Subject Visit Calendaring

Clinic visits and follow-up phone calls can be easily calendared and viewed. Within each calendar visit:

• Specify the responsible staff member(s)
• Track the completion of protocol visit activities
• Assess associated data completion efforts
• Provide relevant visit comments
• View previous and future subject visits
• Track planned protocol visits and unscheduled safety visits

Site Contracts and Payments

Manage investigator site contracts, generate invoices, track payments received. For each study:

• Track contractual details for study start-up items, EC and vendor fees, and end-of-study activities
• Manage multiple contracts, complicated studies, protocol amendments and Sponsor holdback requirements
• Monitor payments due for subject visit activities and fixed fee items
• Generate detailed invoices for Sponsors and/or CROs with fixed fee items and subject information by subject/visit/item
• Manage payments made to study staff, external vendors, and subject stipends
• Track invoices sent against payments received
• Post and reference historical invoices for study reconciliation

Study Start-up, Milestones
& Action Items

Use Startup Tracking to manage activities from initial Sponsor/CRO contact to first patient enrolled. Assign action items and manage team resources, and view overall study progress against relevant Study Milestones. By study:

• Utilize common workflows within your team to manage Sponsor surveys, consent form development, essential document progress, budget negotiations, IRB/EC activities and subject recruitment efforts.
• Customize tracking views and establish team workflows that accommodate study, Sponsor or CRO needs
• Associate study milestones and custom trackers to other studies to promote consistent workflow rules by Sponsor, study type or team
• Utilize the Study Milestones to track start/end dates, dependencies and visualize progress
• Alerts are available by email and in the workspace view for milestones and action items almost due and overdue to prioritize study efforts

CTMS Reports and Exports

Run standard reports within one study, across studies, or across sponsors. Save report customizations to save time for other team members. Export study-specific views in common formats for further manipulation.

• Standard CTMS reports include rosters, study planning, calendar tracking, documents, study subjects and site contracts and payments.
• Review startup tracking and milestones to assess efforts across studies and oversee resources needed
• View calendar visit schedules across teams and studies
• Run document reports to highlight priority documents for study startup, draft documents to finalize, items for EC submission and items to have available for study closure
• Oversee recruitment and enrollment efforts within across studies to focus on screen failure reasons or subject retention hurdles
• Manage study finances by sponsor, study and overall while tracking status of invoice and payment efforts

Screening & Enrollment

Screening and enrollment activities can be easily managed by study. For each subject record:

• Manage informed consent signature, screening, enrollment, ET and/or completion dates
• Assess subject visit scheduling against protocol visit windows
• View study participation progress based on calendared visit information
• Track subjects by study cohort and across different visit schedules
• Manage visit schedule changes associated with protocol amendments
• Track and trend screen failure reasons
• Monitor study status for each subject and unscheduled visits
• View recruitment graphs and enrollment performance dashboards

Document Management & Organization

Pick or define a folder structure for your organization, study and site and utilize document upload and tracking features with built-in expiration alerts. Features include:

• CTMS has a built-in TMF document repository for ease of document sharing and tracking
• Relevant folder structures are available out-of-the-box and can be easily associated with studies
• Build-your-own folder structures can be generated and reused across multiple studies
• Alerts are available by email and in the workspace view for expired and nearly expired documents
• Folders and tracking views can be organized for documents applicable across studies (e.g. physician CVs, lab certifications) and company level documents (e.g. training policies, intake forms)
• Critical required documents (e.g. FDA Form 1572) can be identified and tracked with urgency
• Upload documents individually or via multi-file upload; users may view individual files or perform zip file downloads of multiple documents.
• Track additional document details as needed -- document status, document version, version date, expiration date, expiration status and other related fields

Contact Management

Manage internal and external team members to facilitate communications, action items, and alerts.

• Associate Sponsor, CRO, IRB/EC, and vendor team members that work on your studies
• Associate internal team members with studies and specify their role on the study
• Manage key details such as title, role, phone, email and physical address
• Provide CTMS accounts to study team members to view and manage study activities across studies
• View comprehensive contact database for all sponsors, CROs and vendors
• Run CTMS Roster Reports for one or more studies to assess internal resourcing needs

Additional Benefits

• Use Calendar to record monitoring visits by study, staff out of office time, or in-servicing activities
• Alerts are visible to each user upon login and can facilitate activities across studies such as documents about to expire, study milestones coming due (e.g. CRF queries) or individual action items.
• Create a study based on another study for ease of tracking. Use this model to accommodate specific sponsor or study needs
• Customize tracking to suit your needs. Hide system columns that don’t apply and add columns for your study needs. Update styling and order to help prioritize team member workflows
• Admin users may facilitate subscription changes directly within the application without need for assistance from CTMS vendor