Setting Up Your Study

There are multiple views and areas to add your study details and start setting up critical areas that will allow you to begin tracking important information and build the foundation for complex study management. 

Below are the most common and critical areas to complete, as appropriate for your study:

1. ADMIN > USER MANAGEMENT: Add any users that will need access to SimpleTrials. Note: All users listed as Global in their User Details will automatically be added to this study upon study creation.
2. STUDY > STUDY TEAMS & CONTACTS: Build out your study teams and vendors. Assign Contacts and Users to their team and indicate which users are eVR Approvers and Document QC Reviewers. Note: the sponsor should appear here automatically as will any other Teams, Contacts, and Users who are either Global or if this was study was created from another study.
3. SITES > SITES & CONTACTS: Add the sites that are planned to participate. Ensure the relevant countries have been added to the STUDY PROFILE (see below) as sites must be associated to their country. Note: sites and site contacts be imported within the SITE & CONTACTS and STARTUP TRACKING views. Also, if this study was created from another study, those sites and contacts will automatically be added. 
4. STUDY > STUDY PROFILE: Capture basic, high level study information about the protocol and study management. The following sections are the most critical, as they impact the ability to enter other key data:
• Section 2: Participating Countries: Add all of the participating countries. Sites cannot be added unless their country has been added here. 
• Section 3 – Site Essential Doc Defs: Review and revise site essential document folder and placeholder settings, specify country-specific items, update requirements for availability at site activation or study end. Once sites are added, folders will populate in Documents area BY SITE folder for individual named site folders
• Section 5 - Subject Definitions: Add screen failure reasons and protocol deviation reasons for tracking of screen failure reasons in Screening and Enrollment area and protocol deviations in Protocol Deviations area.
• Section 6 - Subject Visit Schedule: Add the visit schedule and visit windows for visit tracking within subjects and areas, and related contract and payment actions. Utilize the sync option settings if tracking of subject visits and projected subject visits will take place in the visit calendar and subject visits areas
• Section 9 - Automations: Set the rules for relationship and system rules for calendar records, subject visit status, data status, payment status and document status. Please also see the "Automations Guide" for more detailed information. 
5. STUDY > MILESTONES & METRICS: Start building out the project milestones and tasks along with any projected and actual dates, dependencies, and priorities. Note: this view can be copied from another study, from within the source study’s MILESTONES & TASKS view.
6. PORTFOLIO > DOCUMENTS: If using the eTMF, ensure the folder structure is set up properly within the named study folder and make adjustments as needed. Site level folders are set Study Profile/Section 3 per above.

Users Access Requirements

Admin, Manager

Subscription Requirements

Trial, Standard, Premium, Premium for Sites, Premium Plus, Enterprise