Create Research Sponsors, Projects, and Records

Before Starting

Creating Research records in URMA is a three-step process:

1. Locate or create the Research Sponsor.
2. Locate or create the Research Project.
3. Create the related Records (boxes).

Step 1 – Locate or Create the Research Sponsor

Start on the Research Sponsor tab. 

Search for the Sponsor by adding a full or partial name to the Sponsor Name search field. 

• If your Sponsor is located, move to Step 2 – Locate or Create the Research Project.

If you did not locate your Sponsor, click Create. 

Field-by-Field Data Entry

All fields with an asterisk (*) are required. The Record will not save if a required field is left blank.

Sponsor Name: Enter the fuller form of the sponsor’s name with any acronyms at the end.  Example: National Institutes of Health (NIH)

Sponsor Affiliation: Select type of sponsor affiliation from the drop-down list.

Saving Options

Save & Close: takes you back to the Home Page Grid

Save & View: takes you to view what you just created

Save & New: opens a new data entry screen

Step 2 – Locate or Create the Research Project

Click Research Projects tab.

Search for your study/project by entering information in one or more of the Quick Search fields.  Typically, Research Group Number produces the best results. 

• If your Project is located, move to Step 3 - Creating Research Records section.

If you did not locate your Project, click Create.

Field-by-Field Data Entry

Note that all fields with an asterisk (*) are required.  The Project cannot be saved if left blank.

Research Group Association: Select the correct association from the drop-down menu.

Research Group Number: Enter the IRB or other review board number; enter zeroes if not known.

Primary Sponsor Protocol/Study Number: Enter the sponsor’s protocol number, if known.

Primary Sponsor: Search for and select the sponsor of the project using the search fields. 

Primary Sponsor Department/Division: Enter the sponsor department name, if known.

Primary Sponsor Address: Enter the complete sponsor mailing address, if known.

Primary Sponsor Contact Name: Enter the first and last name of the sponsor contact person, if known.

Primary Sponsor Contact Email: Enter the email address of the sponsor contact person, if known.

Primary Sponsor Contact Phone: Enter the phone number of the sponsor contact person, if known.

Add Secondary Sponsor: If a second or co-sponsor exists, select Yes.  If not, select No.  If Yes is selected, contact information fields will appear.

Study/Trial Name: Enter the complete study/trial/project name.  Avoid using only abbreviations and/or acronyms.

Study/IRB Status: Select the correct study status from the drop-down menu.

Drug IND/IDE Number: Enter the IND or IDE number if the study tests a drug or device.

Drug/Device Name: Enter the drug or device name if the study tests a drug or device.

Retention Language Per Contract: Enter any specific retention language found in the protocol, contract, or agreement.

Study Subjects: Select the type of study subjects from the drop-down menu

IRB Close Date: Enter the study close date as found in the IRB Online record.  Leave blank if study is still active.

PI Computing ID: Enter the UVA computing ID of the principal investigator.  

PI Name: Enter the first and last name of the principal investigator.  Enter “unknown” if name is not known.

Notes: Used if needed to record additional information; otherwise leave blank.

Attachment: Attach documentation from the sponsor regarding retention or disposition, if applicable.

Saving Options

Save & Close: takes you back to the Home Page Grid

Save & View: takes you to view what you just created

Save & New: opens a new data entry screen

Step 3 - Create the Research Box Record(s)

Start on the Records tab. 

Click Create. 

Setting Record Creation Defaults

If you typically enter the same information in certain fields each time you create Records, you should Set Defaults for these fields.  All Records you enter will automatically default to the values you selected for these fields going forward.  This is not a required step, but it can make data entry go more quickly.

Defaults can be:

• Set on any field.
• Updated/deleted using the procedure below as many times as needed.
• Overridden by deleting text or using the Clear button in the fields you wish to change.

From the Records Create screen, enter information in the fields you wish to set as defaults. 

Click Set Defaults button at top/right.

Field-by-Field Data Entry

All fields with an asterisk (*) are required. The Record will not save if any required fields are left blank.

Organization:  Search for your Organization by the name or number.  If you have a Default set, it will auto-populate.

Record Series: URMA automatically displays all available Record Series once an Organization is selected.  Use the search fields to locate and select the series.

• For HSR studies with adult subjects: enter 200233 in the Record Series Number search box and select the Adult Subjects series.
• For HSR studies with minor subjects: enter 200233 in the Record Series Number search box and select the Minor Subjects series.  [also use for studies with both minors and adults]
• For SBS studies, enter 101170 in the Records Series Number search box and select the SBS series.
• For studies without human subjects, enter 101170 in the Records Series Number search box and select the Non-Human Subject series.
• Click Search or hit Enter.

Primary Contact: Search for and select the Primary Contact for the records (must be an URMA user).  If you have a Default set, it will auto-populate.

Vendor Barcode: Leave blank.  RIM Office will enter vendor numbers if you use off-site storage.

Legacy Box Number: Enter a number only if you have a numbering system you wish to retain.

Electronic File/Folder Path: If records are Physical, leave blank.  If records are Electronic, enter the full file/folder path of their location.

Electronic File Size in MB: If records are Physical, leave blank.  If records are Electronic, enter the size of the file in megabytes (MB) only.  (Convert from KB, GB, or TB if needed).

Record Type: Select Research. A new field will appear called Research Project.

Research Project: Search for and select the Research Project associated with this box of records. 

Description of Records: Enter any pertinent information that might aid in searching/locating Records later.  Make sure information is not duplicated elsewhere.

Identifying Number: Leave blank unless you have another number or identifier you wish to retain.

Date Range - Start: Enter the start date of the records.

Date Range - End: Enter the end date of the records.

Retention Trigger Date: Leave blank unless you have received notification of a destruction date from the study sponsor or the RIM Office.

Override Scheduled Disp. Date: Leave blank; for RIM Office use.

Attachment: Attach a content listing or other information about the records by clicking Add, if applicable. Do not attach documents that contain highly sensitive data (HSD).

Storage Type: Select Electronic or Physical.

Saving Options

Save & Close: takes you back to the Home Page Grid

Save & View: takes you to view what you just created

Save & New: opens a new data entry screen