Summary

This article covers the default fields available in the add product form and how to access and save the form.

Table of Contents


Products used in studies are managed in CTMS by the Product form, one of many Configurable Forms. It is from this screen that relevant information concerning a Product can be collected. What is displayed on this form can be configured from CTMS Settings.

The Product form is labeled Add Product for a new record and Edit Product for an existing record.

Access Add Product Form

The Add Product form can be reached by clicking the “Add Product” Action found in the Actions Menu on the Product Manager screen.


The Product form for existing Products may also be accessed by clicking on the Product Name in the Product Manager and the Edit Product form shall appear.


Default Fields

The Product form contains the following fields by default:


Product Name Field

The Product Name field is a Text field, and is used to identify the product within managers and other parts of the system. By default, the Product Name field is a required field and a black alert will fire if the product name is not provided and the form cannot be saved until the product name is entered.

Product Code Field

The Product Code field is a Text field, and is used to identify the product by a code or internal number within managers and other parts of the system. By default, the Product Code field is a preferred field and a red alert will fire if the product code is not provided.

The Sponsor field is a Dropdown Select field, and is used to identify the Sponsor who owns the Product. These options can be configured via the Sponsor Managed List found in CTMS Settings. By default the Sponsor Managed List is blank and shall be populated at the beginning of use of the CTMS. By default, the Sponsor field is a preferred field and a red alert will fire if the Sponsor is not provided.

Product Type Field

The Product Type field is a Dropdown Select field, and is used to identify what type of product the record is. By default options available are “Drug”, “Device”, “Biologics” and “Other”. These options can be changed via the Product Type Managed List found in CTMS Settings. By default, the Product Type field is a preferred field and a red alert will fire if the product type is not provided.

Form Field

The Form field is a Dropdown Select field, and is used to identify the form of the product. By default options available are:

AerosolFor SuspensionPaste
Bar, ChewableGasPastille
BeadGelPatch
BlockGeneratorPellet
CapsuleGlobulePill
CementGraftPlaster
CigaretteGranulePoultice
ClothGumPowder
ConcentrateImplantRing
ConeInhalantRinse
CreamInjectionSalve
Cream, AugmentedInsertShampoo
CrystalIntrauterine DeviceSoap
CultureIrrigantSolution
DiaphragmJellySponge
DiscKitSpray
DoucheLiner, DentalSpray, Metered
DressingLinimentStick
Drug Delivery SystemLipstickStrip
ElixirLiquidSuppository
EmulsionLotionSuspension
EnemaLozengeSuspension/ Drops
ExtractMouthwashSuture
FiberOilSwab
FilmOintmentSyrup
For SolutionPackingTablet

These options can be changed via the Delivery Form Managed List found in CTMS Settings. By default, the Form field is a preferred field and a red alert will fire if the form is not provided.

Route Field

The Route field is a Dropdown Select field, and is used to identify the route of the product. By default options available are:

Auricular (Otic)

Intradural

Irrigation

Buccal

Intraepidermal

Laryngeal

Conjunctival

Intraesophageal

Nasal

Cutaneous

Intragastric

Nasogastric

Dental

Intragingival

Not Applicable

Electro-Osmosis

Intraileal

Occlusive Dressing Technique

Endocervical

Intralesional

Ophthalmic

Endosinusial

Intraluminal

Oral

Endotracheal

Intralymphatic

Oropharyngeal

Enteral

Intramedullary

Other

Epidural

Intrameningeal

Parenteral

Extra Amniotic

Intramuscular

Percutaneous

Extracorporeal

Intraocular

Periarticular

Hemodialysis

Intraovarian

Peridural

Infiltration

Intrapericardial

Perineural

Interstitial

Intraperitoneal

Periodontal

Intra-Abdominal

Intrapleural

Rectal

Intra-Amniotic

Intraprostatic

Respiratory (Inhalation)

Intra-Arterial

Intrapulmonary

Retrobulbar

Intra-Articular

Intrasinal

Soft Tissue

Intrabiliary

Intraspinal

Subarachnoid

Intrabronchial

Intrasynovial

Subconjunctival

Intrabursal

Intratendinous

Subcutaneous

Intracardiac

Intratesticular

Sublingual

Intracartilaginous

Intrathecal

Submucosal

Intracaudal

Intrathoracic

Topical

Intracavernous

Intratubular

Transdermal

Intracavitary

Intratumor

Transmucosal

Intracerebral

Intratympanic

Transplacental

Intracisternal

Intrauterine

Transtracheal

Intracorneal

Intravascular

Transtympanic

Intracoronal, Dental

Intravenous

Unassigned

Intracoronary

Intravenous Bolus

Unknown

Intracorporus Cavernosum

Intravenous Drip

Ureteral

Intradermal

Intraventricular

Urethral

Intradiscal

Intravesical

Vaginal

Intraductal

Intravitreal


Intraduodenal

Iontophoresis



These options can be changed via the Delivery Route Managed List found in CTMS Settings. By default, the Route field is a preferred field and a red alert will fire if the route is not provided.

Therapeutic Areas Field

The Therapeutic Areas field is a Multi-Dropdown Select field, and is used to identify the therapeutic areas the product is used for testing. By default options available are

Cardiology/Vascular DiseasesNutrition and Weight Loss
Dental and Oral HealthObstetrics/Gynecology
DermatologyOncology
EndocrinologyOphthalmology
Family MedicineOrthopedics/Orthopedic Surgery
GastroenterologyOtolaryngology
Genetic DiseasePediatrics/Neonatology
Healthy VolunteersPharmacology/Toxicology
HematologyPodiatry
HepatologyPsychiatry/Psychology
ImmunologyPulmonary/Respiratory Diseases
Infections and Infectious DiseasesRheumatology
Internal MedicineSleep
MusculoskeletalTrauma (Emergency, Injury, Surgery)
NephrologyUrology
NeurologyVaccines

These options can be changed via the Therapeutic Areas Managed List found in CTMS Settings. By default, the Therapeutic Area field is a preferred field and a red alert will fire if the Therapeutic Area is not provided.

Indications Field

The Indication field is a Multi-Dropdown Select field, and is used to identify what the indications the product is used for testing. These options can be configured via the Indications Managed List found in CTMS Settings. By default the Indications Managed List is blank and shall be populated at the beginning of use of the CTMS. By default, the Indications field is a preferred field and a red alert will fire if the indications is not provided.

Clinical Trials Performed Field

The Clinical Trials Performed field is a read-only field that is populated by the system when a Product is used on a study.

Save Actions

Save Button

When the Save button is selected the data entered for the questions will be saved and the user will be directed to the Product Manager screen.

Save & New Button

When the Save & New button is selected the data entered for the questions will be saved and the user will be directed to a new Add Product form.

Cancel Button

When the Cancel button is selected the data entered for the questions will not be saved and the user will be directed to the Product Manager screen.

Duplicate Alert Check

If a product name matches an existing product in the Product Manager, upon saving of the form a warning will display notifying the user of the existing record. Selecting Save will save the product, selecting Cancel will close the notice and the form will not save.

 

Importing Products

Primary Identifiers & Required Fields

Tab

Identifiers

Required Fields

Product

·         Product Name

·         Product name

For all Import guidelines click here.


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