--- title: "Protocols" slug: "protocols" description: "Manage clinical trial protocols, including objectives, methodologies, resources, therapeutic areas, and country-specific requirements." updated: 2026-06-29T05:29:39Z published: 2026-06-29T05:29:39Z canonical: "docs.staedean.com/protocols" --- > ## Documentation Index > Fetch the complete documentation index at: https://docs.staedean.com/llms.txt > Use this file to discover all available pages before exploring further. # Protocols A protocol is a document that describes the objectives, design, methodology, and aspects related to the organization of clinical trials. In the Clinical Supplies Management module, protocols play a pivotal role in connecting and bringing together many entities of the Clinical Supplies Management module. Each protocol is specific to a program and a therapeutic area. For instance, within the same clinical program investigating the compound “X” we can have one protocol to investigate the beneficial effects on Diabetes and a second protocol to investigate the beneficial effects on Rheumatoid Arthritis. Also, a protocol can be active only in specific countries or sites, as well as they can include a set of required products. Lastly, protocols can be joined to projects, a very useful tool to track the resources and expenses required for a protocol and create invoices. Users can access the **Protocols** form (**Clinical Supplies Management > Common > Protocols**) to create a new protocol. Among other information, the **Protocols** form allows to include the following: - **Protocol** - **Description** - **Protocol title** - **Program** - **Therapeutic Area** - **Protocol phase** - **Protocol design** - **EudraCT number** - **IND number** - **Sponsor and Sponsor address** - **Number of countries** - **Number of sites** - **Planned total subjects** - **Number of subjects** - **Protocol scheduling** (for example, Start date, First Patient First Visit) When creating a new protocol, users create a unique protocol ID (**Protocol** field) and a description (**Description** field). Next, in the **General** FastTab, a [program](/life-sciences/docs/programs) and a [therapeutic area](/life-sciences/docs/therapeutic-areas) need to be selected in the **Program** field and **Therapeutic area** fields (from the values available in the dropdown). Users can use the **Protocol phase** field to select the stage of the protocol. The **Protocol design** field allows to select a design for the current protocol. In the **Protocol scheduling** FastTab, users can specify the following information: - **Start date:** The global start date of the protocol; - **First Patient First Visit:** The date of the administration of the first dose to the first patient at his first visit; - **Last Patient Last Visit:** The date when the last subject completed the study; - **Planned completion date:** The global planned end date for the protocol; - **Completion date:** The actual completion date for the protocol. Based on these dates, the system automatically calculates the **Trial duration in days** as the difference between the **First Patient First Visit** field and the **Last Patient Last Visit** date fields. ### Countries/regions by protocol By accessing the **Countries by protocol** form (**Clinical Supplies Management > Common > Protocols > Countries/regions** button), users can visualize, add or modify countries involved in the selected protocol. In the **Protocols** form, the **Number of countries** field is automatically populated based on the number of countries specified. ## Sites by protocol Users can specify the sites involved in the selected protocol by clicking the **Sites** button in the **Protocols** form and opening the **Sites by country/region** form. After selecting the country (out of the countries available for the protocol), the users select the site from a dropdown list of sites available for the selected country. For each site, it is possible to enter the following information: - **First Patient First Visit** - **Last Patient Last Visit** - **Language set** - **Number of subjects** The value of the **Trial duration in days** field is automatically calculated as the difference between the **First Patient First Visit** field and the **Last Patient Last Visit** date fields. > [!NOTE] > Note > > The **First Patient First Visit** and **Last Patient Last Visit** dates must be consistent with the protocol dates (for example, the **Last Patient Last Visit** date cannot be after the end of protocol date). In the **Countries by protocol** form, the **Number of sites** and **Number of subjects** fields are populated based on the information entered in the **Sites by protocol** form. The number of subjects is calculated as the sum of the subjects of the sites for a country. In the **Protocols** form, the **Number of sites** and **Number of subjects** fields are automatically populated based on the number of sites and subjects specified in the **Sites by protocol** form. #### Example - **Countries by protocol:** | Country/Region | Number of sites | Number of subjects | | --- | --- | --- | | USA | 3 | 500 | | BRA | 2 | 150 | - **Sites by protocol:** | Country/region | Site | First Patient First Visit | Last Patient Last Visit | Trial duration in days | Language set | Number of subjects | | --- | --- | --- | --- | --- | --- | --- | | USA | USA-IS01 | 2nd Jan. 2022 | 15th Jul. 2022 | 194 | ENG | 150 | | USA | USA-IS02 | 15th Feb. 2022 | 20th Jul. 2022 | 155 | ENG | 150 | | USA | USA-IS03 | 5th Mar. 2022 | 3rd Aug. 2022 | 152 | ENG | 200 | | BRA | BRA-IS01 | 10th Jan. 2022 | 20th Jul. 2022 | 191 | POR | 80 | | BRA | BRA-IS02 | 1st Feb. 2022 | 10th Aug. 2022 | 190 | POR | 70 | - **Protocol:** - **Number of countries:** “2” - **Number of sites:** “5” - **Number of subjects:** “650” ## Projects by protocol It is possible to link a project to a protocol by selecting one of the available values in the dropdown of the **Protocol** field (**Project management and accounting > Projects > All projects > Clinical Supplies Management** FastTab). In the **Protocols** form, by clicking the **Projects** button, it is possible to open the **All projects** form filtered by the projects linked to the selected protocol. From here, it is possible to use all the standard functionalities offered by the **Project management and accounting** module. ## Items by protocol A protocol can be linked to one or multiple items by clicking the **Protocols** button in the **Clinical Supplies Management** tab of the **Released products** form (**Product information management > Products > Released products**). In the **Protocols** form, users can access the **Items by protocol** form and visualize all the items linked to the selected protocol by clicking the **Items** button. ## Related - [Programs](/programs.md) - [Therapeutic areas](/therapeutic-areas.md) - [Clinical Supplies Management](/clinical-supplies-management.md)