: denote if the study is a recruitment study and should allow Silent Enrollment
• Enable Race and Ethnicity: allows for collection of race and ethnicity at the time of enrollment
• Clinical Trial: Denote if the study meets clinical trial criteria. Users accounts with clinical trial access will be flagged.
• Study CSS URL: URL for study specific CSS for Self Assessment customization.
• Assent Date: indicates if the study has the ability to record an assent data upon enrollment for studies with minors
• Add to Recruitment List in p2?: adds study information to p2 Homepage

p2 Homepage Recruitment Information

If the study has decided to be part of your site's recruitment list, also fill out the following information. When enabled, this study and information provided in this section will be displayed in the p2 Homepage recruitment block.

• Self Enrollment Subject Type - This is the subject type that will be assigned to participants that self enroll into the study from the recruitment site. If set to none, participants will still be able to see the study's information, but will not be able to self enroll into the study.
• Purpose of the study
• Protocol Summary
• Any age range eligibility criteria can be specified here.
• Basic Eligibility Criteria
• Name
• Email
• Phone