IRBCo uses a state-of-the-art web based system for IRB submissions, tracking and communication. This system reduces errors and time while enhancing communication between IRB staff, Reviewers and Investigators. If you have any questions about our protocol submission system, please click on the manual, which outlines the process in simple and easy to learn steps. If you still have questions, please feel free to contact us by phone or email.
eProtocol
Many IRBs offer some version of a study management system. There is a wide range in the capabilities and function of the different systems and it is our recommendation that you take a long look at the IRB system before selecting an IRB. Make sure the IRB study management solution is a complete solution. Here is a look at ours:
Overview
eProtocol is a web-based IRB Management system created by Key Solutions and has been established in IRB management through several institutions including Stanford University. eProtocol is a tried and true system ready to tackle the speed and information needs of Sponsors and CRO’s in the Pharmaceutical, Medical Device and Nutraceutical industries.
The feature rich system offers many time saving advantages for Sponsors/CRO’s and Sites:
- Smart Form Technology
- 21 CFR Part 11 Compliant
- Study Management Dashboard
- Complete Document Management
- Green System – paperless submissions and responses
- Communication Management
- Secure Document Version Control
- Centralized – 100% web-based system
- Every study document available online for at least 3 years after study closes
- Equally capable of managing multi-center and single-site studies
- Efficient process for any study, regardless of phase
- Fully validated and secure
We are happy to show off our system at anytime. Please contact us to schedule a demo.
Smart Form Technology – Smart Forms are electronic forms designed to ensure the information important is input properly and collected for each study submission. The Smart Forms direct study personnel to respond to study questions based on answers to previous questions. For example, if you respond that you are submitting a Medical Device study then only questions which apply to Medical Device submissions will be asked.
Also, Smart Forms ensure that submissions are complete by verifying that the form is filled out completely. This saves time in the submission and review process by eliminating errors when filling out IRB documents.
This allows for a far more efficient submission process saving time and money.
21 CFR Part 11 Compliance - the eProtocol system is a Part 11 compliant system allowing for electronic signature capture on documents received in the system and sent from the system, eliminating the need for faxing, copying and shipping paper documents.
Another key element of the system eliminating wasted time and resources.
Study Management Dashboard – this feature in eProtocol gives the study management team a global view of site submission and status in the system. Study Managers will have access to each sites electronic file and see every submission and IRB response made through the system throughout the study and for three years following the study closure.
Complete Document Management – 100% of all study activity and communication between the IRB, Sponsor and each site is submitted and IRB responses are delivered through the eProtocol system. Thus, ending the need for shipping accounts and charges, time delays in document shipments, lost documents, fees for replacing lost documents and wasted time during a monitoring visit. In fact, a sponsor could do a complete site audit of IRB submissions and approval documentation from anywhere in the country. Documents are stored electronically for at least 3 years following the study closure.
Go Green – eProtocol is a complete web-based system. Documents are submitted and delivered and stored through the eProtocol system. IRBCo is dedicated to conserving the environment and our paperless system goes a long way in our conservation efforts.
Communication Management – this future allows Sponsors to view online, comments from the Board during the review process and respond directly through the system. A record of communications is kept for your review and/or internal audits.
Secure Document Version Control – Maintain electronic approval of consent form documents. The eProtocol system maintains all different versions of the consent form but only the current version is made available to Investigators.
Adverse Events are reported directly through the eProtocol system. You may view/print all IRB letters securely through eProtocol.
Centralized – 100% Web-Based System – No software installation or IT department required to begin using. Study information can be accessed anywhere you have a web connection.
