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IP Codes

# For Randomization Study

Add and manage IP codes in the ClinicalDataS IMP module. Assign study groups, set expiration dates, and bulk import codes via CSV.

IP Codes (Randomization mode)​

IP codes are the individual tracking units for investigational product in Randomization-mode studies. Each code can optionally be linked to a Study Group (treatment arm).

Navigate: IMP → Products → IP Code

IP Code list of CARDIO-RELIEF 2025 with Placebo Tablet codes at Tam Duc Heart Hospital and Cho Ray Hospital in Available, Assigned, Returned and Omitted status
  1. Add a single IP code
  2. Import a batch of IP codes from a file

IP Code table columns​

ColumnDescription
IP CodeUnique code identifier (e.g., CRF-0001)
ProductProduct name associated with this code
UnitUnit of measure (e.g., Tablet)
StatusCurrent status (Available, Dispensed, Returned, …)
Study GroupTreatment arm this code is assigned to
WarehouseCurrent warehouse holding the code
SiteSite that received the code (if delivered)
MethodHow the code was added: Manual or Import
Expiration DateIP expiration date
Created OnDate the code was added
Last Updated OnDate of last status change
ActionView and Edit; Validate for codes in New status. The more menu holds Delete, and Remove for codes in New or Released status

Add IP Code (manual)​

Click + Add IP Code to open the add dialog.

Add IP Code form — CRF arm filled

FieldBehavior
ProductPre-set; cannot be changed from this form
UnitPre-set; cannot be changed from this form
IP CodeRequired. Enter the unique code (e.g., CRF-0001)
Study groupOptional. Select the treatment arm for this code
Expiration DateOnly shown when the study uses expiration tracking; required when shown
Unblinded — Restricted Access

The Study group field reveals which treatment arm an IP code belongs to. This is unblinded information. Only users with the Unblinded Supply Manager role (or equivalent) should add or view IP codes with study group assignments.

Study group options (example: CARDIO-RELIEF 2025)​

Study GroupArm
CardioRelief CRF-101Active treatment
PlaceboPlacebo arm

Click Add to save the code.


Import Batch (bulk)​

For large numbers of codes, use Import Batch to upload a CSV or Excel file.

Import dialog with the file upload area and the Download template link
  1. Download the template with the required columns
  1. Click Import Batch
  2. In the dialog, click Download template to get the required column format
  3. Fill the template with your IP codes (one per row)
  4. Upload the filled file using the file selector

Import Batch dialog — file selected

  1. Click OK to import — a success notification confirms the batch was accepted

After import, the IP Code list updates immediately with all new codes.

CSV / Excel template columns​

ColumnRequiredExample value
IP CodeYesCRF-0003
Study GroupNoCardioRelief CRF-101
Expiration DateNo01/15/2028

Rows with no Study Group value import successfully — the code is added unassigned to any treatment arm and can be assigned later.

tip

For a double-blind study with 500 codes per arm, prepare two sets of rows in one file or import separately:

  • 500 rows with Study Group = CardioRelief CRF-101 (CRF-0001 → CRF-0500)
  • 500 rows with Study Group = Placebo (PBO-0001 → PBO-0500)

The system will reject the entire batch if any IP Code already exists, so ensure codes are unique before importing.


Export​

Click the export icon in the toolbar to download the current IP code list as CSV or Excel for audit or verification.