Clinical trials are meant to investigate the safety and efficiency of a new drug (e.g., molecular compounds, peptides, genomic material). As a first step, users should use the Compounds form (Product information management > Setup > Compounds) to specify details about the investigated compound.
Each investigational compound should generate one clinical program, which acts as an “umbrella” entity for all the sub-entities required (e.g., protocols, therapeutic areas, sites, warehouses, etc.).
Users can use the Programs form (Clinical Supplies Management > Common > Programs) to specify details about a program. The form presents the following fields:
Program: Users should insert the desired program ID.
Description: Users should insert a description of the program.
Compound: Users should select the compound to be investigated in this program.
Generic name: Not editable.
Trade name: Not editable.
Status: Not editable.
Values for the Generic name field, Compound field, and Trade name field are automatically inherited from the Compounds form.
By clicking the Therapeutic areas button, users can access the Therapeutic areas form and visualize, add or modify the program’s therapeutic areas.
By clicking the Protocols button, users can access the Protocols form and visualize, add or modify the protocols involved in this program.
A program can be linked to one or multiple items by clicking the Programs button in the Clinical Supplies Management tab of the Released products form (Product information management > Products > Released products). In the Programs form, users can access the Items by program form and visualize all the items involved in this program by clicking the Items button.