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 and a therapeutic area 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
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.